Sunday, May 31, 2009

FDA and EMEA: Minding the Gap

“EMEA is not the FDA of Europe, and the FDA is not the EMEA of the United States.”

That’s how Richard Pazdur – the head of FDA’s Office of Oncology Drug Products – started off a panel on oncology regulatory initiatives at ASCO on May 30. “We recognize that there are different laws, different interpretations of existing laws and different cultural issues that can be brought into play in making regulatory decisions,” he added.

But with consistency, and transparency, in mind, the two regulatory bodies do practice openness. FDA’s entire oncology review team has monthly teleconferences with key EMEA officials. They go over pending regulatory actions, recent meetings with sponsors, proposed regulatory initiatives and even occasional staff exchanges (a regulate-abroad program?).

There is also a free exchange of documents – minutes from end of Phase II meetings, important regulatory letters. “Really the oncology program with this interchange has been one of the models that the FDA and the EMEA want to emulate in other therapeutic areas,” Pazdur said.

Still, Pazdur, who received a personal plaudit for his stewardship of cancer drug approval process with a career recognition award, kept honing in on the differences between the European regulatory system and the FDA process. The way Pazdur referenced some of those differences could constitute a wish list for additional authorities the FDAer would like to have.

One key difference is in the enforcement mechanisms for early approval of innovative therapies – accelerated approval in the US, and conditional approval in Europe. Pazdur deems these functionally equivalent: “it’s a matter of terminologies.”

“But there are differences here. Both of the programs have options to take the drug off the market if clinical benefit or subsequent trials are not done,” Pazdur pointed out. With its longer experience with accelerated approval (EMEA only adopted conditional approvals last year), there have been more tests in the US. And even when a drug has failed in its mandatory trial to confirm the benefit that was the basis of the accelerated approval (AstraZeneca’s lung cancer therapy Iressa), FDA opted not to outright rescind the marketing authorization, instead laying on marketing restrictions and limiting distribution. Still, “most of our drugs have not faced that issue of coming off the market,” Pazdur admitted.

The US legislation on accelerated approval stipulates that sponsors should approach confirmatory trials with “due diligence” – which, Pazdur added, “really is in the eyes of the beholder. Let’s face it, it does not have a legal definition. Whereas I noticed the Europeans were a bit more clever and probably learned from our experience. They put a one-year review, and we don’t have that.”

The EMEA’s Francesco Pignatti made clear that they don’t really have the explicit authority to rescind the approval for compliance reasons, though the one-year re-review remains untested. “It’s only in the case of adverse new information that one could see this change,” he predicted. But the opportunity to reconsider the emerging knowledge of a drug’s risk-benefit was clearly an aspect Pazdur admires.

The FDA official expressed some frustration with the way sponsors handle confirmatory trials for accelerated approval. “Several ODAC meetings have discussed the sometimes lack of due diligence on the part of sponsors in fulfilling these commitments,” Pazdur pointed out. “They are mandatory commitments and should be taken quite seriously by the sponsor.”

There too the EMEA built in a mechanism that FDA would find useful: the European regulators can impose financial penalties if the postmarketing studies are not delivered as agreed.

Consultation with external experts is one area where Pazdur seems to prefer the US system, though he handled the comparison with diplomacy. Unlike the FDA advisory committee system, the EMEA’s Scientific Advisory Group meetings are closed to the public. They’re even mostly closed to the companies involved (there are open portions of the meeting for the sponsor to make a presentation, but then the discussion is closed off again). Pazdur questioned whether the process would be improved or hindered by having public involvement.

Without any experience with that, Pignatti declined to speculate, although he did note the EMEA is “rather far” from having public access for those meetings. Pazdur, however, jumped in – having attended both SAG and CHMP meetings “and obviously the ODAC meetings.”

“To be honest there’s a remarkable similarity as far of the discussions,” he said. In fact, the consistency – reassuringly – holds up with the internal regulatory processes as well, he noted. “Although we’re independent agencies and usually have not discussed the applications prior to our teleconferences, many of the exact same issues come up. And although people love to point to the differences between decisions that the EMEA and the FDA make, by far there’s more similarities than any differences.”

Despite the “lack of transparency” Pazdur noted in the European system for external consultations, the FDAer openly admired the transparency that EMEA gives regarding negative regulatory decisions. The EMEA publishes its negative opinions and reviews on withdrawn applications as well as the positive opinions. “One of the issues that we have in the FDA, which is quite problematic for those of us that work in the FDA,” Pazdur noted, is that when the agency does not approve a drug, the review documents and even the complete response letter that lays out the deficiencies in that application are not released to the public. Companies could release that information (although trust us, they don’t), but FDA is tied from even commenting.

“So this I think is one of the main reasons that we have this apparent lack of transparency, because we cannot release negative information. When we approve a drug, all that information goes out on the web. But for non-approvals, it’s truly the black box warning, so to speak, in its ultimate form,” Pazdur said. --Mary Jo Laffler

Met Fever: Catch It!

From today's AP game story:

So how do the rest of the Mets avoid getting sick on their upcoming trip to Pittsburgh and Washington?

“I need one of those masks,” [David] Wright said. “Just stay away from the sick people, quarantine yourself I guess.

It figures that the one game where I am sitting far closer to the players than I am likely to all year is the one where the unofficial team captain is talking about wearing a mask and quarantining himself.

My friend Roger had great seats to today's game, so I found myself sitting 20 rows behind home plate. Cushions on the seats - but no Purell dispensers.

One minute, John Maine is breezing along with a three-hit shutout, then he suddenly gets removed in the top of the seventh because he caught the same stomach virus that Carlos Beltran has.

Perhaps the discussion in the dugout between Jerry Manuel and Dan Warthen went something like "You go get him. " "No, you go get him."

Though I do admit to being a bit of a hypochondriac, I'm not really worried about catching something at the game. (Besides, as a longtime Met fan, I am used to the Mets making my sick to my stomach.)

With all the injuries and illness the Mets have had (Angel Pagan also got hurt during the game and could go on the DL), it's a wonder that they have now won six of eight. The Mets don't get many hits these days, but they make them count. Twice the Mets sacrificed a man to second and both times they got him home. And the players who drove in those runs were well outside the core - Pagan and Fernando Martinez.

We got to the game so early that there was no line at Shake Shack. My friend Roger said it was the best burger he has ever had at a sporting event. I have somehow managed to skip Shake Shack the last couple of times at the ballpark so it was great to go back.

The other off-the-field highlight: No "Sweet Caroline"!


Squawker Lisa, I know you like Larry David about as much as you like Monty Python, but my trip to the ballpark today did make me think of "Curb Your Enthusiasm." I can just imagine Larry getting a chance to go to the clubhouse to meet the players after the game, only refusing to do so because he didn't want to catch anything and managing to insult everyone in the process.

Or Larry could be the one who brought the bug to the ballpark in the first place and made all the Mets sick, much like the episode where he tripped Shaquille O'Neal at courtside and caused Shaq to tear up his knee.


By the way, Lisa, our section was fairly full and the people there didn't look any different from other fans.

I can just imagine what it would be like to sit behind home plate at the new Yankee Stadium - you'd be surrounded by empty seats except for a couple of guys wearing tuxedos and monocles swatting at foul balls with polo mallets.

Pittsburgh Penguins vs. Detroit Red Wings - NHL Finals Betting Free Picks

NHL Finals Free Picks at Gambling Advisor blogThe Pittsburgh Penguins and the Detroit Red Wings will both be gunning for a victory on Sunday when they meet at Joe Louis Arena in the second game of the Stanley Cup final.

Oddsmakers currently have the Red Wings listed as 140-moneyline favorites versus the Penguins, while the game's total is sitting at 5½.

Gambling Advisor blog Free Pick: Penguins + 140

The Red Wings came away with a 3-1 win over the Penguins in Game 1 of the series on Saturday night.

The Red Wings won that game as -150 favorites, and the four goals fell UNDER the night's posted over/under (5.5).

Brad Stuart, Johan Franzen, and Justin Abdelkader scored for Detroit, while Chris Osgood stopped 31 shots in the win.

Ruslan Fedotenko scored the lone goal for the Pens, and Marc-Andre Fleury made 27 saves in the loss.

A few trends to consider:
Pittsburgh is 5-1 SU in its last 6 games

Pittsburgh is 4-1 SU in its last 5 games on the road

The total has gone UNDER in 9 of Pittsburgh's last 13 games when playing on the road against Detroit

The total has gone OVER in 4 of Pittsburgh's last 6 games on the road

Detroit is 5-0 SU in its last 5 games at home

Detroit is 6-1 SU in its last 7 games

Detroit is 11-4 SU in its last 15 games when playing Pittsburgh

Detroit is 5-2 SU in its last 7 games when playing at home against Pittsburgh

Belmont Stakes Odds – Some Horses to Consider

Belmont Stakes Odds at BSNblogThe Belmont Stakes odds are just a week away and there are some storylines to consider, including jockey Calvin Borel’s push for the Jockey’s Triple Crown. The field isn’t set in stone yet for the big race, but here are a few names to consider.


The Kentucky Derby Winner is obviously another big favorite at the Belmont Stakes odds, though his effectiveness could be determined by his jockey, as Borel rode him for his victory but Mike Smith rode him in the Preakness. Some horse race betting fans feel it’s a trap to bet on Mine That Bird because Rachel Alexandra may still run the race; Alexandra held off Mine that Bird to win the Preakness. However, the Preakness was a shorter distance, Mine that Bird was closing at the end, and the Belmont Stakes odds are longer than both of those races, so Mine That Bird should be the fave.


If the little filly-that-could runs in the Belmont Stakes odds, Borel will likely be the rider as he goes for a personal Triple Crown. While she makes for one of the better online betting picks, Belmont Stakes betting fans have to be careful, as her Preakness triumph came on a 13/16 track.


Not a household name, Charitable Man could sneak up on the field next week. He dominated the Peter Pan at Belmont Park with a 3 3/4 –length score and could sneak up to steal the race the same way Rachel Alexandra did the Preakness.


Could he surprise? He has the upbringing to do it. His Hall-of-fame trainer and owner tandem of Nick Zito and Robert V. LaPenta won the Belmont Stakes odds last year with Da’Tara, so they obviously know what it takes to win. Miner’s Escape won his last start, the Frederico Tesio Stakes, so he has momentum heading into next week. Don’t forget about his Belmont Stakes betting prospects, as he’ll offer better racebook value than the big favorites.

Atlanta Braves vs. Arizona Diamondbacks Betting Odds & Free Picks

MLB Betting Stats at Gambling Advisor blogThe Atlanta Braves and the Arizona Diamondbacks will both be trying to pick up a win on Sunday when they battle at Chase Field.

Kris Medlen will be the starting pitcher for the Braves on this day. Righthander Medlen is 0-2 this season with a 9.72 ERA.

The Diamondbacks will counter Medlen with Max Scherzer. Righthander Scherzer has a 3.42 ERA to go along with a 2-3 record this season.

Oddsmakers currently have the Diamondbacks listed as 155-moneyline favorites versus the Braves, while the game's total is sitting at 9½.

Gambling Advisor blog free Pick: Under 9½

Eric Byrnes singled in the winning run in the bottom of the 11th inning to give the Diamondbacks a 3-2 victory over the Braves on Saturday, as +100 underdogs. The team's played UNDER the posted over/under (9).

Ryan Roberts doubled in a run and scored once for the Diamondbacks. Tony Pena threw two scoreless innings of relief to post the victory.

Kelly Johnson and Garret Anderson drove one run apiece for the Braves, who were favored at -120. Jeff Bennett allowed the winning run and was saddled with the loss.

A few trends to consider:
The total has gone UNDER in 4 of Atlanta's last 6 games when playing Arizona

Atlanta is 2-4 SU in its last 6 games when playing Arizona

Atlanta is 1-5 SU in its last 6 games on the road

Atlanta is 1-5 SU in its last 6 games

The total has gone OVER in 5 of Arizona's last 7 games at home

The total has gone OVER in 4 of Arizona's last 6 games

The total has gone UNDER in 4 of Arizona's last 6 games when playing Atlanta

Arizona is 4-2 SU in its last 6 games when playing Atlanta

White Sox vs. Royals - MLB Betting Odds

MLB Betting Odds at Gambling Advisor blogDivisional bragging rights will be on the line on Sunday when the Chicago White Sox and the Kansas City Royals meet at Kauffman Stadium.

Team records:
Chicago: 23-25 SU

Kansas City: 23-26 SU

The White Sox will give the ball to starter John Danks in this one. Lefthander Danks is 4-3 this season with a 4.59 ERA.

Danks's opponent in this one will be Zach Greinke. The Royals righthander has a 0.84 ERA to go along with a 8-1 record this season.

Oddsmakers currently have the Royals listed as 175-moneyline favorites versus the White Sox, while the game's total is sitting at 7½.

The White Sox scored twice in the top of the ninth inning on Saturday to give them a 5-3 win over the Royals, as a -110 pick'em. The team's played UNDER the night's posted over/under (8.5).

Jim Thome led the White Sox with two RBIs, while Alexei Ramirez had three hits and one RBI. Scott Linebrink got the win in relief, and Bobby Jenks closed out the game with his 11th save.

Mitch Maier drove in two runs for the Royals, while Miguel Olivo went deep. Juan Cruz gave up two runs in relief and suffered the loss.

Atletico Madrid Takes the Last Ticket for the 'Champions'

Soccer Betting News at BSNblogAtletico Madrid won the last ticket was at stake for the next 'Champions' to defeat this Saturday to Almeria 3-0 in the 38th day, which closes the Spanish football league, which helped him secure the fourth because of the championship.

In this way, all rojiblanco, who won with goals from Argentine Sergio 'Kun' Agüero, Raúl García, the Uruguayan Diego Forlan, finished with 67 points behind champions Barcelona (87), who tied this Saturday at the Sports ground La Coruña (1-1), Real Madrid and Sevilla, who play on Sunday.

Barcelona, Real Madrid and Seville were classified directly to the group stage of the Champions League, while Atletico Madrid will have to contest a tie after the European competition.

Villarreal, which finished fifth (65) this Saturday after winning in Mallorca (3-2), and Valencia, sixth (62), which won 2-0 at Athletic Bilbao, Europe vie for the League, the new name will to the UEFA Cup from next season.

Third place for the League is to Europe itself Athletic, despite finishing at the bottom of the table has won the ticket as a finalist in the Copa del Rey, which lost 4-1 to Barcelona, because Catalans played the Champions League.

Atletico Madrid confirmed its fourth place thanks to Agüero, Forlan and Raul Garcia. The Argentine opened the account with a golazo in the 19th minute, which made two cuts to his compatriot Hernan Pellerano and beat up by the Brazilian Diego Alves to the left-handed.

The second is whether Raul Garcia scored in the 27 to a heading from the left by Argentine Maxi Rodriguez.

Forlán has increased at 49 making his 32nd goal this season, which secured the trophy for leading scorer of the Spanish league, ahead of Cameroon Samuel Eto'o (30), scored both of the tie against Deportivo in the 89, and David Villa (28), who scored a double in Saturday's victory against Athletic.

Barcelona, after the celebrations on Wednesday after winning the Champions League in a year that has won a historic triple, tied with a team full of substitutes to the Deportivo La Coruña (1-1), thanks to both Eto'o in the last breath.

With this tie, the whole Galician consolidated seventh place, four points of Valencia.

The Club was scored both by the Equatorial Guinean Rodolfo Bodipo, heading to a center of Mexican Jose Andres Guardado in 31 minutes.

Villarreal, which was probably the last match of their Chilean coach Manuel Pellegrini, who is placed at Real Madrid, dismissed the season with a 3-2 victory in Majorca, thanks to goals from Ruben Garcia 'Cani' (28) and a doublet Joseba Llorente (40 and 52).

Osasuna (18th) will seek to remain the elite of Spanish football, who have already left and mathematically Numancia Recreativo Huelva. If her party wins at home to Real Madrid, Navarre will in the first category.

The other teams threatened by the 2nd division are Sporting Gijón (17th, 40 points), Getafe (16th, 41), Betis (15th, 41) and Valladolid (14th, 40).

Can somebody please tell Joe Torre to just shut up about the Yankees already?

It's funny. Joe Torre accused Alex Rodriguez of wanting to be the center of attention with the Yankees, but if there is anybody who constantly seeks the spotlight, it's St. Joe himself. And it - shocker - usually involves talking about his old team, instead of his new team.

And as long as he's going to keep on yakking about the Yankees, I'm going to keep on proving the disingenuousness of his comments. Like yesterday, when Joe talked about the Bombers before last night's Dodgers' game. He told reporters that he still follows - and roots for - the Yankees:

“I have to pull for them. People think because you leave the Yankees and supposedly you’re unhappy with each other that you’re supposed to pull against them."

Supposedly unhappy, Joe? Really? You're the one who called a $5 million contract offer (with an additional $3 milion in incentives) "an insult." You're the one who wrote a tell-all book on the Yankees, betraying clubhouse confidences.

But hey, it's not like anybody else is going to call you on this. After all, you wrote that David Wells was a bad influence on Sidney Ponson in the Yankee clubhouse, even though the two pitchers were never even teammates. And nobody ever asked you about this egregious error.

Teflon Torre also said:

"But I can’t pull against the individuals over there, least of all Girardi who played for me, coached for me. I recommended him when he had his first managing job. This kid is going to be one of the top managers. This I know is a dream job for him and I’m glad things are getting better for him."

This "kid" is 44 years old. 44 isn't a kid anymore. And it's condescending for you, Joe, to call him that. When you were 37 years old and managing the Mets, would you have liked it if somebody called you a kid? No, I think you would have given that infamous Torre glare over that.

As for not being able to "pull against the individuals over there," you did it with A-Rod, when he was on your own team! And Johnny Damon, and any other player who didn't fit into your little four-rings clique. Spare me the sanctimony, please. And just shut up about the Yankees already (Mike and Mike ought to give you their Just Shut Up award!) I'll stop complaining about you when you stop talking about the Yanks. Deal?

* * *

I was reminded of St. Joe's last "triumph" as a Yankee last night with all the bugs in Cleveland. And with Fausto Carmona pitching against the Yanks - and losing.

What was up with the non-reception for CC Sabathia? It was like he was just any other pitcher, not somebody who once starred for Cleveland. I'm glad he won, and I was hoping CC would have a no-hitter last night, but it was not to be. At least Michael Kay didn't jinx it, though!

There were still a lot of bugs in that ballpark - and seagulls. Maybe it's because "The Birds" traumatized me when I was a kid, but all those birds flapping their wings really freaked me out last night!

Speaking of CC, John Flaherty said the pitcher spent in the five figures to take his teammates to that Cavs game. That's something.

The Yanks are on a roll, but they had better beat Carl Pavano today. That is all.

What do you think? Leave us a comment!

Cincinnati Reds vs. Milwaukee Brewers Betting Stats

MLB Betting Picks at Gambling Advisor blogThe Cincinnati Reds and the Milwaukee Brewers will meet on the field at Miller Park on Sunday in a battle of division rivals.

Team records:
Cincinnati: 26-22 SU

Milwaukee: 29-20 SU

The Reds will pin their hopes on the pitching of righthander Micah Owings in this game. Owings has a 3-4 record and a 5.19 ERA this season.

Owings's opponent in this one will be Yovani Gallardo. The Brewers ace righthander has a 3.32 ERA to go along with a 4-2 record this season.

Oddsmakers currently have the Brewers listed as 200-moneyline favorites versus the Reds, while the game's total is sitting at 8.

The Brewers defeated the Reds for the second straight night with a 9-5 victory on Saturday, as -135 favorites. The game's 14 runs sailed OVER the posted over/under (8).

Prince Fielder went 3-for-4 at the plate, including a three-run dinger for the Brewers. Seth McClung threw three scoreless innings of relief and earned the win.

Jerry Hairston Jr. belted a two-run homer for the Reds, who were +115 underdogs in that contest. Aaron Harang gave up 12 hits and eight runs over 4 1-3 innings in the loss.

A few trends to consider:
The total has gone OVER in 4 of Cincinnati's last 5 games when playing Milwaukee

Cincinnati is 4-2 SU in its last 6 games

The total has gone OVER in 4 of Cincinnati's last 6 games on the road

Cincinnati is 2-4 SU in its last 6 games when playing on the road against Milwaukee

Milwaukee is 4-1 SU in its last 5 games when playing Cincinnati

The total has gone OVER in 4 of Milwaukee's last 5 games when playing Cincinnati

Milwaukee is 6-2 SU in its last 8 games at home

The total has gone UNDER in 5 of Milwaukee's last 7 games

Werder Bremen Won for the Sixth time The German Cup

Soccer Betting News at GABWerder Bremen won for the sixth time in its history the German Cup in football, in the final to defeat Bayer Leverkusen 1-0, Saturday in a balanced match played in the Olympic Stadium in Berlin.

The Werder, who finished tenth in the Bundesliga and was a finalist this year in the UEFA Cup, the trophy case at Bayern Munich, which had been eliminated in the quarterfinals by Bayer Leverkusen.

With this result, the Bremen team 'save' the season, despite their poor league classification, the worst since 1999, and continued disappointment protagonists in recent months.

In the duel on Saturday in Berlin, the 'hero' was the German of Turkish origin Mesut Ozil, who scored in the 58th and allowed them to lift the Cup, despite repeated attempts by the whole match for Leverkusen in the second half and forcing the extension.

In both the play's only had a role the Brazilian Diego, with a great play that allowed the couple Ozil, which many consider his successor, beating the goalkeeper Rene Adler.

The American midfielder disputed his last game against Werder, after this week will confirm that the next campaign wear the colors of Juventus of Turin.

"I am very happy to dismiss poderme of Werder Bremen in this way. It was three years of accomplishments and many joys and this Cup is a way to return all the love I received in Bremen, from the fans and the whole of Germany Werder" "said Diego.

The Brazilian insisted on his dedication to the fans of the soon to be his former team. "It was exciting to see the fans shouting my name and it is better able to lift this Cup," he added.

Despite its problems in the boot of the meeting, Bayer had the opportunity to build your score by Patrick Helmes mainly, but Thomas Schaaf pupils were well arranged and the defense managed to maintain their door to zero.

Werder had the opportunity to extend their advantage to his opponent launched to counterattack, but the Peruvian Claudio Pizarro Hugo Almeida and the Portuguese were not successful, and his team completed its objective of achieving the minimum and suffering.

Chelsea Won the FA Cup Final

Soccer Betting News at BSNblogChelsea recovered after allowing fastest goal in the history of the FA Cup on Saturday and won 2-1 at Everton in the final to win the trophy for the fifth time.

Louis Saha gave Everton advantage after just 25 seconds into the Wembley stadium, but Didier Drogba tied to 21 minutes and Frank Lampard scored the goal of victory in the final 18 minutes.

The comeback gave Chelsea their first trophy in two years and its technical Guus Hiddink perfect farewell before he left office.

We were very hard and the team has always shown that it can react after a setback, which I like, Hiddink said. It was a great success, winning at the Mecca of football.

The FA Cup is something I can not believe.

The referee awarded a goal not to Florent Malouda for 78 minutes, when the French far from finished and the ball hit the crossbar, bounced on the floor and left the bow. Repetition television showed the ball had crossed the goal line.

Chelsea had other opportunities to shake the networks, the most important of Nicolas Anelka and Malouda.

I thought we were going through our best moment when Frank Lampard scored his goal, said the technician Everton, David Moyes. It is a great player and scores goals, and that's what I did.

Saha's goal was the fastest in a Wembley final for 18 seconds.

Drogba scored for the second time in an FA Cup final as the Ivory Coast was the author of the target in extra time with which Chelsea won the title in 2007 on Manchester United.

It was a great season, finished fifth in the Premier League and reach the final, but leaves a bitter taste, said the steering wheel of Everton, Tim Cahill. But it is an experience that can help me in the coming years.

GOP Lawmakers to Fight New Bid to Toll I-80

Pennsylvania House Republicans along the Interstate 80 corridor say they will fight the Rendell Administration's renewed effort to toll I-80. PennDOT Secretary Allen Biehler, who was also recently named as chairman of the Pennsylvania Turnpike Commission, told a House Democratic Policy Committee that PennDOT and the commission plan to submit a revised application for the toll proposal to the federal government later this year. State Representative Scott Hutchinson of Venango County says the I-80 Republicans are unified against this plan which he says would devastate rural northwestern Pennsylvania and transfer money to urban areas...."So we are renewing our fight to stop the tolling plan on Interstate 80, including chopping the Turnpike Commission down to size and maybe eliminating it altogether. I think they have a poor track record, a patronage history and a history of corruption we should end."
Hutchinson says tolling the interstate would hinder the state's economic recovery.

Drug Might Not Help Early Stage Colon Cancer

Researchers from Allegheny General Hospital (AGH) say a drug that's been approved to treat advanced colorectal, breast and lung cancer might not be effective in dealing with early stage colon cancer. Avastin interferes wit the growth of cancer cells by cutting off blood flow to the tumors. Dr. Norman Wolmark, the principal investigator for AGH's Department of Human Oncology, says they had hoped that using Avastin in early stage colon cancer would improve the survival rate, but it did not. However, Dr. Wolmark says the drug might be more effective if administered for more than 1 year. Researchers reported their findings yesterday at a national conference in Orlando.

Specter to Address PA Democratic Committee

When five term Pennsylvania U.S. Senator Arlen Specter announced in April that he was switching parties and would run in the Democratic Primary in 2010, he received the backing of President Barack Obama and Governor Ed Rendell. This week he will try to court Democratic officials at the local levels. Specter is to address the Pennsylvania Democratic State Committee Friday in Pittsburgh. Over the last two weeks, Specter has been participating in conference calls with groups of regional and local Democratic officials to discover their concerns. A spokesman says the senator and his aides have been working on Friday's speech for a week. Congressman Joe Sestak of suburban Philadelphia, who is expected to challenge Specter in the Democratic Primary, says he'll be on hand for Specter's speech.

Saturday, May 30, 2009

Pittsburgh Penguins vs. Detroit Red Wings - NHL Finals Betting Free Picks

NHL Finals Free Picks at Gambling Advisor blogThe fans at Joe Louis Arena will be treated to a game between the Pittsburgh Penguins and the Detroit Red Wings when they take their seats on Saturday for the opening game of the Stanley Cup final.

Oddsmakers currently have the Red Wings listed as 150-moneyline favorites versus the Penguins, while the game's total is sitting at 5½.

The Penguins defeated the Hurricanes 4-1 on Tuesday night for a clean sweep of the best-of-seven Eastern Conference final.

The Penguins won that game as -140 favorites, while the five goals fell UNDER the posted over/under (5.5).

Ruslan Fedotenko, Max Talbot, Bill Guerin, and Craig Adams scored for the Penguins in that victory. Marc-Andre Fleury stopped 30 shots on the night.

The Red Wings defeated the Blackhawks 2-1 in OT in Game 5 of the Western Conference final last time out, as -270 favorites.

The teams played UNDER the posted over/under (5.5).

Darren Helm scored the winner at 3:58 of overtime in that win, and Dan Cleary added his eighth of the playoffs.

Chris Osgood was named the game's first star after posting a 30-save performance in the series clincher.

Gambling Advisor blog Free Pick: Penguins + 130

Team records:
Pittsburgh: 45-28-9

Detroit: 51-21-10

A few trends to consider:
Pittsburgh is 5-0 SU in its last 5 games

The total has gone OVER in 4 of Pittsburgh's last 5 games on the road

Pittsburgh is 4-1 SU in its last 5 games on the road

The total has gone OVER in 6 of Pittsburgh's last 8 games

Detroit is 5-0 SU in its last 5 games at home

Detroit is 5-1 SU in its last 6 games

Detroit is 10-4 SU in its last 14 games when playing Pittsburgh

The total has gone UNDER in 6 of Detroit's last 9 games at home

Seattle Mariners vs. Angeles Angels MLB Betting Picks

MLB Betting Picks at Gambling Advisor blogThe division rival Seattle Mariners and Los Angeles Angels are set to renew hostilities on Saturday when they meet at Angel Stadium.

Felix Hernandez will be the starting pitcher for the Mariners on this day. Righthander Hernandez is 5-3 this season with a 3.76 ERA.

It'll be Matt Palmer toeing the rubber for the Angels in this contest. Righthander Palmer is 5-0 with a 4.71 ERA so far this season.

Oddsmakers currently have the Mariners listed as 115-moneyline favorites versus the Angels, while the game's total is sitting at 8½.

The Mariners rallied with three runs in the third inning to defeat the Angels 5-2 as +160 underdogs on Friday. That game's seven runs went UNDER the posted over/under (8.5).

Ichiro Suzuki went 2-for-5 at the plate and drove in one run for the Mariners. Jason Vargas threw 6 1-3 innings for the win, and David Aardsma collected his seventh save of the season.

Juan Rivera went 3-for-4 at the plate with a solo home run. John Lackey surrendered 10 hits and five runs over 7 1-3 innings in the loss. The Angels were favored at -180 in that contest.

A few trends to consider:
Seattle is 2-4 SU in their last 6 games when playing LA Angels

Seattle is 8-16 SU in its last 24 games

Seattle is 8-17 SU in their last 25 games when playing on the road against LA Angels

Seattle is 3-10 SU in its last 13 games on the road

LA Angels are 17-8 SU in their last 25 games when playing at home against Seattle

LA Angels are 4-2 SU in their last 6 games when playing Seattle

LA Angels are 2-4 SU in their last 6 games

New York Yankees vs. Cleveland Indians MLB Betting Stats & Picks

MLB Betting Stats at Gambling Advisor blogThe New York Yankees and the Cleveland Indians will both be gunning for a victory on Saturday when they meet at Progressive Field.

Ace CC Sabathia will be the starting pitcher for the Yankees on this day. Lefthander Sabathia is 4-3 this season with a 3.42 ERA.

It'll be Fausto Carmona toeing the rubber for the Indians in this contest. Righthander Carmona is 2-4 with a 6.42 ERA so far this season.

Oddsmakers currently have the Yankees listed as 175-moneyline favorites versus the Indians, while the game's total is sitting at 9½.

The Yankees scored early as they went on to defeat the Indians 3-1 on Friday, as +110 underdogs. The three runs went UNDER the posted over/under (9).

Derek Jeter had two hits and drove in the other. Andy Pettitte earned his fifth win, and Mariano Rivera netted his 10th save.

Cliff Lee gave up nine hits and three runs over six innings in a losing effort for the Indians, who were -130 favorties in that game.

Current streak:
New York has won 2 straight games.

A few trends to consider:
NY Yankees are 5-1 SU in their last 6 games on the road

NY Yankees are 13-3 SU in their last 16 games

NY Yankees are 8-4 SU in their last 12 games when playing on the road against Cleveland

NY Yankees are 4-2 SU in their last 6 games when playing Cleveland

Cleveland is 5-1 SU in its last 6 games at home

Cleveland is 4-1 SU in its last 5 games

Cleveland is 4-8 SU in their last 12 games when playing at home against NY Yankees

Cleveland is 2-4 SU in their last 6 games when playing NY Yankees

Cavaliers vs. Magic - NBA Conference Finals Odds & Stats

NBA Betting Odds at BSNblogThe Cleveland Cavaliers and the Orlando Magic will both be trying to pick up a win on Saturday when they battle at Amway Arena in the sixth game of the Eastern Conference Finals.

Oddsmakers currently have the Magic listed as 2-point favorites versus the Cavaliers, while the game's total is sitting at 192½.

LeBron James poured in a game-high 37 points in a triple-double performance to propel the Cavaliers to a 112-102 victory over the Magic on Thursday and cut the series deficit to 3-2.

The Cavaliers covered the 7.5-point spread, while the 214 points sailed OVER the posted total of 197.

James finshed with 14 rebounds and 12 assists in that win. Mo Williams chipped in with 24 points.

Hedo Turkoglu led the Magic with 29 points, and Dwight Howard had a double-double with 24 points and 10 rebounds.

A few trends to consider:
The total has gone UNDER in 5 of Cleveland's last 6 games on the road

The total has gone OVER in 5 of Cleveland's last 6 games when playing Orlando

The total has gone OVER in 4 of Cleveland's last 5 games

Cleveland is 15-4 SU in its last 19 games

Orlando is 5-0 ATS in its last 5 games when playing at home against Cleveland

Orlando is 5-0 SU in its last 5 games when playing at home against Cleveland

Orlando is 9-1 ATS in its last 10 games when playing Cleveland

Orlando is 6-1 ATS in its last 7 games

Los Angeles Dodgers vs. Chicago Cubs - MLB Betting Odds & Stats

MLB Betting Odds at Gambling Advisor blogThe Los Angeles Dodgers and the Chicago Cubs will both be trying to pick up a win on Saturday when they battle at Wrigley Field.

The Dodgers will trot Eric Stults out to the mound in this one. Lefthander Stults has a 4-1 record and a 4.29 ERA this season.

Stults's opponent in this one will be Ryan Dempster. The Cubs righthander has a 4.99 ERA to go along with a 3-3 record this season.

Oddsmakers currently have the Cubs listed as 150-moneyline favorites versus the Dodgers, while the game's total is sitting at 10.

The Cubs scored twice in the seventh inning and held on for a 2-1 victory over the Dodgers on Friday, at EVEN odds. That game's three runs went UNDER the day's posted over/under (8).

Koyie Hill belted a solo home run, and Kosuke Fukudome drove in the other run for the Cubs. Ted Lilly notched the win with a seven-inning performance, allowing four hits and one run.

Matt Kemp went deep in a losing cause for the Dodgers, who were -120 favorites. Chad Billingsley gave up eight hits and both runs in suffering the loss.

A few trends to consider:
LA Dodgers are 5-1 SU in their last 6 games on the road

LA Dodgers are 4-1 SU in their last 5 games when playing Chi Cubs

LA Dodgers are 4-1 SU in their last 5 games

Chi Cubs are 11-4 SU in their last 15 games at home

Chi Cubs are 3-9 SU in their last 12 games

Chi Cubs are 1-4 SU in their last 5 games when playing LA Dodgers

Yankees have first place all to themselves - for now, at least

While the Mets had the dramatic walkoff win, and the Yankees had a rather pedestrian victory last night, at least the Bombers gained sole possession of first place for the first time since September 2006. Hooray!

I don't really have that much to say about last night's game - I missed part of it, and what I did see wasn't exactly drama-backed.

Hopefully Andy Pettitte will be able to make his next start - he left the game after five innings due to his back.

Anyhow, I'm curious to see what kind of reception CC Sabathia will get for tonight's game. Will he get booed? Cheered? Both?

At any rate, he will not get booed as much as A-Rod does in that ballpark!

* * *

In other news, I heard that the Mets have finally come to their senses on something. No more "Sweet Caroline" in the eighth inning! "Meet the Mets" was played last night instead. But I have a question - did the song mention Shea, or did they edit that part out? And was it the original version of the song, or the 80s one?

If only the Yanks could come to their senses on that horrible "Cotton Eye Joe" (yes, that is the correct spelling.) Hate it.

What do you think? Leave us a comment!

Movies... For Free! M (1931)

Welcome to this week's "Movies... For Free!" column, where we showcase classic movies freely available in the public domain (with streaming video!). Read the article and watch the movie right here!

Fritz Lang's M
M, Eine Stadt sucht einen Mörder
, 1931.

Directed by Fritz Lang.
Starring Peter Lorre and Otto Wernicke.

M is the first sound feature from acclaimed Expressionist filmmaker Fritz Lang - described by the British Film Institute as the "Master of Darkness" - and is a highly influential masterpiece of the thriller genre. Written by Lang along with his wife Thea von Harbou, a Nazi sympathiser who would later join the NSDAP, M is a powerful, cold and brutal piece of cinema that explores themes of morality, justice and hysteria.

The film stars Peter Lorre as Hans Beckert, a German child killer and presumed paedophile whose brutal crimes are terrorising Berlin. When the police investigation headed by Inspector Lohmann (Wernicke) fails to identify the murderer, members of the underworld join in the manhunt in order to protect their business interests in the city. This leads to a race between the police and criminals, who eventually trace and capture Beckert and subject him to a kangaroo court that serves to explore the twisted and tormented mind of the killer.

Considered by Lang to be his finest work, M was a success upon release and helped to launch the international career of Peter Lorre, who would often return to the role of the villainous psychopath (see his turn in Alfred Hitchcock's 1934 version of The Man Who Knew Too Much). It also served as a breakthrough for Otto Wernicke, who reunite with the director and the character of Inspector Lohmann in Lang's next movie, The Testament of Dr. Mabuse (1933).

The film is rumoured to be inspired by the real life case of "The Vampire of Düsseldorf" Peter Kürten; a suggestion denied by the director.

Embed courtesy of Internet Archive.

Click here to view all previous entries in our Movies... For Free! collection.


The Cabinet of Dr CaligariNosferatu

Friday, May 29, 2009

Roger Federer Survives

Tennis News at Gambling Advisor blogThe Swiss tennis player Roger Federer emerged Thursday from a "hell" tennis to defeat Jose Acasuso of Argentina and advance to the third round of Roland Garros, for instance that have not reached the Serbian Novak Djokovic, who tied with a September the Ukrainian Sergiy Stakhovsky before the darkness say enough.

Number 45 of the world and native Posadas, Misiones, Acasuso took the victory in his hands at the number two in the central stadium.

The Argentine came to win 6-7 (8-10), 7-5 and 5-1 before handing the victory to Federer, 7-6 (10-8), 5-7, 7-6 (7-2) and 6-2 after three hours and 25 minutes of intense fighting.

Acasuso, 26, had four points in September in the first set, which was placed 6-3 in the tie break 10-8 before delivery. Then in the third part, the Argentine served 40-30 and 5-2, but could not close the set. One winner will get half of the rectangle to give the victory to former world number one.

The Swiss 27 years chose not to answer whether he felt "scared" at some point. "Scared or not, it does not matter. The important thing is to try to play well, build the item. I was looking for the style of game I wanted to do. "

Meanwhile, the fourth favorite Djokovic was surprised in the second set by Stakhovsky, 110 ranquin professional planetarium.

The Serbian took the first set by 6-3, but lost the second 6-4. Darkness forced to leave the resolution of the game today, giving a respite to the number four ranking in the world.

Chelsea Offers 50 Million Euros for Ribery

Soccer Betting Odds & News at BSNblogChelsea offered 50 million euros to Bayern Munich for the Bavarian team's French midfielder Franck Ribéry, as published by the British press on Thursday, while the German club denies the information.

Since the Munich institution, the team's spokesman, Markus Hörwick said that the news about Chelsea's offer is "one more big lie" of linking the player with Gallic eventual signing of a 'big' clubs in Europe.

"Again, we want to renew and Ribéry not sell," he Hörwick.

For its part, the English newspaper The Independent argues that the executive director of Chelsea, it was prepared to finance the signing of star NAFEC, and with 26 years of contract with Bayern until 2011.

The question of the salary of the player is yet to be resolved, says the rotary because Ribéry claimed 144,000 euros per week while Chelsea offers 103,000.

If the signing takes place, Chelsea completed one of the most expensive in the recruitment of world football, although it would be lower than in 2001 by Real Madrid when he signed the French midfielder Zinedine Zidane, worth 52.7 million euros.

Bayern Munich has not ceased to repeat in recent weeks that its star player is unmarketable despite Real Madrid, Milan, Manchester United or the new champion of Europe, Barcelona, aim chips.

Ribéry, who came in summer 2007 at Bayern, where he has become one of the most attractive players in the Bundesliga, recently declared that the AFP has not taken any Decision on its future.

Chelsea Faces its Last Chance in the Cup Final Against Everton

Soccer Betting News at Gambling Advisor blogGambling Advisor blog news: Chelsea faces its last chance this saturday to salvage the season with a title in the Cup final in English football, where you face an Everton always ready to spoil the party one of the big four.

The "blues" were eliminated in the semifinals of the Champions League for the champions in the end, Barcelona; options in the Premier League title were dashed early, after a rough patch at the turn of the year that ended with the dismissal Technician, Luiz Felipe Scolari, and the League Cup on penalties was removed by Burnley, recently promoted to first division.

"A great club like Chelsea needs to win titles every year and almost everybody knows how was this season," said the Dutchman Guus Hiddink, who came to the rescue after the dismissal of Scolari.

With a win on the lawn "sacred" in Wembley, which was widely criticized dismal state, the blues provide the technician of 62 years the perfect farewell gift, because the Dutch will return to his post as coach of Russia after the match.

"We would like to dismiss him with a trophy, as a sign of gratitude," said Frank Lampard English. Under the aegis of Hiddink, appreciated by players and fans, the team lost only one game.

In case of defeat, however, the Chelsea encadenaría his second year in succession without a trophy, too much for the London club's Russian tycoon Roman Abramovich.

"A season without a title is considered a failure, and it is right that is so, if you look at the quality of the workforce," said Lampard.

"It's our last chance," he said on his part the German midfielder Michael Ballack, for whom the traditional end of the tournament, the oldest in Europe, has a special significance.

When Chelsea last won the trophy in 2007, the first of the season in London and Germany, Ballack had to watch the match as a spectator because of a foot injury.

For the German, despite the disappointments, the blues had a good season. "We had good performances. And in the Champions League we were one of the strongest teams, if not the best."

Therefore, after elimination in the final minute of their knockout semi-finals in Champions, the FA-Cup "looks like a consolation prize for the giant London.

"The Cup is a great title, recognized not only in England but throughout the world," said Hiddink, however, always attentive to the motivation of their men, who start as clear favorites to win.

The party, however, will not be any ride. Everton tied at zero, who played two matches with Chelsea in the Premier League and eliminated the league champion, Manchester United, in the semifinals.

"I think it was a moment where we need to win something," said the coach David Moyes, whose team finished fifth in the Premiership and is posited as an alternative to the dominance of the big four United, Liverpool, Chelsea and Arsenal.

"I do not say it now, but will come," insisted the coach of Everton, which is seeking its first title since winning the Cup in 1995.

BSNblog on The Washington Post

Sports Betting blog - BSNblog on the newsWe are pleased to announce to all our friends and readers that BSNblog has been seen on one of the best news sites, The Washington Post.

Here´s the link:

We want to thank all our readers for their daily support.

Latest NHL Final Odds

NHL Finals Odds at BSNblogSeries Price:

  • Pittsburgh Penguins 6/5

  • Detroit Red Wings 2/3

Trophies and Presentation

Odds to Win the Conn Smythe:

  • Sidney Crosby 5/1

  • Evgeni Malkin 11/2

  • Nik Lidstrom 6/1

  • Johan Franzen 9/1

  • Henrik Zetterberg 8/1

  • Marc-Andre Fleury 8/1

  • Chris Osgood 13/2

  • Bill Guerin 12/1

  • Valtteri Filppula 15/1

  • Daniel Cleary 12/1

  • Chris Kunitz 13/1

  • Sergei Gonchar 15/1

  • Marion Hossa 12/1

  • Pavel Datsyuk 10/1

  • Field 9/1

Who will the MVP thank first?

  • Teammates 1/1

  • Owner 9/4

  • Family 10/1

  • Gary Bettman 14/1

  • Sponsor 20/1

  • God 17/1

  • Does not thank anyone 25/1

Historical Props


  • Gretzky (7p - 4g-3a) 1984

  • Messier (4p - 3g-1a) 1984

  • Gretzky (11p - 7g4a) 1985

  • Messier (6p - 2g4a) 1985

  • Lemieux (12p - 5g7a) 1991

  • Jagr (5p - 0g5a) 1991

Game 1 Odds:

+1.5 (6/13)
O 5.5 (4/5)
-1.5 (7/4)
U 5.5 (21/20)

Who will finish with more points in the series?

  • Sidney Crosby 5/6

  • Evgeni Malkin 5/6

Which Stanley Cup finals points total will be higher?

  • Sidney Crosby(2009) 7/5

  • Mario Lemieux (1991) 5/9

Which combined Stanley Cup finals points total will be higher?

  • Crosby/Malkin (2009) 10/11

  • Jagr/Lemieux (1991) 10/13

Which Stanley Cup points total will be higher?

  • Wayne Gretzky (1984) 10/11

  • Sidney Crosby (2009) 10/13

Which combined Stanley Cup points total will be higher?

  • Gretzky/Messier (1985) 5/6

  • Crosby/Malkin (2009) 5/6

TV Ratings

Which Country will average a higher number of viewers?

  • Canada 10/11

  • USA 10/13

Which City will have the highest single game TV rating?

  • Pittsburgh 10/13

  • Detroit 10/11

Which Stanley Cup Ratings will be higher? (per game average)

  • 2008 10/11

  • 2009 10/13

On the Ice

Who will be the finals leading goal scorer?

  • Sidney Crosby 3/1

  • Evgeni Malkin 3/1

  • Johan Franzen 9/2

  • Henrik Zetterberg 5/1

  • Daniel Cleary 8/1

  • Ruslan Fedotenko 10/1

  • Bill Guerin 12/1

  • Marion Hossa 12/1

  • Mikael Samuelsson 15/1

  • Nicklas Lidstrom 12/1

  • Field 8/1

Who will be the finals leading point getter?

  • Evgeni Malkin 7/2

  • Sidney Crosby 7/2

  • Johan Franzen 11/2

  • Henrik Zetterberg 11/2

  • Valtteri Filppula 8/1

  • Nicklas Lidstrom 9/1

  • Sergei Gonchar 10/1

  • Daniel Cleary 12/1

  • Bill Guerin 12/1

  • Chris Kunitz 12/1

  • Ruslan Fedotenko 15/1

  • Marion Hossa 15/1

  • Field 8/1

Who will be the first Penguin to drop gloves?

  • Kris Letang 4/1

  • Matt Cooke 4/1

  • Bill Guerin 7/1

  • Max Talbot 7/1

  • Jordan Staal 8/1

  • Hal Gill 8/1

  • Sidney Crosby 10/1

  • Evgeni Malkin 13/1

  • Field 2/1

Will will be the first Red Wing to drop the gloves?

  • Niklas Kronwall 3/1

  • Jonathan Ericsson 6/1

  • Tomas Holmstrom 10/1

  • Brian Rafalski 4/1

  • Brad Stuart 5/1

  • Kirk Maltby 9/1

  • Chris Chelios 13/1

  • Field 2/1

Will there be a fight in the Stanley Cup Finals?

  • Yes 5/9

  • No 7/5

Will a goalie get a point in the Finals?

  • Yes 10/1

  • No 1/20

Team with most penalties in the series:

  • Detroit Red Wings 10/13

  • Pittsburgh Penguins 10/11

First goalie to get a penalty:

  • Marc-Andre Fleury 1/2

  • Chris Osgood 3/2

Which team will have the best Penalty Kill?

  • Detroit Red Wings 11/10

  • Pittsburgh Penguins 2/3

Which team will have the best Power Play?

  • Detroit Red Wings 5/9

  • Pittsburgh Penguins 7/5

First team to score a Power Play goal:

  • Detroit Red Wings 2/3

  • Pittsburgh Penguins 11/10

Will there be a Shorthanded Goal scored in the series?

  • Yes 10/1

Will a backup goalie win a game in the series??

  • Yes 7/1

How many games will go to overtime?

  • Over 1.5 1/1

  • Under 1.5 5/7

What will be the longest OT game?

  • 1 Period 5/6

  • 2 Periods 10/11

  • 3 Periods 3/1

Will there be a hat trick scored in the series?

  • Yes 3/1

  • No 1/5

Odds and Ends

Will the Stanley Cup be dropped during the skate around?

  • Yes 20/1

Will the winner of the 2009 cup win in 2010?

  • Yes 4/1

Will the anthem singer in any game forget the words?

  • Yes 5/1

Will the anthem singer slip and fall?

  • Yes 4/1

Will an Octopus be thrown on the ice in Pittsburgh?

  • Yes 3/1

Will an Octopus be thrown on the ice in Detroit?

  • Yes 1/8

  • No 16/1

Will Joe Biden attend a finals game?

  • Yes 5/2

  • No 1/4

Will Bill Cowher attend a game in a Red Wings jersey?

  • Yes 8/1

Odds on number of panes of glass that get broken by a shot:

  • Over 1.5 10/11

  • Under 1.5 10/13

Sports and Newsworthy odds can be found at: Sports Betting blog

Lakers vs. Nuggets Betting Odds & Stats

Gambling Advisor blog NBA Betting OddsThe Los Angeles Lakers and the Denver Nuggets will both be trying to pick up a win on Friday when they battle at Pepsi Center in Game 6 of the Western Conference Finals.

Gambling Advisor blog pick : Oddsmakers currently have the Nuggets listed as 5½-point favorites versus the Lakers, while the game's total is sitting at 209.

The Lakers dominated the fourth quarter and came away with a 103-94 victory over the Nuggets in Game 5 on Wednesday to go up 3-2 in the series.

The Lakers covered the 6-point spread, while the 197 points fell UNDER the posted total of 209.5.

Lamar Odom netted a double-double with 19 points and 14 rebounds for Los Angeles. Kobe Bryant poured in 22 points in that win.

Carmelo Anthony dropped 31 points with four rebounds and four assists in the loss for the Nuggets.

Team records:
Los Angeles: 65-17 SU, 42-39-1 ATS

Denver: 54-28 SU, 45-36-1 ATS

A few trends to consider:
The total has gone UNDER in 8 of the LA Lakers last 9 games

The total has gone UNDER in 6 of the LA Lakers last 7 games when playing on the road against Denver

The total has gone UNDER in 10 of the LA Lakers last 12 games when playing Denver

LA Lakers are 13-3 SU in their last 16 games when playing Denver

Denver is 17-1 SU in its last 18 games at home

Denver is 8-1 ATS in its last 9 games at home

The total has gone UNDER in 6 of Denver's last 7 games when playing at home against LA Lakers

The total has gone UNDER in 10 of Denver's last 12 games when playing LA Lakers

DotW: The Jury Is Out

Is the biotech financing climate warming? As the WSJ pointed out yesterday, big deals such as Sanofi's licensing of Exelixis' PI3 Kinase Inhibitors (see below) and JNJ's acquisition of Cougar Biotech might suggest it's time for more optimism in our industry, as does the good news we report below for Cytokinetics.

Still, for a large portion of the sector--notably small cap biotechs whose products or clinical trial data are far from perfect--we suspect the struggles to find financing at a reasonable price continue.

Metabasis, a San Diego-based biotech focused on liver and metabolic disease, is a prime example. Unable to get additional funding , the biotech announced on May 27 that it would be reducing headcount by 85% to just 7 employees. Execs at Curagen likely know what remaining staffers at Metabasis are going through. In February the Connecticut company announced it was looking at strategic options; this week comes news of its sale to Celldex Therapeutics (see below).

And it's likely there will be more examples in the weeks to come. According to Simos Simeonidis, a senior biotechnology analyst with Rodman & Renshaw, "there are still a number of small-cap companies that will fall victim to the crisis and will either go out of business, merge or be taken over at low valuations.” (You can read more about Simeonidis' views of the industry in an upcoming Pink Sheet story, scheduled to appear Monday June 1.)

The jury is out on a number of other big issues as well, including CSL's planned take-over of Talecris. Do recent moves by the FTC signal a more judicious view of mergers under the Obama Administration? Shaking our magic eight ball, we say...the jury is still out, but the consequences could be huge--$3.1 billion big to be exact--for Talecris' PE-backers, Cerberus Partners and Ampersand Ventures.

And then there's the niggling question of rights to Remicade and Simponi. J&J finally made a move this week, asking for arbitration regarding ownership of the anti-TNF bluckbuster and its next-generation follow-on. In a press release, the diversifed pharma noted: "As its public statements have made clear, Merck is acquiring Schering-Plough. The acquisition constitutes a change of control that triggers the right of our Centocor Ortho Biotech subsidiary to terminate the agreements." Seems like the pharma wasn't fooled by all that reverse merger mumbo jumbo and Merck CEO Dick Clark may have to pay for his sandwich--and the loss of Remicade and Simponi--after all.

As you ponder these weighty issues and make your own rulings, take time to peruse...

DxS/Boehringer Ingelheim: There's been no official ruling in the industry about the business model for companion diagnostics, but that hasn't stopped DxS from inking deals. The company's latest pact: an agreement with Boehringer Ingelheim to develop a companion test for the pharma's BIBW 2992 (also known as Tovok), a novel tyrosine kinase inhibitor being tested in non-small cell lung cancer that acts by irreversibly blocking two promoters of tumor growth, the epidermal growth factor receptor (EGFR) and HER2 receptor. Because BIBW 2992 is more effective in patients carrying mutations in the EGFR gene, DxS will aim to develop a test to detect those genetic differences, allowing for the potential segmentation of lung cancer patients and a more personalized approach to therapy. Financial details of the deal were not disclosed. DxS is one of a number of companies to embrace the possiblity that there are real revenues to be had from companion tests, especially in oncology, where the drumbeat for individualized therapies grows ever louder. Last December, DxS signed a US-centered deal with Amgen to provide a companion diagnostic for the Big Biotech's colorectal therapeutic Vectibix. The test maker's so-called TheraScreen K-RAS test is already on the market in the EU and is used to help doctors determine which patients are unlikely to respond well to anti-EGFR therapies such as Bristol-Myers Squibb/ImClone's Erbitux (cetuximab) and Amgen's Vectibix. Moreover, DxS and Amgen have collaborated since last year on selling TheraScreen K-RAS alongside Vectibix in Europe, where the drug is cleared for patients with refractory metastatic colorectal cancer in which there is no K-RAS mutation.

Celldex Therapeutics/Curagen: The jury ruled this week on the case of Curagen and an independent future and decided overwhelmingly against said biotech. On Friday May 29, Celldex Therapeutics, which last year reverse-merged with Avant Therapeutics, announced it was acquiring the Connecticut-based biotech in a tax-free stock-for-stock transaction that values Curagen at approximately $94.5 million. The acquisition adds a portfolio of 11 oncology-focused antibodies to Celldex's immunotherapy medicines, including CR011, a fully human mAB-drug conjugate in Phase II trials to treat metastatic breast cancer and late stage melanoma. Perhaps evem more valuable is Curagen's on-hand cash: the $54.5 million Celldex stands to gain will go a long way to helping fund its pipeline, which includes CDX-110, a potentially break-out cancer vaccine for glioblastoma in Phase II trials and the subject of a partnership with Pfizer in 2008. The news announcement Friday brings to an end the questions about Curagen's specific future, the basic outlines of which had been mapped out in February, when the company disclosed it had hired an investment bank to explore "a broad range of strategic alternatives." The company's stock had been in freefall since a Phase II mucositis drug, velafermin, blew up in clinical trials. The failure of velafermin, and the subsequent decision to exit a partnership with Denmark's TopoTarget for the HDAC inhibitor belinostat, left Curagen a one-trick pony, dependent on the success of CR011. And CR011 is far from a slam dunk. Antibody-drug conjugates have had mixed success in the clinic, with only Wyeth's Mylotarg for acute myeloid leukemia garnering FDA approval.

Amgen/Cytokinetics: With so many option-alliances and option-acquisitions getting signed these days it’s nice to have a reminder that yes, options do in fact get exercised. On Tuesday Cytokinetics said that Amgen was picking up its option on the smaller biotech’s cardiac contractility program, triggering an option payment of $50 million. The program’s lead candidate, the heart failure drug CK-1827452, is a small molecule cardiac myosin activator in Phase II. Back in 2006, when Amgen originally inked its option deal with Cytokinetics, the biotech received a $75 million up-front payment. This latest deal means the small company is now eligible for pre-commercial milestone payments totaling $600 million. What’s more, Amgen now foots the bill for ‘452’s development, cooling the burn on Cytokinetics’ newly boosted $145 million cash balance. It’s all about the runway, people, and Cytokinetics can now see as far as 2012. For a full discussion of Cytokinetics development strategy for ‘452 and a look at how investors in a recent registered direct offering of Cytokinetics shares could make out like bandits, check out the coverage over at The Pink Sheet DAILY--Chris Morrison.

Sanofi-Aventis/Exelixis: One target area the Big Pharma Jury has ruled on: PI3 kinases. And the verdict? KA-CHING! At least that's the case for Exelixis, which cashed in May 28 in a big way in a deal with Sanofi-Aventis. In exchange for $140 million up-front, Sanofi gains world-wide rights to Exelixis's two earlyish-stage clinical compounds, XL147 and XL765 (both are in Phase Ib/II). In addition the two companies will collaborate on the discovery of new, isoform-selective PI3 kinase inhibitors for oncology indications. They will each contribute preclinical compounds for development work, but Sanofi shoulders the cost of the work to the tune of $21 million for the next three years. Importantly Exelixis will reap downstream benefits no matter which companies' molecules are chosen for clinical studies. This latest deal has the requisite biobucks--north of $ 1 billion plus double-digit royalties for XL147 and XL765--that we've come to associate with traditional pharma-biotech deals (it will be quite another matter if said money actually materializes). As Chris Morrison wrote yesterday, IN VIVO Blog is more impressed with the size of the upfront, which is on-par with the biggest clinical-stage deals so far this year: Novartis' global license to Portola's Phase II cardiovascular candidate elinogrel and BMS's deal for Zymogenetics interferon lambda. The out-sized deal price suggests that assets deemed "too good to pass up" still command high value, despite the economic climate. For Sanofi the Exelixis deal is just the latest sign that partnering is in the ascendance at the French pharma, a message repeated recently at BIO, and it allows the company to catch up in an important emerging target area where it lacked in-house programs.

(Image courtesy of flickr user wallyg through a creative commons license.)


Iowa Speedway (May 28, 2009) – The second day of a two-day Star Mazda Championship presented by Goodyear test at Iowa Speedway was run under ideal conditions, with 14 drivers turning a total of 4,628 laps around the 7/8ths-mile oval.

Widely experienced in road racing in both Europe and the U.S., but with no previous experience of any kind on an oval, current championship leader Englishman Adam Christodoulou redefined his comfort zone and turned the fastest lap of the day -- and the test -- a 22.059 (145.900 mph) in his #11 JDC Motorsports / Molecule Mazda. The best time on day one was set by Louisiana racer Alex Ardoin with a 22.109 (145.589 mph) in his #51 JDC Motorsports / Oral & Facial Surgery Center / Twister Trailer Mazda. Billy Goshen ran the most laps of the day, 258, in his #82 Goshen Motorsports / Baker Commodities / GPSTrackit / OTTO / First Quality Concrete Mazda, setting a 9th-fast time of 22.269.

By the time the final lap was run, all 14 cars in the test were within 7/10ths of a second of each other, setting the stage for an evening of extremely competitive, side-by-side racing when the full Star Mazda Championship field takes to the track for 100 laps under the lights at the upcoming Pizza Ranch 100 on July 10.

"It's taken four days to get to the stage we're at; the first three days on an oval (including the Milwaukee test last week) we ended up struggling with the car quite a bit, but we've been chipping away at it," says Christodoulou, the 2008 U.K. Formula Renault champion who is currently leading the 2009 Star Mazda championship points battle with two wins (Sebring and Miller Motorsports Park) and two poles (Miller and Virginia International Raceway). "I didn't realize quite how hard it was going to be just going around in circles. I can't believe how close the racing is, how high the standard of oval racing is – it's been quite a surprise, but I've been working with my team, JDC Motorsports and its all working pretty well now. When you watch oval racing from the grandstands, it looks like they're going around and obviously they're getting a tow and slipstreaming and overtaking each other; but when you're actually in the seat, I reckon the scariest moments are when you come out of the pits because the first lap you've got to have faith in the car to know that it's going to stick to the ground and obviously around Iowa its touch-and-go flat-out all the way around, but with a wall five meters on either side of you there's not much room for error. Luckily I managed to keep it off the wall for the four days, but it takes a lot of getting used to; you have to start out with a bit of understeer in the car -- the last thing you want on an oval is oversteer -- so you have to start with understeer and build it up lap by lap. I reckon it was about my 30th lap when I got used to the track and realizing how wide and fast it was."

Although the Star Mazda Championship has raced on ovals previously, including Pikes Peak and the Milwaukee Mile, this will be the first visit to the 7/8ths mile Iowa Speedway Oval by the rotary-powered, 250-horsepower Star Mazda Championship cars. By way of comparison, the fastest lap by a V-8-powered, 420 horsepower Indy Lights car at this track last year was 20.0971 sec. Michael McDowell (the 2004 Star Mazda series champion), raced to a 2nd-place finish in the 2007 ARCA RE/MAX Prairie Meadows 250 after qualifying 7th with a lap of 23.999-sec. in his No. 2 Z-Line Designs / Mission Residential / Beck Dodge. McDowell, who graduated from Star Mazda to Indy Cars and prototype sports cars before moving to stock cars, went on to race NASCAR Sprint Cup in 2008 and is currently driving the #47 in the NASCAR Nationwide Series.

The Star Mazda Championship presented by Goodyear is scheduled to make its first appearance at the Iowa Speedway in the Pizza Ranch 100 on July 10. The format will feature 100 laps of flat-out racing under the lights during an ARCA RE/MAX weekend, with the green flag scheduled to wave at 8:30 pm.

The Star Mazda Championship presented by Goodyear is now in its 19th year as one of the most successful open-wheel driver development series in North America. The Star Mazda Championship the college basketball, the triple-A baseball of auto racing, a high-speed training ground for future stars of the sport and a major step on the MAZDASPEED Motorsports Development Ladder and automaker-supported scholarship program that provides funding for young champions to move up to the next level of racing. Graduates of the Star Mazda Championship included three drivers in last weekend's Indy 500 field; Marco Andretti, Graham Rahal and Raphael Matos, as well as seven of 21 drivers in the Indy Lights series.
Iowa testing photo courtesy of Ryan at Junior Open Wheel Talent