While You Were Calling the Old Man

A belated happy fathers day to all you dads out there, and a happy solstice to the rest of you. The news this weekend was largely confined to spills of oil and sports, but we've dug out a few noteworthy tidbits from this morning to get you started this week.

While you were diving/collapsing/going Gaga ...

• Biovail and Valeant are merging. The nearly 50/50 transaction is a bit complicated but suffice to say the two specialty pharma companies will combine operations under the Valeant banner but with Biovail's corporate structure and HQ'd in Canada. Valeant investors (who will hold 49.5% of the newco) get a one-time payout of $16.77 per share plus 1.7809 shares of Biovail for each share of Valeant. Valeant CEO J. Michael Pearson will become CEO of the newco while Biovail CEO Bill Wells will become chairman.
• Affymax and Takeda released this morning their top-line Phase III results for Hematide -- all looks good except for the adjusted cardiovascular composite safety endpoint in non-dialysis patients in two of the four pivotal trials ...
• Sosei is acquiring Japanese drug formulation company Activus for 500 million yen.
• GSK has licensed rights to a topical lip-patch from Germany's Labtec GmbH for the treatment of cold sores.
• And finally ... Exelixis has regained full development and commercialization rights to its Phase III MET/VEGFR2/RET inhibitor from partner Bristol-Myers Squibb Co. BMS entered a 50/50 dev-co arrangement for '184 as part of a deal signed in December 2008 that also included the Phase I cancer candidate XL281. Both drugs had been passed over by GSK when its broad option-alliance with Exelixis ended earlier that year. As part of this weekend's breakup BMS will pay Exelixis $17 million. There has been no major hiccup in '184's development, and the drug is in testing in more than a dozen tumor types. So what happened? As part of the 2008 agreement, goes Exelixis' statement, "BMS and Exelixis had originally agreed to certain clinical development plans, and Exelixis maintained key rights regarding timing and funding of current and future clinical trials. Given the recent progress of BMS’ wholly-owned oncology pipeline and positive data generated by XL184, Exelixis and BMS were not able to align on the scope, breadth and pace of the ongoing clinical development of XL184." The companies will continue to work together on other oncology candidates.

While You Were Drawing

Depending on your perspective, the US either pulled off hard-won draw on Saturday night with the help of a gift from England keeper Rob Green, or lucked into a point they didn't deserve thanks to the Hand of Clod. We prefer to see the States' cup performance as half-full and 1-all a good reflection of the play on the field, and a draw as frankly the best result. (A win might have resulted in bodily harm to this blogger, well behind enemy lines.)

Without ASCO news the weekend seemed much calmer, much more, well, weekendy. While you were listening to the song of the vuvuzelas ...

• Bayer reports disappointing results for Nexavar in advanced NSCLC this morning; the drug did not meet the primary endpoint of overall survival.
• The NYT reports that sequencing the human genome -- at least in terms of advancing treatment of diseases -- has largely been a bust. Not everyone agrees -- quoth Eric Topol (via Twitter): "NY Times Nicholas Wade discounting progress in genomics for about the 10th time."
• After Gilenia seemingly sailed through its advisory committee last week, lots of ink spilled on what potential approval means for the current market. Yesterday, Haaretz reported on the risks to Teva's Copaxone franchise. Our own position (from an IN VIVO feature last year) is a little more nuanced but we'll sum it up: don't discount the years of safety data amassed by biologics; market share will surely shift, but not suddenly.
• Note to Phillies. Spotting teams 10-run leads isn't working. Time for new tactics.
• UPDATE: Human Genome Sciences said this morning that preliminary feedback from FDA on its Zalbin (albuferon) BLA isn't good, from a risk-benefit perspective, and that "HGS has concluded that licensure of this dosing regimen [900-mcg every two weeks] is unlikely." The drug's European application was pulled from the EMA in April 2010 by HGS partner Novartis.

While You Were Perfect

Twenty-seven up, 27 down. Roy Halladay's perfect game on Saturday against the Marlins is an oasis in a desert of slump for the Phillies, which in a way makes it a little more remarkable. The 20th PG in baseball history (this blogger was lucky enough to be in attendance for the 16th, David Cone's in Yankee Stadium), Halladay's gem has potentially led to the first post-facto sellout in baseball history: the Florida Marlins are selling unused tickets from the game at full face value. Video of all 27 outs here.

We hope you had a perfect Memorial Day/Bank Holiday weekend.

Meanwhile, while you were falling in an 0-2 hole ...

• Novo Nordisk, unhappy with mandated price-cuts in Greece, is taking its ball and going home. Or at least it's taking its modern insulin franchise off the market. Reuters reports that Novo is the first company to pull its drugs from Greece, but that dermatology-focused Leo Pharma yanked its medicines soon after.
• A Korean blockbuster is going global, after Merck buys from Hanmi Pharmaceutical the rights to incrementally modified hypertensive amlodipine product Amosartan in North America, China and Europe, PharmAsiaNews reports. The drug will be sold under Merck's brand Cozzar XQ.
• J&J's Centocor Ortho Biotech this morning bought the small, pulmonary disease focused biotech Respivert, which was founded by former GSK execs and backed by Advent Venture Partners, Fidelity Biosciences, Imperial Innovations and SV Life Sciences. Financial details aren't immediately clear but Imperial Innovations disclosed that it made a 4.7x return (£9.5mm gross) on its 13.4% stake in the company, a three-year investment. UPDATE: J&J inked a second respiratory-focused deal announced this morning. Orexo, a Swedish biotech, says it signed a three-program R&D collaboration with J&J, worth $10 million up front. Two of the assets come from Orexo, the third from J&J.
• Not long after its Phase III MermaiHD debacle, NeuroSearch CEO Flemming Pedersen resigns. No word on Pedersen's next move although the company's release notes he is taking another position.
• FDA will more closely monitor OTC manufacturing operations and require comprehensive changes at firms with systemic quality deficiencies as a result of its investigation of Johnson & Johnson's McNeil Consumer Healthcare, reports The Tan Sheet.
• AstraZeneca's attempts to extend its PPI franchise hit a snag as FDA issues a complete response letter for its esomeprazole/aspirin combo and rejects an expanded label for Nexium. Bloomberg reports.
• The Rose Sheet reports that increased scrutiny of anti-aging products entering the US presages "a major enforcement initiative" against illegal cosmetic claims that will impact domestic personal-care firms, large and small Oh and just to be clear, reading 'The Rose Sheet' doesn't actually make you look younger -- just smarter.
• Novartis/Roche's Xolair hits another hurdle as NICE rejects coverage of the drug by the NHS.

While You Were Going to Overtime

Hockey fans, it doesn't get much better than yesterday's gold medal game. Canada took the gold, 3-2 in Overtime. To say it was exciting would be like saying the East Coast got a little bit of snow this winter.

Meanwhile, while you were going hostile (again) ...

• Merck KGAA is buying bioprocessing/bioproduction specialist Millipore in a $7.2 billion deal announced this morning.
  
• Astellas is making public its attempts to buy OSI Pharma for $3.5bb.


• The NYTimes reports on the scourge of drug resistant gram negative bacteria.


• President Obama says health care reform can't wait a generation.


• UK's NICE finally relents on PharmaMar's soft tissue sarcoma drug Yondelis, after Bayer commits to picking up some more of the tab.
  
• Vertex is going combo on HCV--telaprevir, meet 222. 222, meet telaprevir.
  
• AZ is buying out Merck's interest in its non-PPI products this year, the companies said. Price tag: $647 million.
• Will set backs for Actelion's IPF drug mean smooth sailing for Intermune next week?

image from flickr user Mary-Kay G used under creative commons

While You Were Upsetting

Big upset at the Olympics last night, but before we get to that there is of course the latest industry news. Until you can get biopharma wrap-ups at ESPN, we'll keep on keepin' on.

While you were pondering reconciliation ...

• A bad weekend for GSK (after a tough week): a report released by Sens Baucus and Grassley that notes FDA reviewers' 2008 recommendation that diabetes drug Avandia get pulled because it causes "500 additional heart attacks per month" was the subject of about six thousand articles. Oh look, here's one.


• A good weekend (a good Monday morning, anyway) for Novartis. Oral MS drug candidate Gilenia (f.k.a. FTY720) received notice of FDA priority review and meningococcal disease vaccine Menveo received FDA approval.


• The NYTimes begins a new three-part series, Target Cancer, with a moving, in-depth look at oncologist's attempts to push forward new targeted therapies for melanoma: earlier failures and hopefully a success story of Plexxikon/Roche's PLX4032.

• It's almost time for that health care summit at the White House. Reuters reports on the administration's updated proposals, expected out on Monday. Here's a Bloomberg piece on a proposal to limit insurance price hikes.


• HOCKEY: USA 5 - 3 Canada. Wow.
  
• You're probably reading this at about 7am. You know, if you stay up late to watch olympic hockey, it's never too early for a nap.
• UPDATE: The board battle you've all been waiting for... Icahn v Genzyme. Adam Feuerstein at TheStreet.com has the scoop.
  
  image © VANOC/COVAN

While You Were Watching Winter Sports ...

flickr user Stefan introduces the Imperial curling team

We do enjoy the Winter Olympics, if only because we only get to watch fun sports like curling and Nordic Combined about, oh, once every four years. It's brilliant competition, except, well, when it isn't.

Canada's women's ice hockey team beat up on Slovakia 18-0 on Saturday, which isn't much of a game. Nor did we think it was particularly sporting of the canucks, until we remembered that Slovakia was the team that destroyed Bulgaria 82-0 in an Olympic qualifying match. Fair play, Canada.

While you were couch-luging ...

• AstraZeneca has shelled out $100 million up-front for a global license to Rigel's Phase II oral RA treatment fostamatinib, the furthest along Syk-inhibitor in the industry pipeline. The billion dollars in biobucks that may eventually follow are heavily weighted toward sales milestones, but the deal is still an expensive one for AZ, perhaps a reflection of the company's acute need to bring in late-stage pipeline projects.
  
• NICE to Novo: Victoza use should be limited on NHS's dime, er, ten-pence.


• Bloomberg reports on how Affymax could eat into Amgen's anemia franchise. It's all about pricing.


• Merck appointed ex-J&J Baby Global Business Unit chief Bridgette Heller as EVP and president of consumer health care.


• What's that awful smell? It's metformin, reports Reuters. The diabetes drug literally 'stinks' and in a letter to the Annals of Internal Medicine some doctors suggest this may be why patient compliance with treatment is low.


• The New York Times unpacks GSK, Sanofi, and others' push into global branded generics.


• We're all for properly handled generic substitution, but come on, Vancouver Olympics organizers, don't send a generic ice resurfacer to do a Zamboni's job.

While You Were: Snowpocalypse Now

Snow snow snow. It appears that the whitewash in Philly, Washington and other parts of the mid-Atlantic isn't quite over, with more winter weather forecast for later in the week and schools and government offices remaining closed today. Shovel and drive carefully, folks!

Oh yeah, the Super Bowl. N'awlins and Indy, Brees and Manning, Daltrey and Townshend, Dave and Jay (and Oprah). Here at IVB's UK HQ we didn't stay up all night to watch, but wish we had: we hear it was a good show. Congrats to the Saints.

Now, while you were digging your car out of the snow ...

• Biotech Blowup: wish we thought of this ourselves.
• Will Pharma rue cutting R&D? Meh, we're not convinced.
• WSJ's Peter Loftus breaks down Sanofi-Aventis' options regarding its animal health JV with newly-enlarged Merck & Co.
• Pfizer's new eCard goes live in Russia this month, reports the FT, and should come on line in other emerging markets later this year. The discount drug card will allow Pfizer to collect data on patients' drug use.
• AZ is teaming up with Cancer Research UK to discover and develop drugs that target cancer metabolism, the non-profit said on Sunday.
• President Obama has announced a televised, bipartisan, half-day health care reform summit to take place at the White House this month (snow permitting?). Move over Super Bowl ...

image courtesy flickr user RRRPhotos used under a creative commons license.

While You Were Saying 'Aha!'

Time for an annual December treat: It's the NYTimes Magazine's annual 'year in ideas' issue. We weren't as taken with the issue as we have been in years past, but it's always worth a read.

While you were drinking your lithium ...

• News out of the San Antonio Breast Cancer Symposium: positive data on T-DM1 from ImmunoGen and Roche; on Pfizer's neratinib; on Array's ARRY-380; on Celldex's CDX-011;
• Cubist is buying the VC-backed anti-infectives play Calixa Therapeutics for $92.5 million in up-front cash plus earn-outs related to the progress of one of Calixa's Phase II drug candidates that could total $310 million. Looks like a solid return for Domain/Canaan/Frazier, which put $30mm into the company since it was founded in 2007.
  
• Mammogram screening debate, meet math. Math, meet mammogram screening debate. You two have much to discuss.
  
• AstraZeneca's argument to dismiss Crestor's generic rivals via summary judgment was rejected, and the parties head to court in February, reports Reuters. Don't forget Crestor's FDA advisory committee is on tap for later this week ...
  
• HCR: Lieberman is a Nay. Didn't see that coming?
  
• So far we've nominated seven deals in our 2009 Deals of the Year competition: You can view them here. There are eleven more to come (six each in three categories). Voting will begin on Wednesday December 23 and continue until Tuesday January 5.
• Oh, Eagles 45, Giants 38.
  

While You Were Eating Beignets...

It's the first weekend in December and that means it's time once again for the American Society of Hematology meeting. This year, reps from biotech and pharma travel to N'awlins to make news--or at least issue press releases--before the last year of the first decade of the 21st century comes to a close.

And for the foodies/cultural mavens in the industry, how can you blame them? Where else can you indulge in chicory coffee, beignets (essentially fried dough, but the French makes it sounds waaaay better), and gumbo, while also soaking up the music scene?

If you weren't at ASH, you were likely debating the merits of football's popularity contest, aka the Bowl Championship Series, or Tim Tebow's oscar-winning performance after the Gators lost to Alabama. Or maybe you were engaged in that annual ritual now closely tied with propping up the national economy...filling recycled, reusable bags with unnecessary plastic items manufactured in China.

Away from food, footballs and rituals: this week's dealmaking got off to a healthy start, with Celgene announcing it was buying private firm Gloucester Pharmaceuticals for $340 million in cash, plus up to $300 million in future US and international regulatory milestones. The deal further strengthens Celgene's cancer franchise--more specifically, its blood cancer franchise--as Gloucester's romidepsin (Istodax), a histone deacetylase inhibitor, was approved by FDA in November for cutaneous T-cell lymphoma.

Not that Celgene's early Monday morning shopping should overshadow our hand-picked selection of the weekend events that happened while you were searching in vain for a $10 Zhu Zhu hamster... (Fuhgedabout it!)

New Yorker's Atul Gawande analyzes the current health care reform bill under review in the Senate. The fact that there is no grand master plan for curbing costs is actually a good thing, he argues. (If you haven't read Gawande's latest, you should. He's required reading in the West Wing.)

The WSJ reports Obama went to the Hill to urge the Dems to stay united as the Senate debated a proposed compromise option to the public plan. Meanwhile NYT's Prescriptions Health Blog outlines the advantages of a hybrid plan, the Federal Employees Health benefits Program.

There's lots for Sharfstein and Hamburg, the FDA's dynamic duo, to keep an eye on as they promote their safety first agenda. This weekend news surfaced that a Fresno, CA-based company recalled 22,723 ounds of ground beef potentially linked to salmonellosis; and then there was the NYT article on the safety of plasma products.

Also in the NYT this weekend, a story on the outsized pricing of cancer med Folotyn. The article is sure to spark renewed debate from payers about reimbursement for high priced meds that add just a few months of life. That's bad news for pharmas looking to cash-in on this specialty market.

ASH-related headlines: Cell Therapeutic's pixantrone increases median survival by 3.3 months in patients with relapsed/refractory NHL; Onyx/Proteolix presented updated Phase IIb data from studies of their next-generation proteosome inhibitor, carflizomib; privately-held Gloucester Pharmaceuticals presents additional data on newly approved ISTODAX in cutaneous T-cell lymphoma.

It wasn't just cancer at ASH; new data about next-generation blood thinners from Johnson & Johnson and Boehringer Ingelheim were reported at the meeting in conjunction with an article in the NEJM.

(Image by flickrer and[w] used with permission through a creative commons license.)

While You Were Eating Leftovers ...

As you shake off your turkey-induced coma and try to forget about your miserable fantasy football performance and another burgeoning financial crisis, we welcome you back to the working world.

Aaand unless you're really affected by tryptophan or were hanging out in Tiger Woods' SUV, you probably know that not a whole lot happened in our neck of the woods.

While you were putting up with your in-laws ...

• FDA neg'd a label expansion for Theravance's telavancin antibiotic, saying not-yet to use in nosocomial pneumonia patients in a Complete Response letter on Friday. Meanwhile, the European review continues apace.
  
• What are Bayer's M&A plans? Reuters reports, but Bayer hedges.
• The FT's 'Everything you ever wanted to know about Lipitor' piece.
• Complaining about the 'Bo-Tax' on elective cosmetic surgery procedures in the NYT.
• With ASH around the corner, it's Velcade vs Revlimid at Bloomberg News.


• Venture philanthropy, not just for private companies: Rxi said this morning it was pulling in money from three ALS organizations to support a UMass study of its self-delivering RNA interference platform.
• Sanofi's Multaq this morning became the first anti-arrhythmic approved in Europe in a decade.

image from flickr user sniffette used under a creative commons license.

While You Were at ASCO

Hey you'll never guess, but there was an oncology meeting down in Mickey-Mouse land this weekend. No, seriously. Small group of cancer docs, it flies below the radar. Yeah that's probably why you hadn't heard of it. Say it with us: Aaasssssccccoooooohhhhh. No, ASCO.

There have been announcements galore from the annual meeting, and some interesting discussions as well. Mary Jo Laffler reported last night on a compare and contrast of FDA and EMEA, where FDA's oncology chief Richard Pazdur observed “EMEA is not the FDA of Europe, and the FDA is not the EMEA of the United States.” And this morning we wrote that Merck and AstraZeneca are announcing a tie-up in the oncology space, a rather limited but still significant deal to test the industry's most advanced mek and AKT inhibitors together in an early-stage clinical trial. We'll have more on that deal in The Pink Sheet DAILY later this morning.

Did you take the weekend off (god forbid!)? Well then, get ready for an onslaught of oncology development news. While you were winning #250 ...

• Some non-cology news to cleanse the palate: WSJ reported late friday night that Elan was close to selling a minority stake to Bristol-Myers. Reuters follows that up with this update, which includes a rumor of a second suitor (no word if second suitor is positioned on the grassy knoll). [UPDATE: Or, maybe BMS isn't buying, says Bloomberg.]
  
• Herceptin boosts survival in Her-2 positive stomach cancer patients.
  
• That fluorinated version of Nexavar that Onyx isn't happy about? Seems to be working just fine, says Bayer.
  
• Calistoga's PI3k inhibitor advances through Phase I, with flying colors.
  
• Genentech has released full results of its C-08 trial of Avastin in the adjuvant colorectal cancer setting. Full coverage from The Pink Sheet DAILY, here.
• Good data in lung cancer from (separate) studies of Lilly's Alimta and OSI's Tarceva.
• Glioblastoma data on drugs from Merck KGaA and BMS/Exelixis look good.
• There are six hundred more press releases and probably six hundred more on the way. Tell you what, get the rest of the headlines here and check back in with us later today. More to come!

image from flickr user StevenM_61 used under a creative commons license.

While You Were Long Weekending

We hope you enjoyed the long Memorial Day / Bank Holiday weekend, and that the sun shone whether you attended a parade or laid a wreath or barbecued or landed the space shuttle Atlantis or took two of three from the Yankees or won the Monaco Grand Prix.

So, while you were ...

• ... exercising: Amgen has exercised its option to Cytokinetics' cardiac contractility program. Cytokinetics got $75 million up-front in a combined stock sale and technology license fee in the January 2007 deal that gave Amgen the option on the then-Phase I heart failure drug CK1827452. So far today Cytokinetics has announced a 9am conference call, and Andy Pollack at the NYT is reporting the alliance is a go. The deal's original terms called for Cytokinetics to foot the R&D bill, so the $50 million from Amgen triggered by today's news will come in handy; oh, and the usual biobucks milestones and royalties.
• ... resigning: out with the old at Daiichi's Ranbaxy unit as CEO Malvinder Singh was ousted and COO Abtul Sobti promoted to the top spot.
• ... euphemizing: Awwww, it's business time. Sciele has licensed worldwide rights (word doc) to Plethora's Phase III candidate for premature ejaculation, PSD502. Plethora gets $8.4mm up-front for the additional territories (Sciele had licensed US rights in 2007).
  
• ... making up new words: Chugai has expanded its commercial license to Gene Bridges' 'recombineering' technology, Red/ET.
  
• ... twittering (during brain surgery): yep, the NYT explores how hospitals are on the (excuse us) cutting edge by web-casting and twittering and generally being hip to new media while simultaneously removing gall bladders and kidneys and tumors of all sorts from patients.
  
• ... settling: Biovail's proxy contest with Eugene Melnyk? It's over. Biogen's fight with Icahn? Not over, yet.
  
• ... blocking: CSL says the US Federal Trade Commission may block its $3.1 billion takeover of PE-backed Talecris Biotherapeutics. Reuters has the story.
• ... approving: FDA has approved tadalafil for PAH. United Therapeutics licensed rights to market the drug in PAH from Lilly late last year.
  

image: NASA

While You Were Getting Rained Out in Atlanta

Having a day to kill in Atlanta it made perfect sense to sit in the sun and root against the Braves, but of course mother nature had other plans. After a two hour rain delay the game was postponed; at least they put the Phillies on the jumbotron for a while. If you didn't fly in early to get the saturday night stay fare, while you were in-transit ...

• Amy Harmon writes in the New York Times about the long and arduous path to get a drug, Iplex from Insmed, approved for use in a compassionate use program to treat a patient with ALS.
  
• Where's the love? Onyx suing sorafenib (Nexavar) partner Bayer for rights to a Phase II compound, fluoro-sorafenib, which it claims Onyx should jointly own. In a release Onyx says, "Onyx was recently advised that the compound, fluoro-sorafenib, is a variant of Nexavar® (sorafenib) tablets and has the same chemical structure as Nexavar, except that a single fluorine atom has been substituted for a hydrogen atom. The new molecule had been identified in 1998 during the research collaboration period by the companies' joint research teams. Discussions with Bayer regarding Onyx's rights to fluoro-sorafenib under the companies' 1994 collaboration agreement were not productive."
• From The Pink Sheet ($): More on Lilly's Lechleiter and pharma's "innovation crisis."
  
• There are a few of us IVBers down here in Atlanta (btw: New Atlanta nicknames: may we suggest Coldlanta or Rainlanta?) and we're going to try to entertain and enlighten you with some blogging and tweeting over the next few days. Of course we've got some stuff to do for the magazines that aren't, you know, free, so check out Pink as well.
• Takeda this morning bought IDM Pharma for $75 million, or $2.64 per share (a 55% premium). IDM recently received approval in Europe for a drug to treat osteosarcoma. Check out the story from Reuters.
  
• Oxford BioTherapeutics and GSK have entered an option/alliance deal around antibodies for certain undisclosed cancer targets. Interestingly the deal goes both ways: GSK is developing mAbs around selected OBT targets, and GSK has an option to one of OBT's ongoing programs.
• In other cancer antibody news, Daiichi Sankyo has exercised its option under an existing deal to start two additional programs with Morphosys, bringing the total programs in the deal to four.

While You Were Watching Hoops

The West is where things got particularly ugly this weekend for anybody who took this advice about Cornell, but with zero surprises among the top 12 tournament seeds it's likely that most of you are still alive in your office pools. Unless you took our other advice about the Big East being overrated.

So what else happened this weekend, while you were developing a strong dislike for Coke Zero based solely on its NCAA ad blitz ...

• You got your vacation in my surgery! You got your surgery in my vacation! NYT on medical tourism.
  
• Clinical trials increasingly are conducted globally as companies hunt for treatment-naive patients and less expensive studies. The WSJ discusses some of the drawbacks and difficulties.
  
• Is it splitsville for FDA's food and drugs arms? AP reporting in the Boston Globe and elsewhere that pharma industry advocates are pushing for such reform.
  
• Will there be new life for the blockbuster in 2009? The Pink Sheet examines the 2009 user fee calendar at FDA and makes some interesting predictions and observations ($).
• Merck-Serono is launching a strategic venture capital fund. News of which would have come in handy when a colleague asked us last Friday, "does Merck-Serono have a strategic venture capital fund?" The group will invest up to Eur 40mm over the next five years. Interested? Click here.
  

ugly bracket image by invivoblog

While You Were Studying Bracketology

Allow me to lapse into first-person singular as to not tar my colleagues' collective basketball wisdom with the brush of my own ignorance. Living in the UK, I no longer get to watch enough college basketball to have any solid inkling of which teams and players are likely to have a great March (as if i ever really did). But by most people's reckoning that should put me in good stead for the office pool--he or she who knows least has a great shot at winning--as I select teams based on past allegiances, a 25-year-in-the-making unified theory of NCAA tournament upsets, a deeply ingrained belief that the Big East is overrated, and my two-and-a-half-year old's affection for birds and extreme dislike of "scary monsters." In other words, lots of guessing and prejudice. Its a lot like drug development. Hey-O!

Anyway watch out for the West's 14 Seed, if Cornell's shooters get open from beyond, it's curtains for Missouri ... Meanwhile, while you were filling out your bracket ...

• Astellas takes its directors, its lawsuit and its cash, and goes home: "Astellas is a disciplined acquirer and does not see value for Astellas stockholders in CV Therapeutics at the price level of the sale announced on March 12."
• Headline of the day: "Chuck Norris sues, says his tears no cancer cure" at Reuters. (Seven companies to announce today they are no longer pursuing drugs based on Norris' bodily fluids.)
  
• The "day of reckoning" has arrived for Massachusetts health care costs, says the NYT. Part of the solution: to revamp the way doctors and hospitals are paid by the state. "They want a new payment method that rewards prevention and the effective control of chronic disease, instead of the current system, which pays according to the quantity of care provided." This would be a first.
  
• MRSA is living high on the hog, says Nicholas Kristof, who asks of POTUS and his Ag secretary: "So Mr. Obama and Mr. Vilsack, will you line up to curb the use of antibiotics in raising American livestock?"
• Elsewhere in Op-Ed land, David Shaywitz writes in the Washington Post about the need for better understanding of academic science, or at least for politicians to gain an understanding of how that particular sausage is made. "University research is not a pure enterprise; its researchers have feet of clay and are subject to an array of professional biases," he says. "Consequently, our myopic obsession with industry conflicts of interest may have the unintended consequence of distracting us from some of the more important sources of prejudice and concern."
• One last nugget from the NYT (hey there just aren't that many papers left, OK?): reporting from the annual meeting of the Academy of Allergy Asthma and Immunology, the paper describes a new and promising (not to mention tasty) treatment for peanut allergy: a daily (and medically supervised) small dose of peanuts. The race for the pegylated peanut is ON!

While You Were Mulling It Over

For Genentech investors, with the weekend, perhaps, came decisions decisions. And what to make of Friday's big news? A filibuster-proof majority of our astute readership (at least based on the sample of those of you who decided to vote) say the new $93/share Roche offer for Genentech is inadequate--and most of those predict Roche will come in with (another) higher bid. It ain't scientific, folks, but there you have it. UPDATE: Well, there goes the neighborhood--Merck buying SGP for $41.1 billion.

Meanwhile, while you were reuniting ...

• President Obama lifted Bush-administration restrictions on federally financed human embryonic stem cell research, though he punted on the question of whether federal funds should go toward creating the embryos in the first place. (NYT)
  
• Victory Pharma, privately held specialty pharma & marketer of the NSAID Naprelan, raises $45mm from Essex Woodlands and Ampersand. New money to go toward hiring Robert Duvall for DTC Ad campaign "I love the smell of Naprelan in the morning ... It smells like ... Victory Pharma." **
  
• Some good news for Basilea for a change--Toctino approved to treat adults with severe chronic hand eczema in Scotland.
  
• Takeda shares are reeling following Friday's FDA decision to apply its new diabetes drug development guidelines to the alogliptin NDA. (Reuters)
  

** not true
magic eight ball image from flickr user anth's used under creative commons

While You Were Throwing Snowballs

At least on the East Coast, March has apparently lived up to its reputation and come in like a large cat. Here at IVB we're not so much concerned with the way it begins and ends, but instead would rather focus on the Madness in between.

Speaking of madness: while you were making snowmen ...

• That Sebelius/HHS announcement that made so much news this weekend? Ramsey Baghdadi had the scoop for the IN VIVO Blog.
  
• Art imitates life imitating comedy imitating sad state of the world: Pharma Giles at PharmaGossip.
  
• Wyeth's Prevenar approved in Russia.
• Roche scheme to enhance Pulmozyme compliance probably needed a little more thought, don'cha think? The company has now been censured in the UK for giving out Toys R Us gift certificates to children on the drug, reports the FT.
  
• Actelion's application to expand Tracleer's use into PAH patients with less severe disease greeted with a complete response letter from FDA. FDA says Actelion's REMS first needs to be finalized and approved before it can finish its review of the sNDA.
• Have higher regulatory hurdles affected investment in early-stage Type-2 diabetes companies? VCs weigh in at The Pink Sheet.
  
• Offenses across the NFC East are breathing easier. Sadly, Brian Dawkins, no longer an Eagle, signs 5-year deal with Denver Broncos.
  

While You Were Saying Goodbye to Summer

going, going, gone.

Outta here like a Ryan Howard shot to deep right field, vanished like Keyser Soze, Summer 2008 is now just a memory. Hey, at least football season has begun, right? Below, our roundup of what you might have missed while enjoying that last BBQ of the season.

• European Society of Cardiology: News came thick and fast out of this annual meeting in Munich. The results of a potentially important study of stents vs scalpels in treating clogged arteries are in, and surgery has come out on top. Lilly and Daiichi's prasugrel got a boost in diabetics prior to its 26th September FDA deadline. An analysis of the previously released Triton-Timi 38 trial showed that prasugrel was more effective than standard-of-care clopidogrel (Plavix) in that patient population, reports Reuters. Pronova/GSK's Omacor (fish oil) met both primary endpoints in a Phase III outcomes study in patients with heart failure, who were 9% less likely to die than patients given placebo. AZ's Crestor didn't fare as well in a similar population. Finally, Bayer said it would speed up development of rivaroxaban--putting a little extra pressure on Pfizer/BMS, whose rival candidate apixaban hit a snag last week, as we wrote about here. For more news out of the meeting, click here.
• Shionogi & Co. is the latest in a pretty long line of Japanese pharmaceutical companies buying up cheaper American firms to help expand into western markets. Shionogi bought Sciele Pharma for $1.1 billion ($31/share, a 61% premium to the stock's previous close) plus the assumption of $325 million in debt, the companies announced on Monday. Atlanta-based Sciele had revenues of more than $382 million in 2007, and specializes in women's health, cardiovascular disease, diabetes, and pediatrics. For more on Japanese Pharma appetites, see here, and look for a feature on these trends in an autumn issue of IN VIVO.
  
• Oncology expert Prof. Karol Sikora of CancerPartnersUK diagnoses the ills of the country's NHS and writes this prescription in The Sunday Times: "Radical structural change to the NHS is vital. Competition and choice drive up quality and access, so leading to greater value, just as we’ve seen in other consumer areas such as mobile phones, budget airlines and the high street. Sensible incentives linked to performance and outcomes are essential. Drastic reform, not more money, is now needed."
• Novacea, which begun a strategic review in May after Schering-Plough canceled an alliance around its entered an agreement to merge with Trancept Pharmaceuticals (nee TransOral Pharmaceuticals, click here for our admittedly old 2003 profile of the firm). The latter company, a privately-held specialty pharma that specializes in tweaking the pharmacokinetics of CNS compounds, has raised more than $70 million in venture funding but--surprise, surprise--has been unable in this climate to tap the public markets. If investors buy into this reverse merger, TransCept backers will hold 60% of the combined company, which, the companies say, will have enough cash to pursue FDA approval for and launch its Intermezzo lozenge formulation of the insomnia drug zolpidem (the now-generic Ambien).
• Lipitor ads are back after six months off the air, but you mean nasty bloggers won't have Dr Jarvik to kick around any more! According to the WSJ, Jarvik's out and heart attack survivor John Erlendson is in. What are the odds that he's a rower?
• In the latest installment of its A1 "The Evidence Gap" series, The New York Times asks why more than three million people still take Vytorin/Zetia every day, and notes that some prominent cardiologists are now calling for it to be taken off the market.
  
• The Guardian adds up the challenges facing Big Pharma and, well, that's pretty much it. Would have been nice to see some answers in there too.
  
• Speaking of The Guardian, Ben Goldacre's Bad Science (the book) is on shelves now (at least in the UK). Go on, buy one. And if you haven't already, click the link to his web site in our blogroll to the right to get a preview.
  

While You Were Biden Your Time

For those of you expecting us to pay homage to Usain Bolt, we apologize, but we've moved on. As Beijing passed the torch to London, we bid zai jian to the Bird's Nest, the Cube, and the smog, and say 'ello luv to pub food, double decker buses, and East Enders. And we're pretty sure famed Leona Lewis didn't lip sync her version of 'Whole Lotta Love'.

Meantime Americans were treated to a new phase in a longer and potentially more grueling event than the decathlon--the 2008 election. The Dems finally have a ticket as the party convention gets underway in Denver this week.

But what about the wide world of health care?

• The auction for Elan's drug delivery technologies business continues apace, with Ireland's Sunday Times reporting that Warburg Pincus has entered the fray, joining other private equity players like TPG and Bain Capital (via Reuters).
• MGI Eisai and Helsinn Healthcare received approval for their oral formulation of the nausea and vomiting drug Aloxi over the weekend. The drug, used to treat nausea and vomiting associated with chemotherapy or surgery, is already available as an injection.
• Pfizer has discontinued testing of PF-03187207 for glaucoma in Asia after Phase II results of the NO-donating prostaglandin analog failed to impress. Ex-Asia development was similarly halted earlier this year based on Phase II results in the US. Partner NicOx said this morning that it was in discussions with Pfizer to regain the worldwide rights to the compound, which it felt still had "certain commercial potential which should be realized."

While You Were...Making History

Kudos to Michael Phelps for making it eight straight gold medals and setting a new record for olympic bling in a single games. And don't forget Dara Torres, darling of middle-aged weekend warriors everywhere, proving she's still got the goods to medal against women--I use that term loosely--young enough to be her daughters. Outside of Beijing and South Ossetia, it was a slooow weekend for news. Here's a look at some of the stories you may have missed while you were plugged into your neglectomat.

• The Pink Sheet Daily reports today that the Center for Drug Evaluation and Research's ability to review applications for new drugs and biologics within the timelines specified by the Prescription Drug User Fee Act has slipped a bit, dropping from 90% to 80%. But the drop has nothing to do with summer and those slackers at the FDA. Pink Sheet Daily notes that CDER's performance is better than might have been expected given the center's chronic staffing problems and increased workload.

• Addicted to Roche/Genentech news? The East Bay Business Times reports that a Reuters survey of industry analysts predicts Roche will boost its offer for Genentech to $53 billion, or $107.50-a-share. As colleague Jessica Merrill at Pink Sheet Daily noted in a piece last week, that kind of price tag could prove troublesome for Roche, which might have to cut research budgets or worse in order to wring necessary financial efficiencies out of the deal. Want the inside scoop on the deal? Check out our FREE coverage here.

• Investor's Business Daily has a review of the business strategy of The Medicines Co., which has eschewed blockbusters for more modest selling $200- to $300-million-a-year sellers instead, including the anticoagulant Angiomax and the high blood pressure drug Cleviprex. If the approach sounds familiar, that's because it's taken straight out of the little league manual. Get enough little hits--aka singles--and you score more runs than your opponent and win the game.

• The WSJ reports that Phelps isn't the only one commanding attention in Beijing. J&J, the maker of athlete's foot cream for half a century, has helped rescue one of China's most precious archeological treasures--its terracotta warriors--from a damaging athlete's-foot-like fungus. By nursing one of China's national symbols back to health, J&J hopes to get "a lot of lverage" in China, Alex Valcke, a European J&J exec told the WSJ.

• Finally, the NYT reports on the potential deadly side-effects associated with methadone. Once used mainly in addiction treatment centers to replace heroin, methadone is a synthetic form of opium being given out by family doctors, osteopaths and nurse practitioners for throbbing backs, joint injuries and a host of other severe pains. The drug, which is cheap, long-lasting, and powerful, has helped millions. But because it is also abused by thrill seekers and badly prescribed by doctors unfamiliar with its risks, methadone is now the fastest growing cause of narcotic deaths.
  

(Photo courtesy of Flickr user guano through a creative commons license.)