While You Were Watching Mad Men

On Friday, it seemed like everything happened at once. Generic Lovenox. Teva saying generic Lovenox doesn't mean generic Copaxone (we described that contortion in Pink and on IVB back in January: nobody is in quite the same predicament as Teva). Sanofi-Genzyme? GSK-Genzyme??

Thankfully that momentum failed to generate a wave of weekend announcements and let everyone keep their mind on Sterling Cooper Draper Pryce. Oh, but there was news anyway, of course, news aplenty. And since this is going out late on Sunday, maybe even more news than this -- we'll try to update.

While you were following "team orders" ...

• Britain's new Lib-Con governing coalition is shaking up the NHS, as we and many others wrote about a couple weeks back. The New York Times takes everyone's temperature on the proposal. The reaction is predictably mixed.
• The WSJ profiles NIH's TRND program -- Therapeutics for Rare and Neglected Diseases. Last week "The Pink Sheet" took another look at the program, launched in 2009, to create a drug development pipeline within NIH that can get compounds through preclinical testing and ready for licensing to biotech or pharmaceutical companies in a competitive process.
• Onyx data on carfilzomib expected around 7am -- conference call at 8am ET.
  
• Bloomberg does the math: Teva fell as much as 8% on news that generic Lovenox was approved; analysts suggest shares will be volatile no matter how well Copaxone continues to grow.
  
• Yet another murine version of human disease falls to the almighty sirtuin family, reports the NYT. This time, mouse-Alzheimer's.
• Cerenis pulled in more than Eur 50 million to advance its HDL-mimetic program, and JP Garnier is joining its board. PR on the Eur 40mm Series C here, we'll have more -- including info on the Eur 10.7mm grant the company landed, in today's "Pink Sheet" DAILY.
• A Boston Globe editorial suggests: "Publish data on drug trials -- even when it's not flattering."
  
• A New York Times editorial asks: "Will the agency have the courage to reverse course when a medical treatment that it approved based on preliminary evidence flops badly in follow-up studies?" Gee, i wonder what they're talking about?
  
• Roche's Genentech has licensed a late-preclinical stage fully human IL-17 mAb from NovImmune. Upfront, milestones, royalties -- but specific terms not disclosed.
  
• This is from last week, but it's not every day someone gets a prosthetic arm belonging to the mannequin of Lefty O'Doul in the mail.
• Contador doesn't lose his chain or take a tumble, wins 3rd Tour.
• I'm not sure what I think about Brewdog's End of History beer. Not that I'll ever get to try one. Meanwhile, about a week until the GBBF. Recommendations? In the comments, pls.
  

While You Were Relaxing ...

We hope you enjoyed a lazy summer weekend, and a welcome respite from last week's non-stop craziness. Meanwhile if you're looking for a dozen pages of in-depth advisory committee analysis, you'll find it in this week's Pink Sheet.

While you were dropping three out of four to the Cubs ...

• The New York Times explains the amyloid hypothesis, and takes a look at earlier intervention in Alzheimer's disease. Cameos from Elan's bapineuzumab and Bristol's BMS-708163.


• Also in the NYT, FDA has slapped Columbia University's renowned Kreitchman PET Center for allowing too many impurities in the radiotracers it uses and repeatedly violating FDA regs for four years.


• Reuters reads the Swiss papers so you don't have to: Novartis' Jiminez maintains offer to independent Alcon shareholders is "fair."


• Not all the advisory committee drama was last week: next up, Avastin. The SF Chronicle previews.


• The Washington Post unpacks the debate over consumer genetics testing regulation and previews this week's public hearing.


• Avandia gets Bad Science'd: "an ugly story about our collective medical incompetence."


• Data presented at the AIDS conference in Vienna suggests treating patients with cocktails of HIV drugs can prevent the spread of infection.

image from flickr user virginia zuluaga used under a creative commons license

While You Were Losing Ugly

What did we learn from the World Cup Final? Drop kicking is the new headbutting. Congratulations to the Spaniards, deserved winners last night.

Meanwhile, while you were getting ready for Avandia Week (sorry, Qnexa) ...

• Merck-Serono's oral cladribine has been approved in Russia, and will be marketed there under the name Movectro beginning some time in 2011, once reimbursement is secured.


• Biogen Idec and Swedish Orphan Biovitrum presented Phase I/II data on their long-acting Factor IX hemophilia B treatment at a conference in Argentina over the weekend.


• Does Avid have an Alzheimer's biomarker on its hands with the radioactive dye AV-45? Reuters reports.


• J&J is being sued over its children's OTC medicines recall, with plaintiffs seeking class action status. Apparently, they don't like coupons, reports Bloomberg.


• Reata has raised $78 million in a Series G (as in goodness that's a lot of money) financing led by existing investors CPMG and Novo AS. The cash will fund a second pivotal trial of the company's lead asset, bardoxolone in chronic kidney disease.

screen cap by flickr user keith williamson used under a creative commons license

While You Were Getting Eliminated

Ah, the World Cup Not a pleasant weekend to be an American or English fan of the beautiful game; we could, um, parrot the experts, but we'll spare you. Let's just say it was very disappointing. Of course if you read the press in England, you could be forgiven for thinking it was the end of the world.

But life goes on. ADA continues this week in Orlando -- plenty of GLP and insulin news, below -- and our very own EuroBiotech Forum starts Tuesday in Paris. It's not too late to sign up for two days of partnering and excellent content, including keynote talks from Novartis Pharma CFO Jonathan Peacock and Teva Pharmaceuticals Europe president and CEO Gerard van Odijk.

While you were watching the drugs that watch your blood sugar ...

• Morphosys has licensed a Phase I anti-CD19 antibody from Xencor. The last time we checked in with Morphosys regarding its in-licensing ambitions, CEO Simon Moroney told us "The review isn't complete and we're optimistic, but the ground isn't littered with jewels." We're glad they finally found something shiny enough to pay $13mm u/f for. Xencor will run Phase I for what is now known as MOR208 and then Morphosys picks up development, paying Xencor milestones and royalties on worldwide sales.


• Will Novartis need to up its bid for the eyecare giant Alcon? That company's independent directors committee certainly thinks so, and it has an expert backing it up, reports Reuters.


• Boehringer Ingelheim will work with Marinomed to commercialize in various markets an OTC nasal spray for the common cold. Marinomed gets about €1 million u/f and could receive milestones based on market entry and royalties.


• AstraZeneca and Medicines for Malaria Venture announced a partnership whereby MMV will have access to AZ's compound library for discovery efforts against malaria parasites.


• ADA: Novo Nordisk's diabetes drugs were on display at ADA -- liraglutide bested Januvia as an add-on to metformin and proof of concept achieved for ultra-long-acting insulin Degludec. Analysts report this morning that Novo also began talking about liraglutide Depot, a longer-acting version of the peptide.


• ADA: BMS and AZ put out a trio of releases on Saturday with Onglyza and dapagliflozin data. Onglyza and metformin as first line combo therapy? Check. Onglyza/metformin non-inferiority study vs glipizide/metformin? Check. Dapagliflozin add-on Phase III? Check.


• ADA: There's plenty more from Byetta, Januvia, canagliflozin, taspoglutide and all your other favorites. News roundup here.

image from flickr user baldheretic used under a creative commons license

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 Sealing the Deal

For OSI, it turns out that $4 billion is the magic number. Astellas raised its bid for the biotech to $57.50 per share over the weekend and nailed down an endorsement from the OSI board. The market expected a higher bid -- Astellas' winning price (an improvement over its $52/share bid) suggests no white knight had emerged. Still at 55% above the price of OSI shares before the hostile offer in early March, the Tarceva co. didn't come cheap.

Meanwhile, while you were basking in the Game 7 afterglow ...

• Hospital owner Universal Health Services said this morning it would buy Psychiatric Solutions, a mental-health facilities operator, for $33.75/share ($2 billion cash plus assumption of $1.1 billion debt). Reuters story here. The bid tops private equity player Bain.


• Thrombogenics and BioInvent will share a €10 million milestone from Roche as TB-403 begins an imaging study in patients with metastatic, treatment refractory colorectal and ovarian cancers.


• Bloomberg talks to GSK's Abbas Hussain about the Big Pharma's emerging markets surge, and the ongoing land-grab among the industry's biggest players.


• Halozyme blames Baxter for manufacturing snafus on its Hylenex fluid absorption drug. HALO delivered a notice of breach to Baxter, which has 120 days to comply.


• That sound you heard friday night was the epic collapse of the Boston Bruins (or as we prefer to think about it, the epic comeback of the Philadelphia Flyers). Philly got the Eastern Conf finals off to a good start Sunday night, thwacking Les Habs and the suddenly human Jaroslav Halak 6-0.


• Finally -- this blogger is planning to fly to the US on Wednesday. What does that mean? VOLCANIC ASH! Yes, our old friend Eyjafjallajokull is back! Ugh.

image from flickr user Susan NYC used under a creative commons license

While You Were Bailing Out Europe

What's €750 billion among friends? Finance ministers across the continent scrambled this weekend to come up with a (just-don't-call-it-a-) bailout to relieve the ongoing and potentially spreading European debt crisis. But in the pharmaceutical corner of the world, it seems hard news was replaced by management profiles.


While you were recovering from BIO ...

• Joe Jiminez talks to the FT about settling in as CEO of Novartis, how he works with Dan Vasella, and cost cutting at Big Pharma.


• The NYT profiles generics giant Teva. The secret to Teva's success? Small offices! (Among other things.)


• Takeda said this morning that it would co-promote Velcade in Japan. Takeda's Millennium subsidiary originally licensed Japanese rights -- along with a host of other geographic rights -- to J&J's Ortho Biotech in 2003.

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

While You Were Turning Three

It's IVB's birthday, so have a cupcake. As always, thanks for reading and commenting. And remember, IVB is just the appetizer -- check out the rest of what we have to offer.

On to your weekend news. While you were grounded ...

• Charles River Labs is buying WuXi Pharmatech in a cash/stock deal valued at $1.6 billion, creating a worldwide presence in early stage drug development services. The deal prices WuXi at $21.25/ADS, a 28% premium to Friday's close.


• Nycomed has inked a set of deals with Merck & Co. around European and Canadian rights to Daxas, its first-in-class PDE-4 inhibitor for COPD. The Swiss pharma wasted little time cashing in on the positive opinion it received late last week from EMA's CHMP.


• Index Ventures unveils Index Seed. The VC is dedicating a pool of capital to seed investments and hopes to do 20 over the next two years. The fund will have a technology focus, but life-sciences deals aren't ruled out.


• In the New York Times Magazine, blogger/psychiatrist Daniel Carlat explains a fundamental shift in his field, one that has led to a split between specialists in therapy and psychopharmacology and the implications for patients today and the future of psychiatry.

image from flickr user clevercupcakes used under a creative commons license

While You Were Stranded

Volcano 1 -- IN VIVO blogger, 0.

Yours truly was supposed to fly to the US on Saturday for a few days of work at EBI HQ Monday-Wednesday. (OK, there were tickets to Sunday's Phillies and Flyers games involved too.)

We've heard from industry friends stranded in Vienna after EASL (looking for your liver doc? He/She's probably still listening to Mozart, drinking strong coffee and eating tiny cakes right about now). There are more serious issues, to be sure. Students stranded. Unattended state funerals. Canceled meetings and conferences. Jobs and families to return to.

The news is full of the result of the ash-cloud disruption. On Sunday the airline industry -- reportedly losing $200 million per day -- started to grumble that imposed flight restrictions were over-zealous or just plain unnecessary. How big is the impact? Well, as of this writing the popularity of the underappreciated 1990 film "Joe vs the Volcano" (as measured by IMDb) is up 70% this week.

Today, we are all Joe. Or perhaps we're all another Tom Hanks character, Viktor Navorski, the unlucky man-without-a-state who gets stuck for ages in an airport Terminal.

Stuck somewhere awful? Somewhere not-so-awful? How did the volcanic ash affect your business plans? (A question we never anticipated asking if there ever was one.) Let us know in the comments.

Meanwhile, while you were living out of a suitcase ...

• Avandia: The WSJ reported on Sunday that FDA is considering putting the brakes on GSK's Avandia v Actos (from Takeda) safety study. Quoth the Journal: "Dr. Hamburg's principal deputy, Joshua Sharfstein, said the decision on the trial "cannot be de-linked from the agency's view of Avandia," suggesting that if the trial must be halted, the agency would also consider asking Glaxo to halt sales of the drug."
• Sandoz: Novartis' generic drug unit is acquiring Oriel Therapeutics, a respiratory-focused biotech backed by New Leaf Venture Partners, Thomas, McNerney & Partners, HealthCare Ventures and CHL Medical Partners. Terms weren't disclosed.
• Elan: the Irish biopharma is exploring a spin-off of its Elan Drug Technologies business, a move that would create two publicly listed companies. Getting deja vu? The company reportedly tried to sell EDT back in 2008.
• H Lundbeck: The H is for 'how do you like them apples?' The Danish CNS company wins a round in court and generic versions of escitalopram will be pulled from its home market.
• AACR: At the conference in Washington, Amgen presented the results of a biomarker analysis of the Phase III pivotal trial for Vectibix. The company explored whether nine particular genetic mutations affected response to the drug. Patients with wild-type KRAS and NRAS genes had significantly improved progression-free survival compared to patients with mutant versions of those genes.
• M&A: Astellas says it isn't going to raise its bid for OSI Pharmaceuticals based on expanded approval for Tarceva, though due diligence is ongoing.
• NHL Playoffs. The game we missed turned out to be a solid effort from the Flyers, who might have won 8-2 were it not for the acrobatics of the NHL's finest-ever goalie, Martin Brodeur. Philly up 2-1 in the series.
  

While You Were Time Traveling

OK we haven't seen it yet but on the combined strength of AO Scott's NYT review and the commercials we've seen, we'll go ahead and call next year's best picture winner for "Hot Tub Time Machine". And if you think that isn't a device designed to tie together a few of the weekend's industry happenings, well, you're not paying attention to In Vivo Blog.

While you were finding plutonium for your flux capacitor ...

• One person in the know called it "the worst kept secret in Washington": President Obama will nominate Donald Berwick to head up CMS. We suggested that might happen way back in February 2009. People, either this has taken a very long time, or we have bent space and time. Your call.
• Novartis would probably like to have a spin in the HTTM today, to go back and prevent its younger self from plunking down more than a few million for rights to Antisoma's ASA404 cancer compound. Sadly that drug didn't show a survival benefit in a Phase III lung cancer study, the companies said today. We covered their deal--the second around that compound after original partner Roche handed back rights--back in April 2007. Man, the In Vivo Blog is getting old.
• Predicting benefit from drugs before treatment? How futuristic. Bloomberg reports on the Nature paper that describes a test that may predict response to beta interferons in MS patients.

While You Were Reforming

Eventually those totals you see on the screencap above hit 219 -- 212, followed by a second vote, 220 -- 211, to adopt the tweaks to the Senate bill that were necessary to get the 219 on the first vote.

A couple Obama signatures later and the US has the comprehensive health care reform legislation that has dominated the agenda for months. And now for the hard part: selling the reform bill and coming out the other end politically alive.

Check out our family of pubs-- especially "The Pink Sheet" and The RPM Report -- for various takes on the consequences of the House vote and the implications for industry. Pharma, with its 32 million new customers, is a big winner (as we've been saying all along).

While you were staying up late to watch C-SPAN ...

• The NY Times recaps Sunday's drama.
  
• And Bloomberg looks at the impact on drug companies.
  
• As for the stock market, Reuters reports that at least in Europe, investors aren't fazed by the passage of HCR.


• Meanwhile, Roche aims to extend the label for its Mabthera juggernaut in Europe.


• Finally, some basketball news. You know at one point getting comprehensive health care reform passed seemed less likely than Cornell reaching the Sweet 16 of the NCAA Mens Basketball Tourney. Next up for the Big Red, a looming upset of 1 seed Kentucky up in Syracuse.

image from flicker user paulbettner used under a creative commons license.

While You Were Selecting

It was all ACC and NCAA this weekend, so lets get to the heart of it (thanks we'll be here all week). Actually, no, we have to get something off our chests: The Cornell Big Red deserved better than a 12 seed! Seriously, committee, that's harsh. And pitting Cornell against Temple? Way to make it all about the ex-Penn coaching matchup. Pffft.

Anyway, while you were Springing forward ...

• ACC: Navigator leads Novartis down the wrong path. Studies of Diovan and Starlix in high-risk patients don't pay off for the Big Pharma (Bloomberg).


• ACC: Tricor trips up Abbott. (At least they've got heart valve clips to pick up the slack.) The drug, when added to simvastatin, didn't result in better outcomes than simvastin alone in the five-year ACCORD study conducted by the NHLBI. "The Pink Sheet"'s report is here. Is it the end of Tricor? Is it the beginning (or the middle) of the end for drugs without outcomes data? Did I leave the iron on?


• The NYT muses on the impact of the health reform outcome on the Obama presidency. For the twenty thousandth time.


• Remember that other March madness game of interest? Astellas' unsolicted--hey, we don't want to color your thinking with the word "hostile"--bid for OSI? OSI officially urged shareholders to reject the latest offer this morning. The tender wraps up March 31.


• It was bad news/good news for the Byetta LAR triumvirate Lilly/Amylin/Alkermes. The FDA dinged the drug with a complete response asking for a REMs and clarification about manufacturing processes, but apparently no additional lengthy clinical trials are needed.


• Privately-held Bausch & Lomb announces two ex-Schering execs totop spots. Fred Hassan takes over as chairman and Brent Saunders, who previously served as president of Schering-Plough's consumer healthcare unit under Hassan, will be Bausch's CEO. Does this mean B&L will be more actively eyeing optho Rx and consumer deals?


• What's in YOUR bracket? IVB is curious ... maybe we'll set up a tourney pool this year if we can think of a suitable prize.

image from flickr user mr lynch used under a creative commons license

While You Were Thanking the Academy

Two years ago it was pageboy, this year it's high-and-tight. My how styles change quickly.

"The Hurt Locker" triumphed during last night's Oscar ceremony, taking the big Best Picture and Director awards, Best Screenplay (orig.), best Editing, and nods in two sound categories. "Avatar" didn't go home empty handed, but Cameron & Co. probably figured on beating "Up" by more than just one statuette.

Meanwhile, you know how sometimes there are more technical awards that they don't bother to present in prime time? Where a 30 second montage will do just fine thank you? Well it's a little known fact that during THAT awards ceremony they show a montage of the awards deemed too dorky for the technical crowd.

The envelope, please ...

• Best Pitcher: Pfizer apparently wants Ratiopharm, and wants it bad. How bad? Let's just say Jeff Kindler wasn't hanging out along the Bayern/Baden-Wurttemberg border for kicks on Friday.


• Best Foreign Language FlimFlam: Merck KGaA has "indeed a few ideas," Reuters reports that the Frankfurter Allgemeine Sonntagszeitung reported. Acquisitions "are part of our strategy." In other news, the sun rose in the east.


• Best Drug Biopic: Everything you ever wanted to know about where Sutent comes from, courtesy Bloomberg.


• Best Use of Clinical Acronyms in a Supporting Role: Roche and Biogen Idec said this morning that they were halting certain trials of the Phase II ocrelizumab in RA (where it has been tested in trials called SCRIPT, FEATURE, FILM and STAGE) and lupus (BELONG and BEGIN). A DSMB determined that the safety risk (death from serious infections) outweighed the benefits in these populations, though trials in MS are ongoing.
  
• Best Reason to Keep In-Licensing: AstraZeneca said its first-line metastatic CRC hopeful Recentin was effective but did not meet its primary endpoint in the first of two pivotal trials. AZ hoped the drug would prove non-inferior to Avastin in the Phase III Horizon study in terms of progression-free survival. A second Phase III in glioblastoma should read out in the first half of 2010.


• Best Scoop: Our colleagues at OverTheCounterToday supplement your biopharma diet with consumer medicine goodness, and on Friday, revealed that Sen. McCain was withdrawing his support for the bill he introduced to significantly tighten regulatory requirements for dietary supplements.
  

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 Taking a Homeopathic Overdose

In Britain, hundreds of protesters gathered outside branches of the drug store Boots to endulge in a little comedy 'overdose' of homeopathic pills. The sugar rush must've been amazing.

Meanwhile, in Washington, here comes the budget. And it ain't pretty ...

While you were watching a pretend football game ...

• GSK plans to cut about 4,000 more jobs in the US and Europe, reports the Sunday Times. The official word is expected on Thursday when the Big Pharma reports its 2009 financials.


• Harvard and Imperial College scientists have elucidated the structure of a key HIV enzyme, integrase, reports Reuters. The findings should aid drug discovery and resistance-prevention efforts.


• Merck Serono: no timeline yet on FDA resubmission of MS drug oral cladribine.


• FDA isn't happy about one oft-quoted dermatologist's premature enthusiasm for Dysport in 2007, which hadn't yet been approved. The forum? The women's magazine Allure.
• UPDATE: Cephalon is buying the Merkle-owned Swiss generics company Mepha for $590 million. The deal doubles the size of Cephalon's overseas business, which until now mainly comprised the assets of former European specialty play Medeus.

image from flickr user shellac used under a creative commons license