Impactiviti Daily 052510 Top Pharma News

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TODAY’S NEWS:

Watson gets FDA approval to start shipping generic Valtrex.

Novartis oral MS drug – FDA extends review another 3 months – Novartis will have to wait a bit longer in its bid to get the first oral treatment for multiple sclerosis on the market after regulators in the USA put back a review of Gilenia. The US Food and Drug Administration has extended by three months, to September, its review period for Gilenia (fingolimod), previously known as FTY720…more

Genzyme: Big fine, big changes to get manufacturing back under control.

Another day, another whistleblower suit comes to light. This time, Wyeth and Rapamune promotion for unapproved uses.

Layoffs at Quintiles.

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The Three “I’s” of Tomorrow’s Successful Company. An important perspective from Dennis Urbaniak (VP U.S. Diabetes, Sanofi-Aventis). Titles, Budgets, and Staff are out – Ideas, Initiative, and Inspiration are in.

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50 Beautiful Examples of Architecture Photography.———-

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Today’s Top News in Pharma 071509

FDA to Watson on 24-week Trelstar: Ummm, not yet. Oh, and to Bayer and J&J for Xarelto: Ummmm, not yet.

Bayer’s Yaz and blood clots – the legal wrangling continues.

Solvay selling out on pharma, narrows it down to 2 bidders – Solvay has whittled down the list of bidders for its pharmaceuticals business to Nycomed, the privately held Swiss company, and Abbott Laboratories of the US…more

Transplant drugs have to alter labels to include increased risks – The U.S. Food and Drug Administration today said that it will require manufacturers of some immunosuppressant drugs used in kidney (renal) transplantation to update their labeling to reflect an increased risk of infections…more

More bad news on hormone therapy – Women who took hormone replacement therapy after menopause had a sharply increased risk of ovarian cancer, researchers in Denmark are reporting…more

It’s very early, but this Roche potential cancer drug shows some interesting promise. Glioblastoma is a real problem, in need of some new therapies. And, speaking of early, here’s a very counter-intuitive positive result for an Alzheimer’s treatment. Like, 180-degrees counter-intuitive!

PLUS: From Forrester Research – How to Create a Social Application for Life Sciences without Getting Fired ($$ report).

AND: What are the pharma company early adopters doing on Twitter? Here’s the overview, with stats.

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Today’s Top Three in Pharma 042309

FDA extends review of AstraZeneca/BMS experimental diabetes drug Onglyza.

Teva blocked from launching generic form of Lilly‘s Evista; also rumored to be eyeballing a purchase of Watson.

Roche/Genentech‘s Avastin misses the mark in colon cancer study.

PLUS – you want pharma growth? Sanofi says, Go East! (I know another big pharma also ramping up very rapidly in China…)

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Today’s Top Three in Pharma 040809

Will pharma sales reps be able to go after overtime pay? According to a CT court, the answer is yes – Without getting too technical, at the core of the ruling is the fact that Pharmaceutical Sale Representatives do not actually sell anything. In fact, federal and state law precludes them from making the very sales that would make them exempt. Rather, their role is to inform health care providers about the benefits of a given drug and to attempt to convince those professionals to write prescriptions.

Lying. Not recommended. Ask this BMS exec…oh, and while you’re at it – a cautionary tale about laptops in planes.

New drugs – Sanofi‘s Aplenzin for depression is approved; Watson‘s Rapaflo (approved for BPH in the fall) now available.

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Today’s Top Three in Pharma 040209

Solvay shopping its drug business. Belgian conglomerate Solvay is eying an exit of the drug business with a sale of its pharmaceutical division that could be worth upwards of €5 billion, or $6.6 billion. Solvay didn’t go into details about why it might give up its fastest-growing and most profitable division. But after talk of a deal involving Solvay, the company issued a statement Wednesday saying it was exploring “various options for its pharmaceutical activities,” and that this review involves “discussions with third parties.”

Watson wins an important round with J&J on Concerta going generic.

Genzyme takes over rights to MS and Oncology drugs from Bayer HealthCare – Genzyme has scooped up key worldwide rights to the leukemia drug Campath–which is being studied as a treatment for MS–and two cancer therapies from its development partner Bayer HealthCare in a deal with a potential $2.8 billion payout.

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Today’s Top Three in Pharma 012809

Astellas makes a big to acquire CV Therapeutics. Japan’s Astellas Pharma is offering a billion dollars in cash for CV Therapeutics. The bid comes in at $16 a share, a whopping 41 percent premium over yesterday’s close.

Abilify as an add-on therapy for depression – not everyone is convinced.

Watson‘s topical Overactive Bladder gel (Gelnique) gets FDA approval.

PLUS – Amylin hurting. Abbott‘s Vicodin CR delay means 200 layoffs. And Feds say, “Enough with the off-label promotion already!”

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