BioPharma Today

Coming In Monday's "The Pink Sheet" DAILY

Wendy Diller — Fri, 13 Nov 2009 10:23:22 PST

FDA issued a warning to health care professionals Nov. 13 that lots of five biologicals manufactured by Genzyme, including Cerezyme, Fabrazyme and Myozyme, could be tainted with foreign particle contamination. The contamination is thought to be found in less than...

Best Practices For Patient Registries Are Evolving - Are You Prepared?

Sean — Fri, 13 Nov 2009 06:29:11 PST

Building a smart patient registry can improve regulatory compliance. But it can also be good for business.

Latest News from "The Pink Sheet" DAILY

Wendy Diller — Fri, 13 Nov 2009 04:33:36 PST

Google Creates New Formats To Include Risk Information In Sponsored Search Results - Top Ten Unpartnered Drugs: Trying To Move Past Treating Symptoms In Neuroscience - Glaxo Taps Astex for Fragment-Based Discovery Deal Worth At Least $33 Mil. ...

Editors' Picks from The World Press

Wendy Diller — Fri, 13 Nov 2009 04:29:10 PST

Interaction between 2 genes might serve as drug target for cancer - Talecris to announce expansion, shares company results - WHO: Give antivirals early to groups vulnerable to H1N1 flu. ...

Coming in Friday's "The Pink Sheet" DAILY

Wendy Diller — Thu, 12 Nov 2009 10:49:56 PST

With the go-to antipsychotics and antidepressants headed for a patent cliff, start-ups looking to partner on mood disorder drugs have a double incentive to come up with something novel and effective. Harry Tracy, president of NI Research in Cardiff, Calif.,...

Latest News From PharmAsia News - Astellas, Chugai, IFPMA, Green Cross

Sean — Thu, 12 Nov 2009 09:33:41 PST

Korea's Green Cross Seeks To Unveil Injectable Flu Antiviral Peramivir Even Before KFDA Approval. ...

Will The U.S. Purchase Generic Tamiflu From India? Cipla In Discussions

Sean — Thu, 12 Nov 2009 06:09:45 PST

Known for supplying low-priced anti-retroviral cocktail therapy to frontline African nations to combat the spread of HIV/AIDS, Cipla - India's largest drug maker by market share - is in discussions with U.S. health agencies to boost production of antiviral oseltamivir, the generic for Roche's Tamiflu for treating the rapidly spreading H1N1 virus.

Latest News From "The Pink Sheet" DAILY

Wendy Diller — Thu, 12 Nov 2009 05:23:26 PST

Regeneron Secures Sanofi-Aventis Antibody Funding Through 2017

Is Allergan In A No Lose Situation With Its 1st Amendment Case Against FDA?

Sean — Thu, 12 Nov 2009 05:22:19 PST

Allergan’s lawsuit against FDA over post-marketing safety restrictions for Botox is yet another new wrinkle that may help define the significance of the new “Safety First” regulatory era. But there is more to this case than meets the eye.

Latest News From "The Tan Sheet" - DOJ, FDA, GSK, Perrigo

Sean — Wed, 11 Nov 2009 10:31:29 PST

FDA Gets Strict On Liquid OTC Dosing Devices In Draft Guidance + DOJ To Expand Use Of False Claims Act To Manufacturing And AER Violations + Glaxo Adds Alli Warning Label In Europe +....

Coming In Thursday's "The Pink Sheet" DAILY

Wendy Diller — Wed, 11 Nov 2009 10:25:55 PST

In a joint interview, Pfizer R&D heads Martin Mackay and Mikael Dolsten fill in details of the company’s plan to revamp its R&D site structure and simplify research operations.

Highlights From PharmAsia News - Pfizer, Novotech, Smith & Nephew

Sean — Wed, 11 Nov 2009 09:05:39 PST

Pfizer's Shanghai R&D Site To Serve As R&D Hub For Asia. ...

Latest News From "The Pink Sheet" DAILY

Wendy Diller — Wed, 11 Nov 2009 05:22:49 PST

Bristol Pays $85 Million Upfront To Acquire Rheumatoid Arthritis Compound From Alder

Featured Headlines From Today's Issue Of PharmAsia News

Sean — Tue, 10 Nov 2009 12:00:42 PST

Drug Prices Subjected To Japanese Prime Minister's Budget Trimming Program. ...

Coming in Wednesday's "The Pink Sheet" DAILY

Wendy Diller — Tue, 10 Nov 2009 11:09:15 PST

Privately held Alder Biopharmaceuticals gets a sizeable $85 million upfront from Bristol-Myers Squibb for Phase II antibody for rheumatoid arthritis.

Roche, Alnylam's High-Profile RNAi Alliance Moves into a New Phase

Sean — Tue, 10 Nov 2009 08:37:11 PST

Roche, Pleased with the progress of their 2-year-old relationship, Roche and Alnylam will now collaborate on discovery and development of specific RNAi compounds for select therapeutic areas. Read on...

Sentinel Will Start Small, FDA Tells IoM; Are Expectations Too Big?

Sean — Tue, 10 Nov 2009 08:31:45 PST

FDA, Agency plans to launch two "mini-Sentinel" pilots, one using private data sources and one tying together Medicare, VA and DoD data. More importantly, agency is focusing on using Sentinel for signal strengthening—that is, to test signals generated via existing means, not generate new ones. That position seems to have broad support from thought leaders in epidemiology, but may not match stakeholder expectations for Sentinel. Read on...

The Health Care Reform Corner

Sean — Tue, 10 Nov 2009 08:25:27 PST

What are policymakers and stakeholders in Washington saying and doing about health care reform? In this periodic BioPharma Today feature, the editors of "The Pink Sheet" and "The Pink Sheet" DAILY highlight some of the major developments chronicled in those publications.

Shionogi Files Early NDA For Flu Drug Peramivir, Aims For 3 Million User Annual Supply

Sean — Tue, 10 Nov 2009 08:18:59 PST

Shionogi, Shionogi announced Nov. 4 the company filed a new drug application for influenza drug peramivir with Japan's Ministry of Health, Labor and Welfare in October. The early NDA submission came just three month after the Osaka-based company completed a Phase III study for the drug. Read on...

Cliff Nearing, It's Lilly's Turn to Restructure

Sean — Tue, 10 Nov 2009 08:13:54 PST

Merck, Teetering on the brink of a vast patent cliff, Eli Lilly & Co. in mid-September announced a reorganization and cost-cutting initiative designed to reduce costs by $1 billion by the end of 2010.Read on...

Generic Injectables: Pharma Takes A Shot At A Growing Market

Sean — Tue, 10 Nov 2009 08:00:57 PST

Eli Lilly, When it comes to drugs driving generic growth, usually blockbusters such as Lipitor and Plavix come to mind. But there is another area of the generic market that offers plenty of dynamic potential - sterile drugs administered by injection or infusion. Read on...

Latest News From "The Pink Sheet" DAILY

Wendy Diller — Tue, 10 Nov 2009 06:06:55 PST

Pfizer Selects Sites for its Post-Merger Global R&D Network Newly merged company will cut R&D staff by 15 percent, though timing is unclear. read more Warner Chilcott Transformation Underway With Integration Of P&G's Pharma Biz With the acquisition of Procter...

Coming in Tuesday's "The Pink Sheet" DAILY

Wendy Diller — Mon, 09 Nov 2009 10:18:10 PST

Warner Chilcott begins integrating Procter & Gamble's pharmaceutical business, marking a transformational commercial change. The Supreme Court hears oral arguments in Bilski v. Doll, addressing patent processes. The closely watched case generated more than 60 amicus briefs, including those from...

Latest News From "The Pink Sheet" DAILY

Wendy Diller — Mon, 09 Nov 2009 06:29:56 PST

FTC Investigating CVS Caremark Business Practices The National Community Pharmacists Association and legislators have been pressuring the Federal Trade Commission to revisit the merger between the CVS retail pharmacy chain and the Caremark pharmacy benefit management firm. read more Roche,...

Coming in Monday's "The Pink Sheet" DAILY

Wendy Diller — Fri, 06 Nov 2009 10:31:53 PST

FTC is investigating the business practices of CVS Caremark following a strong lobbying push by independent pharmacists for the government to take action. Gloucester Pharma says it is ready to go it alone launching Istodax, which won FDA approval for...