BioPharma Today

Coming in Monday's "The Pink Sheet" DAILY -- FDA cites Sanofi, Cangene for GMP violations

FDA finds good manufacturing practice violations at Sanofi Pasteur's vaccine production facility in France.

Latest News From "The Pink Sheet" DAILY - Sanofi Leaves Open Possibility Of Acquiring Genzyme

Sanofi Stays Mum On Genzyme But Near-Term M&A Appears Likely

Editors' Picks From The World Press

Pipeline/RD News

• Test helps determine leukemia-drug resistance in patients

Coming in Friday's "The Pink Sheet" DAILY

Sanofi-Aventis is dangling over a serious patent cliff thanks to generic competition to Lovenox and Plavix, two of its top-selling drugs, and the solution to getting back to safer ground could be a significant acquisition. The French drug maker is said to be preparing a formal bid for the U.S. biotech Genzyme, an acquisition that would throw the big pharma into the orphan drug business.

Latest News From "The Pink Sheet" DAILY - Brilinta's Poor U.S. Results Dog Advisory Committee Discussion

UK Government Moves to Combat Low Uptake of Innovative Cancer Drugs

A report highlighting the low use of innovative cancer drugs in the U.K. has prompted the government to target more funding at this area. It may involve a shake-up of NICE, which the pharmaceutical industry has welcomed.   read more

Editors' Picks From the World Press

Pipeline/RD News

• U. of Rhode Island experts work on saliva-based test for drug screening

Off-Label, Online: Know What The FDA Expects Before Internet Promotion Guidance Is Released

Add a new item to your web promotion compliance checklist: website color schemes. Seriously?  Click here for more information, or to register for this Aug. 10 webinar!

Coming In Thursday's "The Pink Sheet" DAILY -- FDA Accepts NDA for Multiple Sclerosis Drug Cladribine, Among Other Stories

Cladribine is back in the running to be the first oral multiple sclerosis therapy to market. EMD Serono, the U.S. affiliate of Merck KGaA, announced that FDA has accepted a refiling of the NDA it rejected in Novmeber and given it a priority six-month review with an action date in the fourth quarter. Competitor Biogen Idec's candidate Gilena has an action date in September.

Clearly Understand Current & Potential Markets for Asia Pacific Healthcare Products

Arm Yourself to Implement Pragmatic Growth Strategies:

Latest News From "The Pink Sheet" DAILY - Sanofi Challenges FDA Approval of Generic Lovenox

Sanofi Sues FDA, Claiming Agency Exceeded Its Authority In Approving Enoxaparin

Editors' Picks From The World Press

Pipeline/RD News

• Survey: Psychiatrists give insomnia drugs that aren't meant for children
• Compound might improve obesity-associated health problems
• Antares drug for bladder control meets the main goal in a Phase III trial

Business Finance

• Pennsylvania biotech firms want in on $1 billion in tax credits
• Teva plans to focus on making deals in Brazil and Mexico
• Merck will partner with Sinopharm to boost its presence in China

Government Legal News

• U.K. government prepares a fund to expand access to cancer drugs
• Seniors group aims to educate consumers about unapproved drugs
• FTC reports a record 21 "pay-for-delay" deals so far this fiscal year
• Think tank wants the FDA to let Americans use EU-approved drugs

Coming In Wednesday's "The Pink Sheet" DAILY - Medco Launches Plavix Study

Anticipating the launch of generic Plavix (clopidogrel) in 2012, Medco is launching a study to find out whether doubling the usual dose of Bristol-Myers Squibb’s anti-clotting drug can offset the problem of reduced effectiveness that comes with concurrent use of a proton pump inhibitor and show that clopidogrel can still be as effective in certain patients as its newer and more expensive competitor Effient. 

Latest News From "The Pink Sheet" DAILY - Positive Data Pushes Drug Filings Forward

Tibotec Files Once-Daily NNRTI Rilpivirine, Part Of Gilead's New Combo For HIV

Studies supporting the application had a mysterious difference in outcomes. Further analysis of virologic failures is under way, says lead investigator.   read more

Coming In Tuesday's "The Pink Sheet" DAILY - J&J's Tibotec Files TMC278 For HIV Indication

Tibotec Pharmaceuticals has filed its once-daily non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine) with the FDA on the heels of releasing Phase III data at the International AIDS Society meeting in Vienna.

Under Pressure: Sanofi's Strategy Will Be Tested By Generic Lovenox Approval

Investor reaction to news of FDA's approval of Momenta Pharmaceuticals M-enoxaparin, a generic version of Sanofi-Aventis' anti-thrombotic Lovenox (enoxaparin) was swift and brutal.

Latest News From "The Pink Sheet" DAILY - Generic Lovenox Approved

FDA Approves Momenta/Sandoz' Lovenox Generic Without Need For Clinical Studies

Agency's five criteria for determining "sameness" of generic enoxaparin to Sanofi-Aventis's low molecular weight heparin could serve as guideposts for future biosimilar approvals. read_more_>