BioPharma Today

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

Wendy Diller — Fri, 30 Jul 2010 10:17:49 PDT

FDA finds GMP violations ate Sanofi Pasteur's vaccine facility in France - FDA cites Cangene for GMP violoations in its manufacture of vaccines - Merck is committed to becoming less "U.S. centric"

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

Wendy Diller — Fri, 30 Jul 2010 06:13:52 PDT

Sanofi stays mum on possibility of acquiring Genzyme - FDA panel okays surrogate endpoint in Revatio pediatric trials - AstraZeneca not interested in acquisitions for scale - Merck teams up with Sinopharm on vaccines - Athersys gets an efficacy signal in Phase I study of adult stem cell product

Editors' Picks From The World Press

Wendy Diller — Fri, 30 Jul 2010 06:04:18 PDT

Pipeline/RD News Test helps determine leukemia-drug resistance in patients Study: 2 diabetes drugs increase fracture risk in older patients Business Finance Reduced funding hampers a global battle against AIDS India seeks a consultant to help boost its drug industry by...

Coming in Friday's "The Pink Sheet" DAILY

Wendy Diller — Thu, 29 Jul 2010 10:37:19 PDT

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.

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

Wendy Diller — Thu, 29 Jul 2010 06:42:34 PDT

UK Government Moves to Combat Low Uptake of Innovative Cancer Drugs

Editors' Picks From the World Press

Wendy Diller — Thu, 29 Jul 2010 05:57:20 PDT

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

Josh — Wed, 28 Jul 2010 11:49:40 PDT

Add a new item to your web promotion compliance checklist: website color schemes. Seriously?

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

Wendy Diller — Wed, 28 Jul 2010 10:33:32 PDT

FDA accepts NDA for EMD Serono's multiple sclerosis drug cladribine - Astellas Pharma extends licensing agreement for Regeneron's Velocimmune technology - FDA advisory committee to look at impact of high-dose aspirin use on Brilinta - Pharma to work with UK government to make innovative cancer drugs more readily available

Clearly Understand Current & Potential Markets for Asia Pacific Healthcare Products

Josh — Wed, 28 Jul 2010 10:30:32 PDT

Arm Yourself to Implement Pragmatic Growth Strategies: Identifying and forecasting healthcare market opportunities across the Asia Pacific region presents a significant challenge to medical technology companies. Differences in language, inconsistent methods of reporting, varying availability of healthcare data, and a...

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

Wendy Diller — Wed, 28 Jul 2010 06:05:46 PDT

Sanofi sues FDA for approving generic enoxaparin - FDA backs surogate endpoint for Pfizer's Revatio - Servier suspected of misleading European Commission in antitrust probe - Sandoz launches generic Lovenox - Medco study to find out if higer dose Plavix can offset reduced effectiveness when used with proton pump inhibitor - German packaging proposals will burden industry and regulator - Glenmark likley to drop research on metabolic disorder compounds

Editors' Picks From The World Press

Wendy Diller — Wed, 28 Jul 2010 05:50:51 PDT

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...

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

Wendy Diller — Tue, 27 Jul 2010 10:42:55 PDT

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

Wendy Diller — Tue, 27 Jul 2010 07:50:26 PDT

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

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

Wendy Diller — Mon, 26 Jul 2010 10:07:28 PDT

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

Josh — Mon, 26 Jul 2010 09:12:59 PDT

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

Wendy Diller — Mon, 26 Jul 2010 06:37:27 PDT

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