Tag Archives: FDA

Engage, But Gently: More Top Line Thoughts on 2014

More Top Line Thoughts on 2014:  Engage, but Gently Two weeks in and the New Year already seems old.  Yet members of our Pharm Exec Editorial Advisory Board are still eager to share their top of line predictions on trends that will shape the industry’s business and reputational assets – forward and backward – over […]
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FDA Push for TRF Therapies Will 'Disrupt Pain Market'

FDA’s push for abuse-resistant opioid formulations will disrupt the pain market, say analysts Frost & Sullivan. The opioid market is currently dominated by non-tamper resistant formulations (TRFs), but FDA’s promotion of TRF therapies “could well result in the departure of non-TRF therapies from the market and shake up its structure.” Unless FDA mandates TRF therapies, […]
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Every Tenth New European Drug Developed in Finland

The number of drugs developed in Turku, Finland and granted marketing authorizations this year now stands at three, with a fourth expected to follow. The FDA has granted market authorization for the IUD Skyla, developed by Bayer and intended for women who have not given birth, and Hormos Medical’s Ophena for postmenopausal symptoms. The European […]
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Deep Breadth: GSK Doubles Down on COPD and Asthma

Will GSK be able to maintain its position in COPD and asthma, post Advair/Seretide? Despite a patent expiry in 2010, generic versions of Advair aren’t expected to appear on the market for two more years. It took FDA eight years to develop a blueprint for how generics manufacturers might establish an acceptable bioequivalence for Advair, […]
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Provider Demand to Drive Compounder Registration with FDA

The Food and Drug Administration is moving fast to implement the drug compounding provisions of new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law. But because FDA cannot compel compounders to opt for agency regulation, implementation will […]
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