FDAnews Drug Daily – Vol. 10 No. 32
FDA Advisers Urge Approval of Cangene’s Botulism-Fighting Biologic
Citing scarce treatment options for botulism, the FDA’s Blood Products Advisory Committee has recommended approval of Cangene’s botulinum antitoxin derived from equine sources. Efficacy studies of the Canadian company’s Botulism Antitoxin Heptavalent (H-BAT) in animals showed the product is reasonably likely to provide clinical benefit for humans, the committee said in a unanimous vote.
Drug Industry Daily
Spain Fails to Fulfill VAT Directive, Ordered to Repay the Difference
In a Jan. 17 ruling, the EU Court of Justice held that Spain violated the value-added tax directive by applying a reduced VAT rate to a broad range of medical products. In 2010, the European Commission sent a reasoned opinion to the Spanish government — the second step in the EU infringement proceedings — requesting that the country revise legislation that permitted a reduced VAT on general medical equipment and on substances used in the production of medicines.
International Pharmaceutical Regulatory Monitor
Ferring Petition: FDA Interpreted Hatch-Waxman Wrong
Ferring Pharmaceuticals is petitioning the FDA for five-year exclusivity on its colonoscopy prep drug Prepopik. The agency erroneously granted just three-years of exclusivity because two of the drug’s three active ingredients were already approved, the company argues. Failure to reward Prepopik (citric acid/magnesium oxide/sodium picosulfate) five-year exclusivity is contrary to the intent of the Hatch-Waxman amendments to the 1938 FD&C Act, which intended to reward innovators that develop drug products containing novel active ingredients.
Washington Drug Letter
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Streamlining Your SOPs— What’s in your SOPs? Are they catch-alls, packed with every detail imaginable — everything from what color ink can be used on which documents to where to find the latest informed consent forms? Are they outdated? Are they so long you don’t even know if they’re outdated? After spending countless hours building out elaborate SOPs, at many sites the result is that no one reads them — or can understand them if they do. The impulse to throw up your hands and walk away from the whole issue is a strong one. This management report will show you how to tame your SOPs. Order today. |
Pharmacyclics Gains ‘Breakthrough’ Status for Cancer Drug
Pharmacyclics won “breakthrough” status from U.S. regulators for the medicine that may lead to quicker marketing approval.
Bloomberg
Bill Puts Focus on Region’s Bioscience, Pharmaceutical Resources
A delegation of southeastern Connecticut legislators have introduced a bill they hope will draw attention, and perhaps funding, to existing talents and facilities in the bioscience and pharmaceutical fields.
The Day
Lycera Expands Partnership With Merck for Potential $600 Million Deal
Lycera doubled its sweet 2011 deal with Merck in a new agreement designed to expand on the companies’ prior relationship, which has centered on retinoic acid-related orphan receptor.
BioWorld
Colorado Biosimilar Bill Passes a Key Hurdle
One week after a bill that would have made it more difficult to allow substitution of biosimilars stalled in the Mississippi legislature, a similar bill was passed by an overwhelming majority of a Colorado committee.
Pharmalot
ESC Responds to EU Clinical Trials Directive Revisions
In anticipation of the consideration of the draft report by the European Parliament Environment, Public Health and Food Safety (ENVI) Committee expected early next week, a position paper by the European Society of Cardiology (ESC) welcomes the “spirit” of the EC’s proposed revision of the text of the European Clinical Trials Directive (EUCTD) as an important contribution to “simplifying, clarifying and streamlining” rules for conducting clinical trials across Europe.
EurekAlert
Hospira Reports Fourth-Quarter and Full-Year 2012 Results
Hospira reported results for the fourth quarter and full year ended Dec. 31, 2012.
Yahoo! Finance
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Free Life Sciences Summit: Tuesday, March 12 |
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From Training to Learning: Improving GMP Performance, Feb. 25-26, 2013, Raleigh, NC— This critical workshop thoroughly covers the best way to convey your GMP knowledge to your staff efficiently, accurately and effectively. Through a series of hands-on exercises, you'll develop and deliver a clear and concise GMP training program that will fully prepare your employees to handle GMP with confidence. Register today. |
Updating Your Technology (World of DTC Marketing Blog)
“While the good news is that more pharma brands are planning to allocate more money to digital marketing, the bad news is that there is this huge misconception that digital marketing is less expensive than implementing traditional marketing,” blogger Rich Meyer writes. In a survey of 100 global brands, Mynewsdesk — a brand management company — found 35 percent display out of date information in their online newsrooms. And 70 percent fail to provide additional information in the form of video, info graphics or other multi-media content, he adds. “As pharma product websites, you should be the expert, not only on your product, but on your disease state as well,” Meyer concludes.