Glaxo R&D Chief Offers A Progress Report
Every so often, an update appears on how GlaxoSmithKline is faring with its so-called DPUs. These are known inside the drugmaker as drug performance units and were formed in 2008 to prompt the R&D folks to think differently about their budgets, goals and performance (back story). The upshot: every three years, they make a pitch […]
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FDA Publishes Final Guidance For Industry On Applications For Nonprescription Drug Products
The U.S. Food and Drug Administration (FDA) recently released a guidance on “Time and Extent Applications for Nonprescription Drug Products” (the “Guidance”). The Guidance describes the FDA’s latest thinking on the information applicants should provide when requesting that conditions be added to the FDA’s over-the-counter (OTC) drug monograph system. Specifically, the Guidance focuses on the […]
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FDA Wants to Ease Way for Innovation
The FDA has announced a new “blueprint” to spur biomedical innovation, which contains a plan to make it easier for drugs and devices that are considered “personalized medicine” to come to market. FDA Commissioner Margaret Hamburg told reporters on Wednesday that the overall plan — released as part of a sweeping report on improving innovation […]
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AstraZeneca to build $200 million plant in China
AstraZeneca has unveiled plans for a $200 million investment in a new manufacturing facility in China. The plant, in China Medical City (CMC), Taizhou, Jiangsu province, represents the company’s “largest-ever investment in a single manufacturing facility globally”. It will produce both intravenous and oral solid medicines and construction of the site is scheduled to be […]
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California Gov Signs Controversial Vaccine Law
Following months of controversy, California Governor Jerry Brown late last week signed into law a bill that removes parental consent for vaccinating children 12 and older against sexually transmitted diseases. Although state law already allows children 12 and older to consent to treatment for sexually transmitted diseases without parental involvement, the new law expands that […]
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A Melnyk Comeback? A Little Shpritz, A Lot Of Sex
Who’s a hockey puck? Eugene Melnyk, whose tenure as chairman of Biovail was marked by turmoil and controversy, seems determined to make a comeback. And as the largest shareholder in Trimel Pharmaceuticals, he may yet find a way. The nascent drugmaker says its successfully completed a test for an experimental sexual dysfunction medicine delivered in […]
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How To Delay Generics? Draw A Line On A Pill
Here is a novel way to thwart generic competition. Simply add a so-called score, or line, across a tablet and the FDA may force generic rivals to rework their own versions, which amounts to a delay in approval. Meanwhile, the cash register at the brand-name drugmaker offices will keep ringing. That’s what Warner Chilcott hopes […]
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Drugmakers Lose Another Hepatitis C Trial
For the second time in a year and a half, Teva Pharmaceuticals and Baxter Healthcare have a lost a trial in which a jury determined they contributed to a 2008 hepatitis outbreak in Nevada due to the way the Propofol medication was marketed. Another defendant was McKesson, the big distributor. The jury awarded three people […]
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FDA Approves Cialis to Treat Enlarged Prostate
Cialis has been approved by the FDA for the treatment of enlarged prostate. It may also be used to treat men who have both enlarged prostate and erectile dysfunction (ED) at the same time. Cialis is the first ED drug to be approved for treating benign prostatic hyperplasia (BPH). Commonly known as enlarged prostate, symptoms […]
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Congress Probes Distributors Over Drug Shortages
Secondary drug distributors are now the focus of a congressional probe in the worsening prescription drug shortage. Elijah Cummings, the ranking Democrat on the House Oversight and Government Reform Committee, has given five distributors two weeks to respond to questions after hospitals have complained that they have received offers of hard-to-find meds at huge mark-ups. […]
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