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Fdanewsdrugdailybulletin

Sept. 14, 2012

Vol. 9 No. 181

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FDA Anticipates Slow, Rocky Start for Biosimilars Program: Woodcock

The FDA is projecting a sluggish start for its new biosimilars approval pathway. Read More

ICH Panel Mulling Revision of Q7 Guideline on API GMPs: FDA Official

An informal working group of the International Conference on Harmonisation (ICH) is looking into revising or rewriting the “dated” Q7 standard on GMPs for active pharmaceutical ingredients (API), an FDA official says. Read More

DPT Lakewood Warned Over Investigation Flubs, Sterility

DPT Laboratories’ investigations into batch failures at its Lakewood, N.J., plant are inadequate and heighten concern about microbiological contamination of topical drugs, according to an FDA warning letter. Read More

FDA OKs PET Agent for Prostate Cancer

The FDA has approved the positron emission tomography (PET) imaging agent Choline C 11 Injection for production and use in detecting recurrent prostate cancer. Read More

Whooping Cough Shots Lose Effectiveness Surprisingly Fast; Another Booster Is Considered

As the U.S. wrestles with its biggest whooping cough outbreak in decades, researchers appear to have zeroed in on the main cause: The safer vaccine that was introduced in the 1990s loses effectiveness much faster than previously thought. Read More

Popular Painkillers Linked to Hearing Loss in Women

Do you have a headache? Stomach ache? Back pain? For many people, the first impulse when they feel pain is to reach for the bottle of Tylenol or their OTC painkiller of choice. Read More

Oncolytics Expands Enrollment for Cancer Drug Late-Stage Trial

Oncolytics Biotech said it expanded enrollment in a late-stage study testing its head and neck cancer drug to determine its effects on two distinct patient groups. Read More

Ethicon Adding Facility, Jobs in Athens

Medical company Ethicon will spend $185 million to add a 100,000-square-foot facility in Athens, Ga., creating 75 jobs through 2016. Read More

Hisun-Pfizer Pharmaceutical to Hire 600 China Staff by Year-End

Pfizer’s joint venture with Zhejiang Hisun Pharmaceutical plans to hire 600 people in China by the end of the year, its CEO said. Read More