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Fdanewsdrugdailybulletin

Oct. 4, 2012

Vol. 9 No. 195

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FDA Asks Judge to Jettison Email Monitoring Suit on Procedural Grounds

The FDA is asking a federal judge to dismiss a lawsuit brought by six agency scientists who say they were subjected to retaliatory personnel actions as punishment for reporting device safety concerns to Congress and the U.S. Office of Special Counsel (OSC). Read More

Cispharma Gets Form 483 Over Testing, Drug Quality Concerns

Cispharma has received a Form 483 with several manufacturing observations, including a lack of evidence that a distributed portion of a lot was acceptable. Read More

CMO Guidance to Discuss Quality Accord Expectations: FDA Official

The FDA will issue guidance detailing what information drugmakers should share with contract manufacturing organizations (CMO) hired to work on their products, FDA officials say. Read More

Nonhormonal Hot Flash Therapy Meets Phase III Goals

Noven Pharmaceuticals reported positive data from separate 12- and 24-week Phase III trials evaluating low-dose mesylate salt of paroxetine for reducing the frequency and severity of moderate-to-severe vasomotor symptoms associated with the menopause. Read More

Takeda Initiates Phase III Lung Cancer Trial in Four Asian Countries

Takeda Pharmaceutical and Millennium: The Takeda Oncology Company have announced that Takeda Bio Development Center has initiated a Phase III clinical trial in Japan, Hong Kong, South Korea and Taiwan, evaluating motesanib in combination with chemotherapy in patients with advanced non-squamous non-small cell lung cancer. Read More

U.S. Judge Approves $700 Million in Abbott Depakote Fines, Costs

A federal judge sentenced Abbott Laboratories to pay $700 million in fines and other costs for illegal marketing of its drug Depakote, in connection with a previously announced settlement, the U.S. Justice Department said. Read More

Merck Releases Positive Data for New Diabetes Drug

Merck’s investigational once-weekly treatment for Type 2 diabetes significantly lowered blood sugar in a Phase IIb study compared with a placebo. Read More

Drug Company in Trials for Treatment of Head Injuries

A New Zealand pharmaceutical company is in advanced trials for a drug they hope will assist in the recovery from concussion. Read More

Hundred Jobs May Be Lost at Pharmaceutical Plant

There is speculation that around 100 jobs are to be lost at Merck Sharp and Dohme in Brinny in Co Cork. Read More