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Sept. 21, 2012

Vol. 9 No. 186

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FDA Reorganizes Regulatory Affairs Office to Respond to Drug Industry Globalization

The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and to keep up with increasingly global operations. Read More

Companies With Supplier Audit Gaps Should Beef Up Incoming Acceptance

While drugmakers should not rely on a “Plan B” for validating suppliers, there are some steps they can take if they can’t conduct sufficient quality audits — primarily beefing up incoming acceptance activities, compliance experts say. Read More

CMO Concerns Draw CRL for Navidea’s Lymphoseek

The FDA has sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities. Read More

Bayer CEO Decries Pressure to Lower Drug Prices

Pressure from governments to lower drug prices risks undermining medical innovation, Bayer AG’s chief executive said on Wednesday, echoing complaints of other drug company executives. Read More

MS Patients Might Benefit From New Oral Drug

Thousands of Americans who suffer from multiple sclerosis (MS) might one day be able to take advantage of a drug that new research suggests is both safe and effective. Read More

Experimental Drug May Help Some Autism Cases, Researchers Say

An experimental drug can improve sociability in patients with fragile X syndrome and may be helpful as a treatment for autism, according to the authors of a new study. Read More

Swiss Pharmaceutical Giant to Open Research Center in NYC

The Swiss drug company Roche plans to open a new research center in Manhattan. Read More

Glenmark Pharma Arm Gets Tentative Nod for Rizatriptan Benzoate

Glenmark Pharmaceuticals said Glenmark Generics had obtained tentative nod from the FDA for rizatriptan benzoate tablets, its generic version of Merck’s Maxalt tablets. Read More

Canada-EU Drug Patents Provoke Backlash

A proposal to extend drug patents in Canada as part of a free trade pact being negotiated with the European Union provoked a backlash this week over fears it would push up health care costs. Read More