FDA

FDA to post inspection information online

Thursday, June 2, 2011 01:46 PM

The FDA will publish more details about inspections and court actions on its web site as part of a drive toward transparency, according to a report on InPharm.

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U.S. R&D productivity often undercounted, as most reports omit FDA biologics approvals

Tuesday, May 31, 2011 09:44 AM

Most reports of pharmaceutical R&D productivity undercount the number of new drugs that reach the market each year, missing out on billions of dollars of sales, because they omit approvals from the Food and Drug Administration’s (FDA) biologics division, according to a new report by London-based research company EvaluatePharma.

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Abbott receives FDA approval for molecular test for HVC

Thursday, May 19, 2011 10:35 AM

Abbott has received approval from the FDA to market its RealTime PCR (polymerase chain reaction) test for measuring the viral load of hepatitis C (HCV). 

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FDA drug approvals on the rise despite slow development time

Wednesday, May 11, 2011 01:02 PM

The FDA has passed nearly twice as many biopharmaceutical drug approvals in the last 10 years than it did in the 1990s, a news release from the Tufts Center for the Study of Drug Development (CSDD) has indicated, according to Mass High Tech.

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FDA approves Novartis drug to treat pancreatic neuroendocrine tumors

Friday, May 6, 2011 12:34 PM

The FDA has approved the Novartis drug Afinitor(everolimus) for the treatment of advanced pancreatic neuroendocrine tumors. 

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Novartis CEO unveils drug development strategy

Wednesday, May 4, 2011 12:43 PM

During a recent interview with Fortune, Novartis CEO Joe Jimenez explained the company's drug development strategy. He reported that Novartis isn’t targeting blockbuster indications but are more focused on pathways, as reported in Fierce Biotech.

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Once-daily Zytiga FDA-approved for prostate cancer

Tuesday, May 3, 2011 01:21 PM

Centocor Ortho Biotech reports that Zytiga (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel has been approved by the FDA.

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Boehringer/Lilly's diabetes drug receives FDA approval

Tuesday, May 3, 2011 12:20 PM

Boehringer Ingelheim and its partner Eli Lilly report that the FDA has approved their once-daily type II diabetes pill linagliptin (Tradjenta).

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C3 Jian and Chinese University establish clinical research center

Monday, May 2, 2011 12:17 PM

California-based C3 Jian has signed an agreement with the West China School of Stomatology at Sichuan University (“West China”) to create a joint clinical research center to test new oral healthcare products in human clinical trials. It will be located at West China’s facilities in Chengdu, China. The research center will operate under U.S. FDA’s GCP.

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Valerie Palumbo joins PharmaNet

Thursday, April 28, 2011 01:01 PM

PharmaNet Development, a provider of clinical development services to pharmaceutical, biotechnology, generic drug and medical device companies, has appointed Valerie Palumbo to serve as senior vice president, corporate quality assurance.

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