FDA

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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FDA to assess drugmakers’ websites

Thursday, April 28, 2011 12:18 PM

U.S. drug regulators will scrutinize consumer reactions to websites for prescription drugs in an attempt to research how to apply advertising rules to social media, according to a Bloomberg report. 

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FDA finds Vertex’s HVC drug effective

Wednesday, April 27, 2011 01:48 PM

The FDA has indicated that Vertex Pharmaceuticals’ experimental drug telaprevir cures more patients of hepatitis C than any current therapies, according to a Bloomberg report. 

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Eli Lilly 's new anti-psychotic offers no weight gain

Wednesday, April 27, 2011 12:49 PM

The schizophrenia drug Zyprexa was one of Eli Lilly's biggest success stories; however, the company has also paid big settlements regarding claims that it hid data about a burdensome weight-gain side effect. As a result, Lilly has begun late-stage trials for a next-generation schizophrenia drug that offers treatment without weight gain, according to FierceBiotech.

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Boehringer enrolls first patient in phase III trial for HVC

Wednesday, April 27, 2011 12:09 PM

Boehringer Ingelheim Pharmaceuticals has begun enrollment at North American sites in its phase III clinical trial program for BI 201335, the company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV). Phase III trials have begun recruiting to evaluate BI 201335 plus standard-of-care (SOC) in both treatment-naive and -experienced patients with chronic genotype-1 HCV, the most challenging HCV genotype to treat.

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A.P. Pharma raises $4.5 million, names new CEO

Tuesday, April 26, 2011 11:58 AM

California-based A.P. Pharma has raised $4.5 million in convertible notes and named a new CEO, according to Silicon Valley/San Jose Business Journal.  The specialty pharmaceutical company's lead drug candidate is designed to prevent acute-onset and delayed-onset chemotherapy-induced nausea and vomiting.

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