FDA

Salix expands partnership with Lupin

Friday, April 8, 2011 10:31 AM

Morrisville, North Carolina-based Salix Pharmaceuticals licensed a drug delivery technology from Mumbai, India-based Lupin Pharmaceuticals in 2009. Salix uses that technology in its gastrointestinal drug rifaximin, marketed as Xifaxan. Lupin recently granted Salix exclusive worldwide rights, outside India, to use that technology and any technology jointly developed by the companies for all rifaximin products for human use, according to MedCity News. 

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AstraZeneca's vandetanib approved for MTC

Thursday, April 7, 2011 11:35 AM

The FDA has approved AstraZeneca’s vandetanib, which is a kinase inhibitor and has no brand name yet, to treat adult patients with late-stage medullary thyroid cancer (MTC) who are ineligible for surgery and who have disease that is growing or causing symptoms. The once-daily oral treatment is the first agency-approved drug for MTC, which is estimated to represent 3%-5% of all thyroid cancer.

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Pharmas eagerly await FDA guidance on social media

Thursday, April 7, 2011 11:01 AM

As the FDA further delays its eagerly-awaited draft guidance on social media, U.S. drugmakers have pointed to the "incredible potential public health benefits" of using electronic media in health care, according to Pharma Times.

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Health Research Bus takes clinical trials on the road to boost recruitment, retention in U.K. cities

Monday, April 4, 2011 10:25 AM

With recruitment for clinical trials being tough and retention being even tougher, some are taking recruitment efforts and patient visits directly to the community, instead of waiting for volunteers to come to them.

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Novotech expands into Taiwan

Wednesday, March 30, 2011 12:08 PM

Novotech, an Australia-based Asia Pacific CRO, has opened a Taiwan office as part of its ongoing Asian expansion. 

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Merck pulls out of Portola collaboration

Tuesday, March 29, 2011 12:49 PM

Merck has returned global rights for the investigational clotbuster betrixaban to California-based Portola Pharmaceuticals, according to PharmaTimes.

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Savient signs agreement with U.S. Dept. of Veterans Affairs

Tuesday, March 29, 2011 11:56 AM

New Jersey-based Savient Pharmaceuticals signed a deal to supply the U.S. Department of Veterans Affairs with Krystexxa, its new gout drug, along with its weight-gain medication, Oxandrin, for five years, according to Fierce Pharma.

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ARX, InnovoCommerce partner

Tuesday, March 29, 2011 11:37 AM

ARX, a provider of digital signature solutions, has partnered with InnovoCommerce, an independent software vendor.

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Drugmakers may face FDA fines for slow efficacy confirmation in cancer drugs

Monday, March 28, 2011 01:04 PM

Winning early U.S. approval of promising cancer treatments could wind up costing drugmakers up to $10 million in fines if they don’t confirm their drugs’ effectiveness in follow-up studies within a restrictive timeframe, FDA officials said, according to a Bloomberg report.

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FDA requires sponsors to inform study volunteers that clinical trial information will be posted online

Monday, March 28, 2011 08:05 AM

The FDA has issued a final rule requiring drug developers to include in informed consent paperwork the disclosure that clinical information from the trial will be entered onto ClinicalTrials.gov.

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