FDA
J&J and Vertex’s hep C drug Incivek approved by FDA
May 24, 2011Sales and Marketing FDA, Incivek, Johnson & Johnson, Vertex, hepatitis C, telaprevir
The FDA has approved Johnson & Johnson/Vertex’s new oral hepatitis C drug Incivek. Incivek (telaprevir), a protease inhibitor, is now …
Shire promotional magnet attracts FDA wrath
May 20, 2011Medical Communications, Sales and Marketing FDA, Shire
The use of a promotional magnet by marketers at Shire has attracted trouble from the FDA. The magnet, which is …
Generic and API firms get latest crop of FDA warning letters
May 10, 2011Manufacturing and Production Cephazone, FDA, FDA warning letter, Ningbo Smart, Teva
Generic drugmakers Teva and Cephazone and API producer Ningbo Smart are the latest companies to receive warning letters from the …
Teva’s Irvine facility gets FDA green light
May 3, 2011Manufacturing and Production FDA, Teva, manufacturing compliance
Teva Pharmaceutical Industries has said that an injectables facility in the USA, shut down last April after quality control problems, …
FDA issues guidance on preventing antibiotic cross-contamination
April 19, 2011Manufacturing and Production FDA, GMP, pharma manufacturing
The FDA has published a new guidance document to help drugmakers prevent cross-contamination of pharmaceuticals with non-penicillin beta-lactam antibiotics. The …
FDA issues guidance on glass contamination
March 29, 2011Manufacturing and Production FDA, GMP, glass contamination
The FDA has issued an advisory to pharmaceutical manufacturers on the topic of contamination with thin glass fragments – or …
Dendreon wins green light for Provenge production
March 22, 2011Manufacturing and Production Cancer, Dendreon, FDA, Provenge, pharma manufacturing, prostate cancer vaccine, sipuleucel-T
US oncology specialist Dendreon has been boosted by the approval of additional production capacity for its therapeutic prostate cancer vaccine …
FDA and EMA join forces on quality-by-design
March 22, 2011Manufacturing and Production EMA, FDA, QbD, Quality by Design, pharmaceutical marketing applications
The FDA has teamed up with the EMA on a new pilot programme that will allow parallel evaluation of marketing …
FDA knocks back Merck KGaA’s oral MS drug
March 2, 2011Sales and Marketing Cladribine, EMD Serono, FDA, MS, Merck KGaA, Movectro, multiple sclerosis, oral MS drugs
US authorities have turned down Merck KGaA’s new drug application for its oral relapsing-remitting multiple sclerosis treatment Movectro. The FDA …
Obama’s generics plan criticised
February 15, 2011Sales and Marketing FDA, Obama, PhRMA, generics, reform
US pharma says new plans to end ‘pay-for-delay’ generics deals and shave five years from biologics exclusivity will threaten innovation …
R&D productivity worse than previously reported
February 15, 2011Manufacturing and Production, Research and Development, Sales and Marketing BIO, BMT, FDA, R&D
A new analysis of pharma’s R&D pipelines suggests the overall success rate for drugs moving from clinical trials to FDA …
Digital Pharma: AZ presses the case for social media in pharma
February 11, 2011Medical Communications AZ, AstraZeneca, Digital Pharma blog, FDA, social media
Seemingly fed up with waiting for the FDA’s delayed social media guidance, AstraZeneca has published details of its own feedback …
Teva plant in Israel cited by FDA, expands in Americas
February 8, 2011Manufacturing and Production Corporacion Infarmasa, FDA, Peru, Teva, Teva Pharmaceutical, generics, generics manufacturing, manufacturing compliance
A manufacturing facility in Jerusalem operated by Teva Pharmaceutical failed to pass muster in an FDA inspection, prompting a warning …
Survey shows doctors support FDA Avastin decision
February 7, 2011Sales and Marketing FDA, Roche, Sermo, avastin, bevacizumab
A survey of US doctors suggests that a majority support the FDA’s decision to take away Avastin’s licence for use …
Bayer’s regorafenib gains orphan status for GIST
February 4, 2011Research and Development, Sales and Marketing Bayer, FDA, GIST, gastrointestinal stromal tumours, orphan drug, regorafenib
Bayer’s investigational compound regorafenib has been granted orphan drug status for the treatment of patients with gastrointestinal stromal tumours (GIST) …
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