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Ranbaxy, FDA enter consent decree over GMP, data breaches
Plans for the $500 million that Daiichi Sankyo set aside to get problem child Ranbaxy out of regulatory jail became clearer Wednesday with the filing of a consent decree. The Indian-based drugmaker and the FDA have agreed to terms that will allow the manufacturer to end several years of market restrictions imposed by the regulator for manufacturing and data-reporting violations. Report
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Also Noted
> "We are committed to ensuring one single high quality standard across Novartis and will invest the necessary resources to achieve this goal in all divisions," said Novartis ($NVS) CEO Joe Jimenez in a financial filing. Story
> Catalent Pharma said it is expanding its Schorndorf, Germany facility, adding R&D and commercial-scale fluid bed technology, OptiMelt hot-melt extrusion and cGMP compliance upgrades. Release
> CMO Patheon has elevated Antonella Mancuso to president, global commercial operations and chief manufacturing officer. Release
> The FDA has added Tromethamine, made by Hospira ($HSP), to the list of resolved drug shortages. Listing.
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Editor's Corner
Pfizer revels in massive Prevnar vax job
Pfizer ($PFE) announced in December it had extended its advance market commitment (AMC) to the Global Alliance for Vaccine and Immunisation (GAVI) for the pneumococcal vaccine Prevnar 13. The drug giant promised an additional 180 million doses through 2023, as did GlaxoSmithKline ($GSK), for its pneumococcal vaccine on top of an existing promise for 300 million doses. Total commitment: 480 million steeply discounted doses.
Special Report
Fierce's 2011 warning letters report
The trend in pharma GMP warning letters for 2011 is that there are more of them, with a higher proportion of warnings to foreign plants, as the letters in this report illustrate.
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- Discovery of new vaccine approach for treatment of cancer
- Illumina’s Board of Directors to Review Unsolicited Tender Offer from Roche
- GenVec Extends Research Collaboration with Global Pharmaceutical Company
- Infinity Reports Update from Phase 2 Study of Saridegib Plus Gemcitabine in Patients with Metastatic Pancreatic Cancer
- Verastem, Inc. Announces Pricing of Initial Public Offering
