FDA
Pharma relieved as Senate backs FDA fees
May 30, 2012Business Services, Manufacturing and Production, Research and Development, Sales and Marketing FDA, PDUFA, PhRMA, US
The US Senate has approved a law that will continue to allow pharma firms to help fund the FDA. The …
Latest FDA warning letters cite Tedec-Meiji, BMP Pharma
May 28, 2012Manufacturing and Production BMP Pharma, FDA, Tedec-Meiji Farma
Spanish drugmaker Tedec-Meiji Farma and German active pharmaceutical ingredient (API) producer BMP Pharma both feature in the latest crop of …
Plavix loses US patent protection
May 18, 2012Sales and Marketing BMS, FDA, Lipitor, Pfizer, Plavix, Sanofi
Sanofi and Bristol-Myers Squibb’s blood thinner Plavix has lost its patent protection in the US. The drug, which made $6.6 …
Gilenya to stay on US market – but with new safety warnings
May 15, 2012Sales and Marketing EMA, FDA, Novartis, PML, gilenya
The FDA says that Novartis’ multiple sclerosis pill Gilenya should stay on the market, but has added new safety warnings …
New Quad HIV pill on track for FDA approval
May 14, 2012Research and Development, Sales and Marketing BMS, Compera, FDA, Gilead, HIV, The Quad
Gilead Sciences’ four-in-one HIV pill has been given the thumbs up by an FDA advisory group. The US regulator is …
Obesity drugs vie for approval as FDA panel backs lorcaserin
May 14, 2012Research and Development, Sales and Marketing Arena, Eisai, FDA, Qnexa, lorcaserin, obesity
An FDA panel has recommended Arena’s obesity drug lorcaserin, setting up a showdown with Vivus’ Qnexa. Qnexa was recommended by an FDA panel …
Genzyme boosts capacity following green light for Waterford plant
May 8, 2012Manufacturing and Production EMA, FDA, Genzyme, Sanofi, Waterford
Sanofi subsidiary Genzyme has doubled its capacity to fill-and-finish two of its drugs for rare disorders following approval of a …
Novartis will restart production at Lincoln plant in May
May 1, 2012Manufacturing and Production FDA, GMP, Lincoln, Nebraska, Novartis, manufacturing
Novartis chief executive Joe Jimenez has said that production at the firm’s troubled consumer health plant in Lincoln, Nebraska, will …
FDA approves greener process for Januvia production
May 1, 2012Manufacturing and Production Codexis, FDA, Januvia, Merck, manufacturing
The US Food and Drug Administration (FDA) has approved a new, more environmentally-friendly manufacturing process for Merck & Co’s diabetes …
FDA approves new erectile dysfunction drug
April 30, 2012Sales and Marketing ED, FDA, Stendra. Pfizer, Vivus, viagra
The FDA has approved Vivus’ erectile dysfunction drug Stendra, and the firm hopes its rapid mode of action will help …
AstraZeneca diabetes drug recommended in Europe
April 23, 2012Sales and Marketing AstraZeneca, CHMP, FDA, Merck, WHO, diabetes
AstraZeneca and Bristol-Myers Squibb’s new type II diabetes treatment Forxiga has received a positive opinion by European regulators. The European …
Aesica approval sets up further US expansion
April 16, 2012Manufacturing and Production Aesica, FDA
UK contract manufacturer and ingredient supplier Aesica says its manufacturing facility at Queenborough has successfully passed its first FDA inspection …
FDA grants priority review for Sanofi cancer drug
April 5, 2012Research and Development, Sales and Marketing Erbitux, FDA, Regeneron, Sanofi, Zaltrap, colorectal cancer, prostate cancer
The FDA has granted Sanofi and partner Regeneron priority review for their colorectal cancer drug Zaltrap. Zaltrap (aflibercept) is seeking a …
AstraZeneca wins fresh US victory with Seroquel XR
April 2, 2012Sales and Marketing AZ, AstraZeneca, FDA, Seroquel XR
AstraZeneca is celebrating a US court verdict in its ongoing battle for intellectual property over the extended release version of …
Merck KGaA manufacturing under scrutiny by FDA
March 27, 2012Manufacturing and Production FDA, Merck KGaA, Rebif, Violations, manufacturing
The US Food and Drug Administration has asked Merck KGaA to undertake a ‘comprehensive and global assessment’ of its manufacturing …
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