FDA
FDA warns against phthalate use in medicines
March 27, 2012Manufacturing and Production FDA, SUPAC, manufacturing, phthalates
The Food and Drug Administration has warned pharma companies not to use two phthalates as excipients in both biological products and drugs, …
AstraZeneca sues FDA over generic Seroquel
March 14, 2012Manufacturing and Production, Sales and Marketing AstraZeneca, FDA, Seroquel, US, generics
AstraZeneca has said it filed a lawsuit against the US FDA in a bid to block approval of generic versions …
Merck warned over missing Januvia safety study
March 13, 2012Research and Development FDA, Januvia, Merck, study
Merck has been warned by the FDA that it must carry out a post-marketing safety study on diabetes treatments Januvia …
WHO joins regulators in manufacturing inspections alliance
March 12, 2012Manufacturing and Production API, EMA, FDA, WHO, manufacturing
The World Health Organization will join a shared inspection programme for active pharmaceutical ingredient (API) facilities piloted last year by …
Prescription drugs could become OTC under FDA plans
March 12, 2012Sales and Marketing COPD, FDA, OTC, prescribing
The FDA is considering new plans to make drugs for chronic conditions available over-the-counter. These drugs could include medicines for …
Synthes plant cited in FDA warning letter
March 8, 2012Manufacturing and Production FDA, J&J, JJ, Synthes, manufacturing
The US FDA has sent a warning letter to surgical equipment manufacturer Synthes upbraiding it for deficiencies at a manufacturing …
Obesity drug supported by FDA panel
February 23, 2012Sales and Marketing FDA, Qnexa, Vivus, Xenical, obesity
Vivus’ obesity drug Qnexa has been supported by an FDA panel, two years after it was knocked back by the …
EMA to open up drug evaluation process
February 22, 2012Medical Communications, Sales and Marketing CHMP, EMA, FDA
The European Medicines Agency will publish ongoing drug evaluations in an effort to make its processes more transparent. The Agency …
Caprelsa approved in Europe for thyroid cancer
February 21, 2012Sales and Marketing AstraZeneca, Caprelsa, FDA, RET, thyroid cancer
The European Commission has approved AstraZeneca’s thyroid cancer pill Caprelsa. Caprelsa (vandetanib) is now available in Europe for the treatment …
Shortages likely as Sandoz’s Canadian plant woes continue
February 20, 2012Manufacturing and Production FDA, Novartis, Sandoz
Ongoing compliance problems at a plant in Canada operated by Novartis’ generics subsidiary Sandoz look set to cause supply disruptions …
FDA accepts Pfizer rare disease drug for review
February 15, 2012Sales and Marketing EMA, FDA, FoldRx, Pfizer, tafamidis meglumine
The FDA has accepted for review Pfizer’s new drug to treat a rare neurodegenerative disease. Pfizer is seeking a licence …
Ranbaxy taken to task by FDA over manufacturing woes
January 31, 2012Manufacturing and Production FDA, Ranbaxy, manufacturing, woes
Indian pharma company Ranbaxy will be banned from manufacturing drugs at certain plants for the US market until it corrects …
Abbott slashes 700 jobs
January 31, 2012Manufacturing and Production, Sales and Marketing Abbott, FDA, manufacturing
Abbott Laboratories has said it will cut 700 jobs across its US and Puerto Rican operations, including hundreds of manufacturing …
Roche’s Erivedge gains FDA approval
January 31, 2012Sales and Marketing Erivedge, FDA, Roche
The FDA has approved Roche’s Erivedge to treat patients with a common form of skin cancer. Erivedge (vismodegib) is now …
Genzyme’s Framingham site cleared by FDA
January 24, 2012Manufacturing and Production FDA, Fabrazyme, Fabry, Genzyme
The FDA has cleared Genzyme to begin production of Fabrazyme at its new manufacturing site. The approval of the new …
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