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Showing 15 posts of 1442 posts found.

WHO joins regulators in manufacturing inspections alliance

March 12, 2012
Manufacturing 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 …

News
FDA picture

Prescription drugs could become OTC under FDA plans

March 12, 2012
Sales 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 …

News

Synthes plant cited in FDA warning letter

March 8, 2012
Manufacturing 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 …

News
FDA picture

Obesity drug supported by FDA panel

February 23, 2012
Sales 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 …

News
EMA image

EMA to open up drug evaluation process

February 22, 2012
Medical 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 …

News
Caprelsa image

Caprelsa approved in Europe for thyroid cancer

February 21, 2012
Sales 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 …

News

Shortages likely as Sandoz’s Canadian plant woes continue

February 20, 2012
Manufacturing 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 …

News
Pfizer picture

FDA accepts Pfizer rare disease drug for review

February 15, 2012
Sales 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 …

News
Ranbaxy picture

Ranbaxy taken to task by FDA over manufacturing woes

January 31, 2012
Manufacturing 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 …

News

Abbott slashes 700 jobs

January 31, 2012
Manufacturing 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 …

News
Roche picture

Roche’s Erivedge gains FDA approval

January 31, 2012
Sales 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 …

News
Genzyme picture

Genzyme’s Framingham site cleared by FDA

January 24, 2012
Manufacturing 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 …

News
Novartis building

Novartis recalls products as GMP issues close OTC facility

January 9, 2012
Manufacturing and Production FDA, Novartis, OTC

Novartis has revealed that it is temporarily shutting down a manufacturing facility in Nebraska, US, and recalling four products as …

News

FDA: don’t broadcast discussion on off-label uses

January 6, 2012
Medical Communications FDA, Facebook, Twitter, off label, social media

The FDA has released long-awaited guidance for pharma firms about social media use. The FDA held a two-day public hearing …

News

FDA accepts Pfizer’s arthritis pill for review

December 22, 2011
Research and Development, Sales and Marketing FDA, Pfizer, tofacitinib

The FDA has accepted Pfizer’s novel arthritis pill tofacitinib for review, and could be on the US market next year. …

News
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