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Showing 15 posts of 1442 posts found.

Gilenya image

Gilenya to stay on US market – but with new safety warnings

May 15, 2012
Sales 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 …

News

New Quad HIV pill on track for FDA approval

May 14, 2012
Research 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 …

News
FDA picture

Obesity drugs vie for approval as FDA panel backs lorcaserin

May 14, 2012
Research 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 …

News
Genzyme image

Genzyme boosts capacity following green light for Waterford plant

May 8, 2012
Manufacturing 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 …

News

Novartis will restart production at Lincoln plant in May

May 1, 2012
Manufacturing 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 …

News
FDA picture

FDA approves greener process for Januvia production

May 1, 2012
Manufacturing 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 …

News
FDA picture

FDA approves new erectile dysfunction drug

April 30, 2012
Sales 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 …

News

AstraZeneca diabetes drug recommended in Europe

April 23, 2012
Sales 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 …

News
Aesica image

Aesica approval sets up further US expansion

April 16, 2012
Manufacturing and Production Aesica, FDA

UK contract manufacturer and ingredient supplier Aesica says its manufacturing facility at Queenborough has successfully passed its first FDA inspection …

News

FDA grants priority review for Sanofi cancer drug

April 5, 2012
Research 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 …

News

AstraZeneca wins fresh US victory with Seroquel XR

April 2, 2012
Sales 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 …

News
Merck KGaA image

Merck KGaA manufacturing under scrutiny by FDA

March 27, 2012
Manufacturing 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 …

News
FDA image

FDA warns against phthalate use in medicines

March 27, 2012
Manufacturing 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, …

News
AstraZeneca picture

AstraZeneca sues FDA over generic Seroquel

March 14, 2012
Manufacturing 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 …

News
Merck image

Merck warned over missing Januvia safety study

March 13, 2012
Research 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 …

News
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