Manufacturing

Sun's FDA Warning Letter

Sun's FDA Warning Letter

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The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.

Sun Pharma to buy Ranbaxy

The announcement will create the fifth largest generics drug maker, reports Reuters.

Ranbaxy shuts two sites

The drugmaker says the voluntary measure was out of an abundance of caution.

FDA's Hamburg says India is a significant pharma partner

FDA's Hamburg says India is a significant pharma partner

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The FDA commissioner said the agency is doing its job, not picking a fight, when it inspects drug-making facilities, and that India must take an active role for a harmonious supply chain.

More Ranbaxy woes

The FDA finds problems at another plant.

Boehringer shutters problematic Ohio plant

1,100 workers will lose their jobs at a plant with a history of around 40 recalls.

Business briefs: Akorn, Bayer, Lonza, plus curbing CNS drug use

Akorn expands, buying Hi-Tech Pharmacal; nursing homes miss their goal to curb antipsychotic-drug use; Bayer cancer drug gets priority review; and Lonza lays off staff

Business briefs: Teva, AbbVie, Novartis, Wockhardt

FDA grants Teva three years exclusivity to sell Plan B OTC for all ages; FDA gives Humira a thumbs-down for spondyloarthritis; a UK vaccine committee rejects Novartis' meningitis B shot; and Wockhardt gets a warning letter from FDA for its manufacturing practices at an Indian plant.

FDA pushes Merck's suvorexant aside

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The regulator says Merck needs to focus on lower doses of the drug.

Business briefs: Bayer, FDA, Ranbaxy

Bayer's prostate cancer drug clears FDA three months early; a House committee is pressing the regulator for employment transparancy; and Ranbaxy takes a multi-million dollar hit over violations

Navidea deploying MSLs in launch of new diagnostic agent

Navidea deploying MSLs in launch of new diagnostic agent

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Medical science liaisons will educate nuclear-medicine clinicians as part of the launch of a new Navidea diagnostic agent for use in breast and skin cancer.

Excedrin relaunch features Sparks, "Thank yous" from migraine sufferers

Excedrin relaunch features Sparks, "Thank yous" from migraine sufferers

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Novartis is hyping its relaunch of Excedrin with a celebrity spokesperson, a migraine app and a survey of women migraine sufferers - along with print and out-of-home ads, radio promotions, direct mail and social media.

Company news: Eli Lilly and Novartis

Eli Lilly to add manufacturing capacity in Indianapolis, Novartis invests more in Singapore

Op/Ed: Meningitis crisis and the threat to pharma

Op/Ed: Meningitis crisis and the threat to pharma

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The deadly meningitis outbreak highlights the threat not only to public health, but also to the pharma industry, posed by the largely unregulated practice of pharmacy compounding.

Company news: UBM Medica, Bristol-Myers Squibb

UBM Medica adds a third iPad app, BMS expands in Puerto Rico.

Company news: GlaxoSmithKline, AstraZeneca, Nature Publishing

GlaxoSmithKline is building its first new UK factory in almost 40 years, the firm said, spurring jobs while breaking new ground at some of its current locations.

Sanofi braces for patent cliff impact

Sanofi braces for patent cliff impact

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Sanofi is girding itself for an ugly year, forecasting a 12%-15% drop in business earnings per share for 2012 as the company absorbs the loss of patent exclusivity on a stable of drugs that brought in more than €4 billion last year.

J&J says no shakeup at McNeil Consumer Healthcare unit

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J&J is pushing back hard against a Wall Street Journal article suggesting that a pair of retirements and a promotion are part of a corporate shakeup of its recall-plagued McNeil Consumer Healthcare division.

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