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FDA

Showing 15 posts of 1445 posts found.

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FDA makes GSK wait

August 6, 2013
Sales and Marketing FDA, GSK, albiglutide, diabetes

The FDA is making GlaxoSmithKline wait for a verdict on the manufacturer’s investigational type 2 diabetes treatment albiglutide, extending its …

News
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FDA ‘lacks authority to oversee compounding pharmacies’

August 2, 2013
Manufacturing and Production FDA, GAO, NECC, Taylor

The US Food and Drug Administration lacks the power to properly regulate compounding pharmacies, according to a new Government Accounting …

News
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Actelion to buy Ceptaris

August 1, 2013
Sales and Marketing Actelion, FDA, ceptaris, valchlor

The US arm of Swiss speciality pharma group Actelion is in line to pay $250 million to buy private firm …

News
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FDA clarifies import rules for ‘pre-launch’ medicines

July 29, 2013
Manufacturing and Production Draft Guidance, FDA, pre launch, pre-launch

New draft guidance on the import of unapproved medicines in anticipation of approval in the US has been published by …

News
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AZ and BMS go for second Forxiga submission

July 29, 2013
Sales and Marketing AZ, BMS, FDA, Forxiga

AstraZeneca and partner Bristol-Myers Squibb have resubmitted their diabetes drug Forxiga to the FDA 18 months after it was rejected …

News

Boehringer nears European approval for first cancer drug

July 29, 2013
Sales and Marketing Boehringer, Cancer, FDA, afatinib

Boehringer’s first cancer drug is just months away from being approved in Europe after a committee for the EMA gave …

News
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AMRI says troubled Burlington plant back on track

July 24, 2013
Manufacturing and Production AMRI, FDA, GMP

It looks like contract research and manufacturing organisation AMRI can put the quality problems at its facility in Burlington behind …

News
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FDA warning letter for troubled Wockhardt plant

July 23, 2013
Manufacturing and Production FDA, Wockhardt, warning

The US regulator has issued a warning letter to a facility operated by Indian drugmaker Wockhardt already subject to an …

News
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J&J says revived OTC brands are ‘winning the hearts of consumers’

July 19, 2013
Manufacturing and Production, Sales and Marketing Control, FDA, GDP, J&J, JJ, OTC

Johnson & Johnson doesn’t usually provide specific financials for its over-the-counter pharmaceuticals business, but did so for the first time …

News
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FDA approves Boehringer’s lung cancer drug

July 12, 2013
Medical Communications, Sales and Marketing Boehringer, FDA, Roche, Tarceva, afatinib, lung cancer

Boehringer Ingelheim’s late-stage lung cancer drug Gilotrif has received an accelerated FDA approval for patients with a certain genetic mutation. …

News

Fresenius Kabi hit by second FDA warning letter

July 10, 2013
Manufacturing and Production API, FDA, Fresenius Kabi, GMP

German generic drugmaker Fresenius Kabi has been sent another warning letter from the FDA citing deficiencies at a manufacturing plant. …

News
GSK image

GSK files cancer combination

July 10, 2013
Sales and Marketing FDA, GSK, Tafinlar, mekinist

GlaxoSmithKline has put in supplemental applications for its Tafinlar/Mekinist combination – a pair of drugs which analysts predict may have …

News

Roche leukaemia drug granted speedy US review

July 3, 2013
Research and Development, Sales and Marketing CLL, FDA, Roche, leukaemia, obinutuzumab

Roche’s investigational leukaemia drug could be available for US patients by the end of the year as the FDA looks …

News
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FDA gives Perjeta priority

July 3, 2013
Sales and Marketing FDA, Perjeta, Roche, breast cancer

The FDA has granted priority review status to an application for Roche’s Perjeta to be used before surgery in HER2-positive …

News
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China tightens quality standards for pharma distributors

July 2, 2013
Manufacturing and Production China, FDA, GMP, GSP

From 1 July new pharmaceutical distributors in China will be obliged to adhere to the country’s recently-issued Good Supply Practice …

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