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Showing 15 posts of 1442 posts found.

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US regulator ponders Arzerra

October 22, 2013
Sales and Marketing Arzerra, CLL, FDA, GSK

GlaxoSmithKline and Genmab have submitted their blood cancer drug Arzerra to the FDA as a first-line treatment for chronic lymphocytic …

News
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Dust settles on US shutdown

October 21, 2013
Medical Communications, Sales and Marketing FDA, Obamacare, PhRMA, shutdown

The FDA has said that it was able to carry out a significant part of its remit during the suspension …

News
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MHRA recalls five Wockhardt medicines

October 18, 2013
Manufacturing and Production FDA, GMP, MHRA, Violations, Wockhardt, recall

The UK drugs regulator has recalled five more generic medicines made by Indian drugmaker Wockhardt after an inspection uncovered quality …

News
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Shire slated following Adderall T-shirt controversy

October 18, 2013
Medical Communications, Sales and Marketing Adderall, EMA, FDA, Shire

A senior doctor and patient welfare advocate has criticised Shire after T-shirts emblazoned with the word ‘Adderall’ appeared for sale …

News
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Former FDA commissioner joins J&J

October 16, 2013
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, J&J, JJ

Johnson & Johnson has announced that ex-FDA commissioner Mark McClellan has been appointed to its Board of directors. Dr McClellan …

Appointment
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FDA throws Ranbaxy a manufacturing lifeline

October 15, 2013
Manufacturing and Production FDA, Ranbaxy, recall

Problems have plagued Ranbaxy’s manufacturing operations in the last couple of years, but it enjoyed a bit of light relief …

News
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US shutdown affecting medical science

October 11, 2013
Research and Development, Sales and Marketing FDA, Obama, Obamacare, us shutdown

American scientists and the latest Nobel Prize winners have condemned the US shutdown this week saying it is putting scientific …

News
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Teva to axe 5,000 jobs in savings drive

October 11, 2013
Manufacturing and Production, Research and Development, Sales and Marketing Copaxone, FDA, Teva, cuts

The world’s largest generic drugmaker Teva will cut around 5,000 jobs from its global workforce as it looks to speed-up …

News
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Bayer pill gains FDA approval despite shutdown

October 9, 2013
Sales and Marketing Bayer, FDA, adempas, hypertension

In the midst of the US shutdown of government agencies the FDA has managed to approve Bayer’s Adempas for patients …

News
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US shutdown derided by pharma groups

October 7, 2013
Medical Communications, Sales and Marketing FDA, Obamacare, PhRMA, shutdown

News
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1,100 jobs to go as Ben Venue confirms closure of Bedford unit

October 7, 2013
Manufacturing and Production, Sales and Marketing Ben Venue, Boehringer, FDA

Boehringer Ingelheim is calling time on its troubled facility in Ohio operated by Ben Venue Laboratories and says it will …

News
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Brintellix ‘yes’ from FDA

October 4, 2013
Sales and Marketing FDA, Lundbeck, Takeda, brintellix

Takeda Pharmaceutical Company and Lundbeck are celebrating after the FDA approved their depression treatment Brintellix – despite there being no …

News
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US shutdown starts to bite – UPDATED

October 2, 2013
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CDC, FDA, Medicare, Obama, Obamacare

Twenty-four hours into the US government’s shutdown, the impact on pharma of the freezing of federal government activity remains hard …

News
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Perjeta becomes first approved drug for early breast cancer

October 1, 2013
Sales and Marketing FDA, Herceptin, Perjeta, Roche

Roche’s Perjeta has become the first preoperative breast cancer drug to be authorised by the FDA after it was granted …

News
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The future of data disclosure in Europe

September 30, 2013
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, FDA, GSK, transparency

The debate of clinical trial transparency has at times appeared a peculiarly British issue, but plans are afoot in Europe …

Feature
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