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FDA

Showing 15 posts of 1444 posts found.

Gilead image

‘Game-changing’ hep C pill gets FDA panel nod

October 29, 2013
Sales and Marketing FDA, Gilead, hep C, sofosbuvir

Gilead Science’s investigational hepatitis C drug sofosbuvir is one step closer to approval in the US after an FDA advisory …

News
Actelion image

Positive CHMP verdicts for Actelion and Lundbeck

October 28, 2013
Sales and Marketing Actelion, CHMP, FDA, Lundbeck

Actelion and Lundbeck both took a step closer to EU approval for two drugs seen as pivotal to their future …

News
gsk image

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
fda image

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
wockhardt image

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
Adderall image

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
mark_mcclellan_jj_fda

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
Ranbaxy image

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
US shutdown image

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
Teva image

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
bayer image

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
FDA image

US shutdown derided by pharma groups

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

News
Ben Venue image

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
Lundbeck image

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
FDA image

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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