FDA

Showing 15 posts of 1442 posts found.

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FDA ‘not trusted’ by Americans

March 19, 2014
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, JAMA, MMR, US, america, conspiracy, yougov

More than one-third of Americans in a new survey think the Food and Drug Administration is holding back new cures …

Pfizer sues over Viagra generic

March 18, 2014
Sales and Marketing ED, FDA, Pfizer, Sildenafil, torrent, viagra

Pfizer is suing Torrent Pharmaceuticals in order to stop it selling copycat versions on its big-selling erectile-dysfunction drug Viagra. The …

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Novo Nordisk unveils plans for $100m API plant

March 17, 2014
Manufacturing and Production API, FDA, Novo Nordisk, Taylor, copenhagen

Novo Nordisk says it will invest around $100m in a new pilot facility to make the active pharmaceutical ingredients (APIs) …

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Roche test for HPV recommended by FDA committee

March 13, 2014
Sales and Marketing Cancer, FDA, HPV, Roche, cervical, cobas

An FDA advisory committee has recommended that a DNA test developed by Roche be approved for use as a primary …

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GSK increases India stake

March 11, 2014
Manufacturing and Production, Sales and Marketing FDA, GSK, India, Nashik, OTC, Thane, bangalore

GlaxoSmithKline has taken a further step into the Indian pharma market by increasing its stake in its subsidiary company there, …

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Ranbaxy hit with second generic Lipitor recall

March 10, 2014
Manufacturing and Production, Sales and Marketing Daiichi Sankyo, FDA, Ranbaxy, hamburg, manufacturing

India’s largest native generic drugmaker Ranbaxy has come under greater pressure this week after the US has again sent out …

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GSK tops drug approval rates

March 7, 2014
Medical Communications, Sales and Marketing FDA, GSK, J&J, JJ, Merck, Sanofi, ep, evaluate pharma, lilly, nme

GlaxoSmithKline is riding high when it comes to the approval of new medicines but US firm Lilly is falling behind. …

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US regulator to launch ‘openFDA’

March 6, 2014
Manufacturing and Production, Medical Communications APIs, FDA, data, manufacturing, open fda

 The FDA is planning to introduce a new digital resource in order to open up its data to the public …

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Manufacturing hitches cited for Lilly/BI drug rejection

March 6, 2014
Manufacturing and Production, Sales and Marketing Boehringer, FDA, diabetes, lilly, manufacturing

The FDA has refused to approve a new diabetes treatment from Lilly and its partner Boehringer Ingelheim due to ongoing …

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InterMune scores in lung trial

February 26, 2014
Research and Development, Sales and Marketing Esbriet, FDA, IPF, InterMune, fvc, lung

InterMune has taken another step on its lengthy road to get the US regulator to approve its drug Esbriet for …

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BMS/AZ fat disorder drug gains FDA approval

February 26, 2014
Research and Development, Sales and Marketing AstraZeneca, BMS, FDA, hep C, metreleptin, myalept

Bristol-Myers Squibb and partner AstraZeneca have been granted FDA approval for a new drug to treat rare and potentially fatal …

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Lilly’s diabetes drug matches Victoza

February 26, 2014
Research and Development, Sales and Marketing EMA, FDA, Victoza, dulaglutide, lilly

Eli Lilly’s once-weekly diabetes candidate dulaglutide has matched Novo Nordisk’s established once-daily Victoza (liraglutide) when it comes to lowering blood …

FDA: India needs more inspectors

February 25, 2014
Manufacturing and Production FDA, India, generics, hamburg

The Food and Drug Administration is to put more inspectors on the ground in India, following a visit there by …

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FDA given $20 million for generic testing

February 24, 2014
Manufacturing and Production, Sales and Marketing ADHD, FDA, generics, hamburg

The FDA has been given $20 million to help it assess generic treatments, a group of drugs that makes up …

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Vimizin shown green light

February 19, 2014
Research and Development, Sales and Marketing BioMarin, FDA, congenital enzyme disorder, vimizin

Regulators have shown the green light to BioMarin Pharmaceutical’s Vimizim as a treatment for a rare enzyme deficiency which affects …

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