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Showing 15 posts of 1445 posts found.

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 …

News
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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 …

News
Biomarin image

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 …

News
FDA Hamburg image

FDA seeks more specialisation in agency structure

February 18, 2014
Manufacturing and Production FDA, GMP, ORA, fdasia, hamburg, opq, ufi

An internal review of the US Food and Drug Administration has concluded that the agency needs to restructure its compliance …

News
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Drug sellers charged for smuggling cancer drugs into US

February 18, 2014
Manufacturing and Production, Sales and Marketing Cancer, FDA, US, smuggling

Two individuals in the US have been prosecuted for smuggling adulterated and misbranded prescription cancer treatments from Turkey and other …

News
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FDA extends licence for Janssen’s Imbruvica

February 13, 2014
Sales and Marketing FDA, Janssen, durect, imbruvica, leukaemia

Janssen and partner Pharmacyclics have been given an extended FDA approval for their new blood cancer treatment Imbruvica. The US …

News
Lilly image

Sanofi files Lilly lawsuit

February 3, 2014
Sales and Marketing FDA, Lantus, Sanofi, lilly

A row which has been brewing between Sanofi and Eli Lilly & Company has now erupted with the French manufacturer …

News
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High-dose Copaxone the right medicine for Teva

January 29, 2014
Research and Development, Sales and Marketing Biogen, Copaxone, FDA, MS, Mylan, Teva

The FDA has approved a high-dose version of Teva’s multiple sclerosis drug Copaxone which will help the firm offset approaching …

News
ranbaxy image

FDA extends Ranbaxy ban

January 27, 2014
Manufacturing and Production, Sales and Marketing API, FDA, Ranbaxy, toansa

India-based generic manufacturer Ranbaxy Laboratories has been dealt a further blow as the US regulator has banned more of its …

News
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J&J profits up amid drug gains

January 23, 2014
Sales and Marketing FDA, J&J, JJ, Remicade, Zytiga, olysio, q4

Johnson & Johnson’s sales in the fourth quarter of 2013 rose 4.5% compared to the same period in the previous …

News
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NICE recommends Aubagio

January 22, 2014
Sales and Marketing Aubagio, EU, FDA, NICE, Sanofi, gilenya

NICE has recommended Genzyme’s multiple sclerosis pill Aubagio for use on the NHS. In final guidance the watchdog said Aubagio …

News

EU regulator recommended 81 medicines in 2013

January 21, 2014
CHMP, EC, EU, FDA, US, rare diseases

Last year the Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for marketing approval, compared with just …

News
Emergent image

Emergent plans to triple anthrax vaccine production

January 21, 2014
Manufacturing and Production Emergent BioSolutions, FDA, anthrax, biothrax

Emergent BioSolutions is planning a major expansion of manufacturing capacity for its anthrax vaccine BioThrax to meet the biodefense objectives …

News
Ranbaxy image

Ranbaxy quality issues hit sixth plant; seeks Diovan workaround

January 20, 2014
Manufacturing and Production FDA, Ranbaxy, fines, manufacturing

Yet another plant operated by India’s Ranbaxy has been held up by US Food and Drug Administration over quality deficiencies, …

News
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Merck recalls Liptruzet on packaging defects

January 20, 2014
Manufacturing and Production FDA, Merck, US, liptruzet, recall

Merck & Co has been forced to undertake a massive recall of its combination cholesterol-lowering drug Liptruzet in the US …

News
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