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Showing 15 posts of 1442 posts found.

GSK has Tafinlar ‘breakthrough’

January 15, 2014
Sales and Marketing Cancer, FDA, GSK, NSCLC, Tafinlar

GlaxoSmithKline is on a roll, with its cancer drug Tafinlar given breakthrough therapy designation by the FDA in lung cancer …

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FDA approves GSK cancer combo

January 14, 2014
Research and Development, Sales and Marketing FDA, GSK, Tafinlar, mekinist

US regulators have shown the green light to a combination of two GlaxoSmithKline skin cancer drugs, Mekinist and Tafinlar, to …

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FDA approves Farxiga

January 10, 2014
Sales and Marketing AstraZeneca, BMS, FDA, Forxiga, diabetes

The FDA has approved Farxiga, the diabetes treatment developed by AstraZeneca and Bristol-Myers Squibb as part of their soon-to-be-defunct diabetes …

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FDA and EMA team up for generic drug inspections

January 6, 2014
Manufacturing and Production EMA, FDA, GMP, Taylor, manufacturing

The regulatory authorities in the US and EU have taken another step towards harmonisation by agreeing to pool their resources …

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Sanofi hit hard by Lemtrada rejection

January 2, 2014
Medical Communications, Research and Development, Sales and Marketing Aubagio, FDA, Genzyme, Lemtrada, MS, Sanofi

News
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Pharma displaying ‘pathological lack of corporate integrity’

December 19, 2013
BMJ, FDA, wolfe. pharma

The system that hands out financial penalties to drug companies for illegal activities is failing to deter companies from repeatedly …

News
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FDA pressure intensifies over cyber attack

December 18, 2013
Medical Communications, Research and Development, Sales and Marketing FDA, PhRMA, cber, digital, leak

The FDA is facing mounting pressure from a US government committee into how it allowed several of its databases to …

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Priority review for Gaucher drug

December 12, 2013
Sales and Marketing EMA, FDA, Gaucher, Genzyme, Sanofi

The FDA is to conduct a speedy investigation into Sanofi’s twice-daily oral candidate for Gaucher disease, which means that Cerdelga …

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Novo Nordisk faces police probe

December 11, 2013
Medical Communications, Sales and Marketing FDA, Novo Nordisk, police

Novo Nordisk is facing an investigation from Denmark’s police over delaying the release of negative information it received from the …

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AbbVie posts strong results for Hep C pill

December 11, 2013
Research and Development, Sales and Marketing 3D, AbbVie, FDA, Gilead, hep C

AbbVie’s investigational hepatitis C pill cured 96% of difficult-to-treat patients in a late-stage clinical trial and looks set to muscle …

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Gilead’s $1,000 per day Hep C drug approved

December 9, 2013
Sales and Marketing FDA, Gilead, hepc, sofosbuvir, sovaldi

Gilead’s Sovaldi has gained FDA approval as a potential cure for hepatitis C after the US regulator sped up its …

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Astellas seeks Xtandi extension

December 5, 2013
Sales and Marketing Astellas, Cancer, EU, FDA, US, Xtandi

Astellas Pharma and development partner Medivation are seeking to extend the reach of oncology brand Xtandi by conducting a trial …

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FDA slaps import ban on Wockhardt facility

November 29, 2013
Manufacturing and Production FDA, MHRA, Wockhardt, recall

The US Food and Drug Administration has banned imports of medicines made at Wockhardt’s Chikalthana plant in India that failed …

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BTG gets FDA nod

November 29, 2013
Sales and Marketing BTG, FDA, Varithena, varicose vein

UK healthcare group BTG has received approval from the FDA for a new type of varicose vein treatment to be …

News
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Google diagnostic firm receives scathing FDA warning

November 26, 2013
Medical Communications, Research and Development, Sales and Marketing FDA, dna. 23andme, google

The Google-backed DNA testing firm 23andMe has received a warning letter from the FDA saying it cannot continue to market …

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