FDA
Europe nod for Gilead HCV pill
January 20, 2014Sales and Marketing FDA, Gilead, HCV, hep C, sofosbuvir, sovaldi
Gilead Sciences’ once-daily, oral hepatitis C treatment Sovaldi has been given the green light by the European Commission, just a …
FDA issues online guidance
January 16, 2014Manufacturing and Production, Medical Communications, Sales and Marketing FDA, Twitter, digital, online, ugc
The FDA has issued new guidance on what online promotional material pharma needs to show it. The document is out …
Reprieve for Merck’s vorapaxar
January 16, 2014Sales and Marketing FDA, Merck, heart, vorapaxar
An FDA committee has voted that Merck’s troubled heart drug vorapaxar should be approved by the US regulator. The advisory …
GSK has Tafinlar ‘breakthrough’
January 15, 2014Sales 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 …
FDA approves GSK cancer combo
January 14, 2014Research 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 …
FDA approves Farxiga
January 10, 2014Sales 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 …
FDA and EMA team up for generic drug inspections
January 6, 2014Manufacturing 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 …
Pharma displaying ‘pathological lack of corporate integrity’
December 19, 2013BMJ, FDA, wolfe. pharma
The system that hands out financial penalties to drug companies for illegal activities is failing to deter companies from repeatedly …
FDA pressure intensifies over cyber attack
December 18, 2013Medical 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 …
Priority review for Gaucher drug
December 12, 2013Sales 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 …
Novo Nordisk faces police probe
December 11, 2013Medical 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 …
AbbVie posts strong results for Hep C pill
December 11, 2013Research 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 …
Gilead’s $1,000 per day Hep C drug approved
December 9, 2013Sales 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 …
Astellas seeks Xtandi extension
December 5, 2013Sales 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 …
