FDA

Showing 15 posts of 1442 posts found.

data report

Sharing trial data should be ‘expected norm’ says US think-tank

January 15, 2015
Medical Communications, Research and Development, Sales and Marketing FDA, Goldacre, Institute of Medicine, clinical trials, transparency

Clinical trial data is in the public interest and should be shared no less than 30 days following regulatory approval …

Brilinta image

AstraZeneca’s troubled Brilinta gets welcome lift

January 14, 2015
Sales and Marketing AstraZeneca, Brilinta, FDA, US Department of Justice, acute coronary syndrome, ticagrelor

AstraZeneca has reported positive primary endpoint results for its anti-clogging drug Brilinta to treat patients who have had a heart …

dendreon image

Another NICE no for Dendreon cancer drug

January 13, 2015
Sales and Marketing Cancer, Dendreon, FDA, NHS, NICE, Provenge, sipuleucel-T

Dendreon has seen its prostate cancer treatment for people whose disease has spread and who are not yet suitable for …

FDA image

FDA approvals: 1996 versus 2014

January 12, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, John LaMattina, LaMattina, NDA, US, appovals, drugs

As highlighted in a number of recent stories, 2014 was a banner year for the biopharmaceutical industry with 41 new …

Daiichi image

Daiichi-Sankyo blood drug gets FDA nod

January 12, 2015
Sales and Marketing BMS, Daiichi Sankyo, Daiichi-Sankyo, FDA, Pfizer, Pradaxa, atrial fibrillation, blood, savaysa

The US Food and Drug Administration has shown Daiichi-Sankyo’s anti-clotting drug Savaysa the green light to reduce the risk of …

Novartis image

Novartis seeks FDA approval for lung drugs

January 8, 2015
Sales and Marketing Advair, FDA, GSK, NVA237, Novartis, QVA149, Seretide, asthma, lung copd

Novartis has submitted two new lung treatments for FDA approval after ‘robust’ Phase III trial results. If approved, QVA149 and …

Sandoz image

Sandoz earns historic first FDA biosimilar vote

January 8, 2015
Sales and Marketing FDA, Humira, Novartis, Sandoz, Zarxio, filgrastim, zarzio

Sandoz has taken a huge step forward in the race to be the first company to market a biosimilar in …

Valeant pharma

Valeant recalls drug used on hospitalised infants

January 6, 2015
Manufacturing and Production, Sales and Marketing Actavis, Allergan, FDA, Valeant, manufacturing, recall, ribavirin, virazole

North American drug firm Valeant Pharmaceuticals has issued a voluntary nationwide recall of Virazole due to microbial contamination. Virazole (ribavirin …

moxifloxacin

Next-generation Cempra antibiotic meets endpoints

January 5, 2015
Research and Development, Sales and Marketing Antibiotics, FDA, cempra, moxifloxacin, solitaire-oral

Cempra Pharmaceuticals has become the first company to publish results from a Phase III study completed under FDA regulations governing …

Pharma industry set for bumper 2015

January 5, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing 2015, FDA, bumper, harvoni, opdivo, pharma, sovaldi

Industry analysts predict 2015 will be another year of growth for the pharma, after approvals of new drugs soared to …

Novo image

Novo Nordisk obesity drug gets FDA nod

December 24, 2014
Sales and Marketing FDA, Novo Nordisk, Victoza, diabetes, liraglutide, saxenda

The US Food and Drug Administration has shown Novo Nordisk’s obesity drug Saxenda the green light to aid chronic weight …

Cyramza

Lilly to market stomach cancer drug in Europe

December 22, 2014
Sales and Marketing Eli Lilly, Europe, FDA, US, cyramza, ramucirumab, stomach cancer

Eli Lilly has been granted permission by the European Commission to market Cyramza in Europe. Lilly’s Cyramza (ramucirumab) is the …

Abbvie

Abbvie Hep C drug gains FDA approval

December 22, 2014
Sales and Marketing AbbVie, FDA, Gilead, Viekira Pak, dasabuvir, harvoni, hepatitis, hepatits C

Abbvie has gained sign-off for its rival treatment to challenge Gilead’s dominance of the growing market for new hepatitis C …

Merck image

Merck acquires Swiss firm OncoEthix

December 19, 2014
Sales and Marketing Cancer, FDA, Merck, OTX015, cubist, keytruda, oncoethix, pembrolizumab

Hot on the heals of its Cubist buyout Merck has confirmed the acquisition of OncoEthix, a Swiss based firm which …

Astrazeneca image

AstraZeneca ovarian cancer drug approved in Europe

December 18, 2014
Sales and Marketing AstraZeneca, BRCA, Cambridge, Cancer, FDA, lynparza, olaparib, ovarian

The European Commission has approved AstraZeneca’s Lynparza for the treatment of advanced BRCA-mutated ovarian cancer. Lynparza (olaparib) has been approved …

The Gateway to Local Adoption Series

Latest content