EMA recommends two new treatments for advanced kidney cancer
July 22, 2016Research and Development, Sales and Marketing EMA, Eisai, renal cell carcinoma
The European Medicines Agency (EMA) has recommended two new medicines for the treatment of advanced renal cell carcinoma, or kidney …
Valeant receives complete response letter from FDA on glaucoma drug
July 22, 2016Medical Communications, Sales and Marketing FDA, Glaucoma, Valeant
Valeant Pharmaceuticals has announced that it has received a complete response letter from the FDA rejecting their new drug application …
MSD faces delay in C. diff drug approval as FDA requests more data
July 22, 2016Medical Communications, Research and Development C diff, FDA, MSD, Merck
MSD, known as Merck in the US and Canada, has received a setback in its bid to get new C. …
Pfizer and Spark Therapeutics granted FDA breakthrough designation for haemophilia drug
July 22, 2016Medical Communications, Research and Development FDA, Pfizer, Spark Therapeutics, haemophilia B, spk-9001
Pfizer and Spark Therapeutics have announced that the US Food and Drug Administration (FDA) has granted a breakthrough therapy designation …
Phase III study confirms similarity of Herceptin biosimilar from Amgen, Allergan
July 22, 2016Medical Communications, Research and Development Allergan, Amgen, Herceptin, Roche, biosimilar, trastuzumab
Amgen and Allergan have announced the results from a Phase III study investigating ABP 980, their biosimilar candidate for Roche’s …
George Scangos to step down as Biogen CEO
July 21, 2016Manufacturing and Production, Research and Development, Sales and Marketing Biogen, George Scangos
In a surprising move, Biogen used the publishing of some promising second quarter results to announce the departure of CEO …
AstraZeneca’s Zavicefta meets primary endpoint in Phase III pneumonia trials
July 21, 2016Research and Development Antibiotics, AstraZeneca, zavifecta
AstraZeneca has announced results from a Phase III trial for its recently approved antibiotic, Zavicefta (ceftazidime-avibactam), which met its primary …
Galenica announces $1.53 billion Replysa acquisition
July 21, 2016Research and Development, Sales and Marketing Relypsa, Vifor pharma, galenica
Galenica has announced that it has entered into an agreement to acquire Relypsa in a deal worth $1.53 billion, which …
Roche beats forecasts in strong H1 results
July 21, 2016Research and Development, Sales and Marketing 2016, Q2, Roche, h1, results
Roche has published very encouraging full results for the first half of this year, with cancer drug sales helping to …
Zafgen ends lead drug development, shares plummet
July 21, 2016Research and Development zafgen
Zafgen has announced that it has dropped development of its lead drug candidate, beloranib, in order to focus on a …
New Irish pharma deal to save €750 million, says minister
July 20, 2016Sales and Marketing Ireland, Irish Pharmaceutical Healthcare Association
The Irish government has struck a deal with pharmaceutical manufacturers regarding the price and supply of medicines, which is expected …
NICE recommends PTC Therapeutics Duchenne muscular dystrophy treatment
July 20, 2016Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, PTC Therapeutics
PTC Therapeutics has announced that the National Institute for Health and Care Excellence has issued final guidance recommending Translarna (ataluren) …
AstraZeneca loses legal bid to block Crestor generics
July 20, 2016Research and Development, Sales and Marketing AstraZeneca, Crestor, FDA, generics, legal
A US district court judge has refused AstraZeneca’s request for a temporary restraining order blocking the approval of generic versions …
J&J boosted by pharma revenue in Q2 results
July 20, 2016Research and Development 2016, Johnson and Johnson, Q2, results
Shares at Johnson and Johnson have reached a record high of over $125 after pharma revenues helped to raise full …
Bristol-Myers Squibb settle $30 million California kickback lawsuit
July 20, 2016Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, california, lawsuit
Bristol-Myers Squibb (BMS) has agreed to pay $30 million to the California Department of Insurance to settle an almost decade …
FDA panel unanimously recommends approval of Valeant’s brodalumab with conditions
July 20, 2016Research and Development, Sales and Marketing FDA, Valeant, brodalumab
Valeant has announced that the US Food and Drug Administration’s (FDA) dermatologic and ophthalmic drugs advisory committee has recommended brodalumab …
Celgene boosts cancer portfolio with deal worth up to $2.5 billion with Jounce Therapeutics
July 19, 2016Research and Development, Sales and Marketing Celgene, jounce
Celgene has entered into a collaboration with Jounce Therapeutics that will see the pair jointly develop and commercialise Jounce’s lead …
Teva sells $15 billion in bonds to fund Allergan generics deal
July 19, 2016Manufacturing and Production, Sales and Marketing Allergan, Teva, bonds, generics
Teva Pharmaceuticals has announced that it has successfully finalised a bond sale totalling $15 billion that will help to fund …
Opdivo to go before EU, US regulators in head and neck cancer
July 19, 2016Manufacturing and Production, Research and Development EMA, EU, FDA, US, head and neck cancer, opdivo
Bristol-Myers Squibb has announced that its lead oncology drug, Opdivo (nivolumab), is set to go before regulators in the US …
Novartis lowers core operating profit outlook in Q2 results
July 19, 2016Manufacturing and Production, Research and Development, Sales and Marketing 2016, Novartis, Q2, results
Novartis has warned that its profits may decline this year as it issued second quarter results, with generic competition for …
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