MHRA approves Sanofi Pasteur MSD’s four-strain influenza vaccine for UK use

July 25, 2016
Manufacturing and Production, Research and Development, Sales and Marketing MHRA, Sanofi pasteur msd, UK, Vaccine, flu, influenza

Sanofi Pasteur MSD has announced the approval of the latest addition to its family of influenza vaccines in the UK: …

Flawed studies at Semler Research Centre calls for suspension of medicines, EMA recommends

July 25, 2016
Manufacturing and Production, Sales and Marketing EMA, Novartis, Teva, manufacturing, semler

Following an FDA inspection and WHO investigation earlier this year, the European Medicines Agency (EMA) has recommended the suspension of …

400 current and former employees join sexual discrimination lawsuit against MSD

July 25, 2016
Research and Development, Sales and Marketing MSD, Merck, discrimination, lawsuit

Over 400 women have come forward to join a $250 million gender bias class action against MSD, called Merck in …

AbbVie scores EU recommendation for shorter treatment of Viekirax in hepatitis C

July 25, 2016
Research and Development, Sales and Marketing EU, Gilead, Viekirax, hepatitis C

AbbVie has received an EU recommendation for a shorter treatment duration of Viekirax (ombitasvir/paritaprevir/ritonavir) plus ribavirin in genotype 4 chronic …

EU recommends PrEP in Gilead’s HIV prevention treatment

July 25, 2016
Research and Development, Sales and Marketing EU, Gilead, HIV, PrEP, prevention

Gilead has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines …

Shire receives positive EU opinion for pancreatic cancer drug

July 25, 2016
Research and Development, Sales and Marketing CHMP, EU, Pancreatic cancer, Shire

Shire has announced that the EU regulator’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion …

EMA recommends two new treatments for advanced kidney cancer

July 22, 2016
Research 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, 2016
Medical 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, 2016
Medical 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, 2016
Medical 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, 2016
Medical 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, 2016
Manufacturing 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, 2016
Research 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, 2016
Research 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, 2016
Research 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, 2016
Research 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, 2016
Sales 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, 2016
Research 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, 2016
Research 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, 2016
Research 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 …

The Gateway to Local Adoption Series

Latest content