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Darzalex receives breakthrough designation in multiple myeloma from FDA

July 26, 2016
Manufacturing and Production, Research and Development FDA, Genmab, Janssen, darzalex, multiple myeloma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Darzalex (daratumumab) in combination with standard of …

News
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AbbVie and BMS partner for Rova-T, Opdivo, Yervoy cancer combo

July 26, 2016
Manufacturing and Production, Research and Development AbbVie, BMS, Yervoy, opdivo, rova-t

AbbVie and Bristol-Myers Squibb have announced that they will collaborate on a clinical trial to test some of their leading …

News
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CHMP issues positive opinion for Orencia Rheumatoid Arthritis treatment

July 25, 2016
Manufacturing and Production, Sales and Marketing BMS, CHMP, Orencia, rheumatoid arthritis

Bristol-Myers Squibb has announced that the Committee for Medicinal Products for Human Use (CHMP) has released a positive opinion of …

News

The ethical battle for the future of pharma

July 25, 2016
Drug pricing, ethics in pharma

A battle is raging for the soul of the pharma industry and the stakes are high. Those companies seeking to …

Feature
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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: …

News
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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 …

News
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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 …

News
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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 …

News
gilead-sciences

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 …

News
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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 …

News
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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 …

News
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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 …

News
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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. …

News

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 …

News
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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 …

News
biogen_austria_238

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 …

News

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 …

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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 …

News
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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 …

News
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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 …

News
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