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UPDATE: Pfizer gets interim stay on cough syrup ban

March 15, 2016
Manufacturing and Production, Research and Development Abbott Laboratories, Corex, Pfizer, Pfizer India

Shares in Pfizer India continued to tumble for a second day even as an Indian court granted the company a …

News

Genentech cancer immunotherapy gets Priority FDA Review in bladder cancer

March 15, 2016
Manufacturing and Production, Research and Development FDA, Genentech, Roche, atezolizumab, bladder cancer, priority review

The US FDA has granted Roche subsidiary Genentech a Priority Review for atezolizumab in treating advanced bladder cancer, whose disease …

News
gwpharma

GW Pharma shares more than double after positive Phase III trials for epilepsy drug

March 15, 2016
Manufacturing and Production, Research and Development Epidiolex, GW Pharma, US FDA, epilepsy in children, phase III

Shares in UK-based GW Pharmaceuticals (Nasdaq: GWPH) more than doubled on the Nasdaq Monday after the company announced positive results …

News
vascepa

COMMENT: What does Amarin’s off-patent victory over the FDA mean for the industry?

March 14, 2016
Medical Communications, Sales and Marketing Amarin, FDA, off label, off-label, vascepa

Last week, Pharmafile.com reported that small biopharma Amarin had settled litigation with US drugs regulator the FDA that will allow …

Feature
lab

Cambridge Epigenetix says raised $21 million, appoints Geoff Smith CEO

March 14, 2016
Business Services, Sales and Marketing CEGX, CEO, Cambridge Epigenetix, fundraising, genome sequencing

Cambridge Epigenetix (CEGX) on Monday said it has raised about $21 million via Series B financing and named Geoff Smith …

News
manmeetsoni

Ariad names Manmeet Soni CFO

March 14, 2016
Business Services, Sales and Marketing Ariad, CEO, appointment, boardroom, cfo

Ariad Pharmaceuticals Inc (Nasdaq: ARIA) named Manmeet Soni chief financial officer, effective March 21, 2016, succeeding Edward Fitzgerald. Mr Soni will …

Appointment
janssen_latest_logo_on_sign_closer

Janssen’s Zytiga boosts survival in early-stage prostate cancer

March 14, 2016
Research and Development, Sales and Marketing Janssen, Zytiga, abiraterone, prednisone, prostate cancer

Janssen has announced data from a post-hoc analysis of a Phase III trial showing that Zytiga plus prednisone boosted overall …

News
xalkori

FDA approves Pfizer sNDA for Xalkori

March 14, 2016
Research and Development, Sales and Marketing Cancer, EMA, NSCLC, Pfizer, Xalkori (crizotinib)

The US FDA has approved Pfizer’s supplemental new drug application (sNDA) for its kinase inhibitor Xalkori in treating patients with …

News
gilead-sciences

EMA starts review of Gilead Sciences’ Zydelig following safety concerns

March 14, 2016
Research and Development, Sales and Marketing EMA, Gilead Sciences, blood cancer, clinical trials, zydelig

Regulators in Europe have initiated a safety review of Gilead Sciences’ (Nasdaq: GILD) blood cancer drug Zydelig (idelalisib) following reports …

News
five_prime_therapeutics_scientist

GSK terminates Five Prime Therapeutics mesothelioma collaboration

March 14, 2016
Research and Development, Sales and Marketing Five Prime Therapeutics, GSK, mesothelioma

GSK is to back out of a licensing deal with California-based Five Prime Therapeutics to develop a mesothelioma drug. Announcing …

News

Pfizer’s India unit stops production of cough drug, shares drop almost 8%

March 14, 2016
Business Services, Sales and Marketing Bombay Stock Exchange, Corex, Pfizer Inc, Pfizer Ltd, Shares

Shares in the Indian arm of drug major Pfizer Inc (NYSE: PFE) dropped nearly 8% on the Bombay Stock Exchange …

News

MSF challenges Pfizer’s pneumonia vaccine patent in India

March 11, 2016
Medical Communications, Research and Development, Sales and Marketing GSK, Pfizer, Prevnar 13, pneumonia vaccine

The charity Médecins Sans Frontières (MSF) has formally opposed Pfizer’s bid to obtain a patent for the pneumonia vaccine PCV13, …

News
grifolslogo

Spanish firm Grifols to spend a total of $360 million on four new plants

March 11, 2016
Manufacturing and Production, Medical Communications grifols, manufacturing, pharma, plasma, production

Grifols (Nasdaq: GRFS) said it will invest a total of $360 million over 2016-2021, to increase the plasma fractionation capacity …

News
facilities_lg06

Dr. Reddy’s, TR-Pharm to collaborate on 3 biosimilars in Turkey

March 11, 2016
Manufacturing and Production, Medical Communications, Sales and Marketing Dr Reddy's Laboratories, TR-Pharm, biosimilar, generics, marketing collaboration

Three biosimilar products by the Indian generics company Dr. Reddy’s will be marketed by TR-Pharm in Turkey, the companies said …

News
arzerra_novartis

Novartis seeks expanded Arzerra use in US

March 11, 2016
Research and Development Arzerra, CLL, FDA, Genmab, Novartis

Novartis has submitted a supplemental Biologics License Application (sBLA) to the US FDA for the use of Arzerra (ofatumumab) in …

News
spark_logo

Spark Therapeutics buys Genable Tech for $6 million in cash and stock deal

March 11, 2016
Business Services, Medical Communications Genable Technologies, Spark Therapeutics, cash & stock, genetic technologies, merger & acquisitions

Spark Therapeutics (Nasdaq: ONCE) said it has acquired Ireland-based Genable Technologies, a privately-held gene therapy firm for $6 million in a cash …

News
shutterstock_38078521

US FDA sets April 25 date to review Sarepta’s DMD drug, shares jump

March 11, 2016
Medical Communications, Research and Development Duchenne Muscular Dystrophy, Eteplirsen, Sarepta Therapeutics, US FDA

Shares in US-based Sarepta Therapeutics (Nasdaq: SRPT) jumped nearly 15% Thursday after the US Food and Drug Administration (FDA) said it …

News
valeant_sign

US Congress Committee pressures Valeant to produce drug pricing documents

March 11, 2016
Medical Communications, Sales and Marketing Drug pricing, Michael Pearson, Valeant

Valeant’s tough month continued yesterday, with a US congressional committee pressuring the company to explain why it has not produced …

News
ivf_worldwide_teva_logos

Teva funds research to protect fertility in women diagnosed with cancer

March 11, 2016
Business Services, Research and Development Cancer, IVF Worldwide, Teva, fertility, radiotherapy

Israeli generics giant Teva has announced it will support IVF-Worldwide with a research grant to improve knowledge of fertility preservation …

News
vials_purple_liquid

Alphabet’s life science unit makes device to aid gathering of health data for research

March 11, 2016
Medical Communications, Research and Development Alphabet, Connectivity Bridge, Verily, google, life sciences

Verily, the life sciences unit of Alphabet, has unveiled Connectivity Bridge, a device designed to sync and collect medical information for …

News
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