FDA approves Novartis Enbrel biosimilar
August 31, 2016Research and Development, Sales and Marketing Enbrel, FDA, Novartis, Sandoz, biosimilar, erzeli
Novartis, through its Sandoz division, has announced that the FDA has approved Erelzi (etanercept-szzs), a biosimilar of Amgen’s blockbuster drug …
Teva to lay off 236 in Pomona, New York
August 30, 2016Manufacturing and Production, Research and Development Teva, closure
Teva is currently in the process of winding down operations at its manufacturing plant in Pomona, New York as it …
UK asthma spending tops £1.1 billion
August 30, 2016Research and Development asthma, university of edinburgh
The University of Edinburgh has released a report that claims UK health service spending on asthma has reached £1.1 billion …
KaloBios cuts ties with former CEO Martin Shkreli, outlines ‘maniacal’ turnaround plan
August 30, 2016Research and Development, Sales and Marketing Daraprim, KaloBios, Martin Shkreli, Retrophin, benznidazole, turnaround
Two months after small drugmaker KaloBios returns from bankruptcy, controversial industry figure Martin Shkreli is no longer a stakeholder in …
Heart disease drug development is falling
August 30, 2016Manufacturing and Production, Research and Development cardiovascular disease, heart disease, research and development
The number of drugs currently in development to combat heart disease has fallen in the last 20 years, it has …
Cipla receives FDA approval for generic version of Valeant antidepressant
August 30, 2016Manufacturing and Production, Sales and Marketing Cipla, FDA, Valeant, Wellbutrin
Indian multinational pharma and biotech company Cipla has announced that its US arm InvaGen Pharmaceuticals has received approval from the …
Amgen’s Prolia achieves positive top-line Phase III results after 12 months
August 30, 2016Manufacturing and Production, Research and Development Amgen, Prolia, denosumab, phase III
Amgen has announced that its drug Prolia (denosumab) generated positive Phase III results investigating its safety and efficacy in patients …
Sanofi & Regeneron’s Praluent cholesterol treatment smashes Phase III target
August 30, 2016Manufacturing and Production, Research and Development Regeneron, Sanofi, apheresis, cholesterol, phase III
Sanofi and Regeneron have announced that their Praluent injection generated positive Phase III results investigating patients with an inherited form …
Vectura asthma treatment fails at Phase III
August 30, 2016Manufacturing and Production, Research and Development asthma, inhaler, phase III, phase III failure, vectura
Respiratory drug specialist Vectura’s asthma treatment Flutiform was unsuccessful in meeting the primary endpoint in its Phase III trial conducted …
Top ten stories in the pharmaceutical industry this week
August 26, 2016Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing pharmafile, top 10
If this week left you feeling with a sense of déjà vu, you could certainly be forgiven. With US politicians …
EMA accepts regulatory submission for proposed Herceptin biosimilar
August 26, 2016Medical Communications Biocon, EMA, Herceptin, Mylan, biosimilar, regulatory, submission, trastuzumab
Mylan and Biocon have announced that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for …
Denali Therapeutics secures another $130 million for neurodegenerative disease research
August 26, 2016Medical Communications
Denali Therapeutics has announced a string of collaborations and financing deals worth $130 million that will see the biotech, which …
Jobs to go at Takeda as it shuts down Cambridge facility
August 26, 2016Manufacturing and Production, Medical Communications Cambridge, Jobs, Takeda, closure
Takeda has announced plans to close its facility in Cambridge in the UK, to refocus its research and development operations …
Mylan announces immediate plans to cut price of EpiPen
August 25, 2016Medical Communications, Research and Development Mylan, clinton, epipen, increase
Subject to intense pressure over the last few days, Mylan has made an attempt to avoid becoming “another Valeant” by …
Boost for Clovis as FDA grants priority review for rucaparib in ovarian cancer
August 25, 2016Research and Development, Sales and Marketing FDA, clovis, ovarian cancer, rucaparib
Clovis Oncology has announced that the US Food and Drug Administration has accepted its new drug application for rucaparib, and …
Positive Phase III results for Novartis MS drug
August 25, 2016Research and Development Novartis, multiple sclerosis, phase III
Novartis has announced positive Phase III results for its EXPAND study, an evaluation of the efficacy and safety of orally-administered, …
Teva loses patent protection on lucrative MS treatment
August 25, 2016Manufacturing and Production, Research and Development, Sales and Marketing Copaxone, Mylan, Teva, multiple sclerosis
Teva’s stock plunged 3% after a US agency ruled that two of its patents related to multiple sclerosis drug Copaxone …
FDA says no to Amgen’s Parsabiv
August 25, 2016Research and Development, Sales and Marketing Amgen, FDA, par
Amgen has announced that the US Food and Drug Administration (FDA) has issued a complete response letter rejecting Parsabiv (etelcalcetide) …
Medical device user fees to increase 68% for 2018 to 2022
August 25, 2016Research and Development, Sales and Marketing FDA, Medical device
The Food and Drug Administration has reached an agreement with the medical device industry and laboratory community on proposed recommendations …
Mylan latest target of US anger on drug pricing with EpiPen price increase
August 24, 2016Research and Development, Sales and Marketing Mylan, US, congress, controversy, epipen, price gouging, price increase
The US congress is again subjecting the pharmaceutical industry to heavy scrutiny over drug pricing policies with Mylan its latest …
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