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 …
NICE approves lung cancer and leukaemia treatments
August 24, 2016Research and Development, Sales and Marketing Alimta, CDF, NICE, bosulif, bosutinib, pemetrexed
The National Institute for Health and Care Excellence (NICE) has issued its approval of two drugs for routine use on …
Pfizer to acquire AstraZeneca’s anti-infective business for $550 million upfront
August 24, 2016Research and Development, Sales and Marketing AstraZeneca, Pfizer, Zavicefta, anti-infective
Pfizer has announced that it is to acquire AstraZeneca’s small molecule anti-infective business in a deal potentially worth up to …
NICE recommends Eylea as first-line treatment for sight threatening condition
August 24, 2016Research and Development, Sales and Marketing Bayer, Eylea, NHS, NICE, first-line treatment
Bayer has announced that the National Institute for Health and Care Excellence (NICE) has recommended Eylea (aflibercept) as a cost-effective …
AbbVie’s leukaemia drug granted positive opinion by MHRA through EAMS
August 23, 2016Research and Development, Sales and Marketing
AbbVie’s investigational treatment for chronic lymphocytic leukaemia (CLL) venetoclax has been granted a positive scientific opinion by the Medicines and …
Foundation Medicine adds new immunotherapy features to its gene profiling products
August 23, 2016Manufacturing and Production, Research and Development FoundationOne, oncology, tumour
Foundation Medicine hopes to enhance oncologist insight into potential immunotherapy responses with the addition of new clinical markers to its …
Roche launches ‘next-generation’ blood glucose monitoring system
August 23, 2016Manufacturing and Production, Sales and Marketing Roche, blood glucose monitoring, diabetes
Roche has announced the launch of its new Accu-Chek Guide blood glucose monitoring system. The system promises to simplify everyday …
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