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EMA accepts regulatory submission for proposed Herceptin biosimilar

August 26, 2016
Medical 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 …

News
clinical_trial_4

Denali Therapeutics secures another $130 million for neurodegenerative disease research

August 26, 2016
Medical Communications

Denali Therapeutics has announced a string of collaborations and financing deals worth $130 million that will see the biotech, which …

News
takeda_tokyo_hq

Jobs to go at Takeda as it shuts down Cambridge facility

August 26, 2016
Manufacturing 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 …

News
mylan_building

Mylan announces immediate plans to cut price of EpiPen

August 25, 2016
Medical 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 …

News
chemo-web

Boost for Clovis as FDA grants priority review for rucaparib in ovarian cancer

August 25, 2016
Research 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 …

News
novartis_malaria_researcher

Positive Phase III results for Novartis MS drug

August 25, 2016
Research 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, …

News
teva_copy

Teva loses patent protection on lucrative MS treatment

August 25, 2016
Manufacturing 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 …

News
amgen_flag

FDA says no to Amgen’s Parsabiv

August 25, 2016
Research 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) …

News
fdaoutsideweb

Medical device user fees to increase 68% for 2018 to 2022

August 25, 2016
Research 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 …

News
mylan_plus_hero_720x510

Mylan latest target of US anger on drug pricing with EpiPen price increase

August 24, 2016
Research 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 …

News

NICE approves lung cancer and leukaemia treatments

August 24, 2016
Research 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 …

News
pfizer_sky

Pfizer to acquire AstraZeneca’s anti-infective business for $550 million upfront

August 24, 2016
Research 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 …

News
eylea-product-box-md

NICE recommends Eylea as first-line treatment for sight threatening condition

August 24, 2016
Research 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 …

News
1397501171305

AbbVie’s leukaemia drug granted positive opinion by MHRA through EAMS

August 23, 2016
Research 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 …

News
t_cell_grey_killing_tumour_cell_yellow

Foundation Medicine adds new immunotherapy features to its gene profiling products

August 23, 2016
Manufacturing 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 …

News
diabetes_injection

Roche launches ‘next-generation’ blood glucose monitoring system

August 23, 2016
Manufacturing 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 …

News
casebia

Bayer’s CRISPR venture opens for business in biotech hub

August 23, 2016
Manufacturing and Production, Research and Development Bayer, casebia, crispr, gene editing, gene-editing

Bayer and CRISPR Therapeutics have joined together to launch Casebia Therapeutics and have chosen Cambridge, Massachusetts, as its base to …

News
gilead-sciences

Gilead gets EU approval for HIV-prevention treatment Truvada

August 23, 2016
Manufacturing and Production, Sales and Marketing EU, Gilead, HIV, PrEP, Truvada, prevention

Gilead Sciences has received marketing authorisation from the European Commission for once-daily Truvada (emtricitabine/tenofovir disoproxil), in combination with safer sex …

News
paul_herendeen

Valeant appoints new executive VP of finance and CFO

August 22, 2016
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Valeant, appointment

Valeant has announced the appointment of Paul S. Herendeen as executive vice president, who will also take over as chief …

Appointment
astrazeneca_logo_building

FDA fast tracks Alzheimer’s drug from Lilly, AstraZeneca

August 22, 2016
Manufacturing and Production, Research and Development Alzheimer's disease, AstraZeneca, BACE, lilly, phase III

AstraZeneca and Eli Lilly have announced that the US Food and Drug Administration (FDA) has granted AZD3293 its fast track …

News
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