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 …

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 …

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, …

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 …

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) …

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 …

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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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

Doctors receiving drugmaker payments more likely to prescribe their products, BMJ study finds

August 22, 2016
Research and Development, Sales and Marketing

US physicians who received gifts and other payments from drug companies were more likely to prescribe branded anticoagulants and diabetes …

lab

MHRA suspends GMP certificate for Pfizer site in India

August 22, 2016
Manufacturing and Production, Sales and Marketing GMP, India, MHRA, Pfizer, ban, facility, import, suspend

The UK’s Medicines and Healthcare Products Agency (MHRA) has recommended that an Indian facility belonging to Pfizer’s Hospira unit be …

sanofi_multaq

FDA delays appraisal of Sanofi, Zealand diabetes drug just days before decision due

August 22, 2016
Research and Development, Sales and Marketing NDA, Sanofi, appraisal, diabetes, iglarlixi, type 2, type-2, zealand

There was unfortunate news for Sanofi and Zealand Pharma as the FDA announced that it required additional information, constituting a …

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