Arzerra

Arzerra approved by US FDA for leukaemia

January 20, 2016
Research and Development, Sales and Marketing Afrezza, CLL, FDA, Genmab, Novartis, chronic lymphocytic leukaemia, ofatumumab, sBLA, supplementary biologics license application

The FDA has signed-off a supplemental Biologics License Application (sBLA), meaning Arzerra is approved for extended treatment of patients who …

J&J to cut up to 3,000 jobs in key business unit

January 20, 2016
Manufacturing and Production, Research and Development Jobs, Johnson and Johnson, pharmajobs, redundancies

Johnson & Johnson has announced a restructuring of its medical devices business unit that could result in up to 3,000 …

Marisol Touraine

French Health Minister criticises CRO’s slow response to clinical trial accident

January 19, 2016
Manufacturing and Production, Research and Development Bial, Biotrial, Marisol Tourain, clinical trial

Days after the clinical trial accident that left one participant dead and five hospitalised with neurological problems, French Health Minister …

China manufacturing

Bayer opens OTC drug plant in China

January 19, 2016
Manufacturing and Production Bayer, China, OTC, TCM, Yunnan, over the counter, traditional Chinese medicine

Bayer has opened a new manufacturing plant to produce over-the-counter (OTC) drugs in China, as the German firm looks to …

Alzheimer’s drugs prescriptions rise six-fold in a decade

January 19, 2016
Manufacturing and Production Alzheimer's, Alzheimer's disease, NHSIC, dementia, prescribing

The number of prescriptions dispensed in England for approved medicines to treat Alzheimer’s increased from 502,000 in 2004 to 3 …

blood

Sobi launches new haemophilia treatment in UK

January 19, 2016
Manufacturing and Production, Sales and Marketing elocta, haemophilia a, sobi

Swedish Orphan Biovitrum Ltd (Sobi) has launched its haemophilia A treatment Elocta (efmoroctocog alfa) in the UK, following its EU …

merck_logo_small

Merck appoints new executive board members

January 19, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Merck

Merck has appointed two new members to its executive board: Udit Batra (45), head of the Life Science business sector, …

stephen_stamp

Ergomed announces board changes

January 19, 2016
Manufacturing and Production, Research and Development, Sales and Marketing ergomed, primevigilance

Ergomed, a specialist provider of drug development services to the pharmaceutical industry, has announced that Neil Clark, current chief financial …

Eisai logo

FDA grants Eisai’s Lenvima priority review for kidney cancer

January 19, 2016
Manufacturing and Production Breakthrough Therapy Designation, Eisai, FDA, Kidney cancer, Lenvima, lenvatinib, priority review, renal cell carcinoma

The FDA has accepted Eisai’s supplemental New Drug Application (sNDA) for its anti-cancer agent Lenvima for use in the treatment …

Samsung beats pharma to develop first EU-approved Enbrel biosimilar

January 18, 2016
Manufacturing and Production Benepali, CHMP, EMA, Enbrel, Samsung, Samsung Bioepis, etanercept, positive opinion

Samsung Bioepis – the collaboration between Samsung Biologics and Biogen Idec, has become the first company to have a biosimilar …

FDA sign

FDA criticised for safety data flaws

January 18, 2016
Sales and Marketing FDA, US Government Accountability Office, pharmacovigilance, post-marketing data, safety

The US FDA is failing to meet its ‘statutorily required’ obligations to track safety data for drugs post-marketing and publish …

cosentyx

Two new US approvals for Novartis’ Cosentyx

January 18, 2016
Research and Development, Sales and Marketing Cosentyx, Novartis

Novartis has won FDA approval for Cosentyx (secukinumab) for the treatment of two new indications – adults with active ankylosing …

eye_iris

Blow for Eleven Biotherapeutics as eye drug fails in late-stage trial

January 18, 2016
Research and Development, Sales and Marketing Eleven Biotherapeutics, allergic conjunctivitis, isunakinra

A study by Eleven Biotherapeutics to prove the clinical value of its eye drug isunakinra has flopped, after the drug …

biotrial_facility_rennes

Man left brain dead after clinical trial dies in hospital

January 18, 2016
Research and Development, Sales and Marketing Bial, Biotrial, clinical trial

A man left brain dead after a clinical trial in France has died in hospital and five remain in a …

Merck MSD

MSD sues German Merck for using name in US

January 15, 2016
Medical Communications, Sales and Marketing MSD, Merck

MSD says it is filing a lawsuit against the German company Merck “regarding their improper use of the name ‘Merck’ …

french_health_ministry

Clinical trial accident leaves six critical, one ‘brain dead’

January 15, 2016
Medical Communications, Research and Development France, clinical trial

Six patients have been left in a critical condition following a serious accident in a clinical trial at a French …

shutterstock_110597087-web

What could artificial intelligence mean for pharma?

January 15, 2016
Medical Communications artificial intelligence, digital, digital pharma, medical technology, medtech, tech

With ever rising costs in research and development, the frustratingly long time spent in bringing new novel drugs to market …

Sanofi scientist

Sanofi Pasteur to join the Human Vaccines Project

January 15, 2016
Medical Communications, Research and Development Human Vaccines Project, Sanofi Pasteur, vaccines

Sanofi Pasteur has become the latest pharma company to add funding to The Human Vaccines Project – a non-profit public-private …

Takeda UK

Takeda to bring UK salesforce in-house

January 15, 2016
Medical Communications, Sales and Marketing Takeda, field sales, marketing, sales, sales reps, salesforce

Takeda UK is to bring all of its sales teams and support resources in-house and reintegrate its field salesforce into …

abbvie

AbbVie replaces retiring VP of Western Europe and Canada

January 15, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AbbVie, Esteban Plata, Pascale Richetta

AbbVie has appointed Esteban Plata as vice president of Western Europe and Canada.He replaces Pascale Richetta who is retiring from …

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