AbbVie/Roche’s venetoclax bags FDA Breakthrough Therapy Designation
January 21, 2016Sales and Marketing AbbVie, Breakthrough Therapy Designation, FDA, Roche, venetoclax
AbbVie and Roche’s cancer drug venetoclax has been granted Breakthrough Therapy Designation by the FDA in combination with rituximab for …
GSK ‘in discussions’ over $1 billion tech deal with Qualcomm
January 21, 2016Medical Communications GSK, beyond the pill, digital pharma, joint venture, qualcomm
GlaxoSmithKline and telecoms giant Qualcomm are reportedly discussing a joint venture agreement worth as much as $1 billion, as the …
Five charged in US for scheme to steal GSK secrets
January 21, 2016Research and Development China, GSK, employee theft, trade secrets
Five people have been charged in the US for a scheme to steal secrets from British drugmaker GlaxoSmithKline and then …
Pharma leads global call for action on antimicrobial resistance
January 21, 2016Manufacturing and Production, Research and Development Davos, Lord Jim O'Neill, Review on antimicrobial resistance, World Economic Forum, antibiotic resistance, antimicrobial resistance
More than 70 leading international pharmaceutical and biotechnology companies, as well as industry associations, have come together to call for …
MSD and GAVI agree Ebola vaccine deal
January 20, 2016Manufacturing and Production, Research and Development Ebola, GAVI, MSD, WHO
MSD and the global vaccine alliance Gavi have agreed a deal to provide 300,000 dosesof an Ebola virus vaccine, to …
Lilly awaits FDA review of new arthritis treatment
January 20, 2016Manufacturing and Production, Research and Development, Sales and Marketing Eli Lilly, FDA, Incyte, NDA, baricitinib, lilly, new drug application, rheumatoid arthritis
Eli Lilly has submitted a new drug application (NDA) to the FDA for baricitinib as a treatment for moderate-to-severe rheumatoid …
Arzerra approved by US FDA for leukaemia
January 20, 2016Research 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, 2016Manufacturing 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 …
French Health Minister criticises CRO’s slow response to clinical trial accident
January 19, 2016Manufacturing 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 …
Bayer opens OTC drug plant in China
January 19, 2016Manufacturing 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, 2016Manufacturing 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 …
Sobi launches new haemophilia treatment in UK
January 19, 2016Manufacturing 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 appoints new executive board members
January 19, 2016Manufacturing 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, …
Ergomed announces board changes
January 19, 2016Manufacturing 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 …
FDA grants Eisai’s Lenvima priority review for kidney cancer
January 19, 2016Manufacturing 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, 2016Manufacturing 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 criticised for safety data flaws
January 18, 2016Sales 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 …
Two new US approvals for Novartis’ Cosentyx
January 18, 2016Research 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 …
Blow for Eleven Biotherapeutics as eye drug fails in late-stage trial
January 18, 2016Research 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 …
Man left brain dead after clinical trial dies in hospital
January 18, 2016Research 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 …
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