Opdivo

NICE ‘yes’ for BMS skin cancer drug Opdivo

January 22, 2016
Medical Communications, Sales and Marketing BMS, Bristol-Myers Squibb, NICE, melanoma, nivolumab, opdivo, skin cancer

NICE has approved Bristol-Myers Squibb’s skin cancer immunotherapy Opdivo (nivolumab) in final draft guidance as monotherapy for NHS patients in England …

martin_shkreli_smaller_same

Martin Shkreli subpoenaed in US to testify over drug pricing

January 21, 2016
Medical Communications, Sales and Marketing Daraprim, Howard Schiller, Martin Shkreli, Valeant, turing

Former pharma chief exec Martin Shkreli has been issued with a subpoena by the US House of representatives, compelling him …

NHS logo

UK Pfizer boss criticised for NHS conflict of interest

January 21, 2016
Erik Nordkamp, Keep Our NHS Public, King's College Hospitals NHS Trsut, NHS, Pfizer, conflict of interest, privitisation

Anti-privatisation campaigners have called on a London NHS hospital trust to revoke its decision to appoint the head of Pfizer …

FDA logo

AbbVie/Roche’s venetoclax bags FDA Breakthrough Therapy Designation

January 21, 2016
Sales 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 …

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GSK ‘in discussions’ over $1 billion tech deal with Qualcomm

January 21, 2016
Medical 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 …

China pharmacy

Five charged in US for scheme to steal GSK secrets

January 21, 2016
Research 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 …

WEF

Pharma leads global call for action on antimicrobial resistance

January 21, 2016
Manufacturing 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 …

GAVI logo

MSD and GAVI agree Ebola vaccine deal

January 20, 2016
Manufacturing 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 …

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Lilly awaits FDA review of new arthritis treatment

January 20, 2016
Manufacturing 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

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 …

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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 …

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