EMA to review Pfizer’s Xeljanz for patients with rheumatoid arthritis
March 24, 2016Research and Development, Sales and Marketing EMA, Pfizer, Xeljanz, approval, authorisation, marketing, review, rheumatoid arthritis
Pfizer (NYSE: PFE) has announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) …
Novartis settles bribery charges in China for $25m
March 24, 2016Medical Communications, Sales and Marketing Novartis
Novartis will pay $25 million to the US Government’s Securities and Exchange Commission to settle charges that it bribed healthcare …
Teva announces FDA approval for asthma injection, Cinqair
March 24, 2016Research and Development, Sales and Marketing FDA, Teva, approval, asthma, cinqair
The US Food and Drug Administration has approved Cinqair (reslizumab), an injection for patients with severe asthma developed by Teva …
Biotech Micreos appoints CMO to lead clinical development of antibiotic alternative
March 23, 2016Research and Development
Dr Johan Frieling has been appointed as the new chief medical officer of Dutch biotech company Micreos, at a pivotal …
Sanofi and Regeneron meet endpoint in Phase III Praluent study
March 23, 2016Research and Development Regeneron, Sanofi, endpoint, escape, hefh, odyssey, phase 3, phase III, positive, praulent, trial
Sanofi and Regeneron Pharmaceuticals have announced that their Phase III ODYSSEY ESCAPE clinical trial evaluating Praluent (alirocumab) met its primary …
Bristol-Myers Squibb to acquire Padlock Therapeutics for up to $600m
March 23, 2016Research and Development, Sales and Marketing Bristol-Myers Squibb, Padlock Therapeutics, rheumatoid arthritis
Bristol-Myers Squibb is to acquire Massachusetts-based auto-immune disease specialist Padlock Therapeutics in a deal worth up to $600 million. The …
Thirty-seven arrested in China vaccine scandal
March 23, 2016Sales and Marketing China, vaccines
Police in China have arrested 37 people in eastern China in relation to illegal vaccine sales conducted by a ring …
AstraZeneca’s Brilinta fails to best aspirin in treating stroke patients
March 23, 2016Research and Development AstraZeneca, Brilinta, stroke
AstraZeneca has announced top-line results from the Phase III SOCRATES trial, confirming that twice-daily doses of its drug Brilinta (ticagrelor) failed …
PCI Pharma Services’ Hay-on-Wye site launches specialist packaging design department
March 23, 2016Manufacturing and Production
Leading pharmaceutical outsourcing provider PCI Pharma Services has launched Technical Services, a new packaging design and development function, at its …
Federal jury rules in MSD’s favour in Gilead blockbuster hepatitis C drug dispute
March 23, 2016Medical Communications, Research and Development Gilead, MSD, blockbuster, federal court, federal jury, hit, patents, sales, sales hit, sofosbuvir, sovaldi
Gilead’s dominance of the hepatitis C market is under severe threat after a federal jury ruled in favour of MSD …
NDA Group and PharmApprove announce merger
March 23, 2016Sales and Marketing NDA Group
NDA Group, a leading strategic regulatory and HTA consultancy in Europe, and PharmApprove, a leading strategic regulatory and scientific communications …
FDA approves Lilly’s plaque psoriasis drug Taltz
March 23, 2016Research and Development, Sales and Marketing Eli Lilly, Enbrel, Taltz, plaque psoriasis
The US Food and Drug Administration (FDA) has approved Eli Lilly’s Taltz (ixekizumab) for the treatment of moderate-to-severe plaque psoriasis in …
FDA announces strongest warnings for opioid pain medications
March 23, 2016Medical Communications, Research and Development FDA, abuse, addiction, boxed, label, misuse, opioids, public health, restrictions, safety, warnings
The US Food and Drug Administration has announced class-wide safety labelling changes for immediate release (IR) opioid pain medications. The …
NICE draft guidance says ‘no’ to cystic fibrosis drug Orkambi
March 23, 2016Research and Development, Sales and Marketing NICE, Orkambi, Vertex, cystic fibrosis
NICE has issued draft guidance not recommending Vertex’s Orkambi (lumacaftor/ivacaftor) for use on the National Health Service (NHS) in England …
Targeted cancer therapies can suppress T cell immune responses, study finds
March 23, 2016Research and Development T cell, anti-cancer drugs, immunosuppresive, superagonist, wistar institute
Researchers at the Wistar Institute have developed a new method whereby targeted cancer therapies can provide appropriate therapeutics without supressing …
Celyad teams-up with Institut Curie to advance its immuno-oncology program
March 22, 2016Manufacturing and Production, Research and Development Cancer Immunotherapy, Celyad, Institut Curie, cellular immunotherapies
Celyad (Nasdaq: CYAD) on Tuesday said it has partnered with Institut Curie to develop its NKR-T pipeline in cellular immunotherapies …
Eisai withdraws application for neurodegenerative-disease drug in Japan
March 22, 2016Manufacturing and Production, Research and Development Eisai, mecobalamin, neurodegenerative disease
Pharma major Eisai (TYO: 4523) on Tuesday said the Japanese regulators have stalled the approval of its drug to treat …
BioMarin reports mixed Phase III results for genetic disorder trial-drug Pegvaliase
March 22, 2016Manufacturing and Production, Research and Development
Biotech firm BioMarin Pharmaceutical (Nasdaq: BMRN) reported mixed results for its trial drug to treat genetic disorder phenylketonuria. Trial drug, …
Darzalex to be trialled in combination with atezolizumab in multiple myeloma and solid tumours
March 22, 2016Research and Development Genentech, Genmab, Janssen, Roche, atezolizumab, clnical trials, multiple myeloma, phase ib, solid tumours, tumour
Phase Ib clinical studies are set to begin, which will evaluate Darzalex (daratumumab) in combination with atezolizumab in a solid …
Raptor’s Procysbi gets Priority Review from Health Canada
March 22, 2016Manufacturing and Production, Research and Development Canada, Health Canada, Procysbi, Raptor Pharmaceutical, genetic condition
Raptor Pharmaceutical (Nasdaq: RPTP) said Canadian regulators have accepted a priority review for its drug to treat a rare genetic …
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