Final Nice appraisal says no to cystic fibrosis drug, Orkambi
June 17, 2016Medical Communications NICE, Orkambi, Vertex Pharma, cystic fibrosis, recommendation, regulation
The National Institute for Health and Care Excellence (Nice) has issued a final appraisal determination rejecting cystic fibrosis drug, Orkambi …
Roche gets a NICE knockback for melanoma drug, Cotellic
June 16, 2016Medical Communications, Research and Development, Sales and Marketing Cotellic, NICE, Roche
The National Institute for Health and Care Excellence (NICE) has announced that that it has not recommended Roche’s melanoma drug, …
SMC recommends treatment for potentially fatal chemotherapy-related disease
June 16, 2016Research and Development, Sales and Marketing Menarini, SMC, adneuric
The Scottish Medicines Consortium has recommended Adenuric (febuxostat), a treatment for a severe complication that can affect chemotherapy patients in …
Chiasma cuts staff by 33% after FDA rejects rare disease drug, Mycapssa
June 16, 2016Research and Development, Sales and Marketing FDA, chiasma, cutbacks, failure, workforce cuts
US-based biopharmaceutical company, Chiasma (NASDAQ: CHMA), has announced substantial job cuts as it attempts to restructure following the US Food …
UK biotech in great shape, according to new industry report
June 16, 2016Research and Development Europe, UK, biotech, uk bioindustry association
The UK biotechnology sector is going from strength to strength, having raised an “unprecedented” £900 million on the London Stock …
Roche secures EU approval for Gazyvaro in new lymphoma indication
June 16, 2016Research and Development, Sales and Marketing EU, Gazyvaro, Roche, follicular lymphoma
Roche (SIX: RO) has announced that the European Commission has approved Gazyvaro (obinutuzumab), in combination with bendamustine chemotherapy, in patients …
Teva returns rights to heart cell therapy to Mesoblast
June 16, 2016Research and Development, Sales and Marketing Mesoblast, Teva, chronic heart failure, phase III
Israeli drugmaker Teva (NYSE: TEVA) has returned full rights to a drug for heart condition in late stage trials to …
Marathon Pharma submits application for Duchenne muscular dystrophy drug to FDA
June 15, 2016Research and Development, Sales and Marketing FDA, duchenne, marathon pharmaceuticals
Marathon Pharmaceuticals has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration …
Phase II failure sees stock plunge and job cutbacks for Infinity Pharmaceuticals
June 15, 2016Research and Development, Sales and Marketing AbbVie, infinity pharmaceuticals, non-Hodgkin lymphoma, trial failure
Shares at Infinity Pharmaceuticals (NASDAQ: INFI) fell around 70% upon the announcement of new Phase II data for their non-Hodgkin …
Sobi says US FDA approves higher dose of Orfadin to treat rare genetic disorder
June 15, 2016Research and Development, Sales and Marketing US FDA, genetic disorder, regulation, sobi
Swedish Orphan Biovitrum AB (Sobi) on Wednesday said the US Food and Drug Administration (FDA) has approved a higher strength …
FDA issues warnings on Janssen, AstraZeneca diabetes drugs
June 15, 2016Research and Development, Sales and Marketing AstraZeneca, FDA, Janssen, farxiga, invokana
The US Food and Drug Administration has issued a warning of the risk of acute kidney injury for the type-2 …
German Supreme Court grants Lilly appeal to block Alimta generics
June 15, 2016Research and Development, Sales and Marketing Actavis, Alimta, Eli Lilly
Eli Lilly (NYSE: LLY) has announced that it has been granted an appeal by the German Federal Supreme Court, in …
Actelion says blood pressure drug Uptravi now available in Germany
June 15, 2016Research and Development, Sales and Marketing Actelion, EU, blood pressure, product launch
Actelion (SIX: ATLN) said its high blood pressure drug Uptravi (selexipag) is now available in Germany. The European Commission granted …
Novartis says to develop antimalarial treatment with Medicines for Malaria Venture
June 15, 2016Research and Development, Sales and Marketing Novartis, antimalarial drug, drug trial
Swiss pharma major Novartis (NYSE: NVS) said it has partnered with Medicines for Malaria Venture (MMV) and the Bill & Melinda …
Shire adds to gastrointestinal portfolio with Pfizer compound acquisition
June 14, 2016Research and Development, Sales and Marketing Pfizer, Shire, acquisition, compound
Shire (LSE: SHP) has announced that it has acquired an investigational biologic for the treatment inflammatory bowel disease from Pfizer …
Janssen says Imbruvica shows improved PFS in blood cancer in long-term effectiveness study
June 14, 2016Manufacturing and Production, Research and Development Janssen, blood cancer, drug trial, imbruvica
Janssen said late-stage studies to test long-term effectiveness for its Imbruvica (ibrutinib) in blood cancer showed improved progression free survival …
Marinus says will stop developing adult focal onset seizure drug as Phase III trials fail; shares plunge
June 14, 2016Manufacturing and Production, Research and Development Drug-Resistant Epilepsy, Marinus Pharmaceuticals, drug trial, ganaxolone
Shares in Marinus Pharmaceuticals (Nasdaq: MRNS) more than halved in value Monday after the company said it plans to stop …
MSD insulin glargine biosimilar meets primary endpoint in late-stage trials
June 14, 2016Manufacturing and Production, Research and Development, Sales and Marketing MSD, Merck, biosimilar, insulin, insuline glargine
MSD (NYSE: MRK), known as Merck in the US and Canada, has announced results from two Phase III studies evaluating …
FDA to review data on Amgen’s Humira biosimilar
June 14, 2016Manufacturing and Production, Research and Development, Sales and Marketing Amgen, FDA, Humira, biosimilar
Amgen (NASDAQ: AMGN) has announced the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee will review data supporting the …
Novo Nordisk says Victoza lowers risk of heart attacks in diabetes patients
June 14, 2016Manufacturing and Production, Research and Development Novo Nordisk, Victoza, drug trial, type 2 diabetes
Danish diabetes drugmaker giant Novo Nordisk (NYSE: NVO) on Tuesday said a large study showed its Victoza (liraglutide) reduced the risk of …
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