Nice rejects Janssen’s Imbruvica in draft guidance
June 1, 2016Medical Communications, Research and Development
The UK regulators have not recommended Janssen’s leukaemia drug Imbruvica (ibrutinib) to treat in draft guidance. The National Institute for …
Biogen says European regulatory committee adopts positive view for Tysabri
June 1, 2016Medical Communications, Research and Development, Sales and Marketing Biogen, CHMP, EMA, Tysabri, multiple sclerosis
Biogen (Nasdaq: BIIB) said the European regulatory committee has backed the approval of a variation to the marketing authorization for its …
Biomarin withdraws regulatory submissions for Duchenne muscular dystrophy drug
June 1, 2016Research and Development, Sales and Marketing BioMarin, Duchenne Muscular Dystrophy, EMA, FDA, Kyndrisa, failure, rejection
Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …
GSK’s gene therapy Strimvelis gets European regulatory nod
June 1, 2016Research and Development, Sales and Marketing EU, European Commission, GlaxoSmithKline, Strimvelis, gene therapy, regulation
UK drugmaker GlaxoSmithKline (LSE: GSK) said its gene therapy Strimvelis has secured backing from the European regulators. The European Commission …
FDA approves Lilly/Boehringer Ingelheim type-2 diabetes drug
June 1, 2016Research and Development, Sales and Marketing Boehringer Ingelheim, Eli Lilly, FDA, diabetes, jentadueto, jentadueto xr, lilly, partnership, type 2, type-2
The US Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin and metformin hydrochloride extended release) tablets for the …
FDA asks Teva for further study on Huntington drug candidate
June 1, 2016Medical Communications, Research and Development Huntington disease, Teva, US FDA, regulation
Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) said the US regulators have put on hold the approval for its drug to …
AbbVie, Janssen’s Imbruvica gets European approval to teat CLL
May 31, 2016Manufacturing and Production, Research and Development, Sales and Marketing AbbVie, CLL, drug trial, regulation
AbbVie (NYSE: ABBV) on Tuesday said Imbruvica (ibrutinib) has secured European regulatory backing to treat chronic lymphocytic leukemia or CLL. …
Roche launches Bluetooth-enabled self-testing device to check blood clotting in EU
May 31, 2016Manufacturing and Production, Research and Development, Sales and Marketing HealthTech, Heart Conditions, Roche, blood clotting, product launch
Swiss drug firm Roche (Six: ROG) has launched a blood-clott monitoring system for patients with different heart conditions. The CoaguChek …
Jazz Pharmaceuticals to acquire Celator in $1.5 billion deal
May 31, 2016Manufacturing and Production, Sales and Marketing $1.5 billion, Vyxeos, acquisition, celator, jazz, leukaemia, merger, oncology
Jazz Pharmaceuticals (NASDAQ: JAZZ) has announced that it has entered into a definitive merger agreement with Celator Pharmaceuticals (NASDAQ: CPXX) …
Weekly Movers: XenoPort, Akari, Bayer…
May 31, 2016Manufacturing and Production, Research and Development, Sales and Marketing Bayer, Sarepta Therapeutics, Stick Market, Stock, Xenoport, finance
Bayer-Monsanto story comes close on the heels of Sanofi-Medivation tussle as the pharma sector goes through the motions of consolidation. …
Genmab receives milestone payment for first Darzalex sale in Europe
May 31, 2016Manufacturing and Production, Sales and Marketing EU, FDA, Janssen, commercial, commercialised, daratumumab, darzalex, genman, multiple myeloma, sale, sales
Genmab (NASDAQ: GEN) has announced that the company is set to receive a milestone payment of $30 million from its …
EU green-lights Samsung Bioepis, Biogen’s Remicade biosimilar Flixabi
May 31, 2016Manufacturing and Production, Research and Development, Sales and Marketing Biogen, Samsung Bioepis, biosimilar, drug trial, regulation, research
Samsung Bioepis and partner Biogen (Nasdaq: BIIB) said the European Commission has approved Flixabi, a biosimilar version of Johnson & …
Roche’s MabThera gets European approval to treat chronic lymphocytic leukaemia
May 31, 2016Manufacturing and Production Roche, chronic lymphocytic leukaemia, drug approval, regulation
Swiss drugmaker Roche (SIX: ROG) on Tuesday said the European Commission (EC) has approved the subcutaneous (SC) formulation of its …
Uni spin out gets new chariman, CFO, COO
May 27, 2016Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Caldan Therapeutics is a spin-out company from the Universities of Glasgow and Southern Denmark which is looking at developing novel …
EMA to revise clinical trial guidelines
May 27, 2016Medical Communications, Research and Development EMA, Guidelines, amend, clinical trial, review, revise
The European Medicines Agency (EMA) has announced that it will conduct a review in an attempt to revise its guidelines …
Shire gets positive opinion from EMA on rare gastrointestinal disease treatment
May 27, 2016Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, Revestive, Shire, gastrointestinal, paediatric, short bowel syndrome, treatment
Shire (LSE: SHP) has announced that it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for …
Roche says comparison study for its Gazyva/ Gazyvaro showed superior progression-free survival in follicular lymphoma
May 27, 2016Medical Communications, Research and Development Comparison Study, Roche, drug trial, follicular lymphoma
Roche (SIX: ROG) on Friday said late-stage comparison trials for its drug to treat a slower form of non-Hodgkin lymphoma …
AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA
May 27, 2016Medical Communications, Research and Development AstraZeneca, NDA, US FDA, regulation
UK pharma firm AstraZeneca (LSE: AZN) on Friday said the US Food and Drug Administration (FDA) has issued a complete …
FDA approves first buprenorphine implant for opioid dependence
May 27, 2016Medical Communications, Sales and Marketing FDA, addiction, buprenorphine, dependence, implant, opioid, probuphine
The US Food and Drug Administration (FDA) has approved Probuphine, which is the first buprenorphine implant for the maintenance treatment …
AstraZeneca says its Faslodex shows superiority in comparison study for advanced breast cancer
May 27, 2016Medical Communications, Research and Development, Sales and Marketing AstraZeneca, breast cancer, comparision study, drug trial
UK drugmaker AstraZeneca (LSE: AZN) on Friday said late-stage comparison trials for its drug to treat advanced breast cancer showed …
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