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Sanofi looks to set date for showdown with Medivation shareholders

June 2, 2016
Sales and Marketing Medivation, Sanofi, hostile, record date, shareholders, takeover

Sanofi (NYSE: SNY) has announced that it has attempted to fix a record date with Medivation (NASDAQ: MDVN) where the …

News
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Janssen says its Trevicta gets European regulatory approval as maintenance therapy for Schizophrenia

June 2, 2016
Medical Communications, Research and Development European Commission, Janssen, Trevicta, schizophrenia

Janssen said the European Commission has approved its Trevicta (paliperidone palmitate, a 3‑monthly injection) as maintenance treatment of schizophrenia.  Trevicta …

News

Nice rejects Janssen’s Imbruvica in draft guidance

June 1, 2016
Medical 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The UK regulators have not recommended Janssen’s leukaemia drug Imbruvica (ibrutinib) to treat in draft guidance.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 …

News
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Biogen says European regulatory committee adopts positive view for Tysabri

June 1, 2016
Medical 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 …

News

Biomarin withdraws regulatory submissions for Duchenne muscular dystrophy drug

June 1, 2016
Research 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Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …

News
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GSK’s gene therapy Strimvelis gets European regulatory nod

June 1, 2016
Research 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 …

News

FDA approves Lilly/Boehringer Ingelheim type-2 diabetes drug

June 1, 2016
Research 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 …

News
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FDA asks Teva for further study on Huntington drug candidate

June 1, 2016
Medical 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 …

News
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AbbVie, Janssen’s Imbruvica gets European approval to teat CLL

May 31, 2016
Manufacturing 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. …

News
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Roche launches Bluetooth-enabled self-testing device to check blood clotting in EU

May 31, 2016
Manufacturing 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 …

News

Jazz Pharmaceuticals to acquire Celator in $1.5 billion deal

May 31, 2016
Manufacturing 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) …

News
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Weekly Movers: XenoPort, Akari, Bayer…

May 31, 2016
Manufacturing 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. …

Feature
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Genmab receives milestone payment for first Darzalex sale in Europe

May 31, 2016
Manufacturing 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 …

News
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EU green-lights Samsung Bioepis, Biogen’s Remicade biosimilar Flixabi

May 31, 2016
Manufacturing 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 & …

News

Roche’s MabThera gets European approval to treat chronic lymphocytic leukaemia

May 31, 2016
Manufacturing 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 …

News
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Uni spin out gets new chariman, CFO, COO

May 27, 2016
Manufacturing 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 …

Appointment
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EMA to revise clinical trial guidelines

May 27, 2016
Medical 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 …

News
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Shire gets positive opinion from EMA on rare gastrointestinal disease treatment

May 27, 2016
Medical 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 …

News
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Roche says comparison study for its Gazyva/ Gazyvaro showed superior progression-free survival in follicular lymphoma

May 27, 2016
Medical 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 …

News

AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA

May 27, 2016
Medical 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 …

News
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