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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
janssen_latest_logo_on_sign

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
samsung_bioepis

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
frank_armstrong_chairman

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
clinical_trial_3

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
shire_image_4

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

FDA approves first buprenorphine implant for opioid dependence

May 27, 2016
Medical 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 …

News

AstraZeneca says its Faslodex shows superiority in comparison study for advanced breast cancer

May 27, 2016
Medical 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 …

News
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Sam Eldessouky named new corporate controller at Valeant

May 26, 2016

Valeant Pharmaceuticals (NYSE: VRX) has announced that Sam Eldessouky has been named senior vice president and corporate controller. Eldessouky joins …

Appointment
eli_lilly_logo

Nice does not recommend Eli Lilly’s lung cancer drug in draft guidance

May 26, 2016
Research and Development, Sales and Marketing Cancer Drugs Fund, Eli Lilly, NICE, lung cancer

The National Institute of Care and Excellence (Nice) did not recommend US drugmaker Eli Lilly’s (NYSE: LLY) Portrazza to treat …

News
janssen_latest_logo_on_sign

Janssen says its Stelara maintained clinical remission in Crohn’s disease in Phase III trials

May 26, 2016
Research and Development, Sales and Marketing Crohn’s disease, Janssen, Stelara, crohn's disease, drug trial

Janssen said its maintenance therapy for Crohn’s disease showed remission for patients in late-stage trials.  The company said a significant …

News
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Shares at Sarepta Therapeutics jump after FDA delay in drug approval review

May 26, 2016
Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, FDA, Sarepta Therapeutics, approval, delay, delayed announcement, muscular dystrophy, sarepta, treatment

Sarepta Therapeutics (NASDAQ: SRPT) has witnessed a sharp rise in the price of its shares after the US Food and …

News

US FDA committee recommends approval of Sanofi’s combination therapy for type 2 diabetes

May 26, 2016
Research and Development, Sales and Marketing

French drug firm Sanofi (Euronext: SAN) said the US Food and Drug Administration (FDA) advisory committee has recommended the approval …

News
clinical_trial_4

FDA approves CSL haemophilia A drug

May 26, 2016
Sales and Marketing CSL, afstyla, haemophilia a, treatment

CSL (ASX: CSL) has announced that the US Food and Drug Administration (FDA) has approved Afstyla (antihaemophilic factor [recombinant), single …

News

NICE recommends Jevtana for advanced prostate cancer

May 25, 2016
Sales and Marketing Jevtana, NICE, approval, prostate cancer, recommendation

The National Institute for Health and Care Excellence (NICE) has recommended Sanofi Genzyme’s Jevtana (cabazitaxel), in combination with prednisone or …

News
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Sanofi makes move to remove Medivation board; Medivation hits back

May 25, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Medivation, Sanofi, removal of board, takeover

Sanofi (NYSE: SNY) has taken their proposed takeover of Medivation (NASDAQ: MDVN) up several notches, with the French company filing …

News
gilead-sciences

Gilead names Kevin Young new chief operating officer

May 25, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Gilead

Gilead Sciences (NASDAQ: GILD) has announced two new senior appointments, including Kevin Young as its new chief operating officer. Martin …

Appointment
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