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CSL’s flu vaccine scores FDA approval

May 24, 2016
Manufacturing and Production, Research and Development, Sales and Marketing CSL, FDA, Vaccine, flu, four strain, four-strain, influenza, influenza a, influenza b, seqirus

Seqirus, a division of CSL, has announced that the US Food and Drug Administration (FDA) has approved Flucelvax Quadrivalent (influenza …

News
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Sandoz biosimilar accepted for regulatory submission by EMA

May 24, 2016
Manufacturing and Production, Research and Development, Sales and Marketing EMA, Sandoz, biosimilar

Sandoz, a division of Novartis, has announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application for …

News

US FDA advisors question usefulness of Sanofi’s combination diabetes therapy

May 24, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Sanofi, US FDA, diabetes, drug trial, regulation

US Food and Drug Administration staff questioned the benefits of French drugmaker Sanofi’s (Euronext: SAN) diabetes drug candidate as well …

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French authorities pins blame on Bial and Biotrial for fatal drug trial

May 24, 2016
Manufacturing and Production, Research and Development Bial, Biotrial, France, blame, clinical trial, death, disaster, minister for health, report

Authorities in France have criticised the pharmaceutical company and the clinical research organisation at the centre of the Rennes clinical …

News
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Janssen’s Darzalex gets conditional European Commission approval to treat multiple myeloma

May 24, 2016
Manufacturing and Production, Research and Development, Sales and Marketing

Janssen said the European Commission (EC) conditionally approved its biologic Darzalex (daratumumab) to treat blood cancer.  The company said Daratumumab …

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Kite Pharma names Paul Jenkinson CFO

May 23, 2016
Research and Development, Sales and Marketing appointment, cfo, kite pharma

Kite Pharma (Nasdaq: KITE) has appointed Paul Jenkinson its chief financial officer. Jenkinson succeeds Cynthia Butitta, who will continue in her role as …

Appointment
novartis_outside_1

Novartis’ heart failure drug Entresto gets top US, EU recommendation

May 23, 2016
Research and Development, Sales and Marketing Ernesto, Novartis, heart failure, regulation

Swiss drugmaker Novartis (VTX: NOVN) said its heart failure drug Entresto (sacubitril/ valsartan) has secured top recommendations in the US …

News
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China to cut prices of GSK, AstraZeneca drugs

May 23, 2016
Sales and Marketing AstraZeneca, China, GSK, drug prices

Chinese health authorities have announced steps to cut the prices of three costly drugs in their latest attempt to reduce …

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Weekly Movers: Valeant, Anacor, Regeneron…

May 23, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Acorda, Aduro Biotech, Anacor Pharma, Financial, MacroGenics, Merck, Regeneron Pharma, Valeant Pharma

The earnings season came to a close with Germany’s Merck doubling its first-quarter profits. For the week, drug trials, analyst …

Feature
gavel

Biotech firm fined $3.5 million for animal mistreatment

May 23, 2016
Medical Communications, Sales and Marketing US department of agriculture, animal cruelty, animal mistreatment, antibody, santa cruz biotechnology, usda

A US-based biotechnology company has been fined $3.5 million by the US Department of Agriculture (USDA) for a case related …

News

Bayer offers $62 billion for Monsanto in all cash deal

May 23, 2016
Research and Development, Sales and Marketing Bayer, Deals, Financial, Merger & Acquisition, monsanto

German pharma and crop sciences giant Bayer (ETR: BAYN) has made an unsolicited $62 billion all-cash offer for Monsanto Co …

News

Pfizer and Spark Therapeutics present early data on bio-engineered haemophilia drug

May 23, 2016
Research and Development, Sales and Marketing Pfizer, Spark Therapeutics, gene therapy, haemophilia B

Pfizer (NYSE: PFE) and Spark Therapeutics (NASDAQ: ONCE) have announced that they will present data showing encouraging signs in their …

News
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EMA to review Pfizer’s meningococcal vaccine

May 20, 2016
Research and Development, Sales and Marketing EMA, Pfizer, meningitis, meningococcal vaccine, trumenba

Pfizer (NYSE: PFE) has announced that the European Medicines Agency has accepting the marketing authorisation application for its meningococcal group …

News
msf

MSF says staff member shot dead in Central African Republic; suspends activity in the area

May 20, 2016
Medical Communications Central African republic, MSF

The medical aid charity Doctors without Borders (MSF) said it is suspending activities in the Central African Republic (CAR) following an …

News
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Nice backs Novartis’ lung cancer drug

May 20, 2016
NHS, NICE, Novartis, ceritinib, lung cancer, recommendation, regulation

The National Institute for Health and Care Excellence (Nice) has recommended Novartis’ (VTX: NOVN) Ceritinib (zykadia) as a treatment for …

News
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Horizon to acquire worldwide rights to Boehringer Ingelheim genetic disease drug

May 20, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Boehringer Ingelheim, actimmune, agreement, horizon, interferon gamma-1b, worldwide rights

Horizon Pharmaceuticals (NASDAQ: HZNP) has entered into a worldwide rights agreement with Boehringer Ingelheim to acquire interferon gamma-1b, which is …

News
roche_glass_building

UK regulators do not back Roche’s breast cancer drug

May 20, 2016
Medical Communications, Research and Development, Sales and Marketing NICE, Perjeta, Roche, breast cancer, recommendation

The National Institute for Health and Care Excellence (Nice) has provisionally turned down Swiss drugmaker Roche’s (VTX: ROG) breast cancer …

News
chugai_pharmaceutical

Chugai partners with Osaka University in £62 million immunology collaboration

May 20, 2016
Medical Communications, Research and Development Chugai, collaboration, immunology, osaka university

Chugai Pharmaceuticals (TOKYO: 4519) has announced a collaboration agreement with Osaka University in advanced immunology research worth up to £62 …

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Celator receives FDA breakthrough therapy designation for leukaemia drug

May 20, 2016
Medical Communications, Research and Development FDA, Vyxeos, acute myeloid leukaemia, breakthrough therapy, celator

A new treatment for acute myeloid leukaemia and other blood cancers from Celator Pharmaceuticals (NASDAQ: CPXX) has been granted breakthrough …

News

Urgent action needed on antimicrobial resistance, says government report

May 19, 2016
Manufacturing and Production, Medical Communications, Research and Development ABPI, Lord Jim O'Neill, NICE, antimicrobial resistance

A new UK governmental report has warned that the global rise of antimicrobial resistance is set to worsen, with the …

News
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