Research and Development

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FDA suspends Juno Therapeutics cancer drug trial after patient deaths

July 8, 2016 Medical Communications, Research and Development FDA, juno therapeutics, patient deaths

Juno Therapeutics (NASDAQ: JUNO) has had its Phase II trial investigating JCAR015 in adult patients with relapsed or refractory B …

Lundbeck, Otsuka’s trial Alzheimer’s disease drug gets US FDA fast track designation

July 8, 2016 Medical Communications, Research and Development Alzheimer's disease, Lundbeck, Otsuka, US FDA, drug development, drug trial, fast track designation

H. Lundbeck A/S (CPH: LUN) and Otsuka Pharmaceutical said the US Food and Drug Administration (FDA) have granted Fast Track …
ablynx_flags-web

Ablynx’s RA therapy matches Roche’s Actemra in Phase IIb trial

July 7, 2016 Medical Communications, Research and Development Ablynx, Actemra, Roche

Ablynx (EBR: ABLX) has presented positive data on their rheumatoid arthritis treatment candidate, ALX-0061 (vobarilizumab), in patients with rheumatoid arthritis …
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FDA issues new guidance on next generation sequencing

July 7, 2016 Medical Communications, Research and Development FDA, next generation sequencing, precision medicines initiative

The US Food and Drug Administration (FDA) has issued new draft guidance, as part of the Precision Medicine Initiative, on …
pfizer_enbrel

New data shows Sandoz’s Enbrel biosimilar has equivalent efficacy profile

July 7, 2016 Research and Development, Sales and Marketing Amgen, EMA, Enbrel, FDA, Novartis, Sandoz, biosimilars

Sandoz has announced new data confirming the equivalent safety and efficacy profile of their biosimilar version of Enbrel (etanercept) in …
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Biogen and AbbVie’s Zinbryta gets European backing to treat multiple sclerosis

July 7, 2016 Research and Development, Sales and Marketing Biogen, drug approval, european union, multiple sclerosis, zinbryta

Biogen (Nasdaq: BIIB) and Abbvie’s (NYSE: ABBV) once-monthly Zinbryta (daclizumab) has been approved in European Union for treatment of multiple …
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Shire gets extended market authorization in Europe for drug to treat children with a rare gastrointestinal condition

July 7, 2016 Research and Development, Sales and Marketing European Commission, Revestive, Shire, market authorisation, short bowel syndrome

UK drugmaker Shire (LSE: SHP) said the European Commission has granted extension of Market Authorization for Revestive (teduglutide) to treat …

Pfizer’s blood cancer drug first to be reappraised from Cancer Drug Fund

July 7, 2016 Research and Development, Sales and Marketing Cancer, Cancer Drugs Fund, NICE, Pfizer, blood cancer, bosulif

The National Institute for Health and Care Excellence (Nice) recommended US pharma giant Pfizer’s (NYSE: PFE) Bosulif (bosutinib) to treat …
takeda_world

Takeda says its cancer drug Adcetris gets European backing in for hodgkin lymphoma

July 6, 2016 Research and Development European Commission, Takeda, drug trial, lymphoma

Takeda Pharmaceutical (TSE: 4502) said the European Commission has extended the marketing authorization for its Adcetris (brentuximab vedotin) to treat …
clinical_trial_3

Merck and Pfizer begin Phase III trials for avelumab in ovarian cancer

July 6, 2016 Research and Development Merck, Pfizer, avelumab

Merck (KGaA, Darmstadt) and Pfizer (NYSE: PFE) have announced the initiation of the first Phase III study of investigational compound, …

Wickham Laboratories Announces New In Vitro Pyrogenicity Testing Method

July 6, 2016 Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

Wickham Laboratories is pleased to announce the introduction of a new in vitro test method, the Monocyte Activation Test, for …
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AstraZeneca trigger $10 million milestone payment for Heptares in immuno-oncology candidate

July 6, 2016 Research and Development, Sales and Marketing AstraZeneca, Heptares

AstraZeneca (LSE: AZN) is set to deliver a payment of $10 million to Heptares Therapeutics after the first patient was …

Sanofi says to co-develop Zika vaccine with US government

July 6, 2016 Research and Development, Sales and Marketing Sanofi, US government, Vaccine, Zika virus, drug development, research

French drugmaker Sanofi (Euronext: SAN) said it will co-develop a Zika vaccine candidate with the US government.  No financial details …

Bristol-Myers Squibb acquires Cormorant Pharmaceuticals in deal worth up to $425 million

July 6, 2016 Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, cormorant

Bristol-Myers Squibb (NYSE: BMY) has announced that it has acquired all outstanding capital stock of Sweden-based Cormorant Pharmaceuticals, granting it …

Sanofi signs confidentiality agreement with Medivation for due diligence access for potential deal

July 6, 2016 Research and Development, Sales and Marketing Financial, M&A, MA, Medivation, Sanofi, deal, offer

Sanofi (Euronext: SAN) confirmed it has entered a confidentiality agreement with cancer drugmaker Medivation (Nasdaq: MDVN) under which it will …
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