Weekly Movers: Medivation, Bind Therapeutics, Insys…
July 11, 2016Manufacturing and Production, Research and Development, Sales and Marketing Medivation, XBiotech, juno therapeutics, markets, stocks
Medivation (Nasdaq: MDVN) stock rose after the company announced it has entered a confidentiality agreement with a number of parties …
AstraZeneca files suit to block FDA from approving copies of cholesterol drug Crestor
July 11, 2016Sales and Marketing AstraZeneca, Crestor, US FDA, patent, regulation
Anglo-Swedish drug firm AstraZeneca (LSE: AZN) has filed a temporary restraining order to prevent the US Food and Drug Administration from …
Amgen’s Humira biosimilar candidate “highly similar” to originator, says FDA
July 8, 2016Research and Development, Sales and Marketing ABP-501, AbbVie, Amgen, FDA, Humira, abp 501, biosimilar
A report from a meeting of the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has concluded that Amgen’s …
US FDA approves Roche Cobas HPV Test
July 8, 2016Medical Communications, Research and Development HPV, Roche, US FDA, regulation
The US Food and Drug Administration (FDA) has approved cancer drugmaker Roche’s (VTX: ROG) cobas HPV Test. The first test …
Eisai criticises NICE and CDF for rare cancer ‘black hole’ in England
July 8, 2016Medical Communications, Research and Development CDF, Eisai, NICE, black hole
Japanese pharmaceutical company Eisai (TYO: 4523) has issued a statement expressing its dismay that advanced thyroid cancer patients in England …
FDA suspends Juno Therapeutics cancer drug trial after patient deaths
July 8, 2016Medical 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, 2016Medical 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’s RA therapy matches Roche’s Actemra in Phase IIb trial
July 7, 2016Medical 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 …
FDA issues new guidance on next generation sequencing
July 7, 2016Medical 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 …
New data shows Sandoz’s Enbrel biosimilar has equivalent efficacy profile
July 7, 2016Research 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 …
Biogen and AbbVie’s Zinbryta gets European backing to treat multiple sclerosis
July 7, 2016Research 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 …
Shire gets extended market authorization in Europe for drug to treat children with a rare gastrointestinal condition
July 7, 2016Research 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, 2016Research 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 says its cancer drug Adcetris gets European backing in for hodgkin lymphoma
July 6, 2016Research 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 …
Merck and Pfizer begin Phase III trials for avelumab in ovarian cancer
July 6, 2016Research 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, 2016Manufacturing 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 …
AstraZeneca trigger $10 million milestone payment for Heptares in immuno-oncology candidate
July 6, 2016Research 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, 2016Research 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, 2016Research 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, 2016Research 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 …
