Shares tumble at CytRx as lead oncology candidate fails to impress in Phase III
July 12, 2016Manufacturing and Production, Research and Development aldoxorubicin, cytrx
CytRx (NASDAQ: CYTR) has announced disappointing results from a Phase III trial for its lead drug candidate, aldoxorubicin, compared to …
FDA approves single monthly injection of Amgen’s Repatha
July 12, 2016Manufacturing and Production, Sales and Marketing Amgen, FDA, Repatha, pushtronex
Amgen (NASDAQ: AMGN) has announced that the US Food and Drug Administration (FDA) has approved a new, monthly single-dose administration …
Coherus BioSciences says Neulasta biosimilar shows positive topline results; shares jump
July 12, 2016Manufacturing and Production, Research and Development, Sales and Marketing Amgen, Cancer, Coherus BioSciences, biosimilar, drug trial
Shares in Coherus BioSciences (Nasdaq: CHRS) jumped to close over 27% after the company said its biosimilar copy for Amgen’s …
Shire dry eye treatment gets FDA approval
July 12, 2016Manufacturing and Production, Sales and Marketing FDA, Shire, dry eye, xiidra
Shire (LSE: SHP) has announced that the US Food and Drug Administration has approved its twice-daily eye drop solution, Xiidra …
Ipsen’s CEO to step down, names new chief executive
July 11, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Ipsen (Euronext: IPN) said its chief executive Marc de Garidel is stepping down and will be replaced by David Meek, …
Zydus nabs FDA approval for type-2 diabetes drug
July 11, 2016Sales and Marketing Zydus Cadila, nateglinide
Zydus Cadila, a division of Cadila Pharmaceuticals (NSE: CADILAHC), has announced the US Food and Drug Administration (FDA) has approved …
Opponents of new Medicare reforms received far more in pharma contributions, claims report
July 11, 2016Medical Communications, Sales and Marketing corporate donations, public citizen
A new report has emerged highlighting the extent to which opponents and critics of the Obama administration’s reforms of Medicare …
Pfizer says its Sutent meets primary endpoint in Phase III trials for kidney cancer recurrence
July 11, 2016Research and Development, Sales and Marketing Kidney cancer, Pfizer, Stutent, drug trial
US pharma giant Pfizer (NYSE: PFE) said late-stage trials for its Sutent (sunitinib) met its primary endpoint as a treatment …
Gilead receives EU approval for combo hepatitis C treatment
July 11, 2016Sales and Marketing Epclusa, Gilead, eu approval, sofosbuvir
Gilead Sciences (NASDAQ: GILD) has received a marketing authorisation approval from the European Commission for combination treatment Epclusa (sofosbuvir/velpatasvir) for …
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 …
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