FDA recommends Novartis’s biosimilar for Enbrel in unanimous vote
July 14, 2016Research and Development, Sales and Marketing Enbrel, FDA, Novartis, Sandoz, biosimilar
Sandoz, a division of Novartis, has announced that a US Food and Drug Administration (FDA) advisory committee has recommended their …
Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review
July 14, 2016Manufacturing and Production, Research and Development, Sales and Marketing Johnson & Johnson, US FDA, WHO, drug trial, new drug application, regulation, soil-transmitted helminthiasis
Johnson & Johnson (NYSE: JNJ) said the US Food and Drug Administration (FDA) has granted Priority Review for its New …
US FDA committee recommends approval for Amgen’s biosimilar of AbbVie’s Humira
July 13, 2016Research and Development, Sales and Marketing AbbVie, Amgen, Humira, US FDA, biosimilar, drug approval, drug trial, inflammatory diseases, rheumatoid arthritis
One of the world’s bestselling drug may soon have competition in the US markets after the regulators backed a biosimilar …
US FDA lifts hold on Juno’s CAR-T therapy trials; shares jump
July 13, 2016Research and Development, Sales and Marketing Stock Price, US FDA, drug trial, juno therapeutics
Shares in Juno Therapeutics (Nasdaq: JUNO) jumped to close up almost 30% after the company said the US Food and …
Pfizer gets approval expansion from FDA for pneumonia vaccine
July 13, 2016Research and Development, Sales and Marketing FDA, Pfizer, Prevnar 13, adults, approval
The US Food and Drug Administration (FDA) has issued an expanded approval for Pfizer’s pneumococcal pneumonia vaccine Prevnar 13 to …
Scottish regulators back BMS’ Opdivo for lung cancer
July 13, 2016Research and Development, Sales and Marketing Bristol-Myers Sqibb, NICE, Scottish Medicines Consortium, lung cancer, opdivo, regulation
Bristol-Myers Squibb (NYSE: BMY) said the Scottish Medicines Consortium (SMC) has recommended cancer immunotherapy Opdivo (nivolumab) to treat advanced squamous …
Nice backs UCB’s Cimzia as alternate therapy for severe rheumatoid arthritis
July 13, 2016Research and Development, Sales and Marketing Cimzia, NICE, UCB, regulation, rheumatoid arthritis
The National Institute for Health and Care Excellence (Nice) has recommended UCB Pharma’s Cimzia (certolizumab pegol) on its own or …
AstraZeneca mulling a $10-billion bid for Medivation – report
July 12, 2016Manufacturing and Production, Sales and Marketing AstraZeneca, Celgene, Medivation, Pfizer, Xtandi, cancer drug, merger and acquisition
Anglo Swedish drug firm AstraZeneca (LSE: AZN) is considering a $10-billion takeover bid for Medivation (Nasdaq: MDVN), according to reports. …
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 …
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