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Research and Development

Showing 15 posts of 9578 posts found.

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Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review

July 14, 2016 Manufacturing 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 …
News
fda_logo-web

US FDA committee recommends approval for Amgen’s biosimilar of AbbVie’s Humira

July 13, 2016 Research 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 …
News
junologo

US FDA lifts hold on Juno’s CAR-T therapy trials; shares jump

July 13, 2016 Research 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 …
News

Pfizer gets approval expansion from FDA for pneumonia vaccine

July 13, 2016 Research 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 …
News

Scottish regulators back BMS’ Opdivo for lung cancer

July 13, 2016 Research 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 …
News

Nice backs UCB’s Cimzia as alternate therapy for severe rheumatoid arthritis

July 13, 2016 Research 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 …
News
money_pills_2

Shares tumble at CytRx as lead oncology candidate fails to impress in Phase III

July 12, 2016 Manufacturing 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 …
News
cancerstudy

Coherus BioSciences says Neulasta biosimilar shows positive topline results; shares jump

July 12, 2016 Manufacturing 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 …
News
davidmeek

Ipsen’s CEO to step down, names new chief executive

July 11, 2016 Business 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, …
Appointment
pfizer_building

Pfizer says its Sutent meets primary endpoint in Phase III trials for kidney cancer recurrence

July 11, 2016 Research 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 …
News
stocks1

Weekly Movers: Medivation, Bind Therapeutics, Insys…

July 11, 2016 Manufacturing 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 …
Feature
amgen_hq

Amgen’s Humira biosimilar candidate “highly similar” to originator, says FDA

July 8, 2016 Research 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 …
News
fda_logo-web

US FDA approves Roche Cobas HPV Test

July 8, 2016 Medical 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 …
News

Eisai criticises NICE and CDF for rare cancer ‘black hole’ in England

July 8, 2016 Medical 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 …
News
chemo-web

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 …
News
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