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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

Zydus nabs FDA approval for type-2 diabetes drug

July 11, 2016
Sales 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 …

News
dollars_medicines

Opponents of new Medicare reforms received far more in pharma contributions, claims report

July 11, 2016
Medical 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 …

News
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
gilead-sciences

Gilead receives EU approval for combo hepatitis C treatment

July 11, 2016
Sales 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 …

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
astrazeneca_sign_sky

AstraZeneca files suit to block FDA from approving copies of cholesterol drug Crestor

July 11, 2016
Sales 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 …

News
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

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 …

News
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 …

News
fda_sign_web

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 …

News
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 …

News
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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 …

News
shire_image_4

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 …

News

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 …

News
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 …

News
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, …

News
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