Pharmafile Logo
Pharmafocus logo
Advanced Search

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
logo

AstraZeneca mulling a $10-billion bid for Medivation – report

July 12, 2016
Manufacturing 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. …

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
amgen_flag

FDA approves single monthly injection of Amgen’s Repatha

July 12, 2016
Manufacturing 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 …

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
shire_image_4

Shire dry eye treatment gets FDA approval

July 12, 2016
Manufacturing 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 …

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

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
The Gateway to Local Adoption Series

Latest content

Ofichem brings all brands under single trading name

April 23, 2026

Carvolix strengthens its Board of Directors, advisory board and governance structure

April 23, 2026

Under-Secretary of State for Health Innovation and Safety visits new building on University of Huddersfield’s NHIC

April 22, 2026

Incyclix Bio announces new additions to the Board

April 22, 2026

Remedy Plan Therapeutics Appoints Jotin Marango as CFO and CBO

April 21, 2026