vertex-headquarters

FDA approves Vertex’s Trikafta in new indication, now potentially covering 90% of cystic fibrosis patients

October 23, 2019
Research and Development, Sales and Marketing FDA, Trikafta, Vertex, cystic fibrosis, pharma

The FDA has granted marketing authorisation to Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF), it …

New study shows Prozac no better than placebo in treating autism

October 23, 2019
Research and Development

A small study has found that the commonly prescribed medication for kids and teenagers with autism is no more effective …

opdivo_1_1

BMS’ Opdivo+Yervoy+Chemo combo shows superior overall survival in first-line lung cancer

October 23, 2019
Research and Development Bristol-Myers Squibb, Cancer, NSCLC, Yervoy, lung cancer, opdivo, pharma

Bristol Myers Squibb has lifted the curtain on new Phase 3 data for its blockbuster immunotherapy Opdivo (nivolumab), showing that …

biogen_logo

Biogen aiming for Aducanumab to slow Alzheimer’s progression

October 23, 2019
Research and Development

US firm Biogen is hoping for approval to bring about a treatment that could slow the onset of Alzheimer’s disease. …

takeda_world

Takeda acquires investigational coeliac disease therapy

October 23, 2019
Research and Development

Takeda has acquired licensing for a first-in-class investigational coeliac disease therapy CNP-101/TAK-101. The Japanese pharma giant now has the rights …

shutterstock_159488225

Porton Biopharma signs potential $24m deal to push its intranasal anthrax vaccine into Phase 1 trials

October 22, 2019
Manufacturing and Production, Research and Development FDA, Porton Biopharma, anthrax, pharma

Porton Biopharma has signed a modification to its existing agreement with the US National Institute of Health’s National Institute of …

Novo Nordisk opens first Pharmatech branch office in Singapore

October 22, 2019
Manufacturing and Production Novo Nordisk, Singapore, pharma

Novo Nordisk has celebrated the launch of a new Pharmatech A/S branch office based in Singapore at a grand opening …

teva_copy

Teva offers massive $23 billion to avoid thousands of lawsuits

October 22, 2019
Manufacturing and Production

Israeli drug company Teva has said that it would offer $250 million in cash and a supply of Suboxone, an …

cruk_logo

Cancer Research UK announces push for earlier cancer detection

October 22, 2019
Manufacturing and Production

Cancer Research UK has embarked on a new international alliance with a plan to develop ‘radical new strategies’ and technologies …

vertex-headquarters

US FDA approves Vertex’s new breakthrough therapy for cystic fibrosis

October 22, 2019
Manufacturing and Production

The US FDA has approved Trikafta (elexacaftor/ivacaftor/tezacaftor) – the first triple combination therapy available for patients with most common cystic …

brexit-hintergrund_web

“No deal” Brexit and life sciences: What happens?

October 21, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EU, Europe, UK, brexit, no deal, no-deal, pharma

Prime Minister Boris Johnson may have agreed a withdrawal agreement with the European Union at the 11th hour, but despite …

alexion_sign

FDA approves Alexion’s Ultomiris in atypical haemolytic uremic syndrome for adults and children

October 21, 2019
Sales and Marketing Alexion, FDA, Ultomiris, pharma, rare disease

The FDA has moved to expand the existing label for Alexion’s Ultomiris (ravulizumab-cwvz) to include the treatment of atypical haemolytic …

ema_logo

CHMP recommends several drugs for EU market approval

October 21, 2019
Sales and Marketing

The EMA’s human medicines committee (CHMP) has recommended seven medicines for approval at its October 2019 meet including MSD’s Ervebo, …

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Roche’s Tecentriq/Avastin combo smashes endpoints at Phase 3 in unresectable hepatocellular carcinoma

October 21, 2019
Research and Development, Sales and Marketing Cancer, Roche, immunotherapy, pharma, tecentriq

New Phase 3 data has emerged demonstrating the efficacy of Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) in the …

astrazeneca_sign_sky

AstraZeneca receives FDA approval for Farxiga

October 21, 2019
Sales and Marketing

AstraZeneca have announced that the US FDA has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure …

gsk_boronia_australia

GlaxoSmithKline sells two vaccines for up to £822m

October 21, 2019
Sales and Marketing

GlaxoSmithKline has announced it will divest two of its major vaccines to Denmark-based Bavarian Nordic in a deal that will …

Medical cannabis: Growth by leaps and bounds

October 18, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Canada, Canopy Growth, medical cannabis, pharma

This article follows parts one and two of our trio of in-depth pieces focusing on the growing medical cannabis phenomenon. …

top_10_photo

Top Ten most popular articles on Pharmafile.com this week

October 18, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

It’s time for a rundown of the top 10 articles on PharmaFile this past week. The past seven days saw …

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2019 saw the FDA approve more generic drugs than ever before

October 18, 2019
Medical Communications, Sales and Marketing FDA, US, generic drugs, pharma

Fiscal year 2019 was a record-breaking one, according to the FDA. The US regulator smashed its previous total for annual …

shionogi

FDA panel gives positive vote for Shionogi’s Cefiderocol in Urinary Tract Infections

October 18, 2019
Medical Communications

The US FDA has recommended approval for cefiderocol, a novel antibiotic for complicated urinary tract infections, including pyelonephritis, in patients …

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