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Servier on trial for weight-loss pill that led to 2,000 deaths

September 23, 2019
Sales and Marketing

A trial on one of France’s largest ever healthcare scandals has begun after a weight loss pill was believed to …

News
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Japan approves Astellas and FibroGen’s Evrenzo for anaemia in dialysis patients

September 23, 2019
Sales and Marketing Astellas, anaemia, fibrogen, pharma

Astellas Pharma and FibroGen have revealed that their collaborative drug Evrenzo (roxadustat) has secured marketing authorisation in Japan for the …

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EMA’s CHMP recommends three new medications

September 23, 2019
Sales and Marketing

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) have recommended approval for three new medicines with …

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FDA approves Novo’s new type 2 diabetes pill

September 23, 2019
Sales and Marketing

A new drug from Danish drug maker Novo Nordisk, called Rybelsus (semaglutide), has been approved by the FDA for the …

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Top Ten most popular articles on Pharmafile.com this week

September 20, 2019
Medical Communications

Friday time! This past week has seen numerous potential breakthroughs including a prostate drug that could halt Parkinson’s disease as …

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Antidepressant sertraline works ‘by reducing anxiety symptoms first’

September 20, 2019
Medical Communications, Research and Development antidepressant, sertraline

Researchers at University College London have found that a commonly prescribed antidepressant, sertraline, works in unexpected ways, first relieving users …

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Novo’s Tresiba lowers hypoglycaemia risk compared to insulin glargine in type 2 diabetes

September 20, 2019
Medical Communications, Research and Development Novo Nordisk, Tresiba, diabetes, pharma

Novo Nordisk has unveiled new data for Tresiba (insulin degludec) at the 55th Annual Meeting of the European Association for …

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Biogen to start new Spinraza trial to preserve market share

September 20, 2019
Medical Communications, Research and Development

Biogen is planning a new trial of $1.7billion-a-year Spinraza to investigate much higher doses in spinal muscular atrophy (SMA) and …

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Lundbeck and Takeda’s depression drug approved in Japan

September 20, 2019
Medical Communications, Sales and Marketing Japan, Lundbeck, Takeda, major depressive disorder, pharma

Takeda and Lundbeck have announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has chosen to authorise their drug …

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Almost half of all cancer drug trials show bias and exaggeration

September 19, 2019
Research and Development BMJ, Cancer, cancer drug trials

New research on clinical trials between 2014 and 2016 raise “serious concerns about low standards” as over the three year …

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Sanofi’s Troujeo beats insulin degludec in head-to-head study in type 2 diabetes

September 19, 2019
Research and Development Sanofi, Troujeo, diabetes, insulin degludec, pharma

Sanofi took the opportunity at the 55th annual European Association for the Study of Diabetes to present new data from …

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British baby’s death not caused by Zolgensma says Novartis

September 19, 2019
Research and Development AveXis, Novartis, Zolgensma, spinal muscular atrophy

Swiss drugmaker Novartis have stated that a British baby’s death this year after getting Novartis’ gene therapy Zolgensma, was not …

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FDA expands Janssen’s Erleada label to cover metastatic castration-sensitive prostate cancer

September 19, 2019
Sales and Marketing Cancer, Erleada, FDA, Janssen, pharma, prostate cancer

Janssen has announced that the FDA has expanded the label of its androgen receptor inhibitor Erleada (apalutamide) to include the …

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Poor diabetes control costing NHS £3bn in avoidable treatment

September 19, 2019
Business Services, Sales and Marketing

Findings being presented at this year’s European Association for the Study of Diabetes have shown that the NHS is losing …

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NICE recommends Takeda’s Takhzyro for NHS use to prevent hereditary angioedema attacks

September 18, 2019
Research and Development, Sales and Marketing NHS, NICE, Takeda, Takhzyro, pharma

UK drug watchdog NICE has announced its final draft guidance recommending Takeda’s subcutaneous injection Takhzyro (Lanadelumab) for use on the …

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US, Canada and Australia simultaneously fast-track Keytruda/Lenvima combo for endometrial cancer

September 18, 2019
Research and Development, Sales and Marketing Australian Therapeutic Goods Administration, Cancer, FDA, Health Canada, Lenvima, keytruda, pharma

The FDA has acted under a new initiative in collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, …

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New agreement gives AstraZeneca full responsibility for Linzess in China

September 18, 2019
Research and Development AstraZeneca, IBS-C, Linzess

AstraZeneca has amended its collaboration agreement with Ironwood Pharmaceuticals in China for Linzess (linaclotide), a first-in-class new treatment for patients …

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Swiss biotech raises $16m for ‘undelivery mechanism’ in rare liver disease

September 18, 2019
Research and Development liver disease, versantis

A new method from Swiss Biotech Versantis promises to give far better immediate care and offer a treatment for a …

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Roche bags FDA Breakthrough for Gazyva in lupus nephritis

September 18, 2019
Research and Development FDA, Gazyva, Roche, lupus nephritis

The US FDA has granted Breakthrough Therapy Designation to Gazyva (obinutuzumab) for adults with lupus nephritis. The win comes on …

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New APPG report on access to cutting edge medicines

September 17, 2019
Manufacturing and Production

A new report from the All-Party Parliamentary Groups (APPG) is urging the life science community to work together to speed …

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