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FDA approves Novartis’s Cosentyx for severe plaque psoriasis

June 2, 2021
Research and Development

The FDA has approved Novartis’s Cosentyx for the treatment of children and adolescents with moderate to severe plaque psoriasis. The …

News
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Pharmafile.com’s weekly COVID-19 news round-up

June 2, 2021
Research and Development

The past week has been a mixed bag when it comes to COVID-19 news. The EU is suing AstraZeneca over …

News

Profits over patients: US pharma spending billions on investor payouts

June 2, 2021
Research and Development Trump, US, stocks

In 2017 Donald Trump signed the Tax Cuts and Jobs Act (TCJA), creating billions of dollars in tax rate cuts …

News
moderna_norwood_plant

Moderna submits BLA with FDA for COVID vaccine

June 2, 2021
Research and Development COVID-19, EU, FDA, Lonza, Moderna, production

Moderna has initiated the rolling submission process with the FDA for a Biologics License Application (BLA) for the licensure of …

News
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EU approves Pfizer-BioNTech vaccine for 12-15 year olds

June 1, 2021
Manufacturing and Production, Sales and Marketing

The EMA has approved the Pfizer-BioNTech COVID-19 vaccine for 12-15 year olds. Individual EU member states can now decide if …

News
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Lucida Medical gains CE marking for AI prostate cancer tech

June 1, 2021
Manufacturing and Production AI, MRI, NHS, prostate cancer

Cambridge-based AI company, Lucida Medical, has received CE marking for its new machine learning-based prostate cancer detection software, Prostate Intelligence …

News
laboratory-testing-az

DMD study in vamorolone reports positive results

June 1, 2021
Manufacturing and Production

Santhera Pharmaceuticals and ReveraGen BioPharma have announced positive results from their Phase IIb VISION-DMD study, evaluating the efficacy and safety …

News
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Five-month-old baby receives gene therapy Zolgensma on NHS

June 1, 2021
Manufacturing and Production, Sales and Marketing

A five-month-old baby is one of the first patients to receive Zolgensma, the world’s most expensive drug, on the NHS. …

News

FDA accepts Ipsen’s NDA for ultra-rare genetic disorder drug

June 1, 2021
Manufacturing and Production EMA, FDA, FOP, NDA, ipsen

The FDA have accepted Ipsen’s New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention …

News

Janssen’s one-shot COVID vaccine approved by MHRA

May 28, 2021

The MHRA has approved the use of Janssen’s one-shot COVID-19 vaccine in the UK, becoming the fourth jab approved for …

News
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Pharmafile.com’s top 10 news stories of the week

May 28, 2021
Medical Communications

Among our ten most-read stories this week: a French study has found that dogs can detect COVID-19 with 97% accuracy, …

News
az

AstraZeneca’s lung cancer drug gains EU approval

May 28, 2021
Medical Communications AstraZeneca, EU, lung cancer, oncology

AstraZeneca’s Tagrisso (osimertinib) has been approved in the EU for the adjuvant treatment of adult patients with early-stage (IB, II …

News

FDA approves BMS’s Zeposia for chronic inflammatory bowel disease

May 28, 2021
Medical Communications

The FDA has approved Approves Bristol Myers Squibb’s Zeposia for adults with moderately to severely active ulcerative colitis (UC). UC …

News
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EU: Fine AstraZeneca €10 per dose for COVID-19 vaccine delay

May 28, 2021
Medical Communications

The EU is suing AstraZeneca in a Brussels court over its failure to deliver on its vaccine contract. EU member …

News

NICE recommends Janssen’s active psoriatic arthritis drug

May 28, 2021
Medical Communications Janssen, NICE, UK, arthritis

NICE have released a Final Appraisal Document (FAD) recommending Janssen’s tremfya (guselkumab) as a new option for treating active psoriatic …

News

First COVID-fighting herbal supplement launched

May 27, 2021
COVID-19, herbal supplement

The first herbal supplement shown in clinical trials to prevent COVID-19 symptoms from deteriorating has been launched by Swiss Pharmacan …

News
gilead-sciences

Gilead to supply India one million doses of ‘black fungus’ medicine

May 27, 2021

Gilead Sciences are to supply one million doses of Amphotericin-B to India as black fungus (mucormycosis) cases surge. The drug …

News
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Janssen sees promising PRO data for prostate cancer therapy

May 27, 2021
Janssen, prostate cancer

Janssen has announced patient-reported outcomes (PRO) data from the pre-specified final analysis of their Phase III TITAN study in patients …

News
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Sanofi-GSK Phase III trial begins for COVID-19 vaccine

May 27, 2021

Sanofi and GSK have begun their Phase III clinical study to assess the safety, efficacy, and immunogenicity of their COVID-19 …

News

Medical cannabis more effective painkiller in 86% of chronic pain patients

May 27, 2021
medical cannabis

The Medical Cannabis Clinics (TMCC) have released new data from a survey of patients prescribed medical cannabis to treat pain, …

News
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