Pharmafile.com’s weekly COVID-19 news round-up
June 2, 2021Research and Development
The past week has been a mixed bag when it comes to COVID-19 news. The EU is suing AstraZeneca over …
Profits over patients: US pharma spending billions on investor payouts
June 2, 2021Research 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 …
Moderna submits BLA with FDA for COVID vaccine
June 2, 2021Research 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 …
EU approves Pfizer-BioNTech vaccine for 12-15 year olds
June 1, 2021Manufacturing 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 …
Lucida Medical gains CE marking for AI prostate cancer tech
June 1, 2021Manufacturing 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 …
DMD study in vamorolone reports positive results
June 1, 2021Manufacturing and Production
Santhera Pharmaceuticals and ReveraGen BioPharma have announced positive results from their Phase IIb VISION-DMD study, evaluating the efficacy and safety …
Five-month-old baby receives gene therapy Zolgensma on NHS
June 1, 2021Manufacturing 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. …
FDA accepts Ipsen’s NDA for ultra-rare genetic disorder drug
June 1, 2021Manufacturing 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 …
Janssen’s one-shot COVID vaccine approved by MHRA
May 28, 2021The MHRA has approved the use of Janssen’s one-shot COVID-19 vaccine in the UK, becoming the fourth jab approved for …
Pharmafile.com’s top 10 news stories of the week
May 28, 2021Medical Communications
Among our ten most-read stories this week: a French study has found that dogs can detect COVID-19 with 97% accuracy, …
AstraZeneca’s lung cancer drug gains EU approval
May 28, 2021Medical 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 …
FDA approves BMS’s Zeposia for chronic inflammatory bowel disease
May 28, 2021Medical Communications
The FDA has approved Approves Bristol Myers Squibb’s Zeposia for adults with moderately to severely active ulcerative colitis (UC). UC …
EU: Fine AstraZeneca €10 per dose for COVID-19 vaccine delay
May 28, 2021Medical Communications
The EU is suing AstraZeneca in a Brussels court over its failure to deliver on its vaccine contract. EU member …
NICE recommends Janssen’s active psoriatic arthritis drug
May 28, 2021Medical 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 …
First COVID-fighting herbal supplement launched
May 27, 2021COVID-19, herbal supplement
The first herbal supplement shown in clinical trials to prevent COVID-19 symptoms from deteriorating has been launched by Swiss Pharmacan …
Gilead to supply India one million doses of ‘black fungus’ medicine
May 27, 2021Gilead Sciences are to supply one million doses of Amphotericin-B to India as black fungus (mucormycosis) cases surge. The drug …
Janssen sees promising PRO data for prostate cancer therapy
May 27, 2021Janssen, prostate cancer
Janssen has announced patient-reported outcomes (PRO) data from the pre-specified final analysis of their Phase III TITAN study in patients …
Sanofi-GSK Phase III trial begins for COVID-19 vaccine
May 27, 2021Sanofi and GSK have begun their Phase III clinical study to assess the safety, efficacy, and immunogenicity of their COVID-19 …
Medical cannabis more effective painkiller in 86% of chronic pain patients
May 27, 2021medical cannabis
The Medical Cannabis Clinics (TMCC) have released new data from a survey of patients prescribed medical cannabis to treat pain, …
Doctor vigilance urged for rare instances of stroke following COVID-19 vaccinations
May 26, 2021Research and Development
Doctors have been urged to be vigilant for signs of stroke after three rare instances have occurred in Oxford-AstraZeneca patients. …
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