Novartis report longest median OS in breast cancer study
June 3, 2021Novartis, breast cancer, trials
Novartis has announced updated median overall survival (OS) results for Kisqali (ribociclib), in combination with fulvestrant, in postmenopausal women with …
Organon launches as women’s health company
June 3, 2021Organon has today launched through a spinoff from Merck as a global company focusing on women’s health. The new team …
Biosimilars and Brexit: What’s in store for UK’s biosimilar market?
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing biosimilars, brexit
It’s been 15 years since the first biosimilar entered the market, and the impact of these drugs on the healthcare …
The importance of representation in clinical trials
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Representation, clinical trials
Before any kind of new medicine can be made available to the market, it has to go through a strictly …
Softbox brings in Sean Austerberry as new Director
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Softbox Systems has appointed Sean Austerberry as its Research and Product Development Director. Sean will be responsible for all of …
Sharp adds Robert O’Beirn to its Global Clinical Services Business
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Sharp has appointed Robert O’Beirn as SVP and Managing Director of its global Clinical Services business. In early 2019 Mr …
Debra Hussain new CCO of Acacia Pharma
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Acacia Pharma has appointed Debra Hussain as Chief Commercial Officer. She is a highly experienced commercial leader having spent over …
Redx installs Natalie Berner as Non-Executive Director
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Redx Pharma has appointed Natalie Berner as a Non- Executive Director, she will represent RM Special Holdings 3 LLP on …
NICE rejects risdiplam for treating spinal muscular atrophy
June 2, 2021Research and Development
NICE has issued draft guidance today which does not recommend Roche’s risdiplam (Evrysdi) for treating the rare genetic disorder spinal …
FDA approves Novartis’s Cosentyx for severe plaque psoriasis
June 2, 2021Research and Development
The FDA has approved Novartis’s Cosentyx for the treatment of children and adolescents with moderate to severe plaque psoriasis. The …
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 …
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