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Biosimilars and Brexit: What’s in store for UK’s biosimilar market?

June 2, 2021
Business 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 …

Feature

The importance of representation in clinical trials

June 2, 2021
Business 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 …

Feature

Softbox brings in Sean Austerberry as new Director

June 2, 2021
Business 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 …

Appointment
robert_obeirn

Sharp adds Robert O’Beirn to its Global Clinical Services Business

June 2, 2021
Business 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 …

Appointment
deb_hussain

Debra Hussain new CCO of Acacia Pharma

June 2, 2021
Business 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 …

Appointment
natalie_berner

Redx installs Natalie Berner as Non-Executive Director

June 2, 2021
Business 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 …

Appointment

J&J appoints Charmaine England as MD for Consumer Health Northern Europe

June 2, 2021
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

 

Appointment
roche__tree

NICE rejects risdiplam for treating spinal muscular atrophy

June 2, 2021
Research and Development

NICE has issued draft guidance today which does not recommend Roche’s risdiplam (Evrysdi) for treating the rare genetic disorder spinal …

News
novartis_window

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
covid_cell_1_20

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
ema_building_face_web

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
1c64f360-c5ef-43b6-bcef-13cede36f571

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
baby-2416718_1280

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
top_10_image_2_9

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
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