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Biogen and Capsigen to collaborate on novel gene therapies

May 11, 2021
Manufacturing and Production gene therapy

Biogen and Capsigen have announced a research collaboration to engineer novel adeno-associated virus (AAV) capsids that have the potential to …

Self-administered Crysvita receives positive CHMP opinion

May 10, 2021
Sales and Marketing CHMP, EMA

Kyowa Kirin’s drug for a rare metabolic bone disease, Crysvita, has received a positive opinion from the EMA’s Committee for …

NICE rejects Merck Serono’s Bavencio for urothelial cancer

May 10, 2021
Sales and Marketing MSD, Merck, NHS, NICE, cancer treatment, pharma, pharma news

The use of avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy is not recommended by …

GSK building

EMA begin review of GSK & Vir COVID-19 treatment

May 10, 2021
Sales and Marketing COVID-19, EMA, GSK, covid-19 treatment, pharma, pharma news, vir

The EMA has begun a rolling review of GSK and Vir’s sotrovimab treatment for COVID-19, which will continue until there …

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Pfizer commences process for full FDA approval of COVID-19 vaccine

May 10, 2021
Sales and Marketing BioNTech, COVID-19 vaccine, FDA, Pfizer, Pfizer vaccine, pharma, pharma news

Pfizer and BioNTech have begun a Biologics Licence Application (BLA) with the FDA for full approval of their mRNA COVID-19 …

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Eli Lilly to collaborate with diabetes tech companies on insulin pen

May 10, 2021
Sales and Marketing Eli Lilly, diabetes

Eli Lilly has signed strategic international agreements with four companies – Dexcom, Glooko, myDiabby Healthcare, and Roche – with the …

Pharmafile's top 10 news roundup

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

May 7, 2021
Medical Communications covid 19 news, covid-19 news, news round up, pharma, pharma news, top 10

Among our ten most-read stories this week: NICE has announced that more patients are eligible for a £75,000-a-vial SMA drug, …

Merck kidney and uterus cancer treatments granted priority review by FDA

May 7, 2021
Medical Communications FDA, MSD, Merck, cancer treatment, kidney cancer treatment, pharma, pharma news, uterus cancer treatment

The FDA has granted priority review for Merck (MSD) and Eisai’s application for two new approvals for the combination of …

Deloitte acquires Iperion Life Sciences Consultancy

May 7, 2021
Medical Communications marketing, sales

Deloitte have announced the acquisition of Iperion Life Sciences Consultancy, a globally-operating firm working to support life sciences companies and …

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AstraZeneca secures MHRA licensing and NHS early access for lung cancer drug

May 7, 2021
Medical Communications Astrazenaca, oncology

AstraZeneca have announced that the MHRA has granted a license extension for Tagrisso (osimertinib) in the UK, for use as …

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Biomarker linked to male hair loss found to determine COVID-19 severity

May 7, 2021
Medical Communications COVID-19, hair loss

Findings presented at the European Academy of Dermatology and Venereology (EADV) Spring Symposium suggest that men with genetic characteristics (phenotypes) …

GSK building

GSK lupus treatment approved by European Commission

May 6, 2021
GSK, Lupus, lupus treatment, pharma, pharma news

GSK’s Benlysta treatment, for patients with active lupus nephritis (LN) in addition to systemic lupus erythematosus (SLE), has been approved …

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AstraZeneca to collaborate with Alchemab on prostate cancer research

May 6, 2021
AstraZeneca, prostate cancer

AstraZeneca have announced a new collaboration with Cambridge-based biotech company Alchemab, with the aim of accelerating prostate cancer research. Alchemab …

Canada first country to authorise Pfizer vaccine in children aged 12-15

May 6, 2021
COVID-19, Canada, Pfizer, Vaccine

Canada has become the first country to authorise the use of Pfizer’s COVID-19 vaccine for children aged between 12 and …

Moderna building

COVID-19: Moderna booster shots appear to increase immunity

May 6, 2021
COVID-19, COVID-19 vaccine, Moderna, covid news, pharma, pharma news

Moderna’s mRNA booster jabs for people already vaccinated against COVID-19 have shown positive initial data in a Phase II study …

Sanofi to collaborate with Stanford University in immunology research

May 6, 2021
Sanofi

Sanofi has entered into a three-year research collaboration with Stanford University School of Medicine, working to advance the understanding of …

COVID-19 virus

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

May 5, 2021
Research and Development COVID-19, COVID-19 vaccine, covid 19 news, covid-19 news, pharma, pharma news

The past week has seen more COVID-19 vaccine and treatment news: Moderna will supply up to 500 million jabs to …

Theramex releases Vitamin D gel aimed at women

May 5, 2021
Research and Development Theramex, osteoporosis, pharma, pharma news, vitamin d

Theramex has launched a new gel for Vitamin D deficiency, in the hope that it will particularly treat women experiencing …

UK government to invest £29.3 million on COVID-19 variant testing

May 5, 2021
Research and Development COVID-19, UK government, Vaccine, variants

The UK government has announced an investment of £29.3 million, on top of the £19.7 million already pledged, to be …

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Janssen submits MAA to EMA for novel CAR-T cell therapy

May 5, 2021
Research and Development EMA, EU, Janssen, multiple myeloma

Janssen have submitted a Marketing Authorisation Application (MAA) to the EMA seeking approval of cilta-cel, an investigational B cell maturation …

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