Self-administered Crysvita receives positive CHMP opinion
May 10, 2021Sales 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, 2021Sales 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 …
EMA begin review of GSK & Vir COVID-19 treatment
May 10, 2021Sales 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 …
Pfizer commences process for full FDA approval of COVID-19 vaccine
May 10, 2021Sales 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 …
Eli Lilly to collaborate with diabetes tech companies on insulin pen
May 10, 2021Sales and Marketing Eli Lilly, diabetes
Eli Lilly has signed strategic international agreements with four companies – Dexcom, Glooko, myDiabby Healthcare, and Roche – with the …
Pharmafile.com’s top 10 news stories of the week
May 7, 2021Medical 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, 2021Medical 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, 2021Medical Communications marketing, sales
Deloitte have announced the acquisition of Iperion Life Sciences Consultancy, a globally-operating firm working to support life sciences companies and …
AstraZeneca secures MHRA licensing and NHS early access for lung cancer drug
May 7, 2021Medical Communications Astrazenaca, oncology
AstraZeneca have announced that the MHRA has granted a license extension for Tagrisso (osimertinib) in the UK, for use as …
Biomarker linked to male hair loss found to determine COVID-19 severity
May 7, 2021Medical 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 lupus treatment approved by European Commission
May 6, 2021GSK, 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 …
AstraZeneca to collaborate with Alchemab on prostate cancer research
May 6, 2021AstraZeneca, 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, 2021COVID-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 …
COVID-19: Moderna booster shots appear to increase immunity
May 6, 2021COVID-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, 2021Sanofi
Sanofi has entered into a three-year research collaboration with Stanford University School of Medicine, working to advance the understanding of …
Pharmafile.com’s weekly COVID-19 news round-up
May 5, 2021Research 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, 2021Research 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, 2021Research 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 …
Janssen submits MAA to EMA for novel CAR-T cell therapy
May 5, 2021Research 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 …
New HIV prevention drug application submitted to FDA
May 5, 2021Research and Development FDA, HIV
ViiV Healthcare have initiated a rolling submission of a new drug application (NDA) with the FDA for their long-acting HIV …
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