MHRA grants Promising Innovative Medicine Designation to Sanofi’s RSV drug
January 19, 2021Manufacturing and Production MHRA, Sanofi
The MHRA has granted a Promising Innovative Medicine (PIM) Designation to Sanofi’s nirsevimab, which is being investigated a passive immunisation …
NICE recommends cutting-edge lymphoma treatment for NHS use
January 19, 2021Manufacturing and Production Cancer, NICE
NHS clinicians in England will be able to consider a cutting-edge cancer treatment for some patients with a form of …
Bharat Biotech advises certain groups against taking its COVID-19 vaccine
January 19, 2021Manufacturing and Production Bharat Biotech, COVID-19
India’s vaccine developer Bharat Biotech has advised a number of groups to avoid taking its homegrown COVID-19 vaccine, Covaxin. According …
Novartis’ Cosentyx available on NHS in Scotland
January 19, 2021Manufacturing and Production Novartis
Novartis has announced that Cosentyx (secukinumab) 150mg is available in Scotland on the NHS, licensed for adults with active non-radiographic …
ConserV and Lawrence Livermore National Laboratory to collaborate on coronavirus vaccine
January 19, 2021Manufacturing and Production COVID-19, ConserV Bioscience
ConserV Bioscience, a clinical-stage biotechnology company focused on developing vaccines that protect against endemic and emergent infectious diseases, and Lawrence …
Jubilant and The Wistar Insitute collaborate on potential COVID-19 treatment
January 18, 2021Sales and Marketing Jubilant Therapeutics
Jubilant Therapeutics, a biopharmaceutical company advancing small molecule modulators to address unmet medical needs in oncology and autoimmune diseases, has …
Theramex launches osteoporosis drug Livogiva in Europe
January 18, 2021Sales and Marketing Theramex, osteoporosis
Theramex, a London-headquartered pharmaceutical company dedicated to women’s health, has launched osteoporosis medicine Livogiva to patients in Europe for the …
ViiV and Chelsea & Westminster Hospital launch digital service for HIV patients
January 18, 2021Sales and Marketing HIV, ViiV Healthcare
Global specialist HIV company ViiV Healthcare and Chelsea and Westminster Hospital NHS Foundation Trust have launched a new service, Klick, …
US Department of Defense selects Faron for $6.1m COVID-19 research funding
January 18, 2021Sales and Marketing Faron Pharmaceuticals, US
The US Department of Defense (DoD) has selected Faron Pharmaceuticals’ HIBISCUS study to receive $6.1 million of funding from the …
FDA approves Janssen’s AL amyloidosis drug
January 18, 2021Sales and Marketing FDA, Janssen
The FDA has approved Janssen’s DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone …
Pharmafile.com’s top 10 news stories of the week
January 15, 2021Medical Communications COVID-19
Pharmafile.com’s most popular stories this week include the use of two new, potentially life-saving treatments for on COVID-19 patients, and …
RoosterBio and Sartorius collaborate to scale up cell and gene therapy manufacturing
January 15, 2021Medical Communications RoosterBio, Sartorius
RoosterBio, a leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks, highly engineered media and hMSC bioprocess systems, …
AstraZeneca’s Imfinzi gets EU and UK approval for new dosing option
January 15, 2021Medical Communications AstraZeneca, Cancer, Imfinzi
AstraZeneca’s Imfinzi (durvalumab) has been approved in the EU and the UK for an additional dosing option in locally advanced, …
Alexion pauses Phase III ULTOMIRIS COVID-19 trial enrolment
January 15, 2021Medical Communications Alexion, COVID-19
Alexion has paused further enrolment in the global Phase III study of ULTOMIRIS (ravulizumab-cwvz) in adult COVID-19 patients requiring mechanical …
NICE recommends GSK’s ZEJULA for advanced ovarian cancer
January 15, 2021Medical Communications Cancer, GlaxoSmithKline, NICE
NICE has recommended the use of GlaxoSmithKline’s ZEJULA (niraparib) on the NHS in England for adult women with advanced high-grade …
UroGen and MD Anderson to collaborate on bladder cancer treatment
January 14, 2021Cancer, UroGen Pharma
UroGen Pharma, a biopharmaceutical company dedicated to treating specialty cancers and urologic diseases, and The University of Texas MD Anderson …
Celltrion announces positive top-line results from COVID-19 treatment trial
January 14, 2021COVID-19, celltrion
Celltrion Group has announced that top-line results from its global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody …
Novartis’ ligelizumab granted FDA Breakthrough Therapy Designation
January 14, 2021FDA, Novartis
The FDA has granted Novartis’ ligelizumab Breakthrough Therapy Designation for the treatment of chronic spontaneous urticaria (CSU) in patients who …
COVID-19 vaccine data leaked online by hackers, EMA says
January 14, 2021EMA, Pfizer, Vaccine, data
The EMA has confirmed that data relating to COVID-19 medicines and vaccines that was stolen by hackers in December have …
BeiGene’s tislelizumab gets China approval for non-small cell lung cancer
January 14, 2021BeiGene, Cancer, tislelizumab
BeiGene Ltd has announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) …
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