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MHRA issues positive opinion to avelumab for Early Access to Medicines Scheme
The UK MHRA has given a positive scientific opinion for Merck and Pfizer's avelumab on the Early Access to Medicines Scheme (EAMS).
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Therapeutics
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FSD Pharma applies to FDA for trial testing FSD201 in COVID-19 patients
The Investigational New Drug Application (IND) is for a Phase II trial evaluating the safety and efficacy of FSD201 (ultramicronized PEA) in hospitalised COVID-19 patients.
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IL-6 signalling blockade alleviates severe COVID-19 symptoms
Scientists have shown that treating COVID-19 patients with severe respiratory complications with an IL-6 signalling inhibitor improved their symptoms.
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Further £8.4 million in funding given to UK researchers studying immune response to COVID-19
The funding is being split across three research projects that will hopefully improve the treatment of COVID-19 and inform the development of vaccines and therapeutics.
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How biotech is financing the lockdown dip
The COVID-19 pandemic has had huge knock-on effects on economies around the world. In this article, legal experts from Taylor Wessing explore how the novel coronavirus has hit the life sciences and biotech investment sector and how they see investors behaving as the lockdown and pandemic eases and develops over…
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Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis patients, triggering the drug to be accessible on the UK’s National Health Service.
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AstraZeneca doses first patients in COVID-19 therapy trial
The Phase I trial will assess the safety and pharmacokinetics of the AZD7442 monoclonal antibody combination in 48 healthy participants.
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FDA issues emergency use authorisation for COVID-19 convalescent plasma
The emergency use authorisation (EUA) allows the distribution and administration of COVID-19 convalescent plasma to hospitalised patients in the US.
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India gives nod to cell therapy for Critical Limb Ischemia (CLI)
Stempeucel®, a cell therapy for the treatment of Critical Limb Ischemia (CLI), has been approved for commercial use in India by the Drug Controller General.
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FDA approves Kesimpta® (ofatumumab) for patients with relapsing multiple sclerosis
Kesimpta was approved based on trial results showing the monthly injection significantly reduced the relapse rate and disability progression of MS patients compared to a currently approved treatment.
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Tradipitant may accelerate recovery from COVID-19 pneumonia, finds interim analysis
A preliminary analysis of data from the first COVID-19 pneumonia patients enrolled in the ODYSSEY trial revealed that tradipitant may expedite clinical improvement.
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EMA accepts marketing application for Spinal Muscular Atrophy treatment
The European Medicines Agency (EMA) has accepted the marketing authorisation application for Evrysdi™ (risdiplam) as a treatment of spinal muscular atrophy (SMA).
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Severely ill COVID-19 patients treated with convalescent plasma therapy
Preliminary data from a study has shown that convalescent plasma therapy is safe and can combat COVID-19 in severely ill patients.
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Russia grants regulatory approval to COVID-19 vaccine, according to report
A COVID-19 vaccine dubbed “Sputnik V” has been given regulatory approval in Russia, before completing its clinical trials.
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Pfizer agrees to manufacture remdesivir, investigational COVID-19 drug
Pfizer is to manufacture and supply the investigational COVID-19 treatment remdesivir for Gilead Sciences at one of its facilities.
