Spybiotech Ltd. has filed a clinical trial application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate SPYVLP-01, a vaccine targeting human cytomegalovirus (CMV) using its hepatitis B virus-like-particle platform technology.
Atamyo Therapeutics SAS has filed a clinical trial application (CTA) in Europe for ATA-200, its gene therapy targeting γ-sarcoglycan (SGCG)-related limb-girdle muscular dystrophy type 2C/R5 (LGMD-R5).
Chronic rhinitis is drawing more attention from medical device makers in recent years, with solutions including cryotherapy and temperature-controlled radiofrequency disruption of posterior nasal nerves to halt the condition.
“We’re going to battle,” PTC Therapeutics Inc. CEO Matthew Klein said, responding to a surprise negative opinion from the EMA’s Committee for Medicinal Products for Human Use on converting the conditional marketing authorization to full status for Translarna (ataluren) in the treatment of nonsense mutation Duchenne muscular dystrophy. The opinion applies to the renewal of the existing conditional authorization, too.
Insightec Ltd. broadened its CE mark approval for the Exablate Neuro, a focused ultrasound platform which treats essential tremors, to allow patients to have their second side treated. With some 60 million people estimated to be affected by essential tremor globally, Insightec hopes that with both sides treated, patients will have full body relief from tremor and therefore be able to resume everyday activities.
Choosing blastocysts for transfer based on size could give prospective parents a much better chance of success in welcoming a new member to the family, a study published in the Nature portfolio journal Scientific Reports demonstrates.
Supporting their conclusions with data from the same phase III study, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for extending the use of Oncopeptides AB’s Pepaxti (melflufen) to earlier lines of treating relapsed, refractory multiple myeloma even as the FDA dug in its heels about withdrawing the drug from the U.S. market.
The U.K. government continues to pump money into research projects focusing on the use of artificial intelligence (AI) in health care as it looks to technology to help diagnose and treat patients. It provided £2 million (US$2.5 million) in funding to test innovative ways to tackle cancers with poor survival rates.
AI-Stroke SAS is developing an artificial intelligence (AI)-based application able to detect strokes in real time using a simple smartphone or a tablet. The med-tech firm has just won an award in the i-Lab 2023 innovation competition, supported by the French Ministry of Research and sovereign bank Bpifrance SA. “We use the latest AI and computer vision technology to replicate a neurologist’s expertise immediately anywhere, whereas non-specialists can make diagnostic errors up to 50% of the time,” Cédric Javault, CEO and co-founder of AI-Stroke SAS, told BioWorld.
As part of its quest to advance its three first-in-class heart failure drug candidates toward the clinic, Corteria Pharmaceuticals SAS has closed an oversubscribed €65 million (US$70.7 million) series A, co-led by investors Orbimed and Jeito Capital, companies based in the U.S. and Europe, respectively.
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