Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
Medtronic plc’s new Extended infusion set shows the advantages of tending to details. Tubing doesn’t get much respect, but the changes Medtronic made to its set will substantially reduce the burden of disease management for patients with diabetes who use insulin pumps. The Medtronic Extended infusion set can be used for up to seven days, more than doubling the time between changes. The changes also sharply reduced insulin loss, resulting in a 25% reduction in waste of the increasingly expensive medication.
The government in France has just launched the Health Innovation Agency. This new government agency aims to improve identification of future health technology and better anticipate the impact of innovation in France.
Samantree Medical SA has published clinical data demonstrating a significant reduction in re-operations in breast-conserving surgery using its novel ultra-fast confocal microscopy technology. The study on its medical imaging platform, the Histolog scanner, has just been published in The Breast.
The U.K. National Institute for Health and Care Excellence (NICE) has opened a consultation on the use of five digital health products that can be used to help children and adolescents better manage anxiety or low mood.
Europe is losing its innovative edge in biopharma, especially when it comes to advanced therapy medicinal products, including tissue, gene and cell therapies used to prevent, treat and cure rare conditions and some cancers.
Diagnostic Medical Systems Group SA (DMD) is selling its entire stake in the share capital of Hybrigenics SAS, a biotech company listed on the Paris Euronext Stock Exchange since 2007. This sale of 116,911,328 shares, representing 43.41% of Gard, France-based Hybrigenics’ share capital, will allow DMS Group to refocus on its core imaging business. “We will strengthen our free cash in order to ramp the launch of new technology in medical imaging,” Samuel Sancerni, CEO of Diagnostic Medical Systems, told BioWorld.
Highly targeted light therapy delivered via a sleep mask has been shown to arrest the progress of diabetic retinopathy, and in some cases to improve visual acuity.
Vicore Pharma Holding AB and its partner Alex Therapeutics AB reported positive results from the U.S. pilot phase of a study assessing the effects of digitally delivered cognitive behavioral therapy (CBT) in treating anxiety in patients with idiopathic pulmonary fibrosis (IPF). The four-week study in 10 patients found the digital therapeutic, called Almee, functioned properly, was safe and the user experience was favorable.
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