Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avinger, Cardialen, Istar Medical, Nano-X Imaging, Paracrine, Softwave.
NHS England has struck new pricing agreements that expands access in the U.K. to blood thinning direct oral anticoagulants (DOACs) to tackle strokes in patients with atrial fibrillation. Though still available to NHS clinicians, Boehringer Ingelheim GmbH’s blockbuster DOAC Pradaxa (dabigatran) is notably not involved.
A European approval for Alzheimer’s drug aducanumab by year-end looks even more in doubt. A week after being called in before the EMA’s Committee for Medicinal Products for Human Use (CHMP) for an oral explanation of the trial data, Biogen Inc. said it received a “negative trend vote” on the marketing authorization application. A formal opinion by the CHMP is expected at its December meeting, but analysts are not optimistic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Basilea, Biogen, Crispr, Coya, Cyclo, Cytodyn, Diurnal, Icure, Moderna, Mymd, Siga, Viacyte.
Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) have reintroduced Cures 2.0, legislation they said will increase access to live-saving cures and treatments for a variety of diseases such as Alzheimer’s disease.
Celltrion Inc.’s Regkirona (regdanvimab), a monoclonal antibody treatment for COVID-19, received its latest approval from the European Commission (EC), making it the first Mab developed in South Korea to be approved there. The green light for Celltrion Healthcare Hungary Kft., the Hungarian arm of Korean biopharmaceutical company Celltrion, is for the treatment of adults with COVID-19 aged 18 and over who do not require supplemental oxygen and who are also at increased risk of severe disease.
Artificial intelligence (AI) is quite the buzzword for med tech and regulators alike, but that doesn’t mean rules for AI are just over the horizon. Pat Baird, director of global software standards at Koninklijke Philips NV, said during a recent webinar that problems such as long-standing definitional issues virtually guarantee that regulatory agencies will struggle to enact regulations, a predicament that leaves software developers with the kind of uncertainty that investors in the life science industries abhor.
Peking Jabrehoo Med Tech Co. Ltd.’s genetic testing kit won marketing approval from China’s NMPA. It is the first preimplantation genetic testing for aneuploidy (PGT-A) that uses the reversible termination sequencing method in China, according to the company.
Ono Pharma Korea Co. Ltd. has received approval in South Korea for Velexbru (tirabrutinib hydrochloride), its oral Bruton’s tyrosine kinase (BTK) inhibitor, as treatment of recurrent or refractory B-cell primary central nervous system lymphoma.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advantis Medical, GE Healthcare, Royal Philips.
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