Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Biogen, Biohaven, Cytodyn, Eisai, Mirati, Moderna, Novavax, Owp, Pfizer, Prilenia, Santhera, Serum Institute, Zentalis.
The Health Breach Notification Rule set forth by the U.S. Federal Trade Commission in 2009 was not initially directed toward health apps used strictly for non-medical uses, but the FTC has indicated it will enforce the rule for developers of these non-medical apps as well. The risk is substantial for these developers as the civil penalties for breaches can reach $44,000 per violation per day, which in the case of a mass breach could present a profound financial risk.
The FDA granted Blackrock Neurotech LLC breakthrough device designation for its Moveagain brain-computer interface (BCI) system as it targets 2022 for commercialization of the neural implant. Earlier this year, the Salt Lake City-based company received $10 million from investors including, Re.Mind Capital, Sorenson Impact and Facebook investor Peter Thiel to expand its clinical program. The company said its technology could be key to providing tetraplegic patients the ability to control devices directly from the brain.
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.
RSS
