Acetaminophen (APAP) is a very common nonprescription analgesic, harmless at low doses, that can cause acute liver injury and even death from acute liver failure when overdosed. The temporal course of acetaminophen overdose-induced liver injury (AILI) can be depicted in two stages – injury and recovery.
Johnson & Johnson’s Biosense Webster division reported that its Qdot Micro diagnostic and ablation deflectable tip catheter secured approval for marketing in China from the National Medical Products Administration where options for treating arrhythmias are seeing growing demand. A radiofrequency (RF) ablation catheter, Qdot Micro reduced total ablation procedure time by nearly 90 minutes.
Rapport Therapeutics Inc. launched with $100 million in series A funding and ambitious plans to bring a hitherto unprecedented level of precision to therapies for neurological disease. Although the Boston-based company is new to the world, its underlying platform has been a decade in the making, and it already has one clinical-stage asset, which is in development for seizure disorders. It is currently undergoing a phase I trial.
As several key revenue-driving products fall off patent in coming years, pharmaceutical companies are increasingly focused on mechanisms by which they can draw innovation to them. What launched as the Partner of Choice organization, for example, has now become the newly named Pfizer Ignite model – an end-to-end engine designed to bring innovation to the pharmaceutical company in return for services.
For Aqemia SA, the year got off to a good start, as one of its pharma partners, Les Laboratoires Servier SAS, extended an existing collaboration to drug a supposedly undruggable immuno-oncology target, using its Launchpad artificial intelligence platform.
The U.S. Supreme Court has declined to grant cert for a petition filed by Johnson & Johnson on behalf of its Ethicon subsidiary to review a case in California that will cost the company more than $300 million. The outcome highlights the differential hazards of advertising and promotion in various U.S. states, with California state law allowing fines of up to $2,500 for each violation of state law, an amount that can quickly tally into the hundreds of millions.
Globus Medical Inc. entered into a definitive agreement to buy Nuvasive Inc. in an all-stock transaction that will combine two leaders in the musculoskeletal industry into one of the largest companies in the spinal surgery market. While there are many companies in the spine market, the acquisition may still set off an alarm among regulators concerned about consolidation in the field. Both boards unanimously approved the deal.
GSR Ventures, a venture firm focused on early stage digital health companies, forecasts a much brighter investment picture for 2023 following a hard reset in 2022, said GSR Partner Sunny Kumar in an interview with BioWorld at the J.P. Morgan Healthcare Conference in San Francisco.
As the SARS-CoV-2 virus that’s responsible for COVID-19 continues to evolve across the world, a global response, similar to what’s used with influenza, would be ideal in evaluating and recommending vaccine strain composition changes from year to year. But “the current diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines would make a globally coordinated, simultaneous vaccine composition evaluation and recommendation quite challenging,” the U.S. FDA said in its briefing document for the Jan. 26
meeting of the Vaccine and Related Biological Products Advisory Committee.
A year and a half gone, two HIV vaccine studies shut down. That’s the case with the Janssen Pharmaceutical Cos. of Johnson and Johnson as the phase III Mosaico study of its HIV vaccine regimen was not effective in preventing infection compared to placebo. Based on a data and safety monitoring board’s report saying the study was not expected to hit its primary endpoint, Janssen discontinued the clinical trial more than a year ahead of its estimated March 2024 completion date.
