Belgium-based biotech company BioSenic has announced that it is suspending the development of its investigational allogeneic cell therapy derived from mesenchymal stem cells, called ALLOB, which was being assessed as a treatment for tibial fractures. The decision to pause ALLOB’s development comes after disappointing results in a Phase IIb trial, which had been designed to evaluate the candidate..
Bristol Myers Squibb (BMS) has filed a lawsuit against the Biden administration, following in Merck's footsteps, claiming that an upcoming Medicare drug negotiation program violates the First and Fifth Amendments of the U.S. Constitution. The company alleges that if the drug price negotiation program comes into force, it would force pharma companies to give big discounts to Medicare and sell the..
Clearmind Medicine Inc. and SciSparc Ltd. have partnered to conduct a study on the combination treatment of obesity and metabolic syndrome, using Clearmind's MEAI and SciSparc's Palmitoylethanolamide (PEA). The research agreement has been entered into with the Hebrew University of Jerusalem, led by Professor Joseph Tam. A previous pre-clinical study showed that obese animals treated with MEAI de..
Incannex Healthcare Limited has appointed two principal investigators for its IND opening Phase 2/3 clinical trial, investigating IHL-42X for the treatment of obstructive sleep apnoea (OSA). The lead PIs recruited are Dr John D Hudson of FutureSearch Trials of Neurology, Austin, Texas and Dr Russell Rosenberg of Neurotrials Research Inc, Atlanta, Georgia. Site recruitment and selection in the US..
Sona Nanotech has partnered with Minnetronix Medical to engineer the second generation of its infrared light device for developing pre-clinical Targeted Hyperthermia Therapy for colorectal cancer. The light device will transfer energy by way of infrared light to Sona’s proprietary, biocompatible gold nanorods in cancerous tumors which will then convert the light energy into heat. The device is b..
Merck & Co has acquired Prometheus Biosciences, Inc. for $10.8 billion, making it a wholly-owned subsidiary and helping Merck expand its presence in immunology while strengthening its pipeline with a potential best-in-class candidate for immune-mediated diseases such as ulcerative colitis and Crohn’s disease. The leading clinical candidate, PRA-023, is now known as MK-7240 and is a humanized mon..
Aldeyra Therapeutics has reported that its Phase III trial of Reproxalap, a drug for treating allergic conjunctivitis and dry-eye disease, has produced positive results. The liquid eye drop formulation of the small-molecule modulator of reactive aldehyde species demonstrated statistically significant reductions in eye itchiness across the 11 primary endpoint comparisons for patients treated with..
Clene has announced positive results from the HEALEY ALS Platform Trial, revealing that CNM-Au8 led to significant reductions in plasma neurofilament light chain concentrations in patients with amyotrophic lateral sclerosis (ALS). The company is considering filing a New Drug Application and preparing the complete CNM-Au8 clinical data package for regulatory discussions with the FDA. Developed us..
Roche and AbbVie are set to compete in the lymphoma market with their newly approved bispecific antibodies (BsAbs). Four weeks after AbbVie's Epkinly was approved, the FDA has given its approval for Roche's Genentech's BsAb, Columvi. Both drugs will be available this summer, leading to a head-to-head competition between the two companies. These therapies utilize bispecific antibody design to bin..
Novavax could make a comeback as the FDA's Vaccines and Related Biological Products Advisory Committee unanimously recommends updating COVID-19 shots to cover the latest XBB Omicron subvariant, particularly subvariant XBB.1.5 which accounts for over 65% of all new COVID-19 cases in the US. The committee also recommended a monovalent shot specifically targeting Omicron and its subvariants. Novava..
