The hearing has returned for the first person who has received gene therapy for treating genetic hearing loss in the U.S. Initial results from Akouos Inc.’s phase I/II study showed that within 30 days of receiving AK-OTOF-101, pharmacologic hearing was restored to an 11-year-old who had profound hearing loss from birth. Read More
Final rules the U.S. SEC adopted Jan. 24 to beef up disclosure requirements and investor protection in initial public offerings by special purpose acquisition companies (SPACs) and de-SPAC transactions could be the death knell for the SPAC market. They also could open the door for the SEC to regulate companies like biopharma and med-tech startups as investment companies. Read More
IMU Biosciences Ltd. has raised £11.5 million (US$14.7 million) in a series A round to further develop and commercialize profiling technology that can identify from a blood sample which of more than 2,000 cell types are present in an individual’s immune system. Read More
About two months after reporting that enrollment of its phase II/III study with buntanetap in Alzheimer’s disease had completed enrollment, Annovis Bio Inc. disappointed Wall Street by saying that findings from the phase III in Parkinson’s disease – hoped for by the end of this month – would be delayed for data-cleaning reasons. Read More
The ongoing controversy over patent subject matter eligibility gained new momentum via a Jan. 23 U.S. Senate hearing, during which a bipartisan pair of senators once again pushed the argument that current jurisprudence for subject matter eligibility is hampering U.S. life science companies. Read More
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial. Read More
What’s the status of the U.S. FTC’s investigation into pharmacy benefit managers’ (PBMs) role in prescription drug prices? Inquiring minds in the Senate really want to know, especially since the investigation began more than 18 months ago. “We urge the FTC to complete its 6(b) study in a timely manner,” 14 senators, led by Sens. Chuck Grassley (R-Iowa) and Maria Cantwell (D-Wash.), wrote in a Jan. 22 letter to FTC Chair Lina Khan. Read More
Making them an antibiotic of last resort, the U.K.’s Medicines and Healthcare Products Regulatory Agency introduced new restrictions on the use of fluoroquinolones due to the risk of potentially long-term or irreversible side effects. Read More
Quality-of-life claims in a TV ad for breast cancer drug Kisqali (ribociclib) earned Novartis AG the first untitled letter of 2024 from the U.S. FDA’s Office of Prescription Drug Promotion (OPDP). Read More
Biopharmas raising money in public or private financings, including: Fibrobiologics, Kura, Oragenics, Prism, Sagimet, Scisparc, Synnovation, Zwi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aicuris, Astellas, Beacon Biosignals, Biocytogen, Capricor, Evaxion, Florida, Gate Neurosciences, Invo, Kyowa, Leo Pharma, Locus, Merck, Naya, Orchard, Oxurion, Renbiologics, Timber, Vesper, Vivtex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Caliway, CDR-Life, Cybin, GC Biopharma, Juvena, Outlook, Pfizer, Rezolute, Scholar Rock, Theratechnologies, Vanda. Read More
