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Home » Newsletters » BioWorld

BioWorld

Jan. 24, 2024

View Archived Issues
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Hear here: Lilly’s Akouos gene therapy restores hearing loss in an 11-year-old

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

‘Regulatory reaper’ comes for SPACs

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
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With series A funds, IMU Bio’s Cytatlas identifies cell types and immune signatures

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

Buntanetap data gap uncapped in Parkinson’s; Annovis to report phase III ‘very soon’

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
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New effort to reform patent eligibility in play in US Senate

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 moves to once-weekly dosing after oral GLP-1 delivers strong phase I obesity data

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

US senators demand answers about FTC’s PBM investigation

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

UK further restricts use of fluoroquinolones

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

Novartis slapped with first OPDP letter of the year

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

Appointments and advancements for Jan. 24, 2024

New hires and promotions in the biopharma industry, including: Accent, Actio, Benevolentai, Calluna, Rezolute, Soleno. Read More

Financings for Jan. 24, 2024

Biopharmas raising money in public or private financings, including: Fibrobiologics, Kura, Oragenics, Prism, Sagimet, Scisparc, Synnovation, Zwi. Read More

In the clinic for Jan. 24, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Iama, Ipsen, Recce, Sequana. Read More

Other news to note for Jan. 24, 2024

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 actions for Jan. 24, 2024

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

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