With two complete response letters (CRLs) behind them, Abbvie Inc.’s Vyalev (foscarbidopa/foslevodopa) has been approved by the U.S. FDA for treating Parkinson’s disease. The drug is the first subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in adults with advanced disease. The approval was boosted by phase III data that those receiving Vyalev had superior improvement in motor fluctuations compared to those receiving oral immediate-release carbidopa/levodopa. After receiving a CRL in 2023 related to device issues, Abbvie received another in June 2024 for ABBV-951 (foscarbidopa/foslevodopa), that time for issues at a third-party manufacturer. Observations cited by the FDA’s inspection did not relate to ABBV-951 or any other Abbvie drugs, the company said.

FDA feedback shows Clarity path to pivotal radiopharma trial

Clarity Pharmaceuticals Ltd. will begin early next year its pivotal phase III trial for its copper-based radiopharmaceutical, 64Cu-SAR-bisPSMA, for diagnosing prostate cancer in patients with biochemical recurrence following positive U.S. FDA feedback. Clarity’s SAR-bisPSMA is in clinical development for identification and treatment of prostate-specific membrane antigen-expressing metastatic castration-resistant prostate cancer. The product is in five clinical trials, ranging from phase I to phase III. As previously reported by BioWorld, Clarity raised AU$121 million (US$79.29 million) in March that will fund the company’s radiopharma pipeline comprising targeted copper therapies out to early 2026.

Biopharma index up nearly 17% after Q2 results, despite clinical setbacks  

The BioWorld Biopharmaceutical Index (BBI) climbed 16.92% in the first three quarters of the year, bolstered by second quarter results despite disappointing clinical news from several players. The BBI maintained its lead over both the Nasdaq Biotechnology Index, which increased by 9.09%, and the Dow Jones Industrial Average, which saw a 12.31% rise.

Avoiding losses leads to insider trading settlement

Insider trading isn’t always about profits. Sometimes it’s avoiding losses. That was the basis of the U.S. SEC’s complaint against Matthew Groom, an information technology consultant to Spero Therapeutics Inc. This week, Groom agreed to a $28,000 settlement to resolve the complaint stemming from a trade of Spero shares that enabled Groom to avoid $13,000 in losses when news of the company’s downsizing and negative study results became public.

What immunology can learn from oncology

During an Innovation Ignited webinar sponsored by Johnson & Johnson, experts talked about how precision medicine has helped advance the field of oncology and how those lessons can be applied to immunology. From databases to biomarkers to CAR T cell therapies, there’s quite a bit of overlap in the fields.

The BioWorld Insider podcast: A quantum leap into the future of drug development

In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Quantum computing could lead to more efficient drug discovery by identifying promising compounds faster, understanding their effects at the molecular level, and then reducing the need for costly or time-consuming lab experiments. Lipinska is one of the more than 100 experts who will evaluate the future of health care at the upcoming 2024 Biofuture conference. Each year, a group of trailblazers, disruptors and forward-thinking executives converge to evaluate and forecast the future of health care. This year, BioWorld is a sponsor of the Oct. 28-30 event in New York. If you attend, you'll have the chance to hear panels and join workshops and fireside chats with key opinion leaders like Lipinska.

Also in the news

Akeso, Alnylam, Alzamend, Arch, Astria, Athos, Atomvie, Beacon, Cerevance, Certara, Endopure, Exelixis, Exscientia, GB Sciences, GSK, Hutchmed, Iktos, Ipsen, Merck, Mid-Atlantic, Moderna, Monument, Neurogastrx, Novavax, NS Pharma, Nurix, Optus, Orasis, Palvella, Pfizer, Pharmaust, Radiopharm, Sanofi, Scilex, Upstream, Tennor, Theriva, Tonix, Triana, Urogen, Wave Life