If there is one therapeutic area for which numerous biopharma companies and investors have shown increasing amounts of interest in 2023, it is obesity through follow-on glucagon-like peptide-1 (GLP-1) receptor agonists, as well as combination and solo efforts with other potential mechanisms. Analysts have suggested the obesity market (which includes overweight individuals) could grow to more than $50 billion by 2030. At least.

Top Trends of 2023: Breakthrough approval of malaria vaccine expected to close supply gap

It is not the first malaria vaccine, but R21, recommended for use by the World Health Organization in October, is the first that can be manufactured at modest cost and the sort of scale needed for widespread prevention of the killer disease in Africa.

Top Trends of 2023: Leqembi a taste of things to come in Alzheimer's

In July, Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd.) became the first amyloid-targeting drug to win traditional approval from the U.S. FDA, after getting accelerated approval in January based on the surrogate endpoint of plaque removal. But the regulatory win did not resolve outstanding questions regarding the relationship between amyloid plaques and Alzheimer’s disease. Nor did it resolve outstanding issues on pricing and reimbursement.

Korea sets 2024 health care budget, predicts turnaround for exports

Nearing the end of 2023, South Korea’s National Assembly approved hiked-up budgets for three of its major health care agencies. Its health policy think tank also forecast an uptick in industry exports in 2024.

Biden calls DPA into force for essential drugs, MCMs

In his latest effort to boost the U.S. manufacturing base, President Joe Biden is invoking the Defense Production Act (DPA) to expand the domestic production capabilities for essential medicines, medical countermeasures (MCMs) and their critical inputs. In a Dec. 27 memo, the president determined that such products “are industrial resources, materials or critical technology items essential to the national defense” and that without the DPA action, the U.S. biopharma and med-tech industry “cannot reasonably be expected to provide the capability for the needed” medical products. The determination paves the way for government purchases and funding of the domestically produced drugs, MCMs and inputs.

MSD, Roche highlight new subanalysis data at ESMO Asia in Asia-prevalent cancers

MSD had a banner year at the ESMO Asia Congress earlier this month, presenting 14 abstracts on eight different types of cancers, including gastric, esophageal, colorectal, biliary tract, kidney, urothelial, breast and gynecological cancers. Ten of these studies were focused on Asian-related data. Roche AG, meanwhile, presented Asia-specific results from the phase III Alina study in patients with ALK-positive early stage non-small-cell lung cancer.

Rebate rule delayed until 2032

In keeping with a provision in the Inflation Reduction Act (IRA), the U.S. Department of Health and Human Services will not implement a final rule removing the anti-kickback safe harbor for the rebates drug companies pay pharmacy benefit managers (PBMs) until Jan. 1, 2032. Also delayed under the IRA are new safe harbors created by the 2020 rule for fixed PBM fees and certain point-of-sale price reductions offered by manufacturers on prescription drugs covered by Medicare Part D, according to a notice scheduled for publication in tomorrow’s Federal Register.

BioWorld Insider Podcast: Six biopharma executives consider a tough 2023 and are hopeful for a better 2024

One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. In a preview of the annual Biotech Showcase conference, an investor conference for private and micro- to mid-cap biotech companies Jan. 8-10 in San Francisco, BioWorld spoke with Dave Bearss, CEO of Halia Therapeutics Inc., Vimal Mehta, CEO of Bioxcel Therapeutics Inc., Paul Lammers, CEO at Triumvira Immunologics Inc., Chris Pirie, COO of HDT Bio Corp., Thijs Spoor, CEO of Perspective Therapeutics Inc., and Shelley Hartman, CEO of Aegle Therapeutics Corp. They offered insights brought about by years of hard-won experience.

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60 Degrees, Amgen, Applied Molecular Transport, Asieris, Beyond Cancer, Caliway, Clarity, Coherus, Cyclo, Cytokinetics, Enveric, Everest Medicines, First Wave, Hoth, Hyloris, Innovent, Iovance, Jemincare, Mediwound, Milestone, Mundipharma, Nectin, Neurobo, Nkgen, Oncternal, Orion, Palisade, Scilex, Sellas, Senhwa, Shanghai Henlius, Sumitomo, Tyra, UCB, Xuanzhu, Zealand, Zevra