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 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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
In keeping with a provision in the Inflation Reduction Act, 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 until Jan. 1, 2032. Read More
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. Read More
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: 60 Degrees, Beyond Cancer, Caliway, Clarity, Cytokinetics, Hoth, Hyloris, Nectin, Oncternal, Orion, Sellas, Sumitomo, Tyra. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied Molecular Transport, Cyclo, Enveric, Innovent, Mediwound, Palisade, Xuanzhu. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Asieris, Coherus, Everest, Iovance, Jemincare, Milestone, Nkgen, Scilex, Senhwa, UCB, Zealand, Zevra. Read More