Even as the U.S. Congress continues to kick the can down the road on prescription drug pricing, pressure to finally confront the issue is increasing. But as lawmakers debate price controls via direct Medicare negotiations vs. innovation, along with inflationary caps on price increases, one factor often gets downplayed: the role biologics are playing in the country’s overall spend on prescription drugs. While generics account for 90% of the drugs prescribed in the U.S., the other 10% of drugs prescribed account for more than 80% of the annual spending, according to the Association for Accessible Medicines. Read More
Despite big wins in precision oncology – such as last year’s accelerated FDA nod for Amgen Inc.’s Lumakras (sotorasib) in KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer – industry has barely scratched the surface of the field’s potential. Part of the problem is on the scientific front. Only about a third of patients are currently eligible for targeted therapy, since the majority of patients “do not have a known therapeutic vulnerability for which we have a drug match,” Keith Flaherty, director of clinical research at Massachusetts General Hospital, said during a Feb. 14 session at the BIO CEO & Investor Conference. “And that’s a big problem.” Read More
Collegium Pharmaceutical Inc. said it plans to acquire all outstanding shares of Biodelivery Sciences International Inc. for $5.60 each, putting the price tag at about $604 million. At the heart of the deal are Biodelivery Sciences' Belbuca (buprenorphine buccal film), a schedule III opioid, and Elyxyb (celecoxib), an oral migraine treatment that gives Collegium a foothold into the neurology market. Read More
As investors await the Sept. 10 PDUFA date for deucravacitinib from Bristol Myers Squibb Co. (BMS) in psoriasis, handicappers continue to weigh the odds of other tyrosine kinase 2 (TYK2) inhibitors, and ponder what a regulatory victory – or defeat – might mean for the space.
China’s NMPA has given conditional approval to Pfizer Inc.’s COVID-19 oral pill Paxlovid (nirmatrelvir/ritonavir). The drug was approved for the treatment of adults with mild to moderate COVID-19 and a high risk of progression to severe disease. This includes the elderly, and people with chronic kidney issues, diabetes, cardiovascular, and chronic lung disease. Read More
The overwhelming focus of research into the cellular immune response to SARS-CoV-2 has been investigating the reaction of vaccinated people, in an effort to establish correlates of protection required to fight off infection. But with a majority in many African and Asian countries still unvaccinated, it also is important to understand the natural cellular immune response, and to track the emergence of SARS-CoV-2 variants with the potential to escape immunity in these populations. Read More
With the study of long COVID-19 continuing to evolve, the BioWorld team is taking a closer look at the condition – a complex syndrome affecting more than 100 million people globally –
and what's being done about it. In this episode, BioWorld Senior Science Editor Anette Breindl and Staff Writer Lee Landenberger, fresh off writing a pair of detailed stories about these issues, join us to talk about how consensus around what long COVID is has emerged.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acura, Astrazeneca, Azafaros, Campbell Neurosciences, Cyclica, Dermira, Eli Lilly, Glenmark, JN Nova, Journey Medical, M6P, Maze, Moleculin, Netramark, Nurosene, Obseva, Oncology Pharma, Point Biopharma Global, Regen, Theramex, Therapeutic Solutions. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, Biontech, Cytryx, Eli Lilly, Innovent, Journey Medical, Metacrine, Noema, Novavax, Pfizer, Pharmacyte, Roche, Spectrum, Veru, Y-mabs. Read More
