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The FDA has launched a pilot program to increase the efficiency and predictability of biosimilar development, and decrease the cost and time of development — and has released a “research roadmap” to help researchers reach those goals. Read More
FDA Principal Deputy Commissioner Janet Woodcock announced Thursday that, after careful review, a new regulatory pathway for cannabidiol (CBD) review is needed and the agency is denying three citizen petitions to allow marketing of CBD products as dietary supplements. Read More
An FDA advisory committee yesterday recommended that the next generation of COVID-19 vaccines should combine the current primary vaccine against the original Wuhan strain and the bivalent booster against Omicron strains BA.4 and BA.5. Read More
Cassava Sciences is claiming a phase 2 win with its investigational Alzheimer’s treatment simufilam in patients with mild-moderate disease — but the open-label study lacks a placebo comparator, and the topline numbers didn’t come with context indicating their statistical validity. Read More
The agency said it believes that the existing regulations balance “the need to incentivize the development of drugs for rare diseases and conditions with the need to provide patient access to orphan drugs.” Read More
Attorneys who work in the biopharmaceutical industry say the landmark $740 billion Inflation Reduction Act (IRA) — passed in August and beginning to go into effect this month to lower drug costs — is chaotic, hard to understand and has the drug industry very nervous. Read More
North American Custom Laboratories earned an FDA warning letter for failing to prove it had corrected manufacturing problems that could have impaired product sterility. Read More
Bristol Myers Squibb (BMS) has filed a complaint in federal court alleging AstraZeneca’s cancer therapy Imjudo (tremelimumab) infringes on its blockbuster immunotherapy drug Yervoy (ipilimumab). Read More
Merck’s KEYNOTE trials of its mega-blockbuster cancer drug Keytruda (pembrolizumab) had mixed results this week, failing in another bid for prostate cancer but hitting the mark with biliary tract cancer. Read More