While the Biden administration continues applauding the savings it claims will be delivered by the first round of Medicare negotiations, many U.S. patients and their families are worried about the cost of the biopharma price-setting program – a cost they measure not in dollars and cents, but in worsening illness and lives that may be lost to a downturn in innovation and an upturn in barriers to access.
“For us geeks, this is the trailer. This isn’t the movie,” John Stanford told BioWorld as he reacted to the prices the U.S. Centers for Medicare & Medicaid Services announced Aug. 15 for the 10 drugs selected for the first round of negotiations under the Inflation Reduction Act. While the prices are generally in line with what was expected, Stanford said they raise more questions than answers. The rationale for those prices, which must be released by March 1, will be part 1 of the movie as it should provide some insight into the price setting, said Stanford, the executive director of Incubate, a coalition of investors in the early stage life sciences sector.
The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline), reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.”
In turning the U.S. Department of Health and Human Services’ (HHS) one initial defeat into a victory, a federal district court handed HHS a 7-0 record in getting constitutional challenges to Medicare price negotiations dismissed.
Scientists from Abbvie Inc. and the Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center have discovered a new allosteric MALT1 inhibitor, ABBV-MALT1, for the treatment of certain types of diffuse large B-cell lymphoma (DLBCL).
Frontier Medicines Corp. has advanced lead candidates for further optimization in an Abbvie Inc.-partnered program targeting a key transcription factor for cancer cell survival, triggering an accompanying milestone payment.
A schizophrenia drug in Cerevel Therapeutics Inc.’s lineup understandably stole much of the thunder during coverage of Abbvie Inc.’s takeover late last year to the tune of $8.7 billion, but much further back in the pipeline awaits another potentially lucrative prospect: a kappa opioid receptor antagonist (KORA) for major depressive disorder (MDD).
A bipartisan bill aimed at limiting patent thickets on biologics moved a step closer to law July 11 when the Senate passed it with unanimous consent in an unexpected vote that came more than one-and-a-half years after the Judiciary Committee reported it favorably to the Senate floor. The Affordable Prescriptions for Patients Act, S. 150, which would limit the type and number of patents that can be litigated under the Biologics Price Competition and Innovation Act (BPCIA), now awaits House action.
After receiving a complete response letter (CRL) in 2023 related to device issues, North Chicago-based Abbvie Inc. received another CRL for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in advanced Parkinson’s disease, this time for issues at a third-party manufacturer.
Through a global rights agreement with Futuregen Biopharmaceutical Co. Ltd., Abbvie Inc. continues to build its immunology portfolio to help offset losses from Humira as biosimilars tighten their grip on the mega-blockbuster.
