The industry is again raising concerns that new EU health technology assessment rules coming into force on Jan. 12, 2025, will have the opposite of the desired effect and slow down access to innovative therapies.
In May, the U.S. FDA approved 11 new drugs, a significant drop from the 26 approvals in April, which was the sixth-highest monthly total since 2016. This also falls short of March’s record-setting 30 approvals, the highest number recorded by BioWorld.
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
Novo Nordisk A/S’ CEO Lars Jørgensen is set to be the next executive in the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee’s pharma parade of shame. HELP Chair Bernie Sanders (I-Vt.) announced June 24 that Jørgensen will testify before the committee Sept. 24 about his company’s U.S. pricing of its blockbuster semaglutide drugs, Ozempic and Wegovy.
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.
The U.S. FDA has approved the NDA for Sofdra (sofpironium) for treating excessive underarm sweating from Botanix Pharmaceuticals Ltd. The approval was based on two pivotal phase III studies and is approved for those ages 9 and older.
Medicare spending in the U.S. continues to climb at a worrying pace, given that policymakers are apt to respond by putting the squeeze on the doctors and hospitals that purchase and implant medical devices.
Adicet Bio Inc. has obtained FDA clearance of its IND application to evaluate ADI-270, an armored allogeneic λδ CAR T-cell therapy candidate targeting CD70-positive cancers, for the treatment of relapsed or refractory renal cell carcinoma (RCC).
4D Molecular Therapeutics Inc. has obtained IND clearance by the FDA for 4D-175, an R100 vector-based intravitreal genetic medicine, for the treatment of patients with geographic atrophy.
EG 427 SAS has received IND clearance from the FDA for EG-110A, a gene therapy for the treatment of neurogenic detrusor overactivity in patients with spinal cord injury. A phase Ib/IIa study is being initiated.
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