The U.S. Department of Justice recently announced the formation of a task force that will advocate the roll-back of regulations that affect a wide swath of sectors of the American economy. Health care is one of the areas of interest for the task force, which will examine state as well as federal regulations.
It’s time for the U.S. Congress to finally put some guardrails on the 340B prescription drug discount program it created more than 30 years ago as a way to help fund health care for low-income patients. That’s the overall conclusion of a majority staff report from the Senate Health, Education, Labor and Pensions Committee that follows a years-long investigation into the program.
Nervousness about the Trump administration’s attitude to vaccines has spurred the formation of the Vaccine Integrity Project, which has the aim of safeguarding the use of vaccines and ensuring vaccine policy “remains grounded in the best available science,” and is “free from external influence.”
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
Rona Therapeutics Co. Ltd. has obtained IND clearance from China′s National Medical Products Administration (NMPA) for RN-1871, a small interfering RNA (siRNA) drug targeting angiotensinogen (AGT) for hypertension.
Onward Therapeutics SA’s subsidiary Emercell SAS has received investigational medicinal product dossier (IMPD) approval from the EMA to initiate a phase I trial of OT-C001, an allogeneic natural killer (NK) cell therapy, in combination with an anti-CD20 monoclonal antibody, rituximab.
Tagworks Pharmaceuticals BV has received IND clearance from the FDA for a phase I trial evaluating its antibody-drug conjugate (ADC) TGW-101 in patients with advanced solid tumors. The company has initiated the first-in-human trial.
The U.S. FDA has granted de novo clearance for Epiminder Pty. Ltd.’s Minder implantable device for continuously monitoring brain activity in patients with epilepsy.
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