Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy.
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.
Innorna Co. Ltd.’s investigational mRNA therapy, IN-013, has been awarded orphan drug and rare pediatric disease designations by the FDA for the treatment of Wilson disease.
Blackfinbio Ltd. has obtained IND clearance from the FDA for its novel AAV gene therapy, BFB-101, for hereditary spastic paraplegia type 47 (SPG47), which is caused by changes in the AP4B1 gene. A phase I/II trial will be conducted in the U.S. at Boston Children’s Hospital.
The U.S. FDA granted breakthrough device designation to Mursla Bio Ltd.'s Evoliver. The biopsy blood test uses extracellular vesicles to survey hepatocellular carcinoma in high-risk cirrhotic patients.
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.
RSS
