Novarock Biotherapeutics Ltd., a subsidiary of CSPC Pharmaceutical Group Ltd., has received FDA approval of its IND application for NBL-028, a CLDN6-CD137 bispecific antibody.
It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
As a U.S. appeals court ruling that restores the original restrictions the FDA imposed on the abortion drug mifepristone in 2000 heads to the Supreme Court for what will likely be full argument, the Biden administration continues to insist that the courts have no business overriding the FDA’s “scientific, evidence-based decisions.” Commenting on the Aug. 16 opinion from the U.S. Court of Appeals for the Fifth Circuit, which reinstated the original use restrictions, Vice President Kamala Harris said, “It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA.”
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China. The approval is for treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia (abnormal lipid levels). Tafolecimab marks Innovent's first cardiovascular drug as well as the company’s 10th approval.
There are plenty of companies chasing the first U.S. FDA-approved treatment for the ultra-rare disease fibrodysplasia ossificans progressiva (FOP), but Ipsen SA stayed the course longer and won that approval Aug. 16 with Sohonos (palovarotene). Other companies have struggled to develop a treatment for FOP, which affects about 400 people in the U.S. and about 900 people worldwide. Some potential competitors are still in the clinic, trying to catch up.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bluewind Medical, Nemaura Medical, Icad.
Hypertrophic cardiomyopathy (HCM) might not be the talk of the town in the world of cardiology medical devices, but the condition has a devastating effect on a large number of lives, particularly in the case of early disease onset. San Francisco-based Viz.ai Inc. has won a de novo from the U.S. FDA for its algorithm for identification of patients at risk of HCM, the aptly named Viz HCM, a product the company believes will not only save lives but may save the U.S. health care system a large amount of money as well.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artiva, Biophytis, Bluebird, Servier, Sonnet, US Worldmeds.
Oncusp Therapeutics Inc. has received IND clearance from the FDA to begin clinical trials with CUSP-06, a cadherin-6 (CDH6)-targeting antibody-drug conjugate designed for the treatment of multiple solid tumors. CDH6 is overexpressed in cancers including ovarian, renal, uterine, thyroid, lung, and cholangiocarcinoma. A phase I trial will pave the way for expansion in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.
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