Samsung Bioepis Co. Ltd., of Incheon, South Korea, gained U.S. FDA approval of Epysqli (eculizumab-aagh) as the second biosimilar product to Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) to treat two rare diseases. The regulatory clearance July 22 grants use of Epysqli to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome – two rare hematologic- and kidney-related disorders known to affect about 50,000 and 5,000 patients in the U.S., respectively.
The U.S. Department of Health and Human Services’ Office of the Inspector General disclosed an advisory opinion finding Bluebird Bio Inc.’s fertility support program for a gene therapy treatment could run afoul of federal anti-kickback statutes. That follows a similar opinion against Vertex Pharmaceuticals Inc., and its fertility program associated with gene-editing therapy Casgevy (exagamglogene autotemcel). Vertex subsequently filed a lawsuit.
Noting that the median list price of new drugs that entered the U.S. market last year hit $300,000, senior officials of the three biggest pharmacy benefit managers (PBMs) in the country once again denied responsibility for those prices as they testified before the House Oversight Committee July 23 in the third hearing the committee has held on PBM practices.
The U.S. FDA approved 28 new drugs in June, marking the third-highest month in BioWorld’s records, following March 2024’s 30 approvals and June 2020's 29 approvals, and a significant increase from May’s 11 FDA drug approvals. For context, the FDA approved an average of around 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
The U.S. FDA cited Criticare Technologies Inc. for significant lapses in the company’s corrective and preventive action procedures, which suggests a need for outside certification of compliance because this problem was also observed in a warning letter from 2017.
The U.S. Patent and Trademark Office has provided updated guidance on the question of patent subject matter eligibility for inventions that rely on artificial intelligence, stating that a patent claim that does little more than recite an abstract idea is not subject-matter eligible.
Royalties for licensed patents ordinarily need not be paid after the underlying patent has expired, but the case of Zimmer Biomet Holdings Inc. v. Insall would seem to throw out a cautionary flag regarding such agreements.
Zymeworks Inc. has received IND clearance from the FDA for ZW-191, the company’s novel folate receptor-α (FRα)-targeted topoisomerase I (TOPO1) inhibitor antibody-drug conjugate (ADC). Clinical development is set to begin this year, with filings to initiate studies outside the U.S. to be made in the second half of this year.
As the U.S. Congress continues to pass laws that require federal agencies to issue rules to implement new statutory provisions, a group of lawmakers is reminding the agencies that it will be looking over their shoulders to ensure they don’t stray beyond the scope of the law or overstep their authority.
The U.S. FDA approved 28 new drugs in June, marking the third-highest month in BioWorld’s records, following March 2024’s 30 approvals and June 2020's 29 approvals, and a significant increase from May’s 11 FDA drug approvals. For context, the FDA approved an average of around 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
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