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Regulatory
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Prescription drug bottle, pills shaped in $ sign

House Oversight hearing cuts through PBM blame game with warning

July 23, 2024
By Mari Serebrov
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.
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Injection syringes
Biopharma regulatory actions and approvals June 2024

Eylea, Neupogen, Stelara biosimilars among 28 FDA nods in June

July 23, 2024
By Amanda Lanier
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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FDA icons and doctor

Maker of patient monitors hit with repeat citations in US FDA warning

July 23, 2024
By Mark McCarty
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.
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AI biotech research concept with lightbulb and digital background

US PTO revisits subject matter eligibility for AI

July 23, 2024
By Mark McCarty
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.
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Judge's gavel with US flag

A royalty pain: Zimmer liable for payments despite patent expiry

July 22, 2024
By Mark McCarty
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.
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3D illustration demonstrating antibody-drug conjugate.
Immuno-oncology

Zymeworks obtains IND clearance for FRα-targeted ADC

July 22, 2024
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.
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Magnifying glass on wooden table

Loper Bright bringing more scrutiny, uncertainty to US agencies

July 19, 2024
By Mari Serebrov
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.
Read More
Injection syringes
Biopharma regulatory actions and approvals June 2024

Eylea, Neupogen, Stelara biosimilars among 28 FDA nods in June

July 19, 2024
By Amanda Lanier
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.
Read More

US FDA restructures device center

July 19, 2024
By Mark McCarty
The U.S. FDA’s Center for Devices and Radiological Health has rewired its organizational structure on several fronts, including a promotion of its communication function into a “super office,” which the agency said will help it be more agile and responsive to its strategic priorities.
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Delay to bot/bal colon cancer filing pressures Agenus stock

July 18, 2024
By Karen Carey
The U.S. FDA advised Agenus Inc. to conduct a phase III trial for its immunotherapy combination, botensilimab (bot) and balstilimab (bal), instead of seeking accelerated approval based on phase II data, sending company shares plunging by 58.8% July 18.
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