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Regulatory
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U.S. FDA headquarters

Industry dismayed by limits in FDA’s draft guidance for PCCPs

Nov. 27, 2024
By Mark McCarty
The FDA’s August 2024 draft guidance for predetermined change control plans (PCCPs) for all device types has provoked some misgivings among industry, with both the Medical Device Manufacturers Association and the Advanced Medical Technology Association blasting the draft’s limitations on the scope of the changes that could be included in a PCCP.
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Product recall concept image

FDA unveils pilot program for improved device recall transparency

Nov. 27, 2024
By Mark McCarty
The FDA announced a new pilot program for communication of medical device recalls, but industry may be wary of a program that seems to be driven toward early notification of what the agency believes “are likely to be high-risk recalls.” The agency’s device center states that this latest effort is designed to “improve the timeliness of communications” of corrective actions undertaken by device manufacturers. This would apply when the corrective action is as significant as a device removal and when the corrective action constitutes nothing more than an update to a product’s instructions for use.
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UK bioethics council seeks updated regulations for embryo models

Nov. 27, 2024
By Nuala Moran
The U.K.’s leading bioethics body is calling for a new law to regulate the generation of stem cell-derived human embryo models and ensure that research does not cross ethical red lines. Currently, there is no statute governing the oversight of these models. In particular, bioethicists say there should be a statutory ban on the transfer of embryo models into the reproductive tract of humans and animals, with legal penalties for contraventions.
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Rendering of iNKT cell

Arovella heads toward clinic with CAR-19-iNKT cells

Nov. 27, 2024
By Tamra Sami
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
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Ocaliva

PBC therapy Ocaliva gets conditional nod revoked in Europe

Nov. 27, 2024
By Nuala Moran
The conditional marketing approval for Ocaliva (obeticholic acid) has been revoked with immediate effect, following a standoff between the EMA and Advanz Pharma Ltd., the company that markets the primary biliary cholangitis (PBC) therapy in Europe. On Sept. 5, London-based Advanz won a short reprieve after challenging the EMA’s June 28 ruling that the marketing authorization for Ocaliva should be revoked, when the General Court of the EU granted a temporary suspension of EMA’s decision. However, on Nov. 27, Advanz announced the court had said it would not be extending the suspension.
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Ribbons of digital data

Hazards of prompt engineering a concern for regulation of GenAI

Nov. 26, 2024
By Mark McCarty
The health care potential for generative artificial intelligence comes with hazards such as the inadvertent effects of poor prompt engineering practices, but Anil Bhatta of Deloitte Consulting told a U.S. FDA advisory committee that this risk could be managed by rules that would thwart any consequent problems, such as an inadvertent jailbreak of the algorithm’s intended use.
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Mast cell releasing histamine during allergic response
Immune

Longbio’s LP-003 receives NMPA clearance to enter clinic for food allergy

Nov. 26, 2024
Longbio Pharma (Suzhou) Co. Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) for LP-003, the company’s next-generation anti-IgE antibody, to enter a clinical trial for the treatment of food allergy.
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NMPA clears Alpha’s oral EGFR-TKI for NSCLC with brain metastases

Nov. 26, 2024
By Marian (YoonJee) Chu
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
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FDA Approved seal
Biopharma regulatory actions and approvals October 2024

Two Stelara biosimilars among 15 US FDA approvals in October

Nov. 26, 2024
By Amanda Lanier
The U.S. FDA approved 15 drugs in October, marking a decline from 24 in September and 22 in August. Despite the drop, the 2024 monthly average stands at about 19 approvals, exceeding last year’s average of 16, 2022’s 12.5, and the 17-per-month averages recorded in both 2021 and 2020.
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Celltrion wins Korea approvals of Prolia, Xgeva biosimilars

Nov. 26, 2024
By Marian (YoonJee) Chu
The Ministry of Food and Drug Safety (MFDS) approved South Korea’s first denosumab (Prolia/Xgeva) biosimilars, developed by Celltrion Inc. under the brand names of Stoboclo/Osenvelt (CT-P41) for respective indications, a move the company hopes will help secure first-mover advantage for the drugs, currently under review in the U.S. and Europe.
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