Drug Safety
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
‘The Run Is Worth The Slide:’ FDA Advisors Urge Expansion Of J&J’s CAR-T Carvykti Despite Initial Upfront Treatment Risks
Oncologic Drugs Advisory Committee also favors earlier use of Bristol-Myers Squibb’s Abecma in multiple myeloma, although some members raise concerns about lack of plateau in progression-free survival benefit and equivocable overall survival data.
BMS And J&J CAR-Ts Flagged For Early Deaths Ahead of Back-To-Back FDA Advisory Panels
Deaths that occurred before a patient randomized to one of the CAR-T products received that treatment don’t necessarily negate the FDA’s concerns, because risks associated with administration of treatment are “integral to the benefit-risk assessment,” the agency said.
New UAE Drug Agency Calls On Companies To Help Shape Mandate
Facilitating and strengthening R&D, intellectual property rights protection and drug safety are among the goals of the soon-to-be-launched Emirates Drug Establishment.
Lilly’s Donanemab Delay: Labeling, Real-World Operationalization May Be Reason For Adcomm
Close watchers of Lilly’s Alzheimer’s drug believe FDA’s last-minute advisory committee request is to deal with how to translate a complicated trial design into label recommendations, not because the agency is thinking of rejecting the drug, which had been seen as a shoo-in for approval.
‘Incremental’ Benefit Of Lumicell’s Cancer Imaging Drug Outweighs Manageable Risk, FDA Panel Says
Most advisory committee members supported approval of the breast cancer imaging product, but indicated labeling and advertising should be carefully crafted to avoid overhyping the likelihood patients experience a clinical benefit.
Lumicell’s Cancer Imaging Drug Faces Clinical Meaningfulness, Anaphylaxis Risk Questions At FDA Panel
US FDA advisory committee briefing documents say drug-device combo Lumisight (pegulicianine) is effective at picking up cancer but it is not clear whether that translates to patient benefit.
Singulair’s Psychiatric AE Risks Still A Problem, But US FDA Has Limited Mitigation Options Remaining
Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.
For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards
Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.
Data Monitoring Committees Can Support Certain Adaptive Design Trials, US FDA Says
Draft guidance describes evolution of DMCs and their responsibilities for monitoring trial conduct, internal analyses and external data.
Postmarketing Surveillance: Biosimilars, First-In-Class Approvals Will Not Get Extra Scrutiny
Revised document on best surveillance practices for US FDA staff deletes some product categories subject to more extensive monitoring. It also no longer recommends focusing on adverse events reported in a specific population.
Pink Sheet Podcast: Janet Woodcock And The US FDA’s G.O.A.T., Puberty Blockers Meeting, CAR-T Safety
Pink Sheet reporters and editor discuss FDA Principal Deputy Commissioner Janet Woodcock’s place in the pantheon of FDA leaders, an agency meeting with stakeholders on puberty blockers, and a new boxed warning for CAR-T therapies.
EMA Clamps Down On ‘Unpronounceable’ Trade Names For Medicines
Major changes have been made to the EU guideline on the acceptability of drug names, with sponsors being asked to consider the phonetic characteristics of an invented name and difficulties in pronunciation in different EU official languages.
Kite’s Tecartus Boxed Warning Will More Closely Resemble Other CAR-Ts After FDA Changes Course
Tecartus label still will not state that secondary malignancy cases have been reported in patients who received the product. CBER officials also address causality questions in a NEJM paper.
CAR-Ts Getting Boxed Warning On Secondary Malignancies Despite Sponsor Causation Questions
Sponsors still say they have no evidence the CAR-Ts cause secondary malignancy even though US FDA ordered their labels updated with a boxed warning of the adverse event. Tecartus label will not state that postmarketing secondary malignancies have been found in patients using the product.
Amgen’s Prolia Boxed Warning On Hypocalcemia Risk Backed By Medicare Data
Newly expanded warning language on denosumab for advanced CKD emphasizes appropriate patient selection and need to closely monitor calcium levels. Boxed warning follows FDA drug safety communication in 2022 about hypocalcemia and two observational studies using CMS data.
UK MHRA Imposes Yet More Restrictions On Use Of Fluoroquinolones
Fluoroquinolones should only be prescribed when other recommended antibiotics have failed, are ineffective or are unsafe to use, says the UK medicines agency.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.