Product Reviews & Approvals
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Approvals
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No More NASHing Of Teeth: Madrigal’s Resmetirom Approval Ends Years Of Industry Frustration
US FDA clears first MASH (formerly NASH) therapy, nearly four years after one had been initially anticipated. With the accelerated approval path established, Madrigal gets the opportunity to create a marketplace with Rezdiffra (resmetirom), and candidates in the pipeline get a clear target.
NASH: Madrigal Files Resmetirom In EU While US Action Date Closes In
Resmetirom, which could become the first approved treatment for non-alcoholic steatohepatitis, is among 11 new drugs that the European Medicines Agency has started to review for potential EU approval. Meanwhile, a decision on whether to approve the drug in the US is due on 14 March.
Novo Nordisk’s Cardiovascular Claim For Wegovy Will Enable Medicare Coverage, CBO Assumes
Medicare has not issued a policy allowing for Part D coverage of obesity drugs with additional health claims like Wegovy’s. But expectations are growing that it will.
Novo Nordisk’s Semaglutide Achieves ‘Cardiodiabesity’ Label
With Wegovy’s new indication for cardiovascular risk reduction in patients with overweight and obesity, the migration of diabetes drugs from a single disease state to address a host of interrelated conditions reaches a new milestone.
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.
Generics Group Urges Action On Licensing Delays As MHRA Unveils Guidance For Established Products
UK MHRA guidance outlining process changes aimed at shortening timeframes for assessing established medicines has been welcomed by the BGMA, which has emphasized the need to clear the regulator’s current approvals backlog that the association says is exacerbating shortages.
Marching On: Eight Novel Agents Among March Goal Dates For US FDA
Crowded calendar could bring to an end the slow start for novel approvals in 2024, as decisions come due for Lilly’s donanemab, Merck’s sotatercept, Regeneron’s odronextamab and more.
Breakthrough Designation Binge In February By US FDA Didn’t Extend To Approvals
Six new breakthrough therapy designations have been announced, all for novel agents, but approvals were fewer and limited to new indications and formulations.
NZ Govt Moves To Speed Drug Access Amid Plans To Wipe Out Major New Act
A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is being introduced in New Zealand, where the new coalition government is working to repeal last year’s landmark Therapeutic Products Act.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Velsipity, Pfizer's treatment for moderately to severely active ulcerative colitis in patients 16 years of age and older.
EU Biosimilar Filings, Opinions And Approvals
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
EU CHMP Opinions And MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Drug Reviews
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Imetelstat Scores Positive ODAC Nod Thanks To Quality Of Life Improvement
Responders to Geron’s proposed anemia treatment could see weeks-long breaks between transfusions, which Oncologic Drugs Advisory Committee members said outweighed efficacy and safety issues.
No More NASHing Of Teeth: Madrigal’s Resmetirom Approval Ends Years Of Industry Frustration
US FDA clears first MASH (formerly NASH) therapy, nearly four years after one had been initially anticipated. With the accelerated approval path established, Madrigal gets the opportunity to create a marketplace with Rezdiffra (resmetirom), and candidates in the pipeline get a clear target.
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.
US FDA Wants Advisory Committee Duty To Be ‘Enjoyable’
Advisory committee reform efforts include streamlining the selection and onboarding processes, in part to understand that members often have other professional priorities, Principal Deputy Commissioner Namandjé Bumpus said.
NASH: Madrigal Files Resmetirom In EU While US Action Date Closes In
Resmetirom, which could become the first approved treatment for non-alcoholic steatohepatitis, is among 11 new drugs that the European Medicines Agency has started to review for potential EU approval. Meanwhile, a decision on whether to approve the drug in the US is due on 14 March.
Geron’s Imetelstat Faces Full Gamut Of US FDA Questions At ODAC Meeting
FDA has efficacy and safety concerns about the proposed anemia treatment and questions whether the results could even apply to US patients given the large number of ex-US study participants.
Novo Nordisk’s Semaglutide Achieves ‘Cardiodiabesity’ Label
With Wegovy’s new indication for cardiovascular risk reduction in patients with overweight and obesity, the migration of diabetes drugs from a single disease state to address a host of interrelated conditions reaches a new milestone.
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.
Late-in-Review Advisory Panels: What Previous Cases Tell Us About Donanemab’s Prospects
Lilly’s Alzheimer’s candidate joins a club that no sponsor wants to be in, but one in which some members do get approved, albeit with less-than-ideal labeling.
Pink Sheet Podcast: Vanda Takes Jet Lag Denial To Court, Mark Cuban vs. PBMs, Austere FDA Budget
Pink Sheet reporters and editor discuss Vanda’s decision to sue the FDA over the rejection of the Hetlioz jet lag indication, Mark Cuban’s comments at a White House event that the federal government and others should stop doing business with the big three PBMs, and the cut in non-user fee dollars in the FY 2024 FDA appropriations bill.
Generics Group Urges Action On Licensing Delays As MHRA Unveils Guidance For Established Products
UK MHRA guidance outlining process changes aimed at shortening timeframes for assessing established medicines has been welcomed by the BGMA, which has emphasized the need to clear the regulator’s current approvals backlog that the association says is exacerbating shortages.
Advisory Committees
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Imetelstat Scores Positive ODAC Nod Thanks To Quality Of Life Improvement
Responders to Geron’s proposed anemia treatment could see weeks-long breaks between transfusions, which Oncologic Drugs Advisory Committee members said outweighed efficacy and safety issues.
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.
US FDA Wants Advisory Committee Duty To Be ‘Enjoyable’
Advisory committee reform efforts include streamlining the selection and onboarding processes, in part to understand that members often have other professional priorities, Principal Deputy Commissioner Namandjé Bumpus said.
Geron’s Imetelstat Faces Full Gamut Of US FDA Questions At ODAC Meeting
FDA has efficacy and safety concerns about the proposed anemia treatment and questions whether the results could even apply to US patients given the large number of ex-US study participants.
US FDA Neuroscience Office In Spotlight With Donanemab Delay, Relyvrio Trial Failure
Lilly’s surprise announcement that the Alzheimer’s drug is going to an advisory committee, followed minutes later by Amylyx’s disclosure that its ALS drug failed a Phase III study, marked a one-two punch of bad news for the Office of Neurosciences’ recent use of regulatory flexibility.
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.
Late-in-Review Advisory Panels: What Previous Cases Tell Us About Donanemab’s Prospects
Lilly’s Alzheimer’s candidate joins a club that no sponsor wants to be in, but one in which some members do get approved, albeit with less-than-ideal labeling.
Advisory Committees: US FDA Standardizing Decisions On When To Vet Applications
Center for Drug Evaluation and Research also is trying to ensure that questions posed at advisory committee meetings are written in clear and consistent language.
Point-Counterpoint: US FDA Adcomm Joint Briefing Document Likely Limited To Oncology For Now
Oncology Center of Excellence Director Richard Pazdur wants to make the single, joint backgrounder standard for Oncologic Drugs Advisory Committee meetings; former Peripheral and Central Nervous System Drugs adcomm member Caleb Alexander says the joint document is risky, citing the negative experience with Biogen's Aduhelm.
‘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.
Sayonara, Yamagata: US Seasonal Flu Vaccines Shift From Quadrivalent To Trivalent For 2024-2025
New US formulations will contain only one B virus antigen after shedding the B/Yamagata component, a strain that has not been detected in circulation since March 2020. However, some US manufacturers will continue to produce quadrivalent vaccine for use in other countries, which have been slower to transition to trivalent.
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.
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