Product Reviews & Approvals
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Approvals
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All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab
If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as a lower cost alternative to biosimilars and premium branded products for the condition, and higher than off-label compounds.
EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab
The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.
BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
New EU Filings
Seladelpar, CymaBay Therapeutics's investigational treatment for primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
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.
Drug Reviews
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The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews
Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for myelodysplastic syndromes and supplemental applications for the CAR-T products Carvykti and Abecma in earlier lines of multiple myeloma.
All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab
If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as a lower cost alternative to biosimilars and premium branded products for the condition, and higher than off-label compounds.
EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab
The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.
‘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.
BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
New EU Filings
Seladelpar, CymaBay Therapeutics's investigational treatment for primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
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.
Advisory Committees
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The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews
Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for myelodysplastic syndromes and supplemental applications for the CAR-T products Carvykti and Abecma in earlier lines of multiple myeloma.
‘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.
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.
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