Drug Review Pathways & Approval Standards
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Review Pathways
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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.
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.
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.
Biosimilar Interchangeability Designation Would Be Nixed Under Biden Proposal
The proposal is not expected to cost or save the government money, but is expected to increase biosimilar uptake, according to budget documents.
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.
A Lesson In Confidence Amid Development Hurdles: How Lilly Has Talked About Donanemab
The Alzheimer’s disease candidate’s positive milestones, and even its review delays, continue to produce confident statements in its future from the sponsor.
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.
Drug Approval Standards
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US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.
‘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.
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.
Early Alzheimer’s Guidance: FDA Puts Forth New Endpoint Possibilities for Stage 3 Disease
New draft guidance opens the door to getting a drug for Stage 3 Alzheimer’s through FDA on cognition alone.
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.
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.
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.
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