February 23rd 2024
The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.
February 22nd 2024
While no company has yet achieved the full promise of AI to radically accelerate time to market, meaningful strides are being made across the drug discovery funnel.
February 21st 2024
The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.
Merck seeks approval for Keytruda (pembrolizumab) plus chemotherapy with carboplatin and paclitaxel for patients with primary advanced or recurrent endometrial carcinoma, alongside chemotherapy (carboplatin and paclitaxel).
Tecvayli is an off-the-shelf bispecific antibody previously granted accelerated approval by the FDA for adults with relapsed/refractory multiple myeloma.
Closing the Digital Gap: FDA’s Oversight of Social Media
The parameters governing pharma promotional speech in digital and social media have struggled to keep pace with the rapidly evolving healthcare communications landscape. How can FDA play catch-up in advancing an agenda more reflective of industry and patient needs?
Vaccine Surpluses Drive Acrimonious European Debates
Member states air concerns over excess supplies of COVID vaccines.
A Rocky Road Ahead for FDA and Industry
2023 is poised to deliver a new set of challenges.
Congressional Probe of Alzheimer’s Drug Hits FDA Interactions with Industry
House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.
FDA Policy Change Heightens Debate Over Medicated Abortion
Regulation revision now allows pharmacies to dispense mifepristone directly to individuals with a prescription.
Massive Government Spending Bill Tackles Key FDA and Research Issues
The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.
Rising Demand Drives Drug Shortages
Current virus “triple whammy” taxes supply levels, while raising concerns over FDA’s limited power to track drug demand spikes.
Seeking Concrete Solutions to Europe’s Supply Problems
No shortage of views being expressed on drug shortages.
Pandemic and Politics Shaped Pharma and FDA in 2022
Year characterized by mix of key advances, contentious stances.
Doing More With Less: How Automation is Reshaping Drug Safety
Better technology is redefining pharmacovigilance as it expands beyond its traditional compliance focus to become a key business differentiator.
Major FDA Reform Unlikely in Closely Divided Congress
Following closely contested election, approval of FDA bills most likely tabled until new year.
Virtual Medical Affairs Audits: A Viable Alternative
Virtual audits proving to be beneficial post-COVID despite continuing challenges.
Long-Sought Reforms To EU Drug Rules Hit A Snag—What Now?
Making sense of surprise rejection of draft proposals.
FDA Embroiled in Reproductive Rights Debate
Agency under pressure from both sides—and potential congressional changes could complicate the issue further.
Pressure Mounts for FDA to Reform Accelerated Approval Program
Potential drug removal spotlights latest debate over the expedited pathway.
FDA Expands Oversight of Cell and Gene Therapies
CBER maps modernization plan to handle surge in research and applications.
Push for Full Embrace of Digital Care Draws Opposition in Europe
Patient safety and data protection concerns highlight hesitancy.
Seeking Harmonized Testing, Regulation, and Manufacturing
FDA backs joint reviews and common research policies around world.
FDA Keeps Its User Fees, but Fails to Gain Important Reforms
The ‘skinny’ user fee reauthorization tables multiple high-profile proposals.
FDA Expands Patient Input on Drug Development
Agency releases a series of new guidances to advance the reliability of patient-focused tools and methods.
Congress Slated to Reauthorize User Fees, Without FDA ‘Improvements’
Seek pared-down measure in funding bill to avert shutdown.
Clinical Trial Modernization Raises FDA Compliance Issues
Agency officials express associated concerns around clinical trial data reliability and quality.
Advanced Biopharma Manufacturing Key to White House Cancer Moonshot
Administration launches national manufacturing initiative, with aim to reduce US reliance on biomedicine from China and other regions.
FDA in Limbo as User Fee Renewal Stuck on Capitol Hill
In countdown to renewal deadline, agency already feeling the effects of still-unclear legislative fate.
The Manufacturing Edge on Path to Market
FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.
New Legislation Overhauls Medicare Drug Pricing and Benefits
Pharma loses battle to block price negotiations, but implementation faces many challenges.
Optimism Abounds On New EU Blood And Tissue Rules
Proposed SoHO reform elicits wide support, but risks acknowledged.
Senate Advances Drug Price Negotiations
Democrats approve curbs for Medicare plans, but not for commercial drug coverage.
Top Priority for Califf is Combating Health Misinformation
Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.
FDA Confirms Ongoing Reliance on Remote Inspection Methods
Citing strong reporting results, hybrid model to continue supplementing on-site inspections.
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