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.
FDA Continues to Grapple with Accelerated Approval Issues
With debate swirling around products cleared through this pathway, reforms and tighter oversight likely.
Gamesmanship Escalates Over FDA User Fee Legislation
With the renewal deadline looming—and disagreement still swirling on enhancing FDA authority—a counter proposal calls for a streamlined, fee-only bill.
FDA Regulation of Nonprescription Drugs in Spotlight
Application for OTC contraceptive highlights efforts to broaden access to medicines.
FDA Joins Effort to Curb Drug Patent Abuses
Agency partners with patent office in addressing anticompetitive practices.
FDA Drug Regulation Challenged by Anti-Abortion Campaign
Some states look to block access to approved drugs.
The True Nature of Danger Behind IP Waiver Proposal
Issue represents a potential threat in fighting future pandemics.
Cracking Down on Speaker Programs
With heightened government scrutiny on educational forums, biopharma manufacturers need a sound framework that demonstrates they are following best practices.
Dynamic Compliance: The Best Defense for Pharma
A proactive and tailored compliance department—with the nimbleness to adapt strategies on the fly—is a critical shield for life sciences companies during government investigations.
Rewriting European Regulations on Rare Disease Treatments
Legislative-reform alliance makes for strange bedfellows.
Regulators Seek More Drug Effects Research Related to Pregnancy, Lactation
Amid push to include this population more in clinical trials, the goal is to uncover improved evidence on the risks/benefits of drugs for these patients.
FTC Probes Pharma and PBM Anti-Competitive Practices
Takes aim at actions that limit access to lower-cost drugs, calls for revamp of M&A-impact guidelines.
A Defining Period for Future of FDA
Agency leaders seek to build public trust in science and gain support for regulation.
FDA User Fee Legislation Advances in Senate
Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access.
FDA Advances Quality Initiatives to Combat Drug Shortages
Agency again pursuing manufacturer rating system.
With Project Optimus, Success Favors the Prepared
Oncology drug developers must start asking questions in preparation of FDA’s dose optimization initiative.
Pharmacists, Manufacturers Rip PBM Practices
Drugmakers join the chorus of blaming pharmacy benefit managers for high product costs, limited access.
FDA Moves Forward with State Drug Import Plans
Though exclusions exist, agency’s new guidance backs the belief that US can reduce costs by importing cheaper, but legitimate products from Canada or elsewhere.
Real-World Evidence Is Becoming a Pivotal Component in Chinese Healthcare
Its use enables key processes such as early access, regulatory approval, and reimbursement listing.
Partnering to Respond to a Possible Nuclear Threat
Recent explosion at Zaporizhzhia nuclear power plant in Ukraine shows how pharma industry can pull together and take action in the face of adversity.
FDA to Continue Inspection Efficiencies After Pandemic
Plan to keep new methods adopted during COVID in place.
Escalating Abortion Battle Threatens FDA Authority
Access to mifepristone, approved by the agency in 2000, also under microscope.
Congress Presses FDA on Key Policies and Operations
Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.
How Regulatory Affairs Is Shaping Tomorrow’s Innovation Landscape
As regulatory reform continues to evolve in the US and Europe, the role of regulatory affairs is poised to help shape the more personalized treatment landscape on the horizon.
Clinical Trial Diversity Advances in Regulatory Agenda
Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.
FDA, Industry Prepare for Post-EUA World
Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.
FDA Revives Initiative to Identify and Reward Quality Drug Operations
Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.
Legislation Targets High Cost of Clinical Trials
Congressional bills put focus on comparator-drug access, more accurate trial and R&D cost determinations.
Europe’s New HTA System Spurs More Debate, Concern
Fresh round of discussions around health technology assessment.
FDA Seeks Expanded Authorities, Along With More Funds
Several legislative initiatives on table that would extend agency’s reach.
Patent Rights Battles Escalate as Debate over Drug Costs and Access Drags On
IP claims under microscope amid arguments over R&D policy and investment.
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