SPOTLIGHT -
May 16th 2024
This is the second accelerated approval the FDA has granted to Bristol Myers Squibb’s chimeric antigen receptor T-cell therapy in the past few months.
Carta Healthcare’s co-founder discusses how a recent ruling on non-compete clauses may help alleviate the coming nursing shortage.
May 15th 2024
Roche’s human papillomavirus solution is reportedly one of the first of its kind to be available in the United States.
May 13th 2024
Dupixent has previously been approved for adults with chronic rhinosinusitis with nasal polyposis whose condition is inadequately controlled.
With competition for follow-on-biologics on the upswing—and a potential market boom perhaps around the corner—continued education and course-setting for all stakeholders in charting the access landscape is paramount.
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.
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.