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 Acknowledges Hurdles in Using Real-World Data
FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into submissions to the agency, while addressing concerns about its relevance and reliability.
FDA Highlights Value and Challenges of Advanced Drug Manufacturing
FDA is expanding its Emerging Technology Program (ETP) and providing more support for new drug applications (NDAs) that present advanced manufacturing technologies, but the agency and industry face key challenges in advancing these initiatives.
Can Califf Bring Clarity and Enhanced Credibility to FDA?
Word is out that the White House will name cardiologist and research pro Robert Califf to the top FDA job, a position he held for almost a year at the end of the Obama administration. But he may face opposition in the Senate.
Pandemic Alters FDA Inspection Process and Policies
Changes prompt collaboration and improved quality management.
FDA, Sponsors Advance Reliance on Real-World Data & Evidence
Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional sources of information into research and approval processes.
FDA Caught in Political Crossfire
Critics say FDA is either acting too fast and risking public safety—or too slow, mired in rules while ignoring important scientific findings.
Biosimilars Gain Traction with Regulators, Manufacturers
The stars finally may be aligned for Americans to gain greater access to alternative biotech therapies in the coming months.
The Next Big COVID Challenge: Vaccines for Children under 12
If the debate over vaccines for adults and the need for extra booster shots has been heated, FDA will face even more scrutiny over the safety and value of vaccinating children under age 12.
Vaccine Booster Battle Reveals Rifts Among Regulators, Sponsors
FDA’s Vaccines and Related Biological Products Advisory Committee announces its recommendations for the authorization of a third dose of the Pfizer/BioNTech Comirnaty vaccine.
FDA Advances New Drugs, Biosimilars
But accelerated approval program faces scrutiny.
FDA Moves to Advance Innovative Excipients
FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics.
FDA, Industry Map New R&D Initiatives under Next User Fee Program
FDA has revealed its plan for revising and renewing its fee program for drugs and biologics.
10 Practical Regulatory Questions to Ask During a Marketing Authorization Transfer Process
With large M&A deals comes a complex Market Authorization Transfer (MAT) process, during which regulatory teams must weigh several operational aspects while creating a roadmap that takes them into account. Cecile Riboud outlines some key questions that are necessary for planning and executing a successful MAT process.
FDA User Fees To Rise – and Fall – as New Fee Agreements Move Forward
While biopharma companies will pay more than $3 million to file an NDA or BLA application during fiscal year 2022, new fees for generic drugs will see modest or no increases and those for biosimilars may drop or hold even.
Biden Highlights Drug Pricing Reforms to Advance Legislative Agenda
The White House is looking to pay for some of its prime social and health initiatives by reducing outlays for prescription drugs, according to an announcement by President Biden.
Biosimilars Move to Center Stage
All eyes are watching closely to see how well Viatris and Biocon Biologics’ Semglee, approved by FDA on July 28, competes with Sanofi’s well-established, long-acting insulin analog, Lantus.
Drug Prices Targeted in Biden Executive Order
Sweeping competition initiative drills in on cost reduction.
FDA’s Pazdur Challenges Attack on Accelerated Approval Program
In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill patients based on early clinical results, Richard Pazdur, director of FDA’s Oncology Center of Excellence, lashed out at the alarmists and urged continued support for this early access process.
New Drug Approvals On Track at FDA
FDA is on track this year to authorize a notable number of new molecular entities and important biotech therapies.
FDA Under Pressure to Restore “Normal” Drug Inspections
FDA acting commissioner Janet Woodcock has outlined FDA’s plan to “transition to standard operations” for U.S. inspections.
Woodcock Seeks Outside Investigation to Restore FDA Credibility
FDA acting commissioner Janet Woodcock has bowed to pressure and called on the HHS’s Office of the Inspector General to examine the review process for Biogen’s Alzheimer’s disease treatment, Aduhelm.
Navigating PV Divergence: Compliance Tips for New Entrants
With small biotechs facing similar expectations as large pharma in drug safety and pharmacovigilance, despite less resources, identifying the key differences between US and EU requirements can help these companies craft a practical path to multi-region compliance.
Biden Budget ‘Wish List’ Maps FDA, Healthcare Priorities
White House backs big boost in funding for research, public health.
Emergency Use Authorization: What We’ve Learned Bringing COVID-19 Therapies to Market
Pandemic forces pharma companies to work faster and smarter to meet hard deadlines.
Full Approval of COVID Vaccines Key to Addressing Hesitancy
The Center for Biologics Evaluation and Research’s top priority is to approve biologics license applications (BLAs) to address vaccine hesitancy, according to CBER director Peter Marks.
New “Cures” Bill Aims to Advance R&D, Drug Development
An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill in anticipation of gaining approval in the coming year.
FDA Advisory Committees Under Scrutiny
CDER launches an initiative to gain more efficient and transparent operations of its advisory panels. Jill Wechsler reports.
Assessing IDMP Maturity
How pharma firms assess their readiness for IDMP (Identification of Medicinal Products) is important for meeting compliance requirements and ensuring they are prepared for the digital product information management future, writes Adnan Jamil.
New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process
FDA’s surprise decision this week to approve Biogen’s treatment for Alzheimer’s Disease has raised serious questions about the validity and value of the agency’s accelerated approval process.
Pharma Prices and Patents Under Attack
Separate pushes for vaccine equity, legislation to lower drug costs.
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