Blogs

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.

Democrats failed to gain sufficient support this week to advance long-debated legislation to permit Medicare drug price negotiations.

Nicole Richie, Global Head Health Equity and Population Science at Genentech/Roche, discusses a renewed strategy in big pharma to incorporate diversity inclusion in clinical trials.

FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics.

White House officials recently announced a nearly $3 billion program to ramp up production of vaccines and their components to better serve patients in the U.S. and globally.

A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.

FDA has revealed its plan for revising and renewing its fee program for drugs and biologics.

Terence Rooney, VP of Clinical Development at Janssen, talks through the journey of how Janssen changed during the pandemic, and what the future holds.

Promises of "more equitable access for those with severe diseases," "decision-making flexibility where it counts," and more in a bid to win post-Brexit business.

The first COVID-19 vaccine, Comirnaty, has received FDA approval. How will vaccination rates be effected?

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.

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.

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.

European Commission proposes new bio-defense preparedness plan.

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.

FDA is on track this year to authorize a notable number of new molecular entities and important biotech therapies.

FDA acting commissioner Janet Woodcock has outlined FDA’s plan to “transition to standard operations” for U.S. inspections.

A draft report from parliament's cancer committee highlights the benefits that precision and personalized medicine offer.

A broad White House proposal to advance competition in major U.S. industries features several measures intended to make medicines more affordable for patients.

Micki Hultquist, Vice President, Global Franchise Head at AstraZeneca, discusses the journey from a missed endpoint in TULIP-1 to a clinical success in TULIP-2

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.

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.

The latest draft supports the creation of the Biden administration’s proposed Advanced Research Projects Agency for Health to accelerate research on cures for cancer, diabetes, Alzheimer’s and more.

Not just COVID is changing the landscape of pharmaceutical policy in Europe.

CDER launches an initiative to gain more efficient and transparent operations of its advisory panels. Jill Wechsler reports.

Thad Wolfram, President, Matrix Clinical Trials at Matrix Medical Network, speaks about his experience utilizing decentralization methodologies to increase clinical trial diversity inclusion by going deep into diverse communities.

Allegedly more than 4,000 clinical trials of medicines are missing results on the European trial registry, in violation of transparency rules.

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.

The Biden administration has rolled out a broad initiative to promote domestic production of critical materials, including medicines and their ingredients.