News & Updates

MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…

EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…

This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…

SciNeuro Pharmaceuticals represents the latest in a string of Arch investments directed at the nervous system, a notoriously challenging area of drug development.

Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s Phase I/II studies of AMT-130 are “unlikely” to provide the primary evidence to support a biologics license application.

Writing in separate editorials in two leading medical journals, former chiefs of federal scientific agencies issued warnings about the changes being proposed to vaccine frameworks by current officials.

The partnership will focus on Crescent’s PD-1/VEGF inhibitor CR-001 and Kelun-Biotech’s SKB105, both of which the companies plan to push into Phase I/II development for solid tumors early next year.

The field of women’s health suffers from a lack of specific and standardized tools optimized for the study of the human vaginal microbiome. Learn about the OMNIgene™•VAGINAL device for the self-collection and stabilization of vaginal samples, and OMNIgene™•XTRACT ULTRA extraction kits for the recovery of vaginal microbial DNA and RNA to support vaginal microbiome discovery.

The OMNIgene™•XTRACT ULTRA kit enables the optimal recovery of large quantities of high-quality DNA and RNA from a wide range of sample types including vaginal samples collected with the OMNIgene™•VAGINAL device. The OMNIgene™•XTRACT ULTRA kit is the first solution validated to provide significantly higher DNA and RNA yields from vaginal samples to better support multi-omic analysis of microbial communities.

Companies who run their early-stage clinical development outside the U.S. would “experience higher fees” according to an FDA proposal made during the negotiation process for the eighth cycle of the user fee program.

Last week, Center for Biologics Evaluation and Research Director Vinay Prasad claimed in an internal memo—without providing evidence—that COVID-19 vaccines were responsible for the deaths of 10 children between 2021 and 2024.

In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for new approach methologies (NAMs) development.

For the second month in a row, job postings on BioSpace increased in key biopharma disciplines. However, application rates also increased.

Job listings in the area have ticked up in the last month. These seven companies are hiring in South San Francisco right now, including scientist and clinical roles.

C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of their applicability, opportunities, and challenges.

With new UK clinical trial rules landing in 2026, the EU Biotech Act on the horizon and China and Australia gaining ground, CROs are zeroing in on study timelines, AI/ML and data privacy as the industry’s next pressure points.

Data from the "ADEPT-2" study, which analysts had hoped would arrive before year's end, are now expected sometime in 2026.

Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” Capricor’s cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial.

Classification of changes

Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.

Analysts had noted “unease” from investors regarding the state of the Phase III ADEPT-2 trial, with BMS at one point telling Leerink Partners that the reopening of enrollment would be a “significant development.”

Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.

While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.

Olympus ligation loops may be unable to release or detach as expected during use and may become unintentionally anchored around patient anatomy
 

CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)Draft page

Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.

Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.

The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.

With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.

Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may provide incorrect low glucose readings

This webpage provides links to certain publicly available external reports and resources relating to patient experience data. The patient community, patient advocates, researchers, drug developers, and federal agencies may find these materials useful.