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…

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.

U.K.-based pharmas will not face tariffs as long as Donald Trump is president, according to the agreement.

A deal announced Monday will see the U.K. temporarily sidestep levies on Britain-originated drugs by loosening rules that restrain prices for new medicines.

Following Novo Nordisk’s price cuts for its own GLP-1 medicines, Eli Lilly is offering discounts for the obesity drug purchased through LillyDirect. Both pharmas recently struck a deal with the White House for cheaper prices via the yet-to-be-launched TrumpRx.

Protego Biopharma is advancing a small-molecule drug that helps light chain proteins fold correctly, in turn addressing the underlying biological cause of AL amyloidosis.

If approved, Ascendis’ TransCon CNP would become the second therapy for achondroplasia, challenging BioMarin’s Voxzogo.

As bispecifics, ADCs, protein degraders, and AI-designed mini-proteins move into the clinic, discovery teams face a new bottleneck: engineering and producing molecules whose complexity challenges conventional workflows.

Certain SJM Pericardial Patches from Glycar SA may not meet the required tensile strength specification

According to the U.S. Food and Drug Administration records, in an average year over 2,500 medical device recalls are issued in the United States. Some of these recalls simply require checking the device for problems, but others require the return or destruction of the device. Once identified, the FDA categorizes the root cause of these recalls into 40 categories, plus a catchall of “other”: situations that include labeling mix-ups, problems with expiration dates, and counterfeiting.

What’s shown here is the breakdown of the five biggest problem categories found among the 56,000 entries in the FDA medical-recall database, which stretches back to 2002: device design, process control (meaning an error in the device’s manufacturing process), nonconforming material/component (meaning something does not meet required specifications), software issues, and packaging.

Software issues are broken down into six root causes, with software design far and away the biggest problem. The other five are, in order: change control; software design changes; software manufacturing or deployment problems; software design issues in the manufacturing process; and software in the “use environment.” That last one includes cybersecurity issues, or problems with supporting software, such as a smartphone app.

Procedural advice for veterinary vaccine antigen master file (VAMF) certification

QE3 Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs

Q3E Guideline for Extractables and Leachables

Pharmaceutical Quality/Manufacturing Standards (CGMP)