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…

The revamped and “more anti-vax skewed ACIP committee” at the CDC “has a bone to pick with mRNA vaccines,” according to Truist Securities analysts. Meanwhile, the FDA moves forward on having Pfizer/BioNTech and Moderna update labels for their COVID vaccines.

The OmniActive lawsuit claims Lute-gen by Bio-gen contains the same ratio as its patent-protected Lutemax 2020.

London-based Zest is offering a Precision Memory Assessment (PREMAZ) test, which aims to detect subtle cognitive changes that may occur decades before dementia symptoms arise.

The Husband platform does not offer genetic testing but does inform its supplement recommendations on insights from 26,000 DNA reports and patient blood work.

The FDA found that data from a single Phase II study were “insufficient” to justify an accelerated approval review for sevasemten in Becker muscular dystrophy.

OTC Monograph Drug User Fee Program (OMUFA); Understanding FY 2025 User Fees and Registration

Altimmune’s pemvidutide failed to significantly improve fibrosis in MASH patients in a Phase IIb study. The biotech crashed 53% in the aftermath of the readout.

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers

FDA’s Examples of Interacting Drugs and Other Substances Involving CYP Metabolic- and Transporter System-Based Pathways for Healthcare Professionals

Calico will leverage 9MW3811’s anti-inflammatory mechanism to advance its mission of addressing aging-related diseases.

While ALTO-203 missed its depression-related endpoints, improvements in EEG biomarkers, attention and wakefulness point to signals of drug activity, William Blair said, though the analysts pointed to other indications as potentially more promising for future development.

Many proposals to reform the PBM industry miss the forest for the trees, experts said this week. Instead, Congress should go after the oligopoly enjoyed by the “Big Three” companies.

Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans – Rev.17

Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2024

In the race to make the most tolerable obesity drug, there seems to be no clear winner—at least not according to analysts parsing the data presented at the American Diabetes Association annual meeting this week.

Thimerosal, targeted by activists who claim it’s linked to autism, shouldn't be used in vaccines administered in the U.S. in the coming flu season, the CDC panel said.

Content: Health products and vaccine adverse reaction data; Product monograph updates: Amphetamines

NEW YORK – June 26, 2025 – PRLog — In a bold fusion of evolutionary biology, aerospace engineering, and comparative physiology, Dr. Vlad Reznikov, MD, PhD, MBA, today unveils “Thought Experiment: Extrapolation of the Reverse Bionic Mechanisms in the Reconstruction of the Anatomy and Biology of a Hypothetical Dragon”. The monograph is the first academically formatted attempt to reverse-engineer the legendary dragon…

Susan Monarez, already acting director of the CDC, said during her confirmation hearing that she sees no causal link between vaccines and autism.

Danone continues focus on gut health trend by announcing the acquisition of The Akkermansia Company just in time for World Microbiome Day. The move represents Danone’s shift to prioritizing gut health, an increasingly popular area of focus thanks to its growing recognition for its role in overall well-being and disease prevention. The Akkermansia Company was recently awarded NutraIngredient’s Microbiome Modulation Product of the Year Award 2025 for its Healthy Weight with Glucose Control supplement.

Jefferies analysts called the proxy filing, which is a standard disclosure after a merger agreement, “much more intriguing than normal” given the regulatory turmoil it revealed.

Minovia’s lead product is MNV-201, an autologous hematopoietic stem cell product that is enriched with allogeneic mitochondria.

Flagship Pioneering’s ProFound Therapeutics will use its proprietary technology to mine the expanded proteome for novel cardiovascular therapeutics. Novartis has promised to pay up to $750 million per target, though it has not specified how many targets it will go after.

Without providing further context, HHS Secretary Robert F. Kennedy Jr. says that Gavi needs to “start taking vaccine safety seriously” by considering “the best science available.”

Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the current administration’s push for transparency and gold-standard science.

Given today’s available local talent pool, biopharma companies are less likely to turn toward international job candidates, according to a talent acquisition expert. Findings from two recent BioSpace LinkedIn polls underscore the issue.