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…

Late-stage results Otsuka presented in IgA nephropathy triggered a sell-off in Vera shares. Elsewhere, investors scrutinized Regenxbio’s Duchenne data and a brain drug study failed.

The Seattle-based company came to ASCO25 with new data on its neuroendocrine tumor–treating lead therapy, with big vibes and speedy speech.

The U.S. Food and Drug Administration has granted OmniActive Health Technologies GRAS (generally regarded as safe) clearance for the use of Lutemax Free Lutein in infant formula.

Kerry Group recently released its Supplement Taste Charts using the latest consumer insights and trend data for the flavors driving demand.

Given the evidence, the committee has recommended that the labels for Novo Nordisk’s Wegovy and Ozempic be updated to include the “very rare” risk of non-arteritic anterior ischemic optic neuropathy.

Otsuka’s investigational antibody sibeprenlimab approximately halved levels of this key biomarker in patients with immunoglobulin A nephropathy.

Vaccine skepticism is at an all-time high in the U.S., and HHS Secretary Robert F. Kennedy Jr. is making some drastic moves in the name of reversing that trend. But misinformation and inconsistencies within the country’s healthcare agencies highlight problems with his approach.

M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol

In a roundtable event on Thursday, HHS Secretary Robert F. Kennedy Jr. said his office will work to eliminate barriers that keep cell and gene therapies from the market.

Analysts at Truist Securities called the mid-stage data a “mixed bag,” also flagging gastrointestinal adverse events. However, the readout is unlikely to be “incremental” to Corcept’s overall stock narrative.

PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicinesTreatment with semaglutide should be stopped if NAION occursEMA’s safety committee (PRAC) has…, Agenda Agenda of the PRAC meeting 2-5 June 2025DraftReference Number: EMA/PRAC/168514/2025 English (EN…, PRAC statistics: June 2025 , PRAC statistics: June 2025 English (EN) (33.18 MB – PDF)First published: 06/06/2025View, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…

Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion

Interim results from a small group of children in a Phase I/II trial are essentially in line with that of Elevidys, according to BMO Capital Markets analysts.

The deal gives Cullinan T cell engagers aimed at BCMA and CD19, which drugmakers are exploring as possible targets for antibody- and cell-based drugs for inflammatory conditions.

This guidance provides recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.

In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can help organizations navigate a rapidly evolving regulatory environment with senior director of regulatory innovation and technology, Michelle Gyzen.

Analysts reacted positively to the news that uniQure is in alignment with the FDA on an accelerated approval pathway and on target for a Q1 2026 submission for its one-time gene therapy for Huntington’s disease—but patients have been here before.

The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases.

Dr. Jelena Vulevic, a gut microbiologist of 25 years, says it is time to move away from focusing on microbiome modulation and towards strengthening gut barrier integrity.

The lawsuit alleges that HHS leadership knew the records they used to guide their layoff decisions were inaccurate and contained errors.

Genrix’s velinotamig complements Cullinan’s own pipeline, according to William Blair, which added that the deal will put Cullinan in a better position to target autoimmune diseases.

The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's rollout.

Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion

Breathing circuits may develop cracks during use, potentially causing ventilation leaks that can result in hypoxia or hypercarbia.

The Shiley Adult Flexible Tracheostomy Tube is being recalled as it may come loose if the flange disconnects, potentially leading to a blocked airway.

Infusion Pump Intermittent Connection Issue from Smiths Medical

Infusion Pump Thermal Damage Issue from Smiths Medical

False Alarm Issue with Infusion Pump from Smiths Medical

The company is one of the first to receive a “platform technology designation,” which could speed the review of certain gene therapy applications it later brings to the regulator.