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…

While the Chicago metropolitan area is not a major life sciences hub, a recent Cushman & Wakefield report predicts the Chicago market should be a growth spot in the coming years. Chicago Biomedical Consortium and COUR Pharmaceuticals executives share what makes the area a hot spot.

For the first time, the five EU health and environment agencies – EFSA (European Food Safety Authority), ECDC (European Centre for Disease Prevention and Control), ECHA (European…, This joint work carries great benefits for public health and shows the value of the One Health approach. By using the unique expertise of EU health organisations outside the…, One Health: main recommendationsTackling azole resistance in Aspergillus requires cross-sectoral collaboration. The One Health approach brought together EU experts from human and…, Video: Resistance to azole fungicides in AspergillusA video explains how the resistance to azole fungicides in Aspergillus is developed and its implications on public health.…

Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory.

The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors.

StatStrip Hospital Glucose and Ketone Meters provide blood glucose and ketone readings in health care settings. A software issue may transmit inaccurate results to patient records.

The layoffs follow an announcement in early January that I-Mab will re-prioritize resources to focus on advancing a CLDN18.2 and 4-1BB bispecific antibody for gastric cancers.

The move is part of a strategic restructuring aimed at getting azenosertib to the market for patients with gynecological malignancies.

The approval continues the trend of GLP-1s expanding to indications outside of diabetes and weight loss.

The discontinuation comes after the investigational drug, volenrelaxin, failed a related heart failure study in an overlapping patient population.

Ahead of Robert F. Kennedy Jr.’s confirmation hearings, experts—and RFK’s own family—expressed concerns about his vaccine-related views, though the same experts are largely unfazed by the level of power he and Marty Makary could ultimately wield over the FDA.

The European Shortages Monitoring Platform (ESMP) is now live with the full scope of functionalities. This will enable marketing authorisation holders (MAHs) and national…

Other payment systems also appear to be offline, suggesting a broader shutdown of federal portals related to grants and funding.

It’s been a rocky few months for BioAge Labs, which shuttered a Phase II trial of its lead candidate azelaprag Tuesday after the molecule caused liver-based side effects.

The results, which come on the heels of the FDA’s approval of J&J’s esketamine nasal spray Spravato as a monotherapy for treatment-resistant depression, could serve to further bolster a space hit hard by the rejection of Lykos’ MDMA-based PTSD therapy in August 2024.

Atara Biotherapeutics’ layoffs could leave the biotech with around 80 employees. The cuts follow news that the FDA rejected Ebvallo, a T cell therapy approved in Europe for a transplant-related blood cancer, and placed a clinical hold on the company’s active drug applications.

Akero Therapeutics announced statistically significant results from a Phase 2b trial of efruxifermin this week, a fibroblast growth factor 21 analog, designed to treat patients with biopsy-confirmed compensated cirrhosis due to MASH.

After two years characterized by layoffs, pipeline reorganizations, FDA delays and clinical holds, Novavax CEO John Jacobs says the company is at a pivot point.

Sage’s board of directors said Biogen’s offer “undervalues” the company, but will explore other strategic alternatives to “maximize” shareholder value.

The GLP-1 IPO arena has been heating up for the past two years and Metsera’s ask is one the largest in recent history.

After missing the primary endpoint in the Phase IIb SYMMETRY trial, Akero Therapeutics’ lead molecule, efruxifermin, showed greater improvements after 96 weeks of treatment in an advanced disease population.

Following disappointing clinical trial results for AK006, Allakos will cut its workforce down to under 20 employees as it explores strategic alternatives.

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database – Chapter 5: Technical specifications

Patients taking Novo Nordisk’s Wegovy plus Veru’s enobosarm saw 71% lower lean mass loss than those who were taking Wegovy alone but investors await more data.

The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.

EMA is celebrating 30 years of operations marking its evolving role at the centre of the European Union (EU) assessing and authorising safe, high-quality medicines for 450 million…, This is a European story to be proud of and to celebrate. We know there are challenges ahead of us, but our future is incredibly bright. I believe that with open communication…, EMA was set up in 1995 to manage the centralised procedure for the authorisation of medicines and to harmonise the work of existing national medicine regulatory bodies. Originally…, The original ambition was to centralise the evaluation of innovative medicines, so that, in the words of the French presidency at the time, ‘all patients in the EU could benefit…, A video with an overview of key milestones and achievements in the authorisation and safety monitoring of medicines for human and animal use in the EU is published today.,

Brenner, who has worked in the FDA’s Center for Devices and Radiological Health, will lead the agency until a permanent commissioner is confirmed.

An experimental drug called amycretin showed signs it could be more potent than Eli Lilly’s rival Zepbound, though analysts cautioned certain aspects of the study may have inflated its performance. 

The Trump administration is bringing new instability to a sector already grappling with a shaky market as well as threats like competition from China.