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…

Lilly will use Rznomics’ proprietary ribozyme technology to develop RNA editing therapies for congenital hearing loss.

Information regarding Umary, a product marketed as a dietary supplement

A gene editing drug custom-made for a critically ill baby showed that, for some ultra-rare diseases, it’s possible to design and test a new CRISPR medicine in just a few months. 

Hydrosome Labs was founded with a clear mission: to harness the transformative potential of ultrafine bubble (UFB) technology and redefine what’s possible across industries, starting with water but extending far beyond. From the beginning, the company recognized that this was not just a novel liquid—it was a new medium for delivering performance, efficiency and sustainability.

As the FDA prepares for a busy Oncologic Drugs Advisory Committee next week, an agency insider told BioSpace that volunteers with little training are scrambling to secure the required expertise after workforce cuts decimated the adcomm planning office.

Sen. Chuck Grassley, R-Iowa, suggested Congress could once again move to overhaul PBMs’ controversial business practices after legislators pass President Donald Trump’s conservative megabill this summer.

After warnings that the dragged-out process was putting the cell therapy company at risk of bankruptcy, bluebird bio now has a new deal to offer shareholders.

The FDA also changed its tune and is now planning to convene an advisory committee to discuss Biohaven’s application.

At a sometimes-contentious U.S. Senate hearing, the Health and Human Services secretary was evasive on the rationale behind cuts being made to the department and his endorsement of the measles vaccine amid a rapidly growing outbreak.

Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ – Version 1.5

Sanofi expects to add “a significant number of high-paying jobs” in the U.S. with $20 billion investment through 2030.

AbbVie’s Emrelis is the first non-small cell lung cancer therapy approved for patients with high c-Met expression levels who have received prior lines of treatment.

Looking for a biopharma job in San Francisco? Check out the BioSpace list of 10 companies hiring life sciences professionals like you.

A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0

The research collaboration, under which Septerna will receive more than $200 million in upfront and near-term fees, is the latest deal Novo has struck to expand its obesity pipeline.

Consumer interest in the microbiome is growing but personalized testing may not be keeping up.

Currently trailing Eli Lilly and Structure Therapeutics in the oral weight loss space, Novo Nordisk strikes a deal with Septerna to put new discovery-stage programs into play.

The ADARx Pharmaceuticals partnership, which could be worth “several billion dollars” in the end, adds to AbbVie’s existing work in the space after the $1.4 billion acquisition of Aliada Therapeutics in October 2024.

GSK secures rights to Boston Pharmaceuticals’ efimosfermin alfa, which the pharma plans to develop for fatty liver diseases such as metabolic dysfunction-associated steatohepatitis and alcohol-related liver disease.

Belrestotug showed underwhelming efficacy outcomes in mid-stage studies of non-small cell lung cancer and head and neck squamous cell carcinoma.

Arcturus is extending its cash runway into 2028 by discontinuing its early-stage vaccine candidates.

PMF dossier requirements – Questions and answers for PMF holders

Roche envisions its Indianapolis site as a “major hub” for the manufacturing of its continuous glucose monitoring systems. The news comes on the heels of an announced $700 million investment in North Carolina.

President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.

Recalls are typically voluntary actions taken by a company to remove or correct products on the market that violate U.S. Food and Drug Administration laws and regulations. Recalls may be initiated proactively by a company, at FDA request, or ordered under statutory authority.

Zurich-based biotech start-up Trilliome is pioneering precision prebiotics derived from lesser-known plants to target specific bacterial strains in the gut microbiome linked to brain, digestive and immune health.

It’s another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a therapy approved.

CGMP/Finished Pharmaceuticals/Adulterated