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…

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

New collaboration for ALS

J.P. Morgan releases its annual look-ahead days before the entire biopharma industry descends on San Francisco for the annual J.P. Morgan Healthcare Conference.

Backed by ARCH Venture Partners, F-Prime Capital and Mubadala Capital, the new company will develop a pipeline of brain-penetrant small molecules to address inflammation, metabolic dysfunction and restoring lysosomal function.

By mid-2025, the biotech will split into two entities: a new, as-yet-unnamed innovative medicines specialist and a cell therapy company, the latter of which will inherit the Galapagos name.

In a rare move, the FDA recommended a minimum of 5% weight-loss for drug developers seeking to establish the efficacy of their investigational obesity candidates.

The investment continues a Novo dealmaking spree to cement its leadership status in the cardiometabolic space, with partnerships with Photys Therapeutics, Ascendis Pharma and two Flagship-backed start-ups.

BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.

CytomX’s workforce cuts could leave the biotech with fewer than 75 employees as it focuses resources on its wholly owned clinical-stage programs, most notably an antibody-drug conjugate for advanced metastatic colorectal cancer.

Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for confirmatory trials for therapies seeking the shortened path to market.

Months after posting weight loss of 7.5% at 36 days for patients taking MET-097i, Metsera releases mid-stage results of just over 11% average body weight reduction at 12 weeks, with no plateau and a promising safety profile.

EudraVigilance – EVWEB user manual

Positive news for BrainChild Bio

The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information regarding models’ development and maintenance.

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication

Given CBD’s regulatory uncertainty in the U.S., some brands are exploring opportunities where regulations are clearer.

The acquisition from Wuxi Biologics, the embattled CDMO named in the BIOSECURE Act, marks another expansion of Merck’s manufacturing operations in Ireland.

Orbis Medicines secures €90M Series A to develop innovative oral macrocycles, offering cost-effective alternatives to biologic drugs and targeting chronic disease markets.

Eli Lilly and Company has invested more than $20 billion in its manufacturing capabilities since 2020 to help meet high demand for its medicines. Its recently announced Lilly Medicine Foundry—which will support research and development efforts—is just the latest example of the ability to research new ways of producing medicines, while also scaling up manufacturing of medicines for clinical trials.

In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza.

Seeking Alpha analyst Terry Chrisomalis regards Viking Therapeutics as the most attractive M&A candidate in 2025, bolstered by its strong obesity candidate VK2735 and largely de-risked MASH therapy VK2809.

Checklist for annual updates for parallel distribution: guidance for industry

Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.

Effectively treating and preventing this common form of dementia will require a cocktail of drugs and a combination of approaches, as well as a drive toward early detection.

Vous Vitamins is focusing extending the reach of its subscription vitamin plans by targeting employee benefit options.

In a recently filed brief, counsel for President-Elect Trump argued there is “ample justification for the Court to stay
the January 19 deadline” for the impending TikTok ban, including issues regarding free speech, court jurisdiction and “possible legislative encroachment.”