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…

This page lists Biosimilars Guidance documents.

Shingrix sales in the U.S. took a 15% dive in the third quarter. GSK is now the second Big Pharma to report declining vaccine sales, after Sanofi reported a similar decline last week.

Already sky high after the success of its limb-girdle muscular dystrophy therapy, reported on Monday, BridgeBio’s shares rose nearly 8% more as encaleret balanced calcium levels in patients with a genetic thyroid disorder.

Mergers and acquisitions are not just for Big Pharma. A new report from Leerink Partners takes a stab at identifying the small- to mid-cap pharmas best prepared to bolster their pipelines with a buyout.

The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025

GSK is shelling out $85 million up front, and possibly $745 million overall, for an RNA-based therapy it sees helping a "broad spectrum" of people with the chronic lung condition. 

Vas Narasimhan confirmed that Novartis is having weekly discussions with the Trump administration on drug pricing, but a deal has not yet been reached.

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

Phase I/II data for rese-cel point to its therapeutic potential in systemic lupus erythematosus and lupus nephritis, as well as other autoimmune conditions.

BioMarin no longer expects to hit its $4 billion revenue target by 2027, citing various market factors such as impending competition for achondroplasia therapy Voxzogo and the divestment of the gene therapy Roctavian.

Executives from Eli Lilly, Merck and other companies foresee the FDA’s new onshoring proposal being anything from a bureaucratic waste of time to a transformative program that will eliminate inspection-related complete response letters.

The company intends to divest Roctavian and “remove it from our portfolio,” CEO Alexander Hardy said, after nearly three years of slow uptake for a medicine once viewed as a future blockbuster.

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development

New interim data from a Phase III trial puts the company on track to file for FDA approval next year in an indication that not only lacks a disease-modifying treatment but suffered significant setbacks after a patient died in a clinical trial for Sarepta’s investigational gene therapy.

Clearance of Lynkuet provides a new alternative to hormone-based treatment for hot flashes and sets up a market battle with Astellas Pharma’s Veozah.

In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.

Intellia earlier this year reported a similar grade 4 liver enzyme elevation associated with the gene therapy nexiguran ziclumeran, though analysts at BMO Capital Markets at the time brushed it off as a “non-concern.”

Selecting the ideal pharmaceutical label manufacturer requires careful consideration. This article compares leading companies, highlighting their strengths in regulatory compliance, material performance, serialization, innovation, and sustainability, to help you make an informed decision for your product’s safety and success.

The deal, which Novartis expects can “unlock multibillion-dollar opportunities” in the years ahead, hands the company a group of medicines for multiple forms of muscular dystrophy.

The deal, announced early Sunday afternoon, will see Novartis gain access to Avidity’s neuroscience assets, while the San Diego biotech spins out a new company to shepherd its early-stage precision cardiology programs.

The $70 million upfront deal adds to a portfolio of drugs Biogen has been growing in various immunological conditions since 2024.

The preclinical drug from Vanqua Bio is designed to inhibit “C5aR1,” a part of the immune system that regulates inflammation.

On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no sati

CGMP/Finished Pharmaceuticals/Adulterated

Lilly’s upfront offer for Adverum, the developer of a gene therapy for age-related macular degeneration, is less than the company’s previous closing share price.

The French pharma’s overall vaccine sales declined 8% in the quarter, with a key driver being slower-than-usual uptake of flu shots in the U.S.

The cornerstone of the deal is Ixo-vec, an intravitreal gene therapy currently in Phase III development for wet age-related macular degeneration. Eli Lilly made another foray into genetic medicine in June, picking up Verve Therapeutics for up to $1.3 billion.

Health Canada is holding a 60-day consultation on revisions to the Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products – Guidance Document for Industry, now entitled “Guidance on preparing and submitting summary reports for marketed drugs and natural health products” and the draft form: Notifying Health Canada of a significant change in what is known about the risks and benefits of a product.