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…

Roche, along with Bristol Myers Squibb, Novo Nordisk, AbbVie, Eli Lilly and others, is making inroads into molecular glues to use in cancer, immunology and other applications.

BioSpace examines the busiest corporate venture capital arms in the pharmaceutical industry. Novo Holdings, which made headlines last year with its $16.5 billion Catalent buy, topped the list.

From a higher bar for regulatory clearance to pricing limitations, drug development is more expensive than ever. This has led firms to make tough pipeline decisions early in the development process. The result may be costly for all of us.

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

Most of the 15 million children with a rare disease have no FDA-approved treatments available to them. And when it comes to the most-rare conditions, there isn’t even a pipeline.

Drugmakers will be expected to commit to aligning U.S. prices with the lowest price set in a group of peer nations for all brand products across all markets that do not currently have generic or biosimilar competition.

Annual report to Congress on the activities and impact of the Office of Combination Products (OCP)

The urban diet has adverse effects on pregnant and lactating women’s microbiomes and the health of their offspring, but a new framework aims to change that.

After over a decade of involvement with the American Herbal Products Association (AHPA), Graham Rigby has been appointed president and CEO. The natural products industry veteran described the role as one he always aspired to, so when the opportunity arose, he felt it was meant to be.

CEO Keith Gottesdiener will be replaced by Prime's CFO as the company cuts 25% of its workforce and deprioritizes its lead program.

While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the company.

The types of DMFs are Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product, Type III Packaging Material, Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation, Type V FDA-Accepted Reference Information.

In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.

A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.

Govorestat failed to meet its primary endpoint in a Phase II/III trial for a rare form of Charcot-Marie-Tooth disease, a few months after the FDA rebuffed the same drug in a similar indication.

Regeneron promised to comply with 23andMe’s consumer privacy policies and related data security laws.

The Shift Toward Real-World, Patient-Centered Evidence

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability.

FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss

The deal “fits like a glove” for BioMarin’s business, according to an analyst who also thinks there could be a “valuable” market opportunity for Inozyme’s main drug.

The first day of Probiota Americas 2025 will feature presentations and panel discussions on topics including microbiome ecology, start-ups, maternal and infant health, oral probiotics and prebiotics

A federal jury found Amgen liable for violating antitrust and tort laws. Elsewhere, Allogene and Kyverna trimmed staff and the FDA scheduled an advisory meeting.

Lars Fruergaard Jørgensen will step down after eight years helming the Danish drugmaker, shares of which have shed half their value in the past 12 months.

Mental health, sleep and longevity research has been historically underfunded, but Susanne Mitschke, co-founder of CRO Citruslabs says robust clinical trials are necessary to move the needle in these key categories.

Global ingredients supplier Prinova is bringing a new ingredient to the European market, designed to add vasodilatory or ‘pump’ effects to pre-workout supplements.

The star of the acquisition is the enzyme replacement therapy INZ-701, being developed for the rare disease ENPP1 deficiency.

The Committee re-elected Johan Schefferlie from the Netherlands as its Chair for a further 3-year mandate.CVMP opinions on veterinary medicinal productsThe Committee adopted by…, Maximum residue limits Lidocaine (Porcine) – Summary opinion of the CVMP on the modification of maximum residue limitsAdoptedReference Number: EMA/CVMP/158077/…

The FDA also approved the use of Zynyz as a monotherapy for patients with squamous cell carcinoma of the anal canal who are intolerant to platinum chemotherapy or whose disease has progressed.

Since Elevidys’ accelerated approval in 2023, experts have been clamoring for more data, particularly in older and non-ambulatory children. New results, presented Friday, show mobility improvements in 8- to 9-year-old patients after one year of follow-up.