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…

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with new Addendum II to Module VI on masking of personal data in individual case safety reports submitted to EudraVigilance

At its July 2025 meeting, EMA’s Paediatric Committee (PDCO), elected Sabine Scherer from Germany as its new chair for a three-year mandate, beginning in September 2025.Dr Scherer…, She is currently involved in several PDCO initiatives and working groups, dealing with topics such as extrapolation, mechanism of action PDCO representatives in the European…, "It is a great honour to be appointed to chair EMA’s paediatric committee. My ambition is to work together with the European Medicines Regulatory Network to further advance…, The main role of the PDCO is to prospectively guide sponsors or companies on how to consider a medicine’s use in children during its development. In this context, the…

The 2025 Product of the Year winners were recently revealed during the 8th Annual NutraIngredients-USA Awards.

Second-quarter earnings come amid many high-level challenges for the biopharma industry. How will these five closely watched biotechs fare?

The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.

Roche obtained CT-173, a PYY mimetic, in its $2.7 billion acquisition of Carmot Therapeutics in December 2023. The company reported the change in its second quarter earnings call.

The latest round of terminations, which will take effect Sept. 15, comes after Genentech fired more than 500 employees in the last 15 months.

The Washington, D.C.–Baltimore area ranks in the top six for life sciences R&D and manufacturing talent, according to a CBRE report. The Maryland Department of Commerce’s director of life sciences discusses the workforce and how the state is adapting to changing needs.

Edwards recalls arterial cannulae due to risk of wire exposure that may cause serious patient harm.

HON-E-LING may be harmful due to hidden drug ingredients

The action will remove from use the very few flu shots that contain the contested preservative, elevating unproven fears it poses health risks.

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience that would make change possible.

The decision follows last month’s vote of the CDC’s revamped vaccine advisory committee. Thimerosal, mostly removed from vaccines decades ago, has long been a target of anti-vaccine advocates for unfounded links to autism and adverse health outcomes.

Marketing veteran Karen Todd, RD, vice president of global brand marketing at Kyowa Hakko USA, discussed the evolution of consumer awareness and messaging in the nutraceutical industry since her early career at Amway. She also highlighted a significant increase in supplement usage, driven by a more educated consumer base focused on lifestyle benefits.

TSI acknowledged that inclusion on the SSE supports China’s emphasis on high-quality, consumption-driven areas including health, wellness and advanced manufacturing.

Looking for a biopharma job in California Check out the BioSpace list of 11 companies hiring life sciences professionals like you.

Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)

Dispatch seeks to address two main challenges of immunotherapies in solid tumors: the lack of a target and the immunosuppressive tumor environment.

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased domestic investment.

The voluntary pauses follow two patient deaths associated with the Duchenne muscular dystrophy gene therapy.

ADARx Pharmaceuticals CEO Zhen Li found her way to biopharma through Merck, where she was inspired by the application of powerful science to human medicine.

When talking to some of the most impressive women in biopharma, the conversation inevitably turned to what these women wanted other entrepreneurs to know. Here’s the best of the best of that advice.

Baxter is removing mobile lift components due to risk of false attachment, which may result in patient injury due to falls.

FDA Commissioner’s National Priority Voucher Program. The Commissioner’s National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.

The French pharma will pay $1.15 billion upfront to buy Vicebio and gain access to non-mRNA vaccine candidates against RSV and metapneumovirus.

Tiny Health received this year’s NutraIngredients-USA Start-up of the Year award for its innovative, science-driven approach to improving child and family health through precision gut microbiome testing. The panel of expert judges recognized its strong scientific foundation, clear mission and notable commercial traction.

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the regulator considers more drastic action.

BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the agency’s decision to issue a complete response letter for Replimmune’s viral treatment RP1 for advanced melanomas. Shares of the company tumbled 75% on Tuesday.

Medline Craniotomy Kits are procedure convenience kits. Kits containing the Codman Disposable Perforator are being corrected by Medline Industries.