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…

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change that could accelerate cell therapies and other new medicines. 

The partnership will allow BMS to advance a T cell–based therapy that is only activated once in the vicinity of a tumor.

The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.

The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid painkillers, Jefferies analysts suggested.

Clinical Outcome Assessments (COA) Frequently Asked Questions

Pfizer CEO Albert Bourla said that the main thing getting in the way of changing vaccine discussions in the U.S. is the Secretary of Health, Robert F. Kennedy, Jr.

In this episode of Denatured, BioSpace editorial team members, Senior Editor, Annalee Armstrong, and News Editor, Dan Samorodnitsky, discuss their post-JPM takeaways and 2026 forecasts after speaking to a range of pharma and biotech executives and investors last week.

Looking for a research and development job? Check out the BioSpace list of 12 companies hiring life sciences professionals like you.

Competition for biotech and pharma employment picked up year over year and remains strong, according to BioSpace data. A survey late last year showed that 64% of employed/contract and 96% of unemployed respondents will actively look for work in 2026.

Fueled by advances in biomarkers, brain mapping, and AI, investment in neuro and CNS innovation shows no signs of slowing, even amid costly setbacks. BioSpace spoke to investors at JPM26 to get their take on recent bets in new therapies and neurotech.

Integra is removing all MediHoney Wound and Burn products and certain lots of CVS Wound Gel that may have breached sterile barriers

Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.

While early, the results indicate drugs known as ITK inhibitors have the potential to match or surpass the efficacy observed with the injectable biologic Dupixent.

Reporting Q4 and full year earnings on Wednesday, J&J executives hailed growth across the healthcare giant’s portfolio while standing fast on its talc lawsuit and tariffs.

EU reference instances (EDQM revision)

Attendance at the Biotech CEO Sisterhood’s annual photo of women leaders and allies in Union Square doubled this year. There’s still more work to do.

After winning a surprise approval for its hereditary angioedema drug Ekterly, KalVista is confident the oral offering will capture the lion’s share of the market for on-demand use.

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Novo Nordisk pulled back from cell therapies last October, scrapping development of a type 1 diabetes therapy and laying off most employees working on this modality.

Genentech, a member of the Roche Group, plans to open the facility in 2029 to ramp up capacity to make obesity candidates, including the dual GLP-1/GIP receptor agonist CT-388.

Ahead of GSK are Bristol Myers Squibb and Merck, which have already won FDA approvals for subcutaneous formulations of their respective PD-1 blockers Opdivo and Keytruda.

At its January meeting, EMA’s Committee for Herbal Medicinal Products…, “The HMPC, through its high-quality scientific recommendations, plays a vital role in harmonising the regulation of herbal medicinal products and substance in the EU. A…, The HMPC is the committee responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonisation of…

As drug candidates discovered via AI move into later-stage clinical trials, the technology seems to be doing as promised: speeding drug development.

The decision comes months after the FDA had suspended the vaccine’s license. One analyst speculated the company might shelve the product altogether. 

SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry.

Biohaven has suffered a few setbacks in recent months, including an FDA rejection and a missed $150 million benchmark payment, but CEO Vlad Coric looked for the brighter side at JPM, specifically emphasizing a serendipitous discovery that could get the company in the obesity game.

In November, Pfizer was reportedly looking to divest its stake in BioNTech, though the German biotech at the time denied these rumors.

The arrangement will boost AstraZeneca’s cell therapy portfolio as the pharma targets $80 billion in revenue by 2030.

In an interview with BioPharma Dive, the veteran biotech CEO said there remains a “significant opportunity” for young companies in a market dominated by Novo Nordisk and Eli Lilly.

BioSpace has revealed its new 2026 Hotbed Maps, showcasing seven regional life sciences hot spots.