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…

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies including Novo Nordisk see hurdles to implementing the changes.

EMA has published an overview of its key recommendations of 2025 regarding the authorisation and safety monitoring of veterinary medicines.In 2025, EMA recommended 30…

Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications 2026-2027

Henry Gosebruch, who has $3.5 billion in capital to deploy, is thinking broad as he steers the decades-old biotech out of years of turmoil. 

In this bonus episode, BioSpace’s Vice President of Marketing ⁠Chantal Dresner⁠ and Careers Editor ⁠Angela Gabriel⁠ take a look at Q4 job market performance and what it signals for 2026.

With inspections always on the table, LOTTE Biologics is pushing a proactive, quality first culture across its dual hubs in Syracuse and Songdo, backing its new single‑use ADC facility with rigorous training, self‑audits and real‑time regulatory surveillance.

As biotechs faced investors at the J.P. Morgan Healthcare Conference this week, they emphasized agreement with the FDA on clinical trial design and regulatory pathways to approval. Atara, meanwhile, lamented the agency’s “complete reversal of position” after its therapy for a rare surgical complication was rejected.

The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Department of Defense.

FDA’s tips for section 804 state importation program (SIP) proposals provide information to assist states and tribes develop their proposals.

FDA has issued policies and taken actions to implement section 804 of the Federal Food, Drug and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada. Learn more.

This quality assurance (QA) tool is designed to assist section 804 importation program (SIP) sponsors prepare proposals that fully comply with the requirements under the final rule.

Less than six months after cutting 20% of its employees, Vedanta Biosciences has again laid off staff. According to one affected staffer, half of the Cambridge, Massachusetts–based biotech’s workforce is being cut while most of the rest are furloughed.

More than 3,000 prescriptions were written for Novo’s GLP-1 pill in its first week on the market. Elsewhere, Emergent reached a settlement over a trading scandal and Sanofi is reportedly circling an eye drug biotech.

Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line.

Ocular Therapeutix’s lead asset is Axpaxli, being developed for wet age-related macular degeneration. A Phase III study is underway, with data expected this quarter.

Speaking on the sidelines of the J.P. Morgan Healthcare Conference, Novo business development executive Tamara Darsow said the company is gunning for obesity and diabetes assets.

The Novo Nordisk Foundation’s funds will go toward supporting early-stage companies working in “human health, planetary health and societal resilience.”

Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion on a marketing authorisation from Elanco for Lotilaner / Milbemycin Elanco (…

After a cacophony of troubles hit the RNA editing biotech last fall, CEO Ram Aiyar is in San Francisco to develop partnerships, pitch the potential of its new AATD program and find more money to keep the dream alive.

A surge in deals and financings had the industry abuzz heading into this year’s J.P. Morgan Healthcare Conference. But some aren’t sure if the rebound is here to stay.

Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion.

CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) after receiving and investigating complaints of device components ejecting or detaching during

AirLife is removing Broselow Rainbow Tapes due to incorrectly printed medication dosing information.

Draeger is removing certain Vapor 2000 and Vapor 3000 Vaporizers due to impurities found within a component.

Medline is removing certain anesthesia circuit kits due to cracks and leaks in the tubing.

Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.

The “Great Healthcare Plan” is vague, but would send money directly to ACA enrollees and entrench the pricing deals the administration has cut with more than a dozen drugmakers.

Just as FDA reviews drugs for humans for safety and effectiveness before they can go on the market, the agency does the same for treatments for animals. Learn how FDA brings new oncology treatments to market and questions to ask your vet about your dog’s cancer diagnosis.