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…

Cancer-focused Eikon Therapeutics is seeking $273.5 million in its bid to trade on the Nasdaq, while hair growth specialist Veradermics is looking for $181.1 million in its foray onto the New York Stock Exchange.

AstraZeneca has risen as one of pharma’s most prolific investors in China, including a $630 million pledge last week for full rights to AbelZeta’s cell therapy for cancer.

Sanofi’s vaccine sales dipped 2.5% in 2025, with almost all immunization products declining. Nevertheless, CEO Paul Hudson doubled down on his support for vaccine development.

Roche aims to become a “top three player” in obesity, Teresa Graham, CEO of the group’s Pharma unit, said Thursday during a presentation of the company’s full-year 2025 earnings.

The Repertoire partnership is Lilly’s second immunology play of the year, after the acquistion of Ventyx in early January for a pipeline of NLRP3 assets.

In this episode of Denatured, Jennifer C. Smith-Parker speaks with RTW’s Rod Wong and Stephanie Sirota how shifting JPM deal timing masks record M&A potential; why oncology, obesity, psychedelics, and neuroscience are attracting fresh capital; and how “alpha stacking” shapes their investment edge in an age of chronic uncertainty. They cover topics discussed in RTW’s new book, “Innovation is the Best Medicine.”

Looking for an IT job? From data engineer to information security, check out the BioSpace list of 10 companies hiring life sciences professionals like you.

More biopharma organizations were actively recruiting at the end of 2025 than 2024, based on the new BioSpace employment outlook report. Areas in demand this year include research and development and clinical. Organizations are also prioritizing artificial intelligence hires.

FDA has identified condition-specific medication health fraud scams that can pose significant risks to consumers.

The potentially $1 billion alliance centered around a flexible gene editing technology adds to a portfolio of cutting-edge treatments the company is developing for hearing disorders.

The discovery of a tumor in a patient who received REGENXBIO’s gene therapy for Hurler syndrome prompted the FDA to place a hold on that program along with the company’s Hunter syndrome program, which is awaiting an FDA decision on or before Feb. 8.

Cellares, which last year became the first company to receive the FDA’s new advanced manufacturing technology designation, expects to support clinical production this year and offer commercial-scale manufacturing services in 2027.

Darzalex Faspro, in combination with an anti-cancer triplet, is the first anti-CD38-based regimen for newly diagnosed patients with multiple myeloma, regardless of eligibility for stem cell transplantation.

Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.

If workloads aren’t adjusted as needed, the company’s priorities are already compromised. Executive coach Angela Justice explores what happens when goals move forward without removing unnecessary work and what to do about it.

BioSpace’s 2026 U.S. Life Sciences Employment Outlook examines the state of the biopharma workforce amid ongoing funding pressure, elevated layoffs and cautious hiring sentiment, while highlighting early signals of stabilization and cautious optimism for the year ahead.

Information Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international partners.

Intellia is instituting new safeguards following the death of a study participant that led regulators to pause two trials in people with transthyretin amyloidosis. One of those tests remains suspended.

A drug Roche acquired in a multibillion-dollar deal could be as effective as Zepbound, but may struggle to stand out in a crowded field, analysts said.

After a patient safety signal and then death, the FDA in October 2025 placed holds on two of the company’s CRISPR programs for hereditary transthyretin amyloidosis.

Roche said the Phase II results help build the case for advancing CT-388 into late-stage testing, which is set to get underway this quarter.

True inspection readiness is about the integrity of a company’s entire system.

Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.

Monthly and quarterly metrics of the FDA Generic Drugs Program.

Investors are apparently taking bets on when Revolution will be acquired. A handful of pharmas could be interested as Merck backs off.

After a spate of patient deaths in 2025 linked to the company’s Duchenne gene therapy, Sarepta shared new data showing benefits of the therapy three years after dosing.

Corcept’s overall survival data “look competitive” with AbbVie’s Elahere and Merck’s blockbuster Keytruda, Truist Securities said Thursday.

Merck had previously offered anywhere from $28 billion to $32 billion to swallow Revolution Medicines.

The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs and biologic products for human use and as required.

Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.