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 goal of this webinar is to provide general audiences information on the development and use of Office of New Drugs (OND) Custom Medical Queries (OCMQs) during premarket safety evaluation. OCMQs are standardized groupings of adverse event terms designed to help identify potential safety issues during review of clinical trial adverse event data a

As Sangamo runs out of cash, Eli Lilly and Astellas have emerged as stalking horse bidders for key assets, including a Fabry gene therapy currently being submitted for potential FDA approval.

Given its intravenous route of administration, Merck’s tulisokibart will likely “need to be meaningfully improved” over Roche’s afimkibart, which can be given subcutaneously, BMO Capital Markets analysts said. Both assets are being tested for ulcerative colitis.

Eli Lilly’s weight-loss franchise—including the tirzepatide products Mounjaro and Zepbound, and the weight-loss pill Foundayo—is projected to account for nearly half of the total sales of the top 10 drugs in 2032.

While existing antibody-drug conjugates have been incredible advancements in cancer care, patients are ready for a better experience. At the BIO International Convention in San Diego on Thursday, BioSpace will lead a discussion on the next generation of ADCs.

China’s Haisco Pharmaceutical continues to wield deals, this time out-licensing rights to two late-stage programs to New Jersey biotech Nuvectis.

Among the health department’s efforts is an expedited investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months.

Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials.

If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.

The air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, affecting the delivered oxygen concentration

A software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.

Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.

The U.S. government has argued that it pays too much of biopharma R&D costs, demanding that other high-income countries contribute fairly to global innovation efforts.

The FDA in February briefly refused to review Moderna’s flu vaccine, citing trial inadequacies, but reversed course a few days later. A verdict is expected by Aug. 5.

Memento’s lead asset is a bispecific antibody that blocks VEGF and activates Tie2. The biotech plans to test the candidate in retinal conditions such as neovascular age-related macular degeneration and diabetic macular edema.

While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.

Information on patents and suitability petitions that impact the availability of generic drugs.

These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion’s untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.

UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?

Backed by institutional investors and seasoned industry leaders, cAMPfield Therapeutics is advancing a clinical program aimed at reshaping the landscape for inflammatory bowel disease.

In this episode of Denatured, you’ll hear from Mark Lowdell, CSO & co-founder at INmuneBio Inc. and Vishwas Seshadri, CEO & director at Abeona Therapeutics. We explore how recessive dystrophic epidermolysis bullosa has become a defining case study for gene and cell therapy and what this ultra‑rare disease reveals about the future scalability of advanced therapies.

The takeovers depend on Moderna reaching an agreement with the German government, which risks losing investment from drugmakers over planned healthcare reforms.

Following the mid-stage readout, Verastem Oncology has decided to move away from its investigational pancreatic cancer drug combo, instead putting resources behind its KRAS inhibitor pill for solid tumors.

RayThera will bring three preclinical assets into the Biogen fold, all with anti-inflammatory activity. The most mature of these assets is expected to enter Phase 1 development in Q3.

After being rejected in June 2022, GSK paid Spero Therapeutics $66 million for an exclusive worldwide license to develop and commercialize the drug. It’s the second oral antibiotic GSK has brought to market since the beginning of last year.

Looking for a job in Boston? Here’s a list of 7 companies on BioSpace currently hiring biopharma roles in Boston–plus a few more hiring in Waltham and Weston.

Cost cutting is just one factor driving biopharmas to whittle away at their workforces. An analyst discusses more common reasons layoffs occur and which employees are most at risk.

Biopharmas that announced Series B financing this year and are looking for employees as they grow include two companies that received $100 million or more. One has partnerships with three Big Pharmas.

While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.