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 funding, which follows the $176 million the government awarded Moderna in June 2024, aims to get mRNA vaccines ready before bird flu strains currently circulating in the wild and on farms can potentially cause human outbreaks.

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 we expect to see ahead.

Phase 2 trial for JNJ-1900

The potential for biosimilars in the UK

Ones to watch: AI and data

Biologics manufacturing

Jennifer Bradford

As the year gets underway, analysts and biotech executives highlight cell therapy’s pivot from oncology to autoimmune diseases, a continued appetite for next-generation obesity drugs and an increased focus on neuromuscular, kidney and cardiovascular diseases.

Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs.

The recent “Failures, F*ups and the Future of Personalized” webinar addressed the evolving business model of personalized nutrition, focusing on the challenges companies face in targeting middle-market consumers.

Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns.

Novo sells semaglutide as Ozempic and Rybelsus for diabetes and as Wegovy for obesity. In price talks, CMS will treat the different forms as a single product.

A high-dose form of Novo’s obesity drug led to 20% weight loss over 72 weeks. Meanwhile, Atara got a complete response letter and Boehringer reported a Phase 3 failure.

The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year.

The data suggest the high dose nearly closes the efficacy gap with Zepbound.

Biopharma executives make their predictions for the year ahead, from a bold forecast for the return of the megadeal to a plea for the slow, healthy recovery of the industry at large.

Drugmakers will have until the end of February to decide whether they want to participate in the second round of Medicare negotiations or not. CMS has until June 1 to send an initial offer for the adjusted prices.

EMA has recommended the approval of the vaccines Bluevac-3 and Syvazul BTV 3 to protect sheep against bluetongue disease. Bluevac-3 is also approved for use in cattle. The disease…

The Phase III CodeBreaK 300 study returned disappointing overall survival data for Lumakras plus Vectibix in metastatic colorectal cancer, but in its approval announcement, the FDA pointed to significant improvements in progression-free survival, calling it the “major efficacy outcome” of the trial.

Announcement of the 15 medicines chosen for the second round of negotiations is one of the Biden administration’s final health policy acts.

Novartis is locked in a legal back-and-forth with MSN Pharma over alleged patent infringement of its heart failure drug Entresto.

Boehringer Ingelheim’s trio of late-stage schizophrenia failures on Thursday came a day after the Department of Health and Human Services hit back on the pharma’s legal challenge to the IRA’s drug price negotiation program.

As I ran from interview to interview across San Francisco, I was consistently warmed by the stories I was told by biotech and pharma executives—and the general comradery in the air throughout the chaotic event.

Atara Therapeutics’ Ebvallo, already marketed in Europe for a transplant-related blood cancer, will not hit the U.S. market just yet, forcing the company to “significantly reduce expenses.”

Pharma dealmaking for drugs invented in China is putting pressure on U.S. biotechs to compete harder, according to investors and executives interviewed by BioPharma Dive at the J.P. Morgan Healthcare Conference.

With incoming president Donald Trump threatening a trade war with China, experts told BioSpace that the new administration will likely understand why medicines should be treated differently.

In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies.