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…

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.

On November 15, 2024, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.

Trace Neuroscience, which launched this week with $101 million, benefited from last year’s approval of Qalsody. Its CEO spoke with BioPharma Dive about how the company came together.

“Many companies just iterate indefinitely without ever making progress toward an actual drug,” said one biotech VC on a panel hosted by BioPharma Dive. 

Bluebird has just two quarters until it’s out of cash. Executives are looking for financing to extend that runway to a projected breakeven point before the end of 2025, with analysts worried they won’t make it.

Eyenovia’s stock craters to its lowest point in its six-year lifespan as a public company following the biotech’s termination of its lead program in pediatric progressive myopia due to lack of efficacy.

Training and Education for healthcare professionals, academia, and consumers from FDA’s Center for Drug Evaluation and Research

Big Pharma had plenty of drama to keep journalists busy this quarter, which painted an accurate portrait of the wild and wonderful world of biopharma.

Trump’s HHS pick, Robert F. Kennedy Jr., is an anti-vaccine campaigner who has previously said that he plans to gut the FDA on allegations of corruption and reduce the NIH’s headcount.

BMS has so far been on a winning streak in the contingent value right cases, which allege that the pharma intentionally delayed regulatory activities for Breyanzi in order to avoid a $6.4 billion payout to Celgene shareholders.

The FDA is alerting health care providers to the recall of certain VasoView HemoPro devices due to risk of silicone detachment during use, and supply concerns.

HemoPro EVH Systems are being recalled due to a risk for silicone to detach from the device and enter the patient during minimally invasive surgery.

If confirmed to the role, Robert F. Kennedy Jr. would oversee the country's top health agencies, including the Food and Drug Administration and the Centers for Disease Control and Prevention. 

The November layoffs are the second known workforce reduction this year for Marinus Pharmaceuticals, which previously announced disappointing Phase III results for ganaxolone in two clinical trials.

Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies

Allogene is ceasing enrollment in a Phase I trial of cema-cel for patients with relapsed or refractory chronic lymphocytic leukemia after Bristol Myers Squibb’s Breyanzi was approved in the indication earlier this year.

The interim phase 2 trial results show a good immune response in participants and the therapy is well tolerated to date.

The Series D financing will support the clinical development of two ADCs.

An analyst note raising questions about Amgen’s MariTide triggered a stock sell-off Tuesday. Elsewhere, Roche and Novartis struck drug discovery deals.

Following patient deaths in a lupus trial that led to the termination of that program, Kezar’s autoimmune candidate zetomipzomib faces a partial clinical hold barring four trial participants from continuing treatment in the open-label portion of the trial, though the trial itself will continue as planned.

Despite crowding in the next-gen weight loss space, Metsera has raised over $500 million since its April launch, indicating a continued appetite for these drugs.

Suggestions that the U.S. should emulate other countries on drug price controls or patents obscure how our present policies have allowed drug development to flourish.

Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics

Under deal terms, GSK will give Vesalius Therapeutics $80 million in upfront and equity payments to identify treatments for Parkinson’s and another neurodegenerative condition.

The U.K. drugmaker also announced plans to drop another $2 billion on expanding its R&D and manufacturing footprint in the “important” U.S. market.

Emraclidine was expected to be a competitor to Bristol Myers Squibbâs recently approved Cobenfy, but trial results put its future in doubt.

The FDA had put a clinical hold on Novavaxâs COVID-19-influenza combo vaccine after an adverse event in a patient.

BioSpace has named 50 biopharma companies to its 2025 Best Places to Work list, including Moderna and Sutro Biopharma, whose executives share what makes their organizations special.

Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.

The shocking failure of AbbVie’s emraclidine has investors questioning the Big Pharma’s long-term neuroscience strategy, which put the drug at the center of expectations.