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…

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for pati

The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: gastrointestinal, lung, and head and neck cancers; neuro-oncology, rare cancers, pediatric

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While it’s impossible to make apples-to-apples comparisons of the many obesity candidates with so many differences across clinical trials, we at BioSpace are giving it our best shot.

The effects of creatine consumption on energy metabolism are well established, but could it affect appetite as well? Researchers from the Applied Bioenergetics Lab at the University of Novi Sad in Serbia drew on data from a nationally representative U.S. population to investigate the potential relationship between higher dietary creatine and lower levels of leptin, a hormone involved in appetite regulation.

By now, many have heard of the gut-brain axis, the gut-skin axis and more. But what about the gut-hormone axis? This refers to the bidirectional communication system between the gut and the endocrine system. For women specifically, this is the estrobolome. Kaneka Probiotics recently launched KABP Menopause, a probiotic that modulates the estrobolome. To hear more on how that works, Jordi Riera, Chief Business Officer at Kaneka Probiotics, joined the NutraCast.

Analysts found the agency's decision to cancel the meeting encouraging. Elsewhere, the Novo Holdings-owned CDMO cut about 350 staff in Maryland.

With results from highly anticipated trials of Eli Lilly’s orforglipron and Viking Therapeutics’ VK2735 “underwhelming” investors, William Blair’s Andy Hsieh predicts weight loss pills will play a bigger role in low- and middle-income countries than in the U.S.

Probiotic supplementation with bifidobacterium bifidum and lactobacillus acidophilus in very low birth weight (VLBW) infants was shown to reduce antibiotic resistance genes (ARGs), suppress multidrug-resistant pathogens, and restore early-life gut microbiota. Using shotgun metagenomics, researchers found that probiotics supported colonisation resistance through specialised HMO metabolism, though horizontal gene transfer (HGT) of resistance genes still occurred.

Trade associations, including the Natural Products Association (NPA), have appealed to the IRS to revise Publication 502, advocating for dietary supplements to be classified as “medical expenses” under the IRC. This change would align with the Make America Healthy Again movement and allow Americans to use HSAs and FSAs for these expenses, promoting healthier lifestyles. Despite legislative attempts, such as the Dietary Supplements Access Act, no bill has yet passed. The NPA continues to engage with IRS policy teams and lawmakers to advance this initiative.

There’s still much more to come from the White House on tariffs, but the European Union has now reached a trade agreement with the U.S.

The drug, for hereditary angioedema, is Ionis’ second wholly owned asset.

Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting that FDA Commissioner Marty Makary revisit the decision.

Krystal Biotech’s decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal Biotech’s KB707. The biotech said this has introduced “heightened uncertainty” regarding a potential accelerated pathway for the candidate.

Among the problems cited were cat hair, bacterial contamination and instrument defects.

Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis due to risk of resistance during device withdrawal

Dawnzera is the third medicine cleared by U.S. regulators this year for the rare genetic condition, and the second wholly owned medicine Ionis has brought to market.

The deal gives Gilead ownership of a technology that can genetically modify immune cells inside the body, an approach could potentially widen access to CAR-T treatment.

A refinancing deal will delay the maturity of $700 million in debt until 2030, allowing the company to “fully fund” its pipeline and meet its near-term financial obligations, CEO Doug Ingram said. 

Washington has had notable life sciences job growth over the past 10 years, according to a Life Science Washington report. The association’s CEO and a biopharma CEO discuss what makes the state stand out, including its talent pool, AI leadership and entrepreneurship support.

Stealth BioTherapeutics originally submitted elamipretide for approval in January 2024, only to receive a rejection in May of this year. In addition to accepting the biotech’s resubmission, the FDA has promised to take action on the candidate by Sept. 26.

In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses clinical trial fail rates and AI’s potential to reduce preclinical costs with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.

President Donald Trump first threatened pharma tariffs in February and recently said they were imminent. Johnson & Johnson’s new investment adds to a $55 billion pledge made by the company in March.

The countries documented provisions of a deal that would set a 15% tariff on many EU imports, including cars, pharmaceuticals and semiconductors.

In an open letter, Health and Human Services employees asked the Secretary to stop and disavow the spread of health misinformation, particularly about vaccines, infectious diseases and federal health agencies.

The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.

Looking for a biopharma job in Massachusetts? Check out the BioSpace list of nine companies hiring life sciences professionals like you.

A deal to acquire Alkermes spinout Mural Oncology is Xoma’s fourth since June and the latest evidence of interest in buying and shutting down struggling drugmakers.

In late May, a patient died after receiving Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, spurring the hold. After lowering the dose and changing the regimen of immune modulators patients receive, the company has received FDA clearance for the trial to continue.

Anne White, a 30-year company veteran who previously led the company’s oncology unit, will step down as head of Lilly Neuroscience at the end of December.