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…

DHA-rich omega-3 supplementation and resistance training (RT) improved muscle strength, reduced inflammation markers like TNF-α, and enhanced cholesterol profiles in overweight postmenopausal women in new research. The 16-week study highlights that omega-3s and RT may support muscle and cardiometabolic health by modulating myokines and reducing cardiovascular risk.

Higher competition for fewer roles remains the status quo for biopharma professionals, based on BioSpace data. Additionally, the U.S. Bureau of Labor Statistics has reported that recent job growth is lower than previously believed.

Strand Therapeutics’ lead asset is STX-001, an intra-tumor self-replicating mRNA therapy that carries a payload expressing the immunomodulatory protein IL-12.

Eli Lilly’s orforglipron cut body weight to a lesser extent than rival Novo Nordisk’s semaglutide, falling into analysts’ bear scenario for the oral med. Executives brushed off the concerns and said the drug will still have a wide advantage on the market.

Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook.

In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses the emerging geopolitical battle for AI supremacy and global AI governance with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Removes Recommended Pause in Use and Approves Required Updated Labeling: FDA Safety Communication

The small molecule drug, acquired by Jazz Pharmaceuticals in its $935 million Chimerix pick-up this spring, is intended for relapsed adult and pediatric patients with H3 K27M mutations.

Post-operative knee replacement infections present a significant clinical challenge with limited noninvasive treatment options. A medical device is being developed that offers a novel therapeutic approach utilizing electromagnetic heating to target infections localized around metal implants. This device, designed using multiphysics simulation, is engineered to place more heat on the infected region and less heat on healthy tissue, thereby eliminating the infection with minimal necrosis of surrounding healthy tissue.

Engineers can use multiphysics software to simulate the complex thermal responses in medical devices. The in silico data generated from these simulations is critical for the FDA approval process, significantly reducing the need for data collection from in vitro and in vivo studies.

In this presentation, Kyle Koppenhoefer and Joshua Thomas of AltaSim Technologies will discuss how multiphysics simulation can be used to predict tissue heating in medical devices and address critical challenges in this area of research.

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One vaccine expert called the move, which cancels some $500 million in messenger RNA research contracts, a “giant step backward for science.” 

A study published in Advances in Therapy highlighted the superior bioavailability of OmniActive’s Zenroot, a low-dose ashwagandha ingredient standardized to 1.5% total withanolides. The study demonstrated that a 125 mg dose of Zenroot resulted in significantly higher plasma concentrations of total withanolides compared to two established commercial products at doses of 500 mg and 600 mg. The findings suggest that Zenroot’s formulation, which includes unique preparation methods and excipients, offers enhanced absorption and efficacy. With the growing demand for ashwagandha in health and wellness markets, Zenroot’s high bioavailability and low dosage make it suitable for versatile product formulations.

The German giant has already trimmed more than 10,000 employees since initiating a massive restructuring initiative in July 2023. Bayer said even more cuts are coming as it weathers up-and-down sales across its portfolio.

Terns, once a rising star in obesity and the MASH space, will refocus on cancer and partner out a handful of obesity assets.

Maziar Mike Doustdar, who was named as Novo Nordisk’s new CEO last week, spoke on a second quarter earnings call of reallocating resources to the company’s “main core” of metabolic disease.

President Donald Trump plans to start with a “small tariff” on pharmaceutical imports before ramping duties up to 250% within a year and a half.

BioNTech also laid off 63 employees in June in conjunction with the discontinuation of its cell therapy manufacturing operations in Gaithersburg, Maryland.

The Department of Health and Human Services is terminating around $500 million in BARDA contracts associated with mRNA vaccine development, a move that will affect several pharma companies, including Moderna, Pfizer, Sanofi and AstraZeneca.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Recall affects certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters

Boston Scientific has issued a letter to affected customers recommending all lots of certain WATCHMAN Access Systems have updated use instructions

“The biotech industry needs to be supported by the government, by Congress,” Pfizer’s Albert Bourla told investors Tuesday in comments on China’s rising competitiveness.

Pfizer's Albert Bourla told investors that major drugmakers are "ready to roll up their sleeves" and build out more direct-to-consumer options.

The public meeting will be held on Wednesday August 27, 2025 and Thursday August 28, 2025, from 10 a.m. to 1 p.m. The meeting agenda, biographies, additional materials, and any other updates will also be posted to this website as they become available.

Albert Bourla confirmed that he called President Donald Trump after receiving a letter asking Pfizer and a clutch of other pharmaceutical companies to lower drug prices or face consequences.

BMN 390 fell short of an immunogenicity threshold that BioMarin was looking for to support its further development. Employees working on the program have been redeployed within the company.

The number of biopharma professionals let go has increased year over year for three straight months. In July, nearly 8,000 people lost their jobs, due largely to Merck cutting roughly 6,000 employees. Sarepta Therapeutics and Moderna also announced significant workforce reductions.

A pilot RCT suggests that combining BCAA supplementation with exercise may significantly improve physical performance, reduce fatigue and alleviate depressive symptoms in older adults with functional decline. Published in Dietetics, the study highlights clinically meaningful gains and calls for larger trials to confirm efficacy.

Vertex reported healthy revenue in its second quarter earnings report, though news of VX-993’s mid-stage trial results and lack of alignment with the FDA regarding an expanded label for Journavx tempered analyst reactions, sending the stock down 13%.

From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to make CGTs commercially viable. But it is possible, experts agreed at a recent panel.

The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry.