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…

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for hot flashes.

The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have become more difficult after the negative advisory committee vote.

A University of Glasgow study found krill oil supplements preserve muscle mass and strength during weight loss. The trial showed krill oil users maintained muscle better than a placebo group, offering potential benefits for diverse weight management strategies.

The objective of this guideline is to provide recommendations for the appropriate inclusion and/or retention of pregnant and/or breastfeeding women in clinical trials and facilitate the generation of robust clinical data that allow for evidence-based decision making on the safe and effective use of

Xoted Biotechnology Labs’ $4.2 million investment in clean manufacturing will provide groundbreaking biotechnology practices and sustainable product development, including plant-based detoxification, seed research, and oil refinement, highlighting Dr. Rahm’s advanced background in sustainable manufacturing, patents, nanotechnology, nutrition, entrepreneurship and more.

Despite the failure, BMS remains “encouraged” by Reblozyl’s clinical activity in myelofibrosis-associated anemia and will approach regulators to discuss potential submissions for this indication, for which few treatment options exist.

The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.

The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute liver failure, the same complication responsible for the deaths of two boys taking Sarepta’s Duchenne muscular dystrophy treatment Elevidys.

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation from Axience for Hemosyvet(etamsylate) for…

Manual resuscitator recalled due to incorrect B/V filter assembly that could delay therapy. May cause hypoxia, hypercapnia, or death if used.

Overall venture funding, as well as “first financing” rounds, fell significantly in the second quarter, erasing what had been a fast start to 2025, according to HSBC.

In advance of CMS’ negotiated price for the blood thinner taking effect next year, partners Bristol Myers Squibb and Pfizer pitched the direct-to-consumer program as a way to allow uninsured, underinsured and self-pay patients to pay less out of pocket.

Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant pipeline shift and adding a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys.

Clinical Investigator

In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the evolving role of local qualified persons for pharmacovigilance with ⁠Ana Pedro Jesuíno⁠, global head local QPPV network at IQVIA.

In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO Vas Narasimhan told reporters that for most medicines, it typically takes three to four years to completely relocate production.

In the first six months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under 130 staff during the same period last year.

FDA reviewers flag “discordant results” in a briefing document published ahead of Friday’s advisory committee meeting for the partners’ application for the antipsychotic in post-traumatic stress disorder.

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

1 in 5 respondents either have had or do have a fractional role, according to a recent BioSpace poll, and over half are considering it. Two recruitment experts, a fractional worker and an aspiring fractional worker share their insights.

Participants in trials of BrainStorm Cell Therapeutics’ NurOwn filed a Citizens’ Petition with the FDA earlier this month seeking a new review of the stem cell therapy that was rejected in 2022 based on real-world data and 90% survival in an expanded access program.

Drive Devilbiss Healthcare is recalling iGo2 DV6X-619 DC car adapter due to complaints of the DC power cord being hot to the touch and/or melting while used.

Dexcom recalls certain receivers that may fail to sound alerts. Missed alerts could delay detection of severe blood sugar events, causing seizures or death.

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

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules that may have been serviced with previously recalled bezel kit assemblies.

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta Therapeutics adds a black box warning to the gene therapy for acute liver injury and failure and parts with more than a third of employees.

The company is also pausing research for several treatments it has been developing for another form of muscular dystrophy.

With venture funding tightening in the post-COVID landscape, efficiency has become more critical than ever. In this interactive webinar industry experts explored actionable strategies for maintaining quality under financial pressure. Watch now.

The antibody anselamimab, which AstraZeneca picked up in its 2021 purchase of Caelum Biosciences, failed to improve survival and reduce hospitalizations, but the company sees promise in data from an unspecified patient subgroup.

Supplementation with a direct butyrate generator from NutriScience Innovations could rapidly improve gastrointestinal health in women and those with upper and lower gastrointestinal (GI) symptoms, says a new study. The results “suggest potential applications for managing digestive discomfort and improving overall digestive quality of life.”