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…

Lallemand’s open innovation challenge is courting start-ups and other companies to showcase microbiome-based solutions.

BML Capital Management, an activist investor that owns 9.9% of Elevation’s shares, is urging the company to wind down operations given “the current state of the public equity market.”

Alis Biosciences’ plan is a familiar tactic in the private equity world, but the firm will instead be listed on the public markets “in due course.”

Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and regulatory expert Steven Grossman.

Industry representatives will still be allowed at these meetings, but they will no longer have a spot on the advisory committee.

Like they say about the weather in Iceland, if you don’t like an action taken by the new administration, wait five minutes; it’ll probably change. The markets, it seems, don’t react kindly to that kind of policymaking.

Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag.

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product

Kingswood Capital Management and Performance Investment Partners announced that they have entered into a definitive agreement through which an affiliate will acquire The Vitamin Shoppe from Franchise Group.

The drug, orforglipron, helped people with diabetes reduce their blood sugar levels while spurring significant weight loss, swelling Lilly's market value by more than $100 billion.

With tariffs pushing manufacturing home to the U.S., Pitchbook warns of reduced M&A activity and venture capital funding.

The French pharma giant has made multiple trips to the artificial intelligence well over the past few years, this time with Delaware-based Earendial Labs.

This audience ranges from professional e-sports players, who build a career out of playing games online with a large following of devoted fans, to those who play games in the evenings or at weekends simply for fun.

Probiotic Lactobacillus plantarum may enhance sports performance by reducing oxidative stress and intestinal damage, as shown in a study involving physically active individuals. The research suggests that probiotics support gut health, antioxidant capacity and aerobic performance, while potentially aiding recovery and fat oxidation.

The Health and Human Services Secretary said that he will find and eliminate the cause of autism by September, an idea that suggests how little he knows about the condition.

Eli Lilly’s shares shot up 11% pre-market on Thursday after orforglipron became the first small-molecule GLP-1 drug to ace a late-stage study in type 2 diabetes, eliciting significant reductions in body weight and improvements in glucose control.

GeoVax was using its HHS contract to develop its next-generation multi-antigen COVID-19 vaccine, which is in Phase IIb development.

Despite these cuts, the FDA should be able to stay above a “trigger” level that would prevent it from collecting fees from the pharma industry and deprive it of approximately half of its annual funding, according to The Washington Post.

Kennedy is planning modifications to the Vaccines Adverse Event Reporting System to identify whether vaccines contribute to an unstated problem. The reporting system is at the heart of the departure of CBER head Peter Marks.

During the first quarter, 22 rounds of biopharma layoffs in California affected about 995 employees total, while 17 rounds in Massachusetts impacted around 410 people, based on BioSpace estimates. Meanwhile, competition for jobs in those states increased year over year, according to BioSpace data.

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

The company’s board reiterated its recommendation to instead pursue an offer from SK Capital and Carlyle that’s worth about $29 million upfront.

Section 508 of PL 112-144 (FDASIA) requires FDA to obtain recommendations and relevant information from interested parties on the required report to Congress submitted by the HHS Secretary every 5 years on the implementation of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (sections 505A and 505B of the FD&C Act).

A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations.

La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the co

In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER director spoke to analysts about potential implications for drug review timelines and agency morale.

Hillary Nitschke, Groupe Berkem’s business development manager, has played a key role in helping the company establish its presence in the U.S. market.

Tariffs are affecting virtually every industry in the United States, from clean energy to aerospace to fast fashion and dietary supplements. The topic dominated conversations at SupplySide Connect, with companies trying to figure out how to minimize risk based on very little information.

The list is updated quarterly. Changes are made to the DMF activity status, DMF type, holder name, and subject.

Despite making an unsolicited bid for gene therapy maker bluebird bio, Ayrmid failed to deliver a binding offer after weeks of due diligence. Bluebird’s board recommended that it go with Carlyle and SK Capital Partner’s original offer to take the company private for $30 million.