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…

With incoming president Donald Trump threatening a trade war with China, experts told BioSpace that the new administration will likely understand why medicines should be treated differently.

In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies.

After a series of strongly worded letters—one of which was addressed directly to Commissioner Robert Califf—the FDA has publicly laid out its reasoning for rejecting Vanda Pharmaceuticals’ gastroparesis drug candidate tradipitant.

In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before.…

AbbVie and Gilead are going back to their roots and leaning on their established areas of expertise to set themselves up for sustainable success in 2025.

Omvoh’s label expansion is important progress for Eli Lilly as it works to diversify its portfolio beyond obesity, according to analysts from BMO Capital Markets.

Annemarie Hanekamp has overseen some of the most transformative changes in oncology over her years in Big Pharma. Now, she will oversee BioNTech’s transition from a COVID-19 vaccine maker to an “end-to-end organizational oncology powerhouse.”

Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes.

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

The FDA issued an update on the recommendations about the potential for exposure to airborne chemicals from neonatal incubators.

While Biogen has made an opportunistic bid for partner Sage, its top executive seemed to play down the urgency for his company to go after larger deals.

While investors and analysts push for a deal, Biogen CEO Chris Viehbacher and Head of Development Priya Singhal refuse to make one out of desperation.

Amidst a “renaissance” of interest in neuropsychiatry, Seaport’s executive team is taking nothing for granted.

Taken together with Keros’ recent pivot away from obesity, the termination of its pulmonary arterial hypertension study could lead to a “difficult path ahead” for Keros, according to Guggenheim analysts.

A report published Tuesday shows hundreds and thousands of percent markups on HIV, hypertension and cancer drugs for Medicare and commercial claims alike.

BioSpace recaps 2024’s top venture capital rounds in biopharma, from Xaira Therapeutics’ blockbuster $1B raise to back-to-back series from obesity-focused Metsera that totaled more than $500M in a space that has garnered more than a fivefold increase in VC dollars this year.

HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.

Executives at Amgen made the case for MariTide's differentiation, while Merck's CEO contended that Keytruda's coming loss of exclusivity can be managed.

The updated guidance, which was largely driven by lower-than-anticipated sales of GLP-1 blockbusters Mounjaro and Zepbound, sent Eli Lilly’s shares cratering by as much as 8% Tuesday, even as the company forecasted robust 2025 revenue.

Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines.

J.P. Morgan kicked off with a flurry of deals, with Eli Lilly, GSK and Gilead all announcing deals potentially worth more than $1 billion while J&J committed $14.6 billion to buy Intra-Cellular. These moves have reinvigorated sentiment across the biopharma industry.

In exchange for its investigational gene therapies, Regenxbio will receive $110 million upfront and up to $700 million in milestones. After hitting an all-time low of $6.95 at close of business yesterday, the stock surged on the news by nearly 20% before markets opened Tuesday.

EMA has published the revised version of its policies on the handling of competing interests of scientific committee members and experts (‘Policy 0044’) and of the EMA Management…

The positive trial results could help Regeneron cushion the blow of its disappointing fourth-quarter sales for Eylea, which exceeded the consensus by a modest 1% and are bogged down by the slow conversion of patients to the high-dose formulation.

The multi-billion deal, in which Eli Lilly will acquire Scorpion Therapeutics’ STX-478 program, is a shot in the arm for PI3K treatments, which have had a mixed history over the past few years.

Passage Bio’s workforce reduction could affect about 32 people, leaving the company with 26 employees as it continues evaluating a treatment for frontotemporal dementia with granulin mutations.

Morning coffee drinkers may live longer than those who drink coffee throughout the day or not at all, according to a recent study published in the European Heart Journal.

On the heels of an FDA approval for its monoclonal antibody Bizengri, Merus will generate three novel cancer-targeting antibodies that it will pass over to Biohaven to link into antibody drug-conjugates.