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…

Of the 25 companies receiving tax incentives in Massachusetts, 23 will add jobs outside of Boston and Cambridge. Medtronic, which is receiving the largest award, will create 220 roles in Billerica. Other recipients include AbbVie, Dyne Therapeutics and Viridian Therapeutics.

In three draft guidance documents, the FDA has laid out pointers to help companies craft better drug development programs and drug applications.

The discontinued CAR T therapy bbT369 came to Regeneron when the pharma bought all of 2seventy bio’s pipeline assets for $5 million upfront in January 2024.

Sales of Sanofi’s COVID-19 and flu vaccines fell 17% in the third quarter amid declining vaccination rates and pricing pressures in Europe.

The antibody-drug conjugate, withdrawn from the market by GSK in 2022 after failing a confirmatory study, was approved Thursday by the FDA for previously treated patients with multiple myeloma. This is despite a negative advisory committee vote in July.

EMA’s Executive Director, Emer Cooke, has handed over the role of chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) to Anthony Lawler from the…, “ICMRA has proven its value both as a platform for sharing information and best practices and as a venue for providing strategic leadership, active exchange of…, At the ICMRA Summit 2025, international medicines authorities addressed the regulators’ role as communicators of reliable, evidence-based, scientific information and the…

The new approval completes a surprise turnaround for Blenrep, which was initially cleared in 2020 but pulled from the market only two years later.

Viking Therapeutics CEO Brian Lian is watching the growth of interest in MASH and obesity but prepared to go it alone.

Roche has already signed several high-ticket deals this year, including the $3.5 billion acquisition of 89bio and Genentech’s $2.1 billion molecular glue pact with Orionis Biosciences.

In this episode presented by Element Materials Technology, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney discuss how small biotechs face mounting pressure amid manufacturing uncertainties.

Fosfomycin Injection

Despite showing no meaningful benefit on lung function, Arcturus’ mRNA therapy ARCT-032 reduced mucus volume in patients with cystic fibrosis—an outcome William Blair found “potentially promising.”

With Avadel under its fold, Alkermes expects to accelerate its expansion into the sleep market, laying the foundation for its late-stage narcolepsy asset alixorexton.

A key question for investors going forward will be whether Moderna’s other latent virus vaccines for Epstein-Barr and shingles can succeed after the failure of the CMV program.

Biopharma professionals have become increasingly likely to be dishonest when interviewing for jobs, based on BioSpace interviews with three talent acquisition experts. The experts discuss the reasons why as well as the types of fraud happening, including people posing as applicants.

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

A shot analysts projected as a multibillion-dollar seller produced results “well below” the company’s expectations, heightening pressure on Moderna’s flagging respiratory vaccine business.

Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program is intended to increase awareness for FDA guidance documents to support the efficient application of the documents’ recommendations.

Analysts called the proposed purchase of Avadel Pharmaceuticals a “clear” strategic fit for Alkermes, handing it an already marketed product for excessive daytime sleepiness.

The deal focuses on ICT01, a monoclonal antibody being tested in acute myeloid leukemia. ImCheck is also developing assets in infectious disease and other oncology indications.

While the threat of tariffs dies down for the pharma industry, President Donald Trump is reportedly weighing a new investigation that could result in import taxes against U.S. trading partners that don’t pay enough for drugs.

Seven in 10 U.S. hiring managers say their company usually considers employing overqualified applicants, according to a survey from Express Employment Professionals and The Harris Poll. However, 75% of employers believe such hires struggle to stay motivated in lower-level roles.

The company cut back in areas while investing in internal and external opportunities to offset the loss of exclusivity on a product that until recently accounted for 20% of innovative medicine sales.

Seven Novo Nordisk board members have resigned. The new board headed by former Novo Nordisk CEO Lars Rebien Sørensen will align behind the new CEO’s massive restructuring plan.

The company is dropping its social anxiety disorder program but will still test the molecule in post-traumatic stress disorder.

The biotechs will assess a combination of two drugs against HER2-positive breast cancer. Elsewhere, Merck unveiled the latest piece of its more than $70 billion domestic manufacturing investment.

The company’s technology, a modified herpes simplex virus used to deliver gene therapies, was given the FDA’s new designation based on its approved topical skin cream. What this will mean for Krystal’s still-in-development eye drop is unclear.

EMA has launched its first social media campaign working with content creators. The #HealthNotHype campaign aims to raise awareness about the safe and responsible use of GLP-1…, “#HealthNotHype is about passing the message that GLP-1 receptor agonists are not magic solutions for weight loss. Like all medicines, they have benefits and risks and…, Partnering with content creatorsThe Agency carefully selected content creators from seven different Member States of the European Union (EU) to ensure a balanced geographical…, CountryChannelFollowers (on 16 October 2025)Finlandjennipuolivali39,000Germanymedicinexcare242,000Italyinfermieregianluca175,000Latviauzlabo32,800…

To tailor cancer therapies to individual patients, Moderna, BioNTech and other companies are rethinking how they optimize manufacturing schedules and resources.