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…

After two years characterized by layoffs, pipeline reorganizations, FDA delays and clinical holds, Novavax CEO John Jacobs says the company is at a pivot point.

Sage’s board of directors said Biogen’s offer “undervalues” the company, but will explore other strategic alternatives to “maximize” shareholder value.

The GLP-1 IPO arena has been heating up for the past two years and Metsera’s ask is one the largest in recent history.

After missing the primary endpoint in the Phase IIb SYMMETRY trial, Akero Therapeutics’ lead molecule, efruxifermin, showed greater improvements after 96 weeks of treatment in an advanced disease population.

Following disappointing clinical trial results for AK006, Allakos will cut its workforce down to under 20 employees as it explores strategic alternatives.

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database – Chapter 5: Technical specifications

Patients taking Novo Nordisk’s Wegovy plus Veru’s enobosarm saw 71% lower lean mass loss than those who were taking Wegovy alone but investors await more data.

The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.

EMA is celebrating 30 years of operations marking its evolving role at the centre of the European Union (EU) assessing and authorising safe, high-quality medicines for 450 million…, This is a European story to be proud of and to celebrate. We know there are challenges ahead of us, but our future is incredibly bright. I believe that with open communication…, EMA was set up in 1995 to manage the centralised procedure for the authorisation of medicines and to harmonise the work of existing national medicine regulatory bodies. Originally…, The original ambition was to centralise the evaluation of innovative medicines, so that, in the words of the French presidency at the time, ‘all patients in the EU could benefit…, A video with an overview of key milestones and achievements in the authorisation and safety monitoring of medicines for human and animal use in the EU is published today.,

Brenner, who has worked in the FDA’s Center for Devices and Radiological Health, will lead the agency until a permanent commissioner is confirmed.

An experimental drug called amycretin showed signs it could be more potent than Eli Lilly’s rival Zepbound, though analysts cautioned certain aspects of the study may have inflated its performance. 

The Trump administration is bringing new instability to a sector already grappling with a shaky market as well as threats like competition from China.

Less than a day into his second term, President Donald Trump ordered a freeze on communications at major public health agencies, among other moves that have sent waves through the biopharma industry.

The unsuccessful Phase III results are the latest to suggest that the blockbuster cancer drug is finally bumping up against its limits after racking up around 50 approvals since getting its first FDA nod in September 2014.

The readout comes on the heels of CagriSema’s disappointing Phase III performance, where it missed Novo’s projection of 25% weight reduction.

The San Diego–based company’s molecules avoid the well-trod GLP-1 pathway in favor of an alternate route in the gut.

The settlement is the largest deal to date with the people primarily who played an “instrumental role” in driving the opioid crisis, according to the office of Massachusetts Attorney General Andrea Joy Campbell.

Robert F. Kennedy, Jr.’s recent disclosures have revealed several potential conflicts of interest, including investments in two biopharma companies.

Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pha

The China-based cancer drug developer’s offering will fund testing of medicines for several blood malignancies — one of which is part of an alliance with Takeda.

Vigil Neuroscience reported a strong safety profile and 50% sTREM2 reduction in an early-stage trial for VG-3927, potentially representing a new avenue for treating Alzheimer’s disease.

Protein degradation–focused Neomorph nabs its third Big Pharma deal of around $1.5 billion in less than a year.

In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of its Ionis-partnered therapy Spinraza for spinal muscular atrophy will be considered by the FDA and EMA.

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

M&As are stressful for multiple reasons, including role changes and getting laid off when staffs combine. Two talent experts share tips for navigating the transition period of your company’s merger or acquisition.

Turn your career aspirations into reality with this step-by-step guide to creating and implementing a strategic professional development plan for 2025.

The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since December 1996 and six patient deaths.

The deal follows a $1.06 billion U.S. contract in July 2024 and a $1.24 billion agreement with an Asia-based pharma a few months later.

The U.S. Court of Federal Claims ruled that Vanda cannot claim a breach of confidentiality for specifications that it did not develop itself.