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…

Procedure for the preparation of European Union herbal monographs and European Union list entries and appointment of HMPC rapporteurs and peer-reviewers

Biogen’s proposed acquisition comes after two difficult years of regulatory and clinical challenges, during which shares of Sage Therapeutics have fallen by more than 90%.

Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.

Benefiting from technological and conceptual groundwork and positive early data, gene therapies are advancing in the clinic for cardiovascular diseases including congestive heart failure, chronic refractory angina and cardiomyopathy.

Philips Monitoring Service Application processes mobile cardiac telemetry data but failed to send critical data for review by healthcare professionals.

Clean Label Project tested 160 products from 70 leading brands and reported that 47% of these protein powders exceeded California Proposition 65 safety thresholds for toxic metals, with organic products showing even higher contamination levels.

Sasanlimab, a subcutaneous immunotherapy developed by Pfizer, could help treat bladder cancer. Elsewhere, Royalty Pharma moved to simplify its corporate structure and Biogen made another hire.

In this short teaser, BioSpace’s Head of Insights Lori Ellis talks to CBER Director Peter Marks and Tom Whitehead, Co-Founder of the Emily Whitehead Foundation about anticipated discussions at the upcoming GenScript Biotech Forum.

Staff cuts could leave IGM Biosciences with fewer than 55 employees. The company is also halting development of two bispecific antibody T cell engagers for autoimmune diseases.

After the successful development of mavacamten and the sale of MyoKardia to BMS in 2020, former executives of the biotech are back together with a mission to make cardiovascular disease curable and preventable.

The director of the FDA's main drug review office will exit on Jan. 18, according to an email sent to staff. Her departure is one of several announced by high-ranking FDA leaders ahead of the coming administration change. 

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2024

The Biotech Ecosystem Venture Fund will combine the sourcing capabilities of venture capital firm Andreessen Horowitz (a16z) with Eli Lilly’s expertise in R&D—plus half a billion in capital from the Big Pharma.

Research has shown remnant cholesterol is a significant factor in cardiovascular disease risk.

The CRISPR company will reduce its workforce by 27% over the course of the year as it discontinues a treatment for alpha-1 antitrypsin deficiency.

If approved, Pfizer’s sasanlimab will distinguish itself from Merck’s blockbuster Keytruda as the first PD-1 inhibitor indicated in combination with BCG for high-risk non-muscle invasive bladder cancer patients who had not previously undergone BCG treatment.

Concurrently, a preprint from the industry-backed Vital Transformation found a 50% drop in company investments into small-molecule drug development.

Eli Lilly’s idiopathic pulmonary fibrosis deal with Mediar is centered around MTX-463, an anti-WISP1 antibody that early studies have found to be safe and capable of engaging its target.

EMA is ready to support the implementation of the new regulation on health technology assessment (HTAR) (Regulation (EU) 2021/2282) when it becomes applicable on 12 January 2025.…, “EMA welcomes the new HTA regulation and is ready to do what it takes to support the European Commission and the Member States in its successful implementation.
While our…, The regulation also creates an EU framework for the assessment of selected high-risk medical devices to help national authorities to make more timely and informed decisions on the…

On Thursday, Boehringer Ingelheim announced a partnership with Synaffix to advance antibody-drug conjugates and exercised its fourth license option under a 2013 collaboration with Oxford BioTherapeutics.

Ouro is planning to leverage T cell engagers to deplete B cells and “reset” the immune system to treat immune-mediated diseases.

Misses from amyotrophic lateral sclerosis hopefuls Denali Therapeutics and partners AbbVie and Calico Life Sciences mark the latest setbacks for the controversial platform trial, the results from which have largely mirrored the dismal success rate in the ALS space overall.

Initial rounds of VC financing totaled $7.7 billion over 137 deals for biopharma in 2024, compared to $3.8 billion over 156 deals in 2023.

MaaT Pharma is focused on developing microbiome-related therapies and its lead candidate is MaaT013, a treatment for acute graft-versus-host disease (aGvHD) with gastrointestinal involvement.

MaaT013 in 2022 was put under clinical hold by the FDA, which cited safety and efficacy concerns with the sample-pooling method used to produce the investigational therapy. The hold was lifted in April 2023.

The company’s lead asset is a potentially first-in-class oral GLP-1 receptor agonist that has the potential to be dosed weekly, which according to CEO Khurem Farooq can help improve accessibility and affordability.

Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.

Vanda called the attention of FDA Commissioner Robert Califf to what it termed the “sentiment that the agency avoids public scrutiny of its decisions.”

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group