Biotechnology FDA slaps hold on Denali's plans for phase 1 rare disease trial The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune reactions to the investigational treatment recorded in preclinical mouse studies. Written by Admin December 5, 2025December 5, 2025 Saving Bookmark this article Bookmarked
Biotechnology Angelini Ventures and EIB launch joint start-up financing As part of the TechEU initiative, the EIB and Angelini will co-invest €150m in high-potential biotechnology, medical technology, and digital health start-ups. Announced today at a press conference at Angelini Ventures’ headquarters in Rome, the initiative forms part of TechEU, the EIB Group’s investment programme to strengthen Europe’s innovation ecosystem and technological leadership. Through TechEU, […] Written by Thomas Gabrielczyk December 1, 2025December 1, 2025 Saving Bookmark this article Bookmarked
Biotechnology Novartis cuts hundreds of jobs; Novo’s dual-acting diabetes drug heading to Phase 3 The layoffs affect Swiss manufacturing facilities. Elsewhere, the FDA pushed back an approval deadline and a mid-stage study showed Novo’s amycretin helps regulate blood sugar. Written by BioPharma Dive staff November 28, 2025November 28, 2025 Saving Bookmark this article Bookmarked
Biotechnology Six key obesity deals of 2025 that will shape 2026 and beyond Since the respective approvals of Novo Nordisk’s and Eli Lilly’s blockbuster drugs a few years ago, obesity deals have become all the rage in the biopharma industry. The dealmaking here is largely dominated by big pharma companies, as they race to expand their metabolic disease pipelines amid the surging demand for next-generation weight-loss therapies. These industry giants are […] Written by Willow Shah-Neville November 25, 2025November 25, 2025 Saving Bookmark this article Bookmarked
Biotechnology FDA says it's hiring more than 1,000 new staffers, launches new comms program for review process The FDA is hiring more than 1,000 new employees and rolling out a pilot communication program in an effort to speed up the review of new drugs. Written by Admin November 21, 2025November 21, 2025 Saving Bookmark this article Bookmarked
Biotechnology Avanzanite secures €32m Series A funding Avanzanite Bioscience NV has raised €32m in a Series A financing round from MVM Partners, marking the company’s first institutional investment since its founding in 2022. The funding will support the expansion of Avanzanite’s operational infrastructure across 32 European countries, accelerate the commercialisation of existing and upcoming orphan drugs, and enable the company to form new […] Written by Thomas Gabrielczyk November 18, 2025November 18, 2025 Saving Bookmark this article Bookmarked
Biotechnology To Wall Street, a new bidding war puts Alkermes in a tough spot Now in a tug of war with Lundbeck, Alkermes could either lose out on a marketed sleepiness drug or end up paying significantly more than it had hoped. Written by Jacob Bell November 15, 2025November 15, 2025 Saving Bookmark this article Bookmarked
Biotechnology Gene Variant Boosts ATXN7L3B Expression In Vivo In the realm of genetic research, a significant breakthrough has emerged surrounding the ATXN7L3B gene, illuminated by a recent study conducted by Degtyareva et al. This study centers on an intriguing genetic variant, G→C rs590352, located within the protein-coding region of the ATXN7L3B gene. What makes this discovery particularly noteworthy is the variant’s profound effect […] Written by Bioengineer November 11, 2025November 11, 2025 Saving Bookmark this article Bookmarked
Biotechnology Top biotech deals in October 2025 The month of October 2025 saw a wave of mergers and acquisitions (M&As) and biotech deals in various therapeutic fields, but particularly for therapies addressing autoimmune conditions. Antibodies, gene therapies, and small molecules were unsurprisingly popular in the licensing deals space, and it looks like artificial intelligence-based drug discovery is sweeping up funding too. Top biotech M&A deals of October 2025 If you thought September was huge for M&As in the biopharma […] Written by Roohi Mariam Peter November 8, 2025November 8, 2025 Saving Bookmark this article Bookmarked
Biotechnology Billionaire-backed Arena BioWorks shutters less than 2 years after launch, cites ‘biotech macro conditions’ Less than two years after emerging, Arena BioWorks is shuttering, citing the “adverse impact of biotech macro conditions” as the reason for the sudden closure. Written by Admin November 5, 2025November 5, 2025 Saving Bookmark this article Bookmarked
The poison frog that fooled scientists for decades Scientists at the University of Kansas Biodiversity Institute and Natural History Museum recently uncovered a mistake that dates back decades involving a poison frog specimen from Peru. The frog had been incorrectly identified and designated as a holotype, which is the single preserved specimen used to officially define a species. While modern taxonomy may also […] Written by Admin January 7, 2026January 7, 2026 Saving Bookmark this article Bookmarked
A silent ocean pandemic is wiping out sea urchins worldwide Sea urchins play a crucial role in the ocean, acting as ecosystem engineers much like large grazers on land. As they feed on seaweed and seagrass, they trim back algae and help protect slow-growing species such as corals and certain calcifying algae. In turn, sea urchins are an important food source for many marine mammals, […] Written by Admin January 6, 2026January 6, 2026 Saving Bookmark this article Bookmarked
The poison frog that fooled scientists for decades Scientists at the University of Kansas Biodiversity Institute and Natural History Museum recently uncovered a mistake that dates back decades involving a poison frog specimen from Peru. The frog had been incorrectly identified and designated as a holotype, which is the single preserved specimen used to officially define a species. While modern taxonomy may also […] Written by Admin January 7, 2026January 7, 2026 Saving Bookmark this article Bookmarked
A silent ocean pandemic is wiping out sea urchins worldwide Sea urchins play a crucial role in the ocean, acting as ecosystem engineers much like large grazers on land. As they feed on seaweed and seagrass, they trim back algae and help protect slow-growing species such as corals and certain calcifying algae. In turn, sea urchins are an important food source for many marine mammals, […] Written by Admin January 6, 2026January 6, 2026 Saving Bookmark this article Bookmarked
The traffic controller: GARLH4 dictates neuroligin synapse-type preference Neuroligin isoforms are commonly thought to intrinsically specify synapse identity. In this issue, Yamasaki et al. (https://doi.org/10.1083/jcb.202507190) show that the auxiliary protein GARLH4 (LHFPL4) instead dictates neuroligin preference via competitive hierarchy, enabling dynamic reassignment between excitatory and inhibitory postsynaptic domains. Written by Admin January 5, 2026January 5, 2026 Saving Bookmark this article Bookmarked
Understanding PMDA Validation Rules v5.0 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has always led the charge in ensuring the safety and efficacy of drug development. Their latest update, the PMDA Validation Rules version 5.0, which took effect on April 1, 2024, marks another significant step in this mission. Let’s break down what these new rules mean and […] Written by Admin July 10, 2024July 10, 2024 Saving Bookmark this article Bookmarked
Enhance Your SEND Submissions! Join PointCross on May 29th, 2024, at 12 PM EST / 9 AM PST for a must-attend webinar: The Most Common Issues in Preparing SEND. Ideal for professionals in data submission and regulatory compliance, this webinar offers valuable insights from our seasoned experts. Why Attend? Why PointCross? With over 10 years of experience and more […] Written by Admin May 23, 2024May 23, 2024 Saving Bookmark this article Bookmarked