Biotechnology Zydus' phase 3 liver disease win tees up filing to challenge Gilead and Ipsen Zydus Therapeutics has racked up a phase 2b/3 win in primary biliary cholangitis, clearing the path to a filing to establish the company as a challenger to Gilead, Intercept Pharmaceuticals and Ipsen. Written by Admin August 30, 2025August 30, 2025 Saving Bookmark this article Bookmarked
Biotechnology Calluna Pharma starts efficacy test with unique IPF antibody Among the 110 drug development programmes currently underway worldwide targeting the US$4.5bn IPF market, Calluna Pharma‘s IgG1 antibody directed against the damage-associated molecular pattern (DAMP) protein S100A4 stands out for its unique mechanism of action. Preclinical studies demonstrated selective inhibition of both fibroblast activation and pro-fibrotic inflammation, alongside a favourable safety and immunogenicity profile, which […] Written by Thomas Gabrielczyk August 27, 2025August 27, 2025 Saving Bookmark this article Bookmarked
Biotechnology FDA cancels adcomm on Biohaven drug; Catalent lays off staff Analysts found the agency's decision to cancel the meeting encouraging. Elsewhere, the Novo Holdings-owned CDMO cut about 350 staff in Maryland. Written by BioPharma Dive staff August 23, 2025August 23, 2025 Saving Bookmark this article Bookmarked
Biotechnology Oxygen Dilemma: Balancing Life’s Vital Element Oxygen: The Dual-Edged Sword that Sustains and Challenges Life Oxygen, the most abundant element on Earth’s surface, is undeniably the cornerstone of life as we understand it. It powers the metabolic engines of almost all complex organisms, enabling the biochemical reactions that sustain life’s intricate processes. Yet, despite its vital role, oxygen’s influence is paradoxical […] Written by Bioengineer August 20, 2025August 20, 2025 Saving Bookmark this article Bookmarked
Biotechnology How biotech is improving the life of your cat Newsletter Signup – Under Article / In Page “*” indicates required fields About a week ago, on August 8th, fell International Cat Day. Even if you are a cat person like I am, you might have missed the event. Don’t worry, your feline probably didn’t know about it either. In this article, we will take a […] Written by Jules Adam August 17, 2025August 17, 2025 Saving Bookmark this article Bookmarked
Biotechnology Vedanta's live bacteria cocktail fails to reduce ulcerative colitis severity in phase 2 trial Vedanta Biosciences’ dreams of using live bacteria to treat inflammatory bowel disease have been dashed. The Massachusetts-based microbiome outfit’s mixture of 16 bacterial strains failed to reduce disease severity in the colons of patients with ulcerative colitis, Vedanta said Wednesday. Written by Admin August 13, 2025August 13, 2025 Saving Bookmark this article Bookmarked
Biotechnology Dewpoint Therapeutics cuts workforce, refocuses pipeline Despite securing US$287m from 16 investors across three funding rounds—US$60m (Series A, 2019), US$77m (Series B, 2020), and US$150m (Series C, 2022)—the firm cited a high burn rate as the reason for scaling back. Dewpoint will now prioritise clinical development of its lead candidate, DPTx3186, a beta-catenin inhibitor targeting the WNT signalling pathway, in gastric […] Written by Thomas Gabrielczyk August 10, 2025August 10, 2025 Saving Bookmark this article Bookmarked
Biotechnology HHS abandons mRNA vaccine research One vaccine expert called the move, which cancels some $500 million in messenger RNA research contracts, a “giant step backward for science.” Written by Delilah Alvarado August 7, 2025August 7, 2025 Saving Bookmark this article Bookmarked
Biotechnology Advancing Microplastic Quantification with NMR Spectroscopy In the ever-evolving battle against plastic pollution, researchers are turning to increasingly sophisticated analytical techniques to quantify and characterize microplastics. A groundbreaking study published in Microplastics & Nanoplastics offers compelling evidence that nuclear magnetic resonance (NMR) spectroscopy could transform the way scientists detect and measure these pervasive contaminants. By leveraging the nuanced molecular insights provided […] Written by Bioengineer August 3, 2025August 3, 2025 Saving Bookmark this article Bookmarked
Biotechnology pipeline drugs to watch in 2025 Newsletter Signup – Under Article / In Page “*” indicates required fields A consistent sleep schedule of going to bed and waking up each day allows the body to rest and helps maintain optimal brain function, physical health, and emotional stability. But for people with narcolepsy, staying awake can be a struggle. And as there […] Written by Roohi Mariam Peter July 31, 2025July 31, 2025 Saving Bookmark this article Bookmarked
FDA Launches the TEMPO Pilot for Digital Health Devices to Improve Patient Access to Technologies – Duane Morris Life Sciences Law By Vicki G. Norton, Ph.d., Frederick R. Ball and Victoria (Tori) Hawekotte The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers’ digital health devices to improve patient access to digital health […] Written by Duane Morris January 8, 2026January 8, 2026 Saving Bookmark this article Bookmarked
Basilea pens collab with US biotech to develop new antifungal Basilea Pharmaceutica is continuing its quest to develop much-needed new antifungal drugs by penning a deal with Prokaryotics worth at least $48 million. Written by Admin January 7, 2026January 7, 2026 Saving Bookmark this article Bookmarked
FDA Launches the TEMPO Pilot for Digital Health Devices to Improve Patient Access to Technologies – Duane Morris Life Sciences Law By Vicki G. Norton, Ph.d., Frederick R. Ball and Victoria (Tori) Hawekotte The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers’ digital health devices to improve patient access to digital health […] Written by Duane Morris January 8, 2026January 8, 2026 Saving Bookmark this article Bookmarked
Basilea pens collab with US biotech to develop new antifungal Basilea Pharmaceutica is continuing its quest to develop much-needed new antifungal drugs by penning a deal with Prokaryotics worth at least $48 million. Written by Admin January 7, 2026January 7, 2026 Saving Bookmark this article Bookmarked
New Arabidopsis BIK1 Alleles Confirm Immunity Role In a groundbreaking study poised to redefine our understanding of plant immunity, researchers have unveiled novel insights into the pivotal roles of the receptor-like cytoplasmic kinases BIK1 and PBL1 in Arabidopsis. These kinases, previously studied primarily through single transfer DNA (T-DNA) insertional mutant alleles, are reaffirmed as central players in the plant’s pattern-triggered immunity (PTI) […] Written by Bioengineer January 7, 2026January 7, 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