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FDA Initiates Public Disclosure of Drug Rejection Letters for Increased Transparency
The U.S. Food and Drug Administration (FDA) has commenced publishing complete response letters—which detail reasons for rejecting drug applications—in real time alongside companies' receipt of...
Atlas Venture Raises $400 Million Opportunity Fund to Strengthen Portfolio Biotechs
Atlas Venture, a prominent biotechnology venture capital firm, has closed a $400 million Opportunity Fund to provide financial support for existing portfolio companies. This fund is specifically...
Treeline Biosciences Raises $200 Million, Unveils Clinical Candidates in Oncology
Stepping out of stealth mode, Treeline Biosciences, a Massachusetts-based oncology biotech, announced a $200 million Series A extension, bringing total funding to $1.1 billion. The company...
Novartis and Arrowhead Collaborate on RNAi Therapeutics for Neurodegenerative Diseases
Novartis has entered a global licensing and collaboration agreement with Arrowhead Pharmaceuticals to develop RNA interference therapies utilizing Arrowhead's Targeted RNAi Molecule (TRiM)...
Mapping Brain-Wide Neural Activity During Decision-Making in Mice
An international consortium, the International Brain Laboratory, has produced the first comprehensive brain-wide map of single-neuron activity during complex decision-making in mice. Utilizing...
Kyoto University Discovers Synthetic Protein Tool to Harness Phagocytosis for Targeted Cell Removal
Scientists at Kyoto University unveiled a novel protein-based therapeutic, Crunch, engineered to redirect phagocytes to selectively engulf living, disease-causing cells. By replacing the natural...
FDA Proposes New Rare Disease Drug Review Pathway Accepting Single-Arm Trials
The FDA announced the Rare Disease Evidence Principles (RDEP) program, a new collaborative review process between drug and biologics centers for ultra-rare diseases affecting fewer than 1,000 U.S....
Atlas Venture Raises $400 Million to Support Biotech Portfolio Amid Market Challenges
Atlas Venture, a prominent biotech investment firm based in Cambridge, Massachusetts, announced the closure of a $400 million Opportunity Fund dedicated to backing its existing portfolio...
Treeline Biosciences Unveils Clinical Candidates, Secures $200 Million Extension Raising Total to $1.1 Billion
Treeline Biosciences, a Massachusetts-based oncology company, revealed details about its first clinical candidates after operating in relative secrecy. The company announced a $200 million Series...
FDA Advances Transparency with Public Release of Drug Rejection Letters
The Food and Drug Administration (FDA) announced a significant policy change to publish complete response letters (CRLs) for ongoing drug applications publicly and in real time. This initiative...
FDA Outlines Rare Disease Evidence Principles for Ultra-Rare Drug Approvals
The FDA announced the Rare Disease Evidence Principles (RDEP) program, a new review pathway designed to facilitate the development and approval of drugs targeting ultra-rare genetic diseases...
Novartis and Arrowhead Expand RNAi Collaboration with $2.2 Billion Deal
Novartis and Arrowhead Pharmaceuticals have entered a substantial global licensing and collaboration agreement for Arrowhead’s preclinical siRNA therapy ARO-SNCA, targeting synucleinopathies...
Innovative Protein Tool 'Crunch' Programmed for Targeted Cell Clearance
Researchers at Kyoto University’s Institute for Integrated Cell-Material Sciences developed 'Crunch,' a synthetic protein-based therapeutic designed to selectively induce phagocytosis of unwanted...
Biogenic Production of Biodegradable Plastic Alternative PDCA by Engineered E. coli
A study from Kobe University bioengineers announced the successful biosynthesis of pyridinedicarboxylic acid (PDCA), a biodegradable alternative to petroleum-based plastics such as polyethylene...
AI-Driven Machine Learning Enhances Cancer Diagnosis and Prognosis
In notable advances within oncology and computational biology, multiple teams have developed and applied machine learning tools to refine cancer diagnostics and prognostication. A Chinese research...
Leadership Turmoil at HHS and CDC Amid Vaccine Policy Disputes
The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) face significant internal turmoil under Secretary Robert F. Kennedy Jr.’s...
FDA Unveils Rare Disease Evidence Principles for Ultra-Rare Drug Approvals
The FDA announced a novel Rare Disease Evidence Principles (RDEP) pathway aimed at expediting the development and review of drugs targeting ultra-rare genetic conditions affecting fewer than 1,000...
Treeline Biosciences Emerges With $200M Extension and Clinical Pipeline Reveal
Treeline Biosciences, a clinical-stage oncology biotech, disclosed a $200 million extension to its Series A round, bringing total funding to $1.1 billion. Alongside the financing, the company...
Novartis and Arrowhead Form $200M Collaboration on RNAi Parkinson’s Therapy
Novartis committed $200 million upfront to Arrowhead Pharmaceuticals to license and co-develop ARO-SNCA, an RNA interference therapy targeting alpha-synuclein protein implicated in Parkinson’s...
Wave Life Sciences Reports Mixed Data on RNA Editing Therapy for Alpha-1 Antitrypsin Deficiency
Wave Life Sciences released additional data from a phase Ib/IIa trial of its RNA-editing oligonucleotide WVE-006 for alpha-1 antitrypsin deficiency. Despite demonstrating target engagement and...