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The Connecticut-based biotech, which emerged from stealth last year, has secured $202 million to date as it looks to move two assets targeting prostate and breast cancer into the clinic.

FibroGen expects its headcount reduction, which is tied to eliminating 75% of its U.S. workforce, to be mostly complete by the end of the first quarter of 2025.

Ascendis Pharma’s palopegteriparatide was previously rejected by the regulator due to manufacturing problems, and the review period for its resubmitted application was extended by three months.

A day after the regulator denied approval of Lykos’ MDMA-assisted PTSD therapy, a medical journal pulled three studies related to the use of the psychedelic in the indication.

Humacyte’s stock price dropped 18% in after-hours trading Friday after the company announced the FDA requires additional time to review its Biologic License Application. No reason was given for the delay or an updated decision date.

ARS Pharma’s neffy on Friday became the first FDA-approved nasal spray to address severe allergic reactions, including those that might lead to life-threatening anaphylaxis.

Hundreds of companies are currently running clinical trials in the increasingly lucrative obesity space. BioSpace looks at five candidates with data expected before the end of the year.

In the next two weeks, the FDA will hand down its verdicts for three drug applications, including ones for multiple myeloma and hypoparathyroidism therapies.

Clinical trial concerns and a negative advisory committee vote ultimately sunk the treatment.

AN2 is discontinuing a study that evaluated epetraborole for treatment-refractory MAC lung disease and plans to shift focus to its boron chemistry platform.

Merck is paying $700 million upfront to buy Curon Biopharmaceutical’s bispecific antibody which depletes B cells and is being investigated for non-Hodgkin’s lymphoma and B cell acute lymphocytic leukemia.

With Medicare expenditures on Stelara increasing nearly tenfold, a new report from the HHS Office of Inspector General has found major differences in drug payment amounts under Part B versus Part D.

Data Presented at Epilepsy Foundation Pipeline Conference Demonstrated Significant Reduction in Epileptiform Activity: KIO-300 is the active pharmaceutical ingredient of KIO-301, Kiora’s ongoing Phase 2 clinical program in vision restoration in patients with gene mutation-agnostic Retinitis Pigmentosa

The Company invites individual and institutional investors, as well as advisors and analysts with an interest in Phio Pharmaceuticals, to attend the live, interactive presentation and one-on-one meetings

Cancer Research UK’s Centre for Drug Development is using TrialAssure LINK AI to support medical writing in CRUK-sponsored studies

CDMO continues on path to commercial growth, expansion

New specialized treatment site expands Paradigm’s capabilities for psychiatric clinical trials and studies evaluating investigational psychedelic-assisted therapies

Key Highlights: · Luxna and BioSpring have extended their existing agreement, enabling the manufacture of next-generation oligonucleotides incorporating Luxna’s GuNA™ amidites, in addition to AmNA™, scpBNA™, and 5′-CP™. · GuNA™ further expands the range of Luxna’s proprietary Xeno Nucleic Acid (XNA) chemistries already available through BioSpring’s oligonucleotide manufacturing services. · GuNA™-modified oligonucleotides are designed to provide enhanced nuclease resistance, improved target binding, reduced immunotoxicity and neurotoxicity; properties that provide key advantages for developing better efficacy and safer therapies targeting neurodegenerative diseases.