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Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.

After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.

The RNA-based medicine is one of a handful of antibody-oligonucleotide conjugates that Novartis acquired last October when it took over neuromuscular-focused Avidity Biosciences.

Novo Nordisk said that the information affected by the breach shouldn’t allow third parties to “identify participants in our clinical trials” despite “unauthorized access” to patients’ personal data.

Strong science, lower costs and growing capital networks are putting Spain and Portugal on the biotech investment map, even as structural bottlenecks persist, according to two investors.

The staffing changes will focus resources on work that creates the highest impact for patients, according to Genentech. The number of employees affected is unknown, but longtime veteran Vishva Dixit is out.

Biotechs are benefitting from the AI tech frenzy and inflation, but validated pipelines and careful planning are still key to the recent record-setting IPOs, experts say.

Takeda eyes an FDA run for its investigational psoriasis pill after the drug elicited total skin clearance in more than 35% of patients at 16 weeks—more than 2.5 times that in controls taking Bristol Myers Squibb’s Sotyktu.

Instead of using viral vectors, SonoThera’s genetic medicines are delivered through an ultrasound-mediated technology that could help sidestep key safety issues with conventional delivery methods.

It’s the latest Big Pharma deal for molecular glue technology and Novartis’ second with Orionis Biosciences, after first linking up in March 2020. The backloaded agreement will see Novartis pay $40 million upfront.

In this episode of Denatured, you’ll be hearing from Hannah Franklin, associate at Biovance Capital and Pablo Gabriel Cironi Lopez, director of life science investment at Caixa Capital Risc as they discuss the rise of Southern Europe’s biotech ecosystem.

Just 23% of respondents to a BioSpace LinkedIn poll expect the biopharma job market will rebound in 2026. Three experts discuss when they see a turnaround happening and how increasing emphasis on cost efficiency is impacting hiring practices.

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.