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After trial flops in spinal muscular atrophy, depression and bipolar disorder—and a costly rare disease drug rejection—Biohaven is undergoing a reset, recasting its former SMA candidate for obesity.

Analysts, investors and partner Summit Therapeutics had all been keenly awaiting the overall survival update, after previous data from Akeso’s HARMONi-6 trial left them wanting.

FDA inspectors found Alchymars failed to adequately maintain equipment used to make active pharmaceutical ingredients for the U.S. market. Over-the-counter drugmakers GC America and Sato Pharmaceutical also received warning letters.

As Summit Therapeutics’ Chinese partner prepares to reveal data for a key trial at ASCO, analysts consider the impact on rivals Merck, Bristol Myers Squibb and BioNTech.

Replimune’s resubmission for RP1 for melanoma comes amid the departures of FDA leaders in place at the time of the drug’s first two rejections, last summer and again in April.

Beren Therapeutics is seeking approval in Neimann-Pick disease type C, an application the FDA was set to decide on by August 17. The new target action date is November 17.

Pfizer continues its dealmaking spree by striking a back-heavy partnership with China’s Innovent Biologics to assemble a pipeline of antibody-based therapies for cancer.

More than half of biotech and pharma job seekers have been looking for their next opportunity for six months or longer, and more than a quarter have searched for over a year, according to a BioSpace LinkedIn poll. Job seekers share their frustrations.

The antisense oligonucleotide was even more effective in patients with relatively low viral activity. More than one-quarter of these individuals had undetectable levels of the virus in the blood for at least six months after stopping treatment.

Kailera Therapeutics is advancing a pipeline of weight loss medicines that mirrors Eli Lilly’s: an injectable GLP-1/GIP dual agonist like Zepbound, an oral GLP-1 like Foundayo and a triple-G therapy like retatrutide.

Decnupaz is the first antibody-drug conjugate for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive blood cancer.

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll be hearing from Ksenija Pavletic, partner and chief commercial officer at Jeito Capital and Thierry Laugel, managing partner at Kurma Partners. We dive into France’s biotech ecosystem and what still needs to happen for more early innovation to translate into investable, scalable biotech.

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.