News
Biogen’s new data, presented at the Alzheimer’s Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.
FEATURED STORIES
Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Surrozen announced it paused its Phase I study in Crohn’s disease and ulcerative colitis as several healthy participants showed increased levels of liver enzymes.
Jnana Therapeutics forged its second small molecule discovery and development collaboration and licensing agreement with Roche valued at up to $2 billion.
ImmunoGen’s Elahere was approved Monday under the FDA’s accelerated pathway for patients who have received one to three previous lines of systemic therapy.
The FDA raised doubts about the future of Ardelyx’s experimental chronic kidney disease drug tenapanor in briefing documents released ahead of a Wednesday advisory committee meeting.
Stoke Therapeutics is gearing up for a pivotal trial of its lead program for a rare genetic epilepsy disease and announced positive results from its Phase I/IIa study in children with Dravet syndrome.
Indivior PLC announced it will acquire Opiant Pharmaceuticals and its lead candidate OPNT003, an intranasal-delivered opioid overdose recovery product.
During its third-quarter earnings call Monday, BrainStorm Cell Therapeutics emphasized its commitment to seek an advisory committee meeting for NurOwn in ALS.
Topline results from the Phase III SUMMIT trial showed Satsuma Pharmaceuticals’ migraine candidate STS101 did not meet its primary efficacy endpoint.
Ionis Pharmaceuticals inked a collaboration deal with Metagenomi with the goal of adding DNA editing to its RNA-targeted technologies focused on up to four genetic targets.
MBX Biosciences secured $115 million in Series B financing to advance its pipeline of Precision Endocrine Peptides for endocrine disorders.