Drug Development
The mid-stage disappointment in Alzheimer’s disease delivers another blow to Neuphoria Therapeutics, which in November last year was forced to launch a strategic business review after a Phase 3 trial in social anxiety disorder failed.
FEATURED STORIES
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
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.
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.
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.
PD-(L)1×VEGF bispecifics have emerged as a closely watched new class in immuno-oncology, with multiple candidates advancing through trials in lung cancer. But the potential of these drugs may be highest in cancers where angiogenesis and immune escape are tightly intertwined.
The FDA’s priority review acceptance of BridgeBio’s BBP-418 is another step toward what William Blair previously dubbed a “diversified commercial portfolio.” It also adds to the rapidly building momentum in muscular dystrophy more broadly.
Apogee’s pipeline in a product drug zumilokibart achieved significant disease clearance in a mid-stage atopic dermatitis trial, but investors were miffed by a royalty financing deal with Blackstone.
FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
Nearly 80% of patients saw tumor shrinkage after being treated with Kura Oncology’s darlifarnib plus Bristol Myers Squibb’s Krazati, findings Mizuho analysts say could open up a $2 billion opportunity for the biotech.
Strong science and early support are not enough on their own. Europe needs more capital depth, cross-border investor backing and a lighter policy framework to keep companies scaling at home, according to two venture capitalists.
Having secured deals with AstraZeneca and Novartis, Niowave is constructing a second facility to meet rising demand for actinium-225, which can be used to develop next-generation radiopharmaceuticals.