Drug Development
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
FEATURED STORIES
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
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Around 40% of Pfizer’s portfolio was realized through partnerships, and Monday, the pharma giant announced three more collaborative deals.
The results over the two-year evaluation period for its Phase III GENEr8-1 trial showed consistent clinical benefit from using valoctocogene roxaparvovec.
The emerging generation of precision gene therapies addresses what has been one of this genre’s greatest challenges to date: the risk of unintended consequences.
BioSpace sat down with 12 executives who shared their thoughts on the coming year and decade.
Biopharma companies are building momentum to carry them through the bulk of 2022. BioSpace takes a look at some of the recent announcements.
The biopharma industry has started 2022 with plenty of clinical trial news. Here’s a look.
On Friday morning, AstraZeneca’s rare disease group Alexion and Switzerland-based Neurimmune entered into a collaboration and licensing agreement for NI006.
Judge Mark Pittman found that the Freedom of Information Act filed by PHMPT is of paramount public importance and demands that the FDA make the data publicly available within eight months.
As the Omicron strain sweeps the world, researchers rush to determine how effective vaccines are at creating immunity against the variant. For that and more, continue reading.
Over the past ten years, Tonix’s pipeline has evolved to also comprise assets in biodefense, immunology and cancer therapeutics.