Drug Development
The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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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.
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.
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GeneTx Biotherapeutics and Ultragenyx Pharmaceutical’s jointly prepared treatment for Angelman syndrome have been provided a green single by DSMB recently.
The NASH trial achieved the primary endpoint of proton density fat fraction and the secondary endpoint of cT1.
An improvement in cUHDRS was observed in more than half of all evaluable patients and was specifically seen in 75% of the evaluable population who showed excess complement activity at baseline.
A bispecific antibody discovered by Twist Bioscience and licensed to Revelar Biotherapeutics neutralizes both the Omicron and Delta variants of SARS-CoV-2 in studies with the live virus.
Evidence continues to accumulate suggesting that Omicron, although significantly more infectious than previous COVID-19 strains, causes less severe disease.
More than 103,000 people in the U.S. were hospitalized on January 3, 2022, for COVID-19—the highest daily figure of hospitalizations since last summer when the Delta variant emerged.
AVROBIO is switching priorities in 2022 away from its Fabry disease program and into its other more lucrative clinical-stage projects.
While women are more statistically susceptible to autoimmune diseases, the research found that men with at least a mild COVID-19 infection had far more autoantibody (AAB) reactivity.
The FDA decided to lift the hold for its Phase IIa trial of SPR720 after Spero submitted a comprehensive analysis from the NHP toxicology study.
Biogen exercised an option to pick up an exclusive global license for a drug to treat spinal muscular atrophy from Ionis. The compound, BIIB115, is an antisense oligonucleotide.