FDA
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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Sanofi, AstraZeneca, Avillion and Diadem recently announced clinical results, providing positive news for patients with multiple myeloma, asthma and Alzheimer’s disease.
In addition to lowering of blood sugar, Mounjaro also enabled patients to lower their weight by 15 to 23 pounds. The drug compared well to other diabetes medications including Novo Nordisk’s semaglutide.
The U.S. Food and Drug Administration (FDA) has approved Mitsubishi Tanabe Pharma America’s oral alternative to its own treatment for amyotrophic lateral sclerosis (ALS).
Stealth BioTherapeutics has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for elamipretide.
The FDA has given approval for the commercialization of Eli Lilly and Company and Incyte’s Olumiant, setting a precedent for upcoming COVID-19 treatments.
Orion announced that it will be focusing on pain and oncology going forward. As a result, 32 working professionals within the company will be terminated, although six of those will be offered different positions.
LogicBio Therapeutics has received the green light to continue dosing participants in its Phase I/II Sunrise trial, following a clinical hold placed by the FDA due to adverse events in pediatric patients.
May has been fruitful for research into the prevention and diagnosis of Alzheimer’s disease, the mechanisms behind early symptoms and potential treatments.
The FDA has extended the review period for Myfembree, following the supplemental New Drug Application from Pfizer and Myovant. Here’s more about this news.
AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval for an earlier form of breast cancer from the U.S. Food and Drug Administration.