FDA
Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently published complete response letter, the agency detailed its reasoning behind the rejection.
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Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
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Wegovy is the first and only once-weekly GLP-1 receptor agonist that’s been approved for weight control in people living with obesity. This is the same drug used to treat type 2 diabetes.
It didn’t take too long before a lawsuit was filed over Bristol Myers Squibb’s failure to meet a deadline for a $9 Contingent Value Rights agreement tied to the company’s merger with Celgene.
REGEN-COV’s 1,200 mg dose is authorized to treat mild-to-moderate COVID-19 in adults and children 12 years and older who weigh 40 kilograms or more.
Alzheimer’s patients and their families wait with hope that this will mean some offer of treatment, while physicians that treat Alzheimer’s patients are mulling the implications of the drug, often with hesitancy and skepticism.
Shares of Protagonist Therapeutics climbed nearly 4% in premarket trading after the company announced its lead drug candidate rusfertide snagged Breakthrough Therapy Designation from the U.S. FDA.
The new vaccination, dubbed VAXELIS, is indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b.
The new approval for Cosentyx marks the first for a pediatric patient population in the U.S. Here’s everything you need to know about this new drug from Novartis.
The newly approved drug, Lybalvi, is a once-daily oral antipsychotic drug that is both a maintenance monotherapy or for the acute treatment of manic or mixed episodes.
Amgen reunites with Kyowa Kirin on the development and potential commercialization of KHK4083, an atopic dermatitis drug, which impacts nearly 30 million people worldwide.
The FDA approves Truseltiq for patients with previously-treated locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement.