The federal agency granted accelerated approval for Tafinlar (dabrafenib) + Mekinist (trametinib) for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no other treatment options.
In December 2021, the FDA issued draft guidance to lifescience researchers on evaluating EHR and claims data in studies to support regulatory decisions. This new draft guidance covers using real-world data from these sources to support regulatory decisions on both safety and effectiveness.
Thanks to the meteoric rise of digital health, the role of data and analytics has also become central across the drug development life cycle, impacting every touch point from pipeline research and development to clinical trial design and implementation. A critical area that has fallen short, however, is applying a commensurate level of enthusiasm and expense for market research in the early phase as that afforded to downstream commercialization efforts. Compounding this challenge is the continued marginalization of disenfranchised communities.
Under the guise of lowering drug prices and curtailing corporate greed, we’re seeing a concerted assault on accelerated approval that insisting drugs whose efficacy is questioned by the FDA be pulled from the market.
Canada has approved Amylyx Pharmaceuticals’ treatment for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, the first such approval for the oral drug. The decision came with certain conditions, including the release of data from its global late-stage study of about 600 patients, which is expected in 2024, as well as additional studies.
Moderna announced that the company’s Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study. The booster contains the original COVID-19 vaccine, Spikevax, as well as a vaccine targeting the Omicron variant.
The U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Leaderboard Branding, a Fingerpaint company – the fast-growing global naming and branding firm that delivers strategic insights and world-class creativity to biopharma and healthcare companies as early as clinical phase 1 – announced the hiring of Max Straka, PharmD, FISMP, a former FDA Division of Medication Error Prevention and Analysis (DMEPA) safety evaluator. As a Director of Leaderboard Branding’s Drug Safety Division, Dr. Straka adds to the broad experience of global leaders and innovators in this important area of drug development.
GSK said on Monday the British drugmaker’s vaccine Priorix was approved by the U.S. Food and Drug Administration for the prevention of measles, mumps and rubella (MMR) in those aged 1 year and above.
A federal agency will start a review if the U.S. Food and Drug Administration properly conducted the health regulator’s inspection of Abbott’s Michigan plant and oversaw baby formula recalls that led to severe shortages in the United States.