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Drugmakers are not pleased with the FDA’s draft guidance on microbiological contamination, published in September to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs). Read More
BioMarin plans to meet with the FDA to discuss these latest findings and expects to file a biologics license application in the second quarter of this year. Read More
In May 2021, Sotorasib received FDA accelerated approval for the same NSCLC indication, becoming the first KRAS G12 inhibitor to gain regulatory clearance. Read More
In overturning the settlement on Dec. 16, McMahon ruled that the federal bankruptcy judge who approved the Sacklers’ settlement plan in September had ruled incorrectly. Read More
Pfizer has partnered with Beam Therapeutics to develop messenger RNA (mRNA)-based therapies for rare genetic diseases — a move to expand its portfolio of mRNA technology used to produce its landmark COVID-19 vaccine. Read More
Bayer and Mammoth Biosciences have announced a deal in which Bayer will shell out $40 million now and potentially up to $1 billion over time for the use of Mammoth’s CRISPR systems to develop in vivo gene-editing therapies. Read More
After flopping a phase 3 trial in hospitalized COVID-19 patients, Molecular Partners’ antiviral ensovibep has scored in a new phase 2 study, reducing viral load and cutting the risk of hospitalization or death by 78 percent in patients with mild-to-moderate disease. Read More
In its first-ever FDA approval, Switzerland’s Idorsia has snagged the regulatory green light for Quviviq (daridorexant), a potential blockbuster treatment for adults with insomnia. Read More