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Antares acquired exclusive rights to Tlando from Salt Lake City, Utah-based Lipocine in October 2021 as part of a $21 million licensing deal. Read More
The FDA has accused a Polish company that manufactures and sells over-the-counter (OTC) products online of making a homeopathic drug cream that contains 100 million times the active concentration that the drug is purported to possess on its label. Read More
In an effort to address differing definitions of the term “digital biomarker” and improve discussions on medical product development, FDA officials have penned an article meant to clear up misconceptions and spur alignment toward the agency-endorsed definition. Read More
Biogen will complete its FDA-mandated phase 4 Aduhelm study in four years — less than half the time the agency allotted when it granted accelerated approved for the controversial antiamyloid antibody last year. Read More
In the final quarter of 2021, makers of brand-name pharmaceuticals increased their drugs’ wholesale acquisition cost, or WAC, by 4.4 percent, up from 3.8 percent during the same period in 2020. However, when factoring in inflation, wholesale prices actually dropped by 2.3 percent. Read More
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee yesterday declined by a vote of 6-4 to recommend approval of Amylyx Pharmaceuticals’ AMX0035, a drug intended to treat amyotrophic lateral sclerosis (ALS). Read More
TLX66 was previously granted Orphan Drug status by the European Medicines Agency, but has not yet received a marketing authorization in Europe. Read More
The FDA has issued warning letters to two companies for making implied claims that their products could prevent or treat COVID-19, making them unapproved new drugs in the agency’s eyes. Read More
The FDA has authorized second booster doses of the Pfizer and Moderna COVID-19 vaccines for adults aged 50 years and older and younger immunocompromised individuals. Read More
Amylyx’s amyotrophic lateral sclerosis candidate goes before the FDA today, the sole survivor in an investigational minefield that continues to explode clinical trials. Read More