FDA Shift In Drug Approvals Halts Trial Of Second Skin Cancer Drug
Krystal Biotech has suspended a study of a skin cancer therapy called KB707, citing a shift in the approach toward drug approvals by the regulatory agency.
Fierce Biotech:
Krystal Discontinues Melanoma Study After FDA's Replimune Rebuff
The FDA’s rebuff of Replimune’s melanoma candidate has sent waves through the industry, prompting Krystal Biotech to shutter a clinical trial. Krystal Biotech has discontinued a phase 1/2 trial assessing intratumoral injections of KB707, a modified herpes simplex virus type 1-based gene therapy, for patients with advanced skin cancer. (Masson, 8/21)
The New York Times:
Where U.S. Medicines Are Made And How Trump’s Tariffs Could Affect Them
President Trump’s repeated threats to impose punishing tariffs on imported medicines have sparked interest in where Americans’ drugs are produced. The picture is complex. Most of the time, drugs are not made in a single country from start to finish. More often, a factory imports raw materials that it uses to make a drug’s active ingredients, which then get shipped to a plant in another country that formulates the drug into a tablet or liquid. (Robbins and Corum, 8/23)
Stat:
Amid Cries For Retraction, A Medical Journal Reviews A Discredited, 24-Year-Old Paper On An Antidepressant
Amid demand for retraction, a leading medical journal is reviewing a study published in 2001 that touted the benefits of a depression pill for adolescents, but was subsequently discredited and became the focal point of a searing controversy over inappropriate marketing of the medicine. (Silverman, 8/25)
The Hill:
New Side Effect Emerges From Weight Loss Drugs Use: 'Ozempic Teeth'
Patients using Ozempic and other GLP-1 drugs are reporting a complication not listed among the drug’s most common side effects. We’re not talking about “Ozempic babies,” but that’s also a thing. Dentists warn they’re seeing cases of something nicknamed “Ozempic teeth.” Medications like Ozempic and Wegovy can lead to dry mouth because the active ingredient, semaglutide, affects the salivary glands, explains Adam Taylor, an anatomy professor at Lancaster University, in an article for The Conversation. The medications can also cause people to drink less water because they feel less thirsty. (Martichoux, 8/23)
