FDA ‘Fast-Tracks’ Gonorrhea Vaccine From GSK

Reuters: GSK's Gonorrhea Vaccine Receives FDA's 'Fast-Track' Designation 
GSK's vaccine candidate to treat sexually transmitted infection gonorrhea has been granted a fast-track designation by the U.S. Food and Drug Administration (FDA), the British drugmaker said on Tuesday. The Neisseria gonorrhoeae investigational vaccine is currently at a mid-stage trial and aims to demonstrate efficacy of the vaccine in healthy adults who are at high risk of the infection, the company said in a statement. (6/27)

Fox News: First AI-Generated Drug Enters Human Clinical Trials, Targeting Chronic Lung Disease Patients 
The first-ever drug generated by artificial intelligence has entered Phase 2 clinical trials, with the first dose successfully administered to a human, Insilico Medicine announced yesterday. The drug, currently referred to as INS018_055, is being tested to treat idiopathic pulmonary fibrosis (IPF), a rare, progressive type of chronic lung disease. The 12-week trial will include participants diagnosed with IPF. (Rudy, 6/28)

Reuters: FDA Declines To Approve Intercept's Fatty Liver Disease Drug 
The U.S. Food and Drug Administration on Thursday declined to grant accelerated approval for Intercept Pharmaceuticals' (ICPT.O) drug to treat a type of fatty liver disease, sending its shares down more than 11% in extended trading. The rejection marks Intercept's second failed attempt at securing approval for the drug to treat patients with non-alcoholic steatohepatitis (NASH) - a liver disease that affects 5% of U.S. adults but has no approved treatments after numerous clinical failures by several drugmakers. (6/22)

CIDRAP: WHO Lays Out Research Priorities For Antimicrobial Resistance
The agenda outlines the 40 research priorities for addressing and mitigating the impact of antimicrobial-resistant bacterial and fungal infections, including drug-resistant tuberculosis (TB), over the next decade. The aim is to identify research that can fill critical knowledge gaps, have a real-world impact, promote health equity, and be translated into evidence-based policies by 2030, in line with the United Nations' Sustainable Development Goals. (Dall, 6/22)

On the drug pipeline from India —

Reuters: Exclusive: Indian Firm Used Toxic Industrial-Grade Ingredient In Syrup - Sources
The Indian manufacturer of cough syrups that Uzbekistan said last year had poisoned 19 children used a toxic industrial-grade ingredient rather than the legitimate pharmaceutical version, two sources with knowledge of the matter told Reuters. (Sharma and Das, 6/27)

The Washington Post: How Troubles At A Factory In India Led To A U.S. Cancer-Drug Shortage
The Intas Pharmaceuticals plant churned out medicine in a sprawling industrial park in western India, far from the minds of American cancer patients until its problems became theirs. The factory accounted for about 50 percent of the U.S. supply of a widely used generic chemotherapy drug called cisplatin, a reality that few understood until the U.S. Food and Drug Administration inspected the site in November. (Gilbert, 6/27)

Stat: The Cancer Drug Shortage Isn’t New — And Neither Are The Solutions
A young girl, maybe 5 or 6 years old, had come into Yoram Unguru’s clinic with acute lymphoblastic leukemia, the most common of all childhood cancers. One of the drugs needed for treatment was methotrexate. The only problem was that the drug was in short supply. “Oftentimes we can cure kids of their disease, but we can’t do that without the drugs,” said Unguru, a pediatric hematologist oncologist at Children’s Hospital at Sinai in Baltimore and the Johns Hopkins School of Medicine. “It’s just so, so maddening.” (Chen, 6/28)