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Morning Briefing

Summaries of health policy coverage from major news organizations

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Wednesday, Jun 28 2023

Full Issue

FDA 'Fast-Tracks' Gonorrhea Vaccine From GSK

Read recent pharmaceutical developments in 杨贵妃传媒視頻 Health News' Prescription Drug Watch roundup.

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)

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.聽The 12-week trial will include participants diagnosed with IPF. (Rudy, 6/28)

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)

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 鈥

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 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)

A young girl, maybe 5 or 6 years old, had come into Yoram Unguru鈥檚 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. 鈥淥ftentimes we can cure kids of their disease, but we can鈥檛 do that without the drugs,鈥 said Unguru, a pediatric hematologist oncologist at Children鈥檚 Hospital at Sinai in Baltimore and the Johns Hopkins School of Medicine. 鈥淚t鈥檚 just so, so maddening.鈥 (Chen, 6/28)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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