Apadamtase alfa /Cinaxadamtase alfa

GSK Asia House Singapore. Credit: GSK/PRNewswire. GSK Singapore has obtained the Singapore Health Sciences Authority’s (HSA) approval for a new indication for Jemperli (dostarlimab) for use with chemotherapy in treating advanced or recurrent endometrial cancer. The programmed death receptor-1 (PD-1)-blocking antibody Jemperli attaches to the PD-1 receptor and blocks its interaction with the PD-L1 and PD-L2 ligands. The approval allows for the use of Jemperli, in combination with carboplatin and paclitaxel, for patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer. It expands Jemperli’s indication to an earlier stage in treatment, offering a new frontline immuno-oncology option. It was previously approved as monotherapy for dMMR recurrent or advanced endometrial cancer patients after a platinum-containing regimen. See Also: Takeda’s ADZYNMA gains EU approval for cTTP treatment Amneal’s CREXONT gains FDA approval for Parkinson’s treatment The recent decision by the Singapore HSA is based on interim analysis from the RUBY Phase III trial, which showed a 72% reduction in disease progression or death risk in the dMMR/MSI-H population. The trial is a comprehensive study evaluating dostarlimab in combination with chemotherapy. Part 1 of the trial, which informed the HSA’s decision, met its primary endpoint of progression-free survival (PFS) and demonstrated a safety profile consistent with the known risks of the individual therapies. Jemperli has shown positive results in treating endometrial cancer by blocking the interaction between the PD-1 receptor and its ligands. GSK Singapore medical director Dr Stephanie Cinthu Stephen Ambrose stated: “Singapore’s expanded regulatory approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in Singapore.” The therapy was originally discovered by AnaptysBio and licensed to TESARO under an exclusive licence agreement signed in 2014. In October 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) authorised Jemperli to treat adult patients with certain types of endometrial cancer.

Purdue Pharma has drawn heavy criticism in the past and has been the subject of numerous lawsuits as many accuse the company of being responsible in large part for the US’ current opioid epidemic. Credit: Shutterstock / JHVEPhoto. Purdue Pharma ’s opioid overdose reversal injection, Zurnai, was granted clearance by the US Food and Drug Administration (FDA) for use in individuals aged 12 years and older to combat overdose due to synthetic opioids. Coming in the form of an auto-injector pen that provides 1.5mg of nalmefene hydrochloride per actuation, it is the longest-acting opioid antagonist currently approved for opioid overdose reversal. The company hopes the system is simple enough to be used by anyone. The approval comes as data published by the Centers for Disease Control (CDC) for over 12 months until February 2024 indicates approximately 90% of opioid overdose deaths were from synthetic opioids, mostly fentanyl. At the same time, research published in the New England Journal of Medicine found that opioid overdose deaths in the US have doubled among teenagers with 22 high school-age adolescents dying each week from overdoses driven by fentanyl-laced prescription pills. Purdue president and CEO Craig Landau said: “Zurnai can be an important new tool to save lives in critical moments. We are committed to delivering solutions to help address the opioid overdose crisis and are working to provide Zurnai at no profit to the company.” Purdue Pharma has drawn heavy criticism in the past and has been the subject of numerous lawsuits. Many parties have accused the company of being responsible in large part for the US’ current opioid epidemic when it engaged in deceptive marketing practices to sell Oxycontin (oxycodone hydrochloride), an opioid painkiller. See Also: Takeda’s ADZYNMA gains EU approval for cTTP treatment Amneal’s CREXONT gains FDA approval for Parkinson’s treatment Purdue says that less than 5% of those administered nalmefene hydrochloride through its Zurnai injector pen saw some adverse effects such as nausea, headache, dizziness and vomiting, among others. The company insists that it is producing the device US-wide at no profit to itself while continuing the production of its nalmefene hydrochloride injection in single-dose vials. Elsewhere, researchers at Canada’s University of Waterloo have developed a new blood testing technique that can identify the presence of potent opioids including the highly potent fentanyl in less than three minutes. At the same time, the FDA has issued a complete response letter to Orexo regarding a new drug application for its high-dose naloxone rescue medication, OX124.