Regulatory approval for medical products can rely on real-world data (RWD) typically only for expanded indications for use, but payers have been missing in action where this data source is concerned. The U.S. CMS has floated a guidance to facilitate the use of RWD in coverage decisions, providing a long-overdue update to Medicare clinical trial policy.
China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.
The EMA has started a review of Novo Nordisk A/S’ GLP-1 receptor agonist, semaglutide, after the Danish regulatory agency raised the possibility it causes an increased risk of suffering from an acute eye condition. After the first report in July 2024, the Danish regulator had received, by Dec. 10, 2024, a total of 19 reports of non-arteric anterior ischemic neuropathy, a rare condition that affects the small blood vessels at the front of the optic nerve. This can lead on to sudden vision loss and visual field defects.
In the final days of the Biden administration, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) laid out the latest 15 drugs that are subject to negotiated prices, with Novo Nordisk A/S’ GLP-1 drug Ozempic for type 2 diabetes topping the list, bringing Rybelsus and Wegovy along for the ride because they share the same active ingredient, semaglutide.
After a five-year court battle in which Gilead Sciences Inc. scored several victories only to have the U.S. government appeal, Gilead has reached a settlement with the Department of Health and Human Services and the Department of Justice to resolve government claims that the company had infringed its patents covering the pre-exposure prophylaxis (PrEP) use of two Gilead HIV drugs.
The EMA recommended the highest number of approvals in the last 15 years in 2024, giving the nod to 114 drugs. That is amongst the highest number in the 30 years of the agency’s existence, said Steffen Thirstrup, the EMA’s chief medical officer.
Atara Biotherapeutics Inc. received a complete response letter (CRL) from the U.S. FDA for its lead product, Ebvallo (tabelecleucel), a breakthrough therapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease that is already approved in the EU, the U.K. and Switzerland.
Axcynsis Therapeutics Pte Ltd. has gained IND clearance from the FDA for AT03-65 for the treatment of patients with CLDN6-positive solid tumors. Axcynsis is planning to initiate a phase I trial in the U.S. during the current quarter in patients with advanced CLDN6-positive solid tumors.
China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
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