The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing prostate-specific membrane antigen (PSMA)-PET imaging for prostate cancer widens the opportunities to treat patients who live far away from large hospitals. The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents. The NDA for Gozellix had a March 24 PDUFA date, so approval came sooner than expected. Gozellix, after radiolabeling with 68Ga, is approved for PET scanning of PSMA-positive lesions in men with prostate cancer who are suspected of having metastasis or those with suspected recurrence based on elevated serum prostate-specific antigen level.
US FDA deals second blow to Hengrui-HLB’s liver cancer drug combo
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib. The FDA issued the second complete response letter (CRL) of the camrelizumab plus rivoceranib as a potential treatment for unresectable hepatocellular carcinoma to HLB’s Fort Lee., N.J.-based subsidiary, Elevar, on March 20. Seoul, South Korea-based HLB disclosed the agency’s decision on the Korea Exchange on March 21, with HLB Chairman Yang-gon Jin relaying the rejection to investors online in an after-midnight address. “The FDA once again issued a CRL requesting supplemental material for rivoceranib at 11:37 p.m. in Korea time,” Jin said. “The first CRL named both camrelizumab and rivoceranib, but the present CRL was issued for solely one reason related to CMC [Chemistry, Manufacturing, and Controls] concerns of Hengrui Pharma’s camrelizumab that were not sufficiently addressed.”
EU seeking talented scientists amid US funding woes
Science ministers from 13 countries in Europe are calling on the European Union to offer a home to researchers affected by the Trump Administration’s cuts. They have written to EU research and innovation commissioner Ekaterina Zaharieva asking her to organize a welcome “for brilliant talents from abroad who might suffer from research interference and ill-motivated and brutal funding cuts.” While the U.S. is not named, the opening line of the letter is all but explicit, saying “the current international context reminds us that freedom of science can be put at risk anywhere and at any time.”
Global drug approvals hit 47 in February, surpassing 2024 monthly average
The U.S. FDA approved 16 drugs in February, up from 12 in January but still falling short of the 2024 monthly average of 19 approvals. Just two of those were new molecular entities (NMEs), continuing a slower pace compared to the year’s average of slightly more than four NMEs per month.
Drug developers show mixed performance in early 2025
After finishing 2024 with a 15.25% decline, the BioWorld Drug Developers Index rebounded 6.93% in January, only to fall back to a modest 1.06% gain by the end of February. The Nasdaq Biotechnology Index and the Dow Jones Industrial Average followed a similar pattern, each rising about 5% by the end of January, before closing February at 3.13% and -2.48%, respectively. The early 2025 volatility reflects broader market trends, with biopharma stocks struggling to maintain momentum after an initial recovery.