Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The company said it’s the first and only drug-releasing system offering extended local delivery of a cancer medication into the bladder. The system offers bladder cancer patients a new option before turning to bladder-removal surgery. The system can be inserted into the patient in a doctor’s office and without anesthesia.

PMV’s rezatapopt wows in ovarian cancer in early phase II readout

PMV Pharmaceuticals Inc. reported a 43% overall response rate (ORR) in a cohort of ovarian cancer patients as part of its interim readout of the ongoing phase I/II Pynnacle trial testing rezatapopt in advanced solid tumors harboring a TP53 Y220C mutation. The positive findings have prompted the firm to aim for a potential accelerated approval filing in early 2027. Shares of PMV (NASDAQ:PMVP) gained in premarket but had dropped nearly 20% at noon, likely on the modest market potential linked to rezatapopt in ovarian cancer and the wait for additional data in larger indications expected next year.

US FDA cracking down on prescription drug ads

It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of serious adverse events. The agency sent thousands of letters yesterday to biopharma companies, directing them to immediately “remove any noncompliant advertising and bring all promotional communications into compliance,” including that on social media. It also issued about 100 cease-and-desist letters to companies with what it considers deceptive drug ads. In addition, the agency is starting rulemaking to close the 1997 “adequate provision” loophole, “which drug companies have used to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust,” the FDA said.

Piecing mosaic of APAC regulations key to Asia biotech growth

“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.” Singapore, for example, is part of the Association of Southeast Asian Nations network, where there are 10 member states, he added. “Then you have China, Japan, South Korea, India, Australia – each with their own sets of definitions, dossier requirements and standards.” The advent of novel technologies like AI and organoids is further pressuring agencies to lay a “regulatory bridge” between countries in the Asia Pacific (APAC) region, multiple speakers said during the two-day meeting.

Hong Kong biotech sector back on track with 13% growth

The Hong Kong biotech sector saw record growth this year, expanding 13%, fueled largely by investment in innovation ranging from CRISPR gene editing tools, cell therapies and artificial intelligence in drug discovery, speakers at the BIO Hong Kong conference said Sept. 10. Biotechnology is a strategic industry for the Hong Kong government, and investment in China’s Shenzhen-Hong Kong-Guangzhou cluster ranked first in the Global Innovation Index 2025 by the World Intellectual Property Organization, Hong Kong Secretary for Health Lo Chung Mau said.

New guidance offers path for non-opioid drug development

The U.S. FDA issued new guidance for the development of non-opioid analgesics for chronic pain indications, with specific details on trial design, patient populations and meaningful outcomes, including reducing the nation’s reliance on opioids. “America’s opioid crisis is not over,” said FDA Commissioner Marty Makary. “We must stay vigilant to address this longstanding problem in new ways. Physicians need more alternatives to opioid medications for patients suffering from chronic pain.” The FDA’s new guidance, which fulfills a mandate from the SUPPORT (Substance Use-disorder Prevention that Promotes Opioid Recovery and Treatment) for Patients and Communities Act, is expected to help make regulatory pathways more predictable for innovators.

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