On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s disease dementia (AAD), marking the first approved treatment for the indication. The approval of the supplemental NDA was highly anticipated following the thumbs up given at the April 14 meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee that voted 9-1 in favor of approval.

Immunitybio’s bladder cancer candidate hit with a CRL

The U.S. FDA issued a complete response letter regarding the BLA for Immunitybio Inc.’s bladder cancer treatment, halting the drug’s development and knocking the stock back more than 50% at midday. The problems stem from the FDA’s pre-license inspection of Immunitybio’s third-party contract manufacturing organizations, the company said, adding that the FDA also had recommendations for specific chemistry, manufacturing and controls issues and assays that need to be resolved before the BLA can be approved. N-803 (Anktiva), an IL-15 superagonist complex that Immunitybio is developing to treat Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer, has a PDUFA target action date May 23. The stock (NASDAQ:IBRX) was down 54% at midday to about $2.85 per share.

HTIT expects to obtain China’s first oral insulin approval 

Hefei Tianhui Incubator of Technologies Co. Ltd. (HTIT)’s NDA for recombinant human insulin capsule ORMD-0801 for type 2 diabetes is under review by the NMPA and, if approved, is expected to be the first oral insulin available in China, where regulators have been on the lookout for new treatment options for the increasingly common disease.

Chance Pharma licenses inhalable PD treatment from Acorda in $140M deal

Chance Pharmaceuticals Co. Ltd. acquired greater China rights to Inbrija (levodopa inhalation powder), used to manage Parkinson’s disease (PD), from Acorda Therapeutics Inc. in a deal worth as much as $140 million. Inbrija has received approval in Europe and the U.S. for treating adult patients with PD who experience intermittent motor fluctuations (known as “off” episodes) while being treated with a levodopa/dopa-decarboxylase inhibitor. Chance Pharma said there are no available treatments for the indication in the China market.

HELP is on the way to reforming PBM practices

The day after grilling top executives from the three largest pharmacy benefit managers (PBMs) in the U.S. about their business practices and the impact they have on prescription drug prices, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 18-3 today to favorably report the bipartisan PBM Reform Act to the full Senate. The bill would increase oversight of the industry, require PBMs to pass the rebates they receive from drug manufacturers to payers and prohibit spread pricing. The no votes may have stemmed from the ban on spread pricing, as a few committee members were wary of the unintended consequences should small businesses and labor unions be denied that option in setting up their health care plans. The committee also signed off on three other drug pricing-related bills that could be bundled with related legislation from other Senate committees.

BIO Korea 2023: Regulatory obstacles stall decentralized clinical trials in Korea

Keeping patients at the center of clinical trials is how the global pharma industry views decentralized clinical trials, but bureaucratic red tape from multiple agencies is preventing companies from deploying decentralized trials in South Korea, speakers said during the Bio Korea 2023 conference in Seoul on May 11. It seems an odd juxtaposition given digital leaders like Samsung are investing heavily in the life sciences space, and clinical investigators are trying to find workarounds that will allow them to use data in a way that can benefit patients. For the most part, Korea’s Ministry of Food and Drug Safety has made progress in ensuring that its regulations are on par with global regulators, but recent changes to cyber security laws and telemedicine regulations are keeping decentralized trials from becoming a reality on the Korean peninsula.

US House committee split on breakthrough device, drug pricing policies

A subcommittee of the U.S. House Ways and Means Committee met to review the status of policies for novel medical devices and drugs, but a partisan rift was immediately evident at the hearing. House Democrats were generally in favor of more drug price negotiation power for the federal government and opposed to immediate Medicare coverage of breakthrough medical devices while Republicans generally steered in the opposite direction, suggesting that drug and device makers should not expect clear legislative sailing over the course of the 117th Congress.

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