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Home » Topics » Regulatory

Regulatory
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Pills, bottle atop $100 bill

HELP is on the way to reforming PBM practices

May 11, 2023
By Mari Serebrov
A 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 May 11 to favorably report the bipartisan PBM Reform Act to the full Senate.
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Immunitybio’s bladder cancer candidate hit with a CRL

May 11, 2023
By Lee Landenberger
The U.S. FDA issued a complete response letter regarding the BLA for Immunitybio Inc.’s bladder cancer treatment, N-803 (Anktiva), halting the drug’s development and slicing the stock value in half. The problems stem from the FDA’s pre-license inspection of Immunitybio’s third-party contract manufacturing organizations, the company said. It said the FDA also had recommendations for specific chemistry, manufacturing and controls issues and assays that needed to be resolved before the BLA can be approved.
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BIO Korea 2023: Regulatory obstacles stall decentralized clinical trials in Korea

May 11, 2023
By Tamra Sami
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.
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HTIT oral insulin capsule

HTIT expects to obtain China’s first oral insulin approval

May 11, 2023
By Doris Yu
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.
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Elderly man with clenched hands holding head

US FDA approves Rexulti as first drug for agitation in Alzheimer’s dementia

May 11, 2023
By Tamra Sami and Karen Carey
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 dementia, marking the first approved treatment for the indication.
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Regulatory actions for May 11, 2023

May 11, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations:  AB, Astrazeneca, Biophytis, Chiesi, Eli Lilly, Hemogenyx, Lighthouse, Minerva, Protalix, Servier, Theravance.
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Regulatory actions for May 10, 2023

May 10, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sibel Health.
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LSX World Congress

European med-tech companies first looking to the US as EU MDR ‘not working’

May 10, 2023
By Shani Alexander
An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
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Doctor examining child in wheelchair

Adcom briefing docs mixed; will FDA see Sarepta’s ‘grander vision’ in DMD gene therapy?

May 10, 2023
By Randy Osborne
How grave they might be remains unknown, but regulatory questions have surfaced in briefing documents related to the soon-to-happen panel meeting on Sarepta Therapeutics Inc.’s gene transfer therapy delandistrogene moxeparvovec in Duchenne muscular dystrophy (DMD). The U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet May 12 to discuss the compound, also known as SRP-9001.
Read More
Alpha-galactosidase enzyme

Protalix, Chiesi win US go-ahead for Elfabrio in Fabry disease

May 10, 2023
By Randy Osborne
On the heels of the marketing OK in Europe, Protalix Biotherapeutics Inc. and the Chiesi Group’s global rare diseases unit scored approval of Elfabrio (pegunigalsidase alfa-iwxj) from the U.S. FDA for adults with Fabry disease.
Read More
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