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Regulatory
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Samsung Bioepis building

Samsung Bioepis wins nod for Korea’s first Stelara biosimilar

April 12, 2024
By Marian (YoonJee) Chu
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
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Multiple myeloma cells in the bone marrow.

FDA adcom backs MRD as new endpoint in multiple myeloma trials

April 12, 2024
By Lee Landenberger
By a unanimous 12-0 vote, the U.S. FDA’s Oncologic Drugs Advisory Committee concluded that new evidence support the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma (MM) clinical trials. The FDA will now consider the recommendation, which, if incorporated into future studies, could dramatically shorten some drug developer timelines and offer more options for treating the aggressive bone marrow cancer.
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CMS logo and website

US CMS eyes new cutoff date for new tech add-on payments

April 12, 2024
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services has proposed a few significant changes to the new technology add-on program for the fiscal year 2025 inpatient prospective payment system, including a boost in NTAP rates for gene therapy services.
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Blood cells and bacteria

Sepsis: FDA greenlights Prenosis rapid test, Bosch/Randox aim for another

April 12, 2024
By Annette Boyle
Prenosis Inc. gained U.S. FDA de novo marketing authorization for an artificial intelligence-powered rapid diagnostic tool for sepsis, one of the most challenging and deadly conditions in hospitals and reported a distribution agreement with Roche Holding AG. Another pairing also made progress in developing a sepsis in vitro diagnostic this week, as Bosch Healthcare Solutions GmbH and Randox Laboratories Inc. joined forces and committed €150 million (US$159.63 million) to the effort.
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3d illustration of human body muscle tissue anatomy
Musculoskeletal

FDA grants orphan drug designation to BLR Bio candidate for systemic sclerosis

April 12, 2024
BLR Bio LLC announced that the U.S. FDA has granted orphan drug designation to BLR-200, the company’s investigational therapy for the treatment of systemic sclerosis (SSc).
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Cancer

FDA clears IND for Lamassu Biotech’s SA53-OS

April 12, 2024
Lamassu Biotech Inc. has announced that its IND for SA53-OS has been cleared by the FDA in the U.S. The planned phase I/IIa trials will investigate the genetically targeted therapy that blocks the MDM2 protein, a key regulator of the tumor suppressor p53 gene.
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Vaccine target
Infection

Soligenix’s vaccine for Sudan ebolavirus granted orphan drug designation in US

April 12, 2024
The FDA has granted orphan drug designation to the active ingredient in Soligenix Inc.’s Suvax, a subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for the prevention and post-exposure prophylaxis against SUDV infection. SUDV is a type of ebolavirus for which there is no current treatment or vaccine.
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Regeneron hit with fraud claims for credit card subsidies

April 11, 2024
By Mari Serebrov
With credit card fees taking a sizable bite of their billings, many U.S. health care providers are fighting back by offering patients cash discounts. But when a drug company covers card processing fees for its distributors to pass on to their provider clients so they can pay for so-called “buy-and-bill” Medicare Part B drugs with a credit card at cash prices, it’s fraud if those concessions aren’t figured into the drug’s average sales price – at least that’s what the U.S. Department of Justice is claiming in a complaint it released April 10 against Regeneron Pharmaceuticals Inc.
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Injection pens and measuring tape

China advances semaglutide biosimilars, Jiuyuan seeks NMPA nod

April 11, 2024
By Marian (YoonJee) Chu
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
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Architectural pillars

Edwards comes up short in US case testing Hatch-Waxman safe harbor

April 11, 2024
By Mark McCarty
The Hatch-Waxman Act provides a safe harbor that allows importation of an FDA-regulated article that would otherwise be deemed a case of patent infringement so long as the importation is for purposes reasonably related to obtaining regulatory approval. Edwards Lifesciences Corp. sued Meril Life Sciences Pvt Ltd. for importation of heart valves in a manner that Edwards argued was infringement under Hatch-Waxman, but while the Federal Circuit ruled 2-1 against Edwards, the dissenting opinion recommended an appeal to a full 12-judge panel that could reverse this outcome.
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