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Two drugs, Miplyffa (arimoclomol) and Aqneursa (levacetylleucine), have been approved by FDA to treat neurological symptoms associated with Niemann-Pick disease, type C in adults and children.

FDA Approves Treatments for Niemann-Pick Disease, Type C

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

Hatch-Waxman Amendments Turn 40

Feliza Mirasol is the science editor for 

Lonza signed a long-term supply agreement to manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

Lonza and Vertex Enter Commercial Supply Agreement for CASGEVY, the Sickle Cell Disease Gene-Edited Cell Therapy

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

The next-generation IRO platform was found to significantly outperform the legacy Prodigy system, showing improvements in cell growth, CAR+ cell yield, and overall efficiency.

Ori Biotech, Charles River Cell Therapy Manufacturing Platform Collaboration Yields Promising Results

The agency is recommending the extension of the smallpox and mpox vaccine, Imvanex, to adolescents aged 12 to 17.

EMA Recommends Mpox Vaccine for Adolescents

The approval of EBGLYSS (lebrikizumab-lbkz) by FDA puts a new biologic treatment for moderate-to-severe atopic dermatitis on the market for patients whose symptoms are not well controlled with topical treatments.

Lilly’s EBGLYSS Offers New First-Line Biologic Treatment for Atopic Dermatitis Following FDA Approval

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

EMA Gives Approval to Several Cancer Treatments

The announcement of the pairing comes several months after Adare Pharma Solutions said it would upgrade several of its facilities, including in Milan, Italy, where the 3D printing operations will be located.

Adare, Laxxon to Collaborate on 3D-Printed Oral Dosage Forms

Vectura’s expertise in the field includes formulation and device development for dry powder inhalers and pressurized metered dose inhalers, among other products and services.

Phillips Medisize to Acquire Vectura, Expanding Inhalation Drug Delivery Capabilities

The collaboration is designed to combine NanoVation Therapeutics’ lipid nanoparticle technology for RNA delivery to cells outside the liver with Novo Nordisk’s knowledge of cardiometabolic and rare disease R&D.

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