FDA approvals once again fill out our list for the most read news stories on American Pharmaceutical Review. Catch up with all the latest news – watch the PharmaFlash
The FDA has granted approval for a prescription nasal spray designed to reverse opioid overdoses. The nasal spray, called OpiXio, contains naloxone, a medication that rapidly reverses the effects of opioid overdose. This approval marks an important development in combating the opioid crisis, as the nasal spray can be easily administered by bystanders or caregivers without any medical training. OpiXio's availability as a prescription medication provides a convenient and potentially life-saving tool for addressing opioid overdoses in emergency situations.
Epkinly (epcoritamab-bysp) injection has received FDA approval as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This includes DLBCL cases that are not otherwise specified and those arising from indolent lymphoma and high-grade B-cell lymphoma. The FDA's decision provides a new option for patients who have not responded to previous treatments or have experienced relapses. Epkinly is an antibody-drug conjugate that targets CD20, a protein found on the surface of B-cells, and delivers a cytotoxic agent directly to cancer cells, potentially improving outcomes for DLBCL patients.
The FDA has granted approval for the first oral antiviral medication to treat COVID-19 in adults. The drug, called Xevudy (molnupiravir), is taken by mouth and is designed to be used early in the course of the disease, within five days of symptom onset. Clinical trials have shown that Xevudy can significantly reduce the risk of hospitalization or death in high-risk individuals with mild to moderate COVID-19. This oral antiviral represents a significant milestone in the fight against COVID-19, offering a convenient and accessible treatment option for patients outside of a hospital setting.
Catalent has expanded its capabilities in Shiga, Japan to support the growing demand for cell and gene therapy. The company has added cryogenic storage and distribution capabilities to its facility, allowing for the safe and efficient handling of sensitive biological materials. This expansion enables Catalent to provide end-to-end solutions for cell and gene therapy clients, from development to commercialization. The investment in cryogenic capabilities in Japan reflects the increasing importance of cell and gene therapies and Catalent's commitment to meeting the evolving needs of the industry.
Ubrigene, a cell and gene therapy CDMO has acquired a of a state-of-the-art GMP manufacturing facility from Mustang Bio, Inc. strengthening its manufacturing capabilities and its position in the cell and gene therapy market. The acquisition will enable the company to offer a broader range of services to its clients, including process development, manufacturing, and commercialization support. This strategic move underscores the growing importance of cell and gene therapies and the Ubrigene’s commitment to meeting the industry's increasing demands.