Entries by Business Wire

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FDA Approves Merck’s Keytruda as Adjuvant Treatment for Adult and Pediatric Patients With Stage IIB or IIC Melanoma Following Complete Resection

The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA expanded the indication for Keytruda as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (12 years and older).

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Real Chemistry Founder and Chief Executive Officer Jim Weiss to Become Chairman and Shankar Narayanan to Become Chief Executive Officer

Real Chemistry, a leading provider of data-driven, tech-enabled communication and marketing solutions for the health care sector, announced Founder and Chief Executive Officer Jim Weiss will become chairman and Shankar Narayanan will become chief executive officer and a member of the board of directors effective January 3, 2022. In addition to his role as chairman and founder of Real Chemistry, Weiss will join New Mountain Capital (NMC), Real Chemistry’s investment partner, as an executive advisor.

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Gilead Submits Biologics License Application to U.S. FDA for Bulevirtide

Gilead Sciences Inc. announced the submission of a Biologics License Application to the U.S. Food and Drug Administration for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease; bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA.

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FDA Advisory Committee Recommends Use Maribavir to Treat Post-Transplant Recipients with CMV Infection and Disease Refractory to Treatment With or Without Resistance

The U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of Takeda Pharmaceutical Company Limited’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease withgenotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

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Bristol Myers Squibb Receives European Commission Approval for Abecma

The European Commission granted Conditional Marketing Authorization for Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel) – a first-in-class B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy – for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

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Opdivo in Combination with Cabometyx Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced RCC

Bristol Myers Squibb and Exelixis announced results from new analyses from the pivotal Phase 3 CheckMate -9ER trial, demonstrating clinically meaningful, sustained efficacy benefits as well as quality of life improvements with the combination of Opdivo (nivolumab) and Cabometyx (cabozantinib) compared to sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC).