Oncology

FDA Approves Merck’s Keytruda for Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable …

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FDA Lifts Partial Clinical Hold on Innate Pharma’s Phase 2 Trial of Lacutamab in Advanced T-Cell Lymphomas

Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the lacutamab TELLOMAK Phase II clinical trial, evaluating the efficacy and safety of lacutamab (formerly IPH4102) in …

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New Publication Highlights Research Showing Potential to Enhance Cancer Treatment by Combining Novel Costimulatory Bispecific Antibodies with Libtayo

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced new scientific findings have been highlighted today in a Science Translational Medicine cover publication. The preclinical research in animal models found that combining Regeneron’s novel class of CD28 costimulatory bispecific antibodies with the anti-PD-1 therapy Libtayo® (cemiplimab) markedly enhanced anti-tumor activity in multiple cancer models, led to long-term T-cell memory …

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FDA Announces First of its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials

The U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has …

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AbbVie Submits sNDA to the FDA for Imbruvica in Combination with Rituximab in Waldenström’s Macroglobulinemia

NORTH CHICAGO, Ill., June 23, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) will review a supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia (WM), a rare and incurable type of …

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FDA Approves Karyopharm’s Xpovio for Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NEWTON, Mass., June 22, 2020 (GLOBE NEWSWIRE) — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved oral XPOVIO® (selinexor), the Company’s first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), …

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Gilead Sciences Secures Exclusive Option to Acquire Pionyr Immunotherapeutics

FOSTER CITY, Calif. & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) announced today that for $275 million the company will acquire a 49.9 percent equity interest in Pionyr Immunotherapeutics Inc., a privately held company developing first-in-class cancer immunotherapies, and an exclusive option to purchase the remainder of Pionyr. …

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Century Therapeutics to Acquire Empirica to Create Brain Cancer CAR-T Therapies

PHILADELPHIA–(BUSINESS WIRE)–Century Therapeutics today announced its acquisition of Empirica Therapeutics to leverage its iPSC-derived allogeneic cell therapies against glioblastoma (GBM). “We are pleased to welcome the Empirica team to the Century family. Their deep expertise and unique capabilities will allow us to accelerate efforts to develop iPSC derived immune effector cell …

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FDA Grants Fast Track Designation to Polynoma’s Melanoma Cancer Vaccine Seviprotimut-L

SAN DIEGO, June 23, 2020 /PRNewswire/ — Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L, its melanoma cancer vaccine …

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Thermo Fisher Scientific and Daiichi Sankyo to Co-Develop Global Companion Diagnostic for Patients with Non-Small Cell Lung Cancer

CARLSBAD, Calif., June 23, 2020 /PRNewswire/ — Thermo Fisher Scientific and Daiichi Sankyo have expanded their partnership by signing a new agreement to co-develop a companion diagnostic (CDx) that will utilize Thermo Fisher’s next-generation sequencing (NGS)-based Oncomine Dx Target Test. The CDx will be designed to identify non-small cell lung …

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