The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
RubrYc Therapeutics, Inc., a biotherapeutics discovery business, announced today it has closed a $10 million Series A Preferred Equity financing round led by Third Point Ventures, with participation by Paladin Capital Group and Vital Venture Capital.
Boehringer Ingelheim, headquartered in Ingelheim, Germany, and OSE Immunotherapeutics, based in Nantes, Frances, signed a collaboration and license deal to jointly develop OSE-172 for myeloid cancers.
Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival (PFS), which is a secondary endpoint. Results from KEYNOTE-042 will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.
The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
The EMA has kicked off its review of Sanofi and Regeneron’s immuno-oncology drug cemiplimab, which is aiming to become the sixth drug in the PD-1/PD-L1 inhibitor class to reach the market.
European regulators have agreed to review Sanofi and Regeneron’s Dupixent for asthma and cemiplimab for advanced cutaneous squamous cell carcinoma.
Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for lanadelumab (SHP643) and also reports that Health Canada has completed screening and accepted the New Drug Submission (NDS) under Priority Review for this investigational compound.
Sequoia China has powered Adagene to a $50 million series C round. The investment positions the Chinese antibody discovery shop to move the most advanced assets in its oncology pipeline into human testing.
Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer
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