Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a pioneer in precision genetic medicine for rare diseases, has announced today that the U.S. Food and Drug Administration (FDA) has accepted and filed the Company’s efficacy supplement to the Biologics License Application (BLA) for…
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) has revealed that the anti-CD20/CD3 bispecific antibody mosunetuzumab has successfully met the primary endpoint of achieving a complete response rate (CRR) in an expansion cohort within the Japanese Phase I study. This study aimed…
Encouraging Outcomes in Japan Phase III Trial of Acoramidis for Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM) Consistent with Global ATTRibute-CM Phase III Trial Positive high-level results from the Japan Phase III trial of acoramidis in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) showed…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).1,2 Whereas available RVO treatments are…
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, and Pierre Fabre Laboratories, a global player in oncology and responsible for worldwide…
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) has reported positive outcomes from its Phase 3 program for VX-548, a selective NaV1.8 inhibitor, designed to address moderate-to-severe acute pain. The Phase 3 program encompassed two pivotal trials following abdominoplasty and bunionectomy surgery, as…
Bristol Myers Squibb (NYSE: BMY) has received regulatory acceptance from both the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for Breyanzi® (lisocabtagene maraleucel). In the U.S., the FDA accepted two supplemental Biologics…
Bayer today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) accepted the submission of an application for regulatory approval of aflibercept 8 mg for the treatment of neovascular (wet) age-related macular degeneration (nAMD).…
Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL) today announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo® (nivolumab) in combination with CABOMETYX® (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). Results continued to show…
Akouos, Inc., a wholly owned subsidiary of Eli Lilly and Company (NYSE: LLY), today announced positive initial clinical results from the Phase 1/2 AK-OTOF-101 study, which demonstrated pharmacologic hearing restoration within 30 days of AK-OTOF administration in the first participant, an individual…
Positive results from the EMERALD-1 Phase III trial showed AstraZeneca’s IMFINZI®(durvalumab) in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) compared to TACE alone in patients with…
Positive results from the EMERALD-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) compared to TACE alone in patients with hepatocellular…