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…
Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). It is indicated in Japan in combination with C5 inhibitor therapy when patients have had an insufficient response to such C5 inhibitors.1 Voydeya is a first-in-class, oral, Factor…
ICON plc, (NASDAQ: ICLR) a world-leading healthcare intelligence and clinical research organisation, today launched its “Optimising biotech funding” whitepaper. This provides an overview of the current state of play for biotech companies and the research and development (R&D) strategies they can…
AbbVie (NYSE: ABBV) today announced Phase 2 results showing adults with moderate to severe hidradenitis suppurativa (HS) who had previously failed anti-TNF therapy who received lutikizumab (ABT-981) 300 mg every other week or 300 mg weekly achieved higher response rates…
Novo Nordisk today announced topline results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. COMBINE 3 was a 52-week, open-label treat-to-target trial comparing the efficacy and safety of once-weekly…
Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that it is initiating GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase 2 trial of AB-1002 (also known as NAN-101)…