Industry

On Track to Dose the First Patient in the Phase 1 Study Evaluating Belzupacap Sarotalocan (AU‑011) for the Treatment of Non-Muscle Invasive Bladder Cancer in Q3 2022 On Track to Initiate Pivotal Trial in Early-Stage Choroidal Melanoma in Q4 2022 BOSTON–(BUSINESS WIRE)–Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of … [Read more…]

Signs Supply Agreement and Receives First Commercial Purchase Order from Top-Tier Medtech Company for Bioptx™ Baseline Band, Targets Fourth Quarter to Begin Shipping Signs First Contract Research Organization Partnership to Develop and Evaluate Rockley’s Bioptx™ Biomarker Sensing Platform for Use in Clinical Trials Bolsters Board of Directors and Establishes Scientific Advisory Board OXFORD, England & … [Read more…]

— Full data support the potential of obicetrapib to address unmet medical need for millions of patients who cannot achieve their LDL-C targets with high-intensity statin therapy (HIS) alone — — Treatment with obicetrapib in patients on high-intensity statin therapy was observed to have statistically significant impact on LDL-C, as well as significant impacts on … [Read more…]

˗ ALBRIOZA™ (also known as AMX0035) now commercially available in Canada, representing first product launch for Amylyx ˗ FDA Advisory Committee meeting to review new drug application for AMX0035 for the treatment of ALS scheduled for September 7, 2022; assigned PDUFA action date of September 29, 2022; U.S. commercial team now launch ready ˗ Marketing … [Read more…]

Company Remains on Track for FDA Submissions of the HeartBeam AIMI™ Software Platform for the Emergency Department in Q3 2022 & AIMIGo™, the Telehealth Solution, in Q4 2022 Acquires Source Code Access Under the LivMor Partnership Agreement that will be Used to Build a Company-branded Version of the LIVMOR’s Halo+ FDA Cleared Turnkey Solution for … [Read more…]

Announced positive topline results from the MISSION Phase 2 Trial evaluating zetomipzomib for the treatment of patients with lupus nephritis Appointed Nick Mordwinkin, Pharm.D., Ph.D. as Chief Business Officer Cash, cash equivalents and marketable securities totaled $306.8 million as of June 30, 2022 SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage … [Read more…]

– Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved for children as young as five years of age – – The FDA also approved Xofluza to prevent influenza in children aged five and older following contact with an infected person – SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, … [Read more…]

BOSTON–(BUSINESS WIRE)–NextRNA Therapeutics, a biotechnology company unlocking the potential of non-coding RNAs to develop novel and transformative therapeutics, announces the appointment of Dominique Verhelle, PhD, MBA as the Chief Executive Officer. Dominique is a co-founder of NextRNA who has led the scientific and corporate strategy since its launch over the past year and a half. … [Read more…]

MADISON, Wis.–(BUSINESS WIRE)–Lumicera Health Services, a specialty pharmacy wholly owned by Navitus Health Solutions, announced today that it will be offering abiraterone acetate 250 mg tablets – the first landmark generic drug made available by CivicaScript™. Availability of this new generic medicine through Lumicera expands access for patients to clinically-proven, cost-effective drugs. Abiraterone, which is … [Read more…]

SAN DIEGO–(BUSINESS WIRE)–Cullgen Inc., a leading biotechnology company developing targeted protein degraders based on its proprietary uSMITE™ platform technology, today announced that the Chinese National Medical Products Administration (NMPA) has allowed the Investigational New Drug (IND) application for CG001419, a TRK degrader for the treatment of solid tumors. CG001419 is a first-in-class, selective, potent oral … [Read more…]