Cosette Pharmaceuticals and Alembic Pharmaceuticals Limited Announce the Approval and Launch of a National Brand Equivalent (NBE) of Abreva® (Docosanol Cream 10%) Including the First Approval in the Pump Format

BRIDGEWATER, N.J. & VADODARA, India–(BUSINESS WIRE)–#abreva–Cosette Pharmaceuticals, Inc (“Cosette”), in collaboration with Aleor Dermaceuticals, a wholly owned subsidiary of Alembic Pharmaceuticals (“Alembic”; BSE: 533573), announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for an NBE version of Abreva® (Docosanol cream 10%) in a 2 gm tube … [Read more…]

Alnylam Presents New Results from the ILLUMINATE-C Phase 3 Study of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1

– Lumasiran Demonstrated Evidence of Improvements in Exploratory Endpoints of Systemic Oxalosis, Including Echocardiographic Structure and Function, Nephrocalcinosis, and Kidney Stone Events – – Expands Upon Previously Reported Reductions in Plasma Oxalate in PH1 Patients with Severe Renal Impairment – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced new … [Read more…]

Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT04 and Reference Product Stelara®

The confirmatory clinical, safety and efficacy study for AVT04, biosimilar candidate to Stelara® (ustekinumab) met its primary endpoint AVT04 (ustekinumab) is part of a broader pipeline of Alvotech’s biosimilars and biosimilar candidates, which includes AVT02 (adalimumab), a biosimilar to Humira® Alvotech is the second company to announce positive top-line results from a patient study utilizing … [Read more…]

Edgility, Inc. Launches EdgeAi, a Breakthrough Explainable and Open-Box Artificial Intelligence to Accelerate Adoption

TAMPA, Fla.–(BUSINESS WIRE)–Edgility, Inc. launches EdgeAi as healthcare’s first operationally embedded AI with Explainability. EdgeAi exposes the internal mechanics of machine learning and deep learning systems in human-understandable terms. Trust in AI model predictions is paramount if care providers and administrators are to accept the decisions based on them. EdgeAi generates a standard label for … [Read more…]

Enhanced Healthcare Partners Adds Autism Therapy Provider Howard J. Chudler & Associates as Platform Investment

NEW YORK–(BUSINESS WIRE)–Enhanced Healthcare Partners (“EHP”), a leading private equity firm focused on investing in middle-market businesses in the healthcare sector, is pleased to announce its strategic investment in Howard J. Chudler & Associates (“HCA”), a behavioral therapy services provider for people with autism and intellectual and developmental disabilities. Founded in 1983, HCA is headquartered … [Read more…]

FDA Approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years

– EFFICACY: In the pivotal Phase 3 clinical trial program, VTAMA cream met all primary and secondary endpoints and demonstrated highly statistically significant improvement versus vehicle in Physician Global Assessment (PGA) score with 36% of patients versus 6% in vehicle in PSOARING 1 and 40% of patients versus 6% in vehicle in PSOARING 2 achieving … [Read more…]

United Therapeutics Announces FDA Approval of Tyvaso DPI™

First approval of a dry powder inhaler for treatment of PAH and PH-ILD DPI device represents a convenient option for administration of treprostinil therapy Commercial launch activities underway; patient availability expected in June 2022 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the … [Read more…]

CN Bio Appoints Dr Paul Brooks as Chief Business Officer

CAMBRIDGE, England–(BUSINESS WIRE)–CN Bio, a leading Organ-on-a-chip Company (OOC) that designs and manufactures single- and multi-organ microphysiological systems (MPS), today announced the appointment of Dr Paul Brooks as Chief Business Officer. Key to the next stage of the Company’s growth, Paul will be responsible for shaping the company’s commercial business strategy and leading the expansion … [Read more…]

Certific Expands Remote Testing Platform for UTI Patients

LONDON–(BUSINESS WIRE)–Digital disruptor in healthcare, Certific, expands its technology platform, enabling healthcare providers to undertake remote medical-testing, and scale the service to more patients. Starting with the launch of its Urinary Tract Infection (UTI) digital screening service, Certific’s process guides the patient through simple certified procedures, so that medical professionals can focus on more complex … [Read more…]

As Europe Becomes World’s Most Attractive Region for Digital Health, HIMSS Convenes Healthcare Community

LONDON–(BUSINESS WIRE)–HIMSS (Healthcare Information and Management Systems Society) is bringing together healthcare and IT leaders who are navigating an extraordinary opportunity to advance the digital transformation of Europe’s health systems. Major changes prompted by the COVID-19 pandemic — including billions of euros invested in healthcare modernization, national regulatory initiatives and the proposed EU legislation for … [Read more…]