Industry

Biolexis and Akston Biosciences Announce Encouraging Top-Line Results from Phase II/III Trial of their Thermostable 2nd Gen COVID-19 Vaccine

Results of 100 subjects bridging study and 1,500 subjects placebo-controlled trial of Akston’s AKS-452 announced. Interim analysis shows a 91% seroconversion rate. Statistically-significant high antibody titers were maintained for six months in the bridging study. The vaccine was well tolerated, with no significant safety issues reported. AKS-452 is shelf-stable for over six months at room … [Read more…]

Investigational Lenacapavir Receives Positive CHMP Opinion for People With Multi-Drug Resistant HIV

– Recommendation is Based on Week 26 Data from the CAPELLA Trial Showing Twice-Yearly Lenacapavir Achieved High Rates of Virologic Suppression in Heavily Treatment-Experienced People with HIV – – If Authorized, Lenacapavir Could Offer a New, Every Six-Month Treatment Option for People with Limited Treatment Choices – FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) … [Read more…]

Clue Genetics Inc. appoints Dr. Peter P. Repetti as VP of Research

ALAMEDA, Calif.–(BUSINESS WIRE)–Clue Genetics Inc. (Clue) is pleased to announce the appointment of Dr. Peter P. Repetti as its Vice President of Research. He will oversee development of Clue’s foundational platform of intellectual property centered on fungal genomes and will lead the company’s research initiatives in metabologenomics. Dr. Repetti is an expert in molecular biology … [Read more…]

Mirum Pharmaceuticals Highlights Data Demonstrating Impact of LIVMARLI® (maralixibat) on Patients with Alagille Syndrome at European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Annual Meeting

– Six-year natural history comparison with maralixibat demonstrates event-free and transplant-free survival in patients with Alagille syndrome – Maralixibat data highlighting predictors of event-free survival in patients with Alagille syndrome nominated for prestigious Alex Mowat Prize – New analysis further characterizes 4-year growth improvement in Alagille syndrome, as well as reports on real world experience … [Read more…]

Harrow Health Announces Launch of IOPIDINE® 1% and MAXITROL® in the United States

NASHVILLE, Tenn.–(BUSINESS WIRE)–Harrow Health, Inc. (NASDAQ: HROW), an ophthalmic‑focused healthcare company, today announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) of recently acquired, FDA-approved ophthalmic medicines, IOPIDINE® 1%, MAXITROL® 3.5mg/10,000 units/0.1%, and MOXEZA® 0.5%. Harrow also announced that IOPIDINE 1% and MAXITROL are now commercially available; Harrow intends to … [Read more…]

Janssen Receives Positive CHMP Opinion for IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the efficacy and safety of ibrutinib plus venetoclax in patients with previously untreated CLL1,2 If approved, this will be the first all-oral, once daily, fixed-duration, combination regimen for first-line treatment of CLL BEERSE, Belgium–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies … [Read more…]

Can-Fite’s CF602 Reverses Erectile Dysfunction in Diabetic Pre-clinical Model: Study Published in Peer-Reviewed Journal Andrologia

CF602’s unique mechanism of action enables potential treatment of diabetic patients and may offer an alternative to PDE5 (Viagra, Cialis, Levitra, and Stendra) non-responders accounting for 30-35% of the $3.6 billion ED market Patents granted in numerous healthcare markets including the U.S., Australia, and Japan PETACH TIKVA, Israel–(BUSINESS WIRE)–$CANF—Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: … [Read more…]

Flow Beverage Corp. Announces Official Sponsorship with Pride Toronto

Flow sponsorship with Pride Toronto promotes both sustainable and healthy choices for consumers TORONTO–(BUSINESS WIRE)–Flow Beverage Corp. (TSX:FLOW; OTCQX:FLWBF) (“Flow” or the “Company”) today announced its official sponsorship of Pride Toronto, participating in various events throughout June to help inspire people to make more sustainable and healthy choices for themselves and the planet. Flow will … [Read more…]

 Tigerlily Foundation and Labcorp Collaborate to Increase Clinical Trial Diversity for Women of Color

BURLINGTON, N.C. & ALDIE, Va.–(BUSINESS WIRE)–Labcorp, a leading global life sciences company, and Tigerlily Foundation (Tigerlily), a leading breast cancer patient advocacy organization, today announced a new collaboration to increase clinical trial diversity for women of color and co-create health equity solutions. Labcorp has signed Tigerlily’s #InclusionPledge for Black Women, joining other healthcare and life … [Read more…]

European Commission Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Adolescent Patients (≥12 Years of Age) With Stage IIB or IIC Melanoma Following Complete Resection

Approval based on recurrence-free survival and distant metastasis-free survival benefit demonstrated by KEYTRUDA in the Phase 3 KEYNOTE-716 trial KEYTRUDA is the first anti-PD-1 immunotherapy approved in the EU for patients 12 years and older as adjuvant treatment across stage IIB, IIC and III melanoma following complete resection and for the treatment of advanced (unresectable … [Read more…]