Month: November 2021

Entera Bio Publishes Key Study Describing its Oral Delivery Technology Platform for Biologic Drugs

11/02/2021

‒Study describes a dual mechanism of action approach to oral drug delivery of large molecules, the “Holy Grail” of drug development. ‒Technology is utilized in Entera’s EB613 oral PTH drug for osteoporosis and several other molecules now in development by Entera and in collaboration with pharmaceutical companies. Excerpt from the Press Release: BOSTON and JERUSALEM,…

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Samsung Receives FDA Clearance for AI Algorithms that Detect Lung Nodules in Chest X-rays

11/02/2021

Chest radiograph without Auto Lung Nodule Detection (ALND) and chest radiograph with lung nodule marked. (Photo: Business Wire) Excerpt from the Press Release: DANVERS, Mass.–(BUSINESS WIRE)–NeuroLogica Corp. today announced it has received Food and Drug Administration (FDA) 510(k) clearance for its Auto Lung Nodule Detection (ALND) tool. The offering provides an on-device, computer-assisted detection (CADe)…

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Data from Phase 1/2a study of RM-1929 Photoimmunotherapy in Patients with Recurrent Head and Neck Squamous Cell Carcinoma was Published in Head and Neck

11/02/2021

Excerpt from the Press Release: SAN MATEO, Calif., Oct. 27, 2021 /PRNewswire/ — Rakuten Medical, Inc. (Rakuten Medical) announced that data from a phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) (RM-1929-101 study, ClinicalTrials.gov Identifier: NCT02422979) was accepted for publication in Head and Neck and published online on October 9th, 2021.…

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HUYABIO Announces FDA Clearance to Initiate a Phase 1 Trial of SHP2 Inhibitor in Patients with KRAS and EGFR Mutated Tumors

11/01/2021

Excerpt from the Press Release: SAN DIEGO, Oct. 28, 2021 /PRNewswire/ — HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the FDA clearance of HBI-2376 as an Investigational New Drug, or IND, for a Phase 1 study. The authorization to proceed enables the first testing in patients for whom…

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Gilead Announces Clinical Trial Collaboration With Merck to Evaluate Trodelvy® (sacituzumab govitecan-hziy) in Combination With KEYTRUDA® (pembrolizumab) in Patients With First-Line Metastatic Triple-Negative Breast Cancer

11/01/2021

Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 28, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) to evaluate the efficacy of Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy® (sacituzumab govitecan-hziy) in…

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BridgeBio Pharma Announces Collaborations with Columbia University and Mount Sinai to Develop Potential Therapies for Genetic Diseases and Cancers

11/01/2021

– The new agreements mean BridgeBio has collaborations with 25 leading academic institutions focused on genetic disease and precision oncology Excerpt from the Press Release: PALO ALTO, Calif., Oct. 29, 2021 /PRNewswire/ — BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced two new academic collaborations with Columbia University…

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