Industry News

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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Helixmith Announces Phase 3 Study Results of Novel Gene Therapy Treatment for Diabetic Foot Ulcers at 2021 Annual Meeting of Diabetic Foot Ulcer Conference (DFCon)

10/29/2021

Data indicate that gene therapy appears to be effective, particularly in neuroischemic ulcers Excerpt from the Press Release: SAN DIEGO, Oct. 22, 2021 /PRNewswire/ — Helixmith, a gene therapy company based in Seoul, Korea and San Diego, CA, announced today the results of a Phase 3 study for the treatment of diabetic foot ulcers with their novel gene therapy VM202 (Engensis)…

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San Diego scientists are working on a vaccine against all coronaviruses. Yes, all of them

10/29/2021

Scientists at La Jolla Institute for Immunology received $2.6 million as part of a larger effort to develop protective shots against past, present and future coronaviruses. Excerpt from the Press Release: SARS. MERS. COVID-19. Coronaviruses caused all three diseases, and scientists are betting other members of this viral family will cause new outbreaks. But what…

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Agilent PD-L1 IHC 28-8 pharmDx Receives CE-IVD Mark as a Companion Diagnostic Test in Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

10/29/2021

Excerpt from the Press Release: Agilent Technologies Inc. (NYSE: A) today announced it has received CE-IVD mark approval for the PD-L1 IHC 28-8 pharmDx to guide options for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers. Gastric (stomach) cancer is the fifth most common cancer and the…

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ALX Oncology Announces First Patient Dosed in ASPEN-05, a Phase 1/2 Study of Evorpacept in Combination with Venetoclax and Azacitidine in Patients with Acute Myeloid Leukemia

10/28/2021

Second study of evorpacept in patients with myeloid malignancies Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Oct. 21, 2021 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the first patient has been dosed in the Phase…

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LIGAND AND CR DOUBLE-CRANE ENTER COLLABORATION AGREEMENT TO DEVELOP AN ORAL COVID-19 THERAPEUTIC USING LIGAND’S BEPRO TECHNOLOGY™

10/28/2021

BEPro is a novel prodrug technology to enhance oral delivery of active nucleotides Excerpt from the Press Release: EMERYVILLE, Calif.–(BUSINESS WIRE)– Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced the signing of a collaboration agreement granting China Resources Double-Crane Pharmaceutical Co., Ltd. (CRDC) exclusive Asia territorial rights to develop a novel investigational oral COVID-19 antiviral therapeutic compound using…

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