News & Updates
Meissa’s intranasal recombinant live attenuated COVID-19 vaccine, MV-014-212, induced a strong nasal IgA antibody response in seropositive and seronegative adults Safety data show that MV-014-012 is highly attenuated, with no serious adverse events reported and no infectious vaccine virus detected from any participants to date MV-014-212 was built on the company’s AttenuBlock™ platform and is…
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Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Synthekine Inc., an engineered cytokine therapeutics company, today announced it is advancing its IL-2 partial agonist, STK-012, into clinical investigation following clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). Synthekine will evaluate STK-012 in a Phase 1a/1b, open-label, multi-center,…
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‒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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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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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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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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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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– 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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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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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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