FDA
COVAXIN™ (BBV152) was recently awarded Emergency Use Listing by the World Health Organization Pediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralizing antibody response as seen in a large adult Phase 3 clinical trial conducted in India COVAXIN™ (BBV152) uses same Vero Cell manufacturing platform as other childhood vaccines,…
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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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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 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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Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita™ platform to detect pancreatic ductal adenocarcinoma earlier in high-risk adults Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Biological Dynamics, Inc., a multiomics liquid biopsy company focused on detecting cancers at the earliest stages, today announced that the U.S. Food…
Read More Emergency Use Authorization (EUA) granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups FDA also authorized the use of Moderna’s booster dose following primary vaccination with other authorized or approved COVID-19 vaccines Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering…
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“Pre-IPO” Biotech Startup Kills Advanced Stage Breast Cancers; Accepts Global Crowdfunding Investors
Excerpt from the Press Release: SAN FRANCISCO, Oct. 14, 2021 /PRNewswire/ — In recognition of Breast Cancer Awareness Month, DeoBioSciences, Inc. (“DBS”), a minority/female founded, preclinical stage, biotech company, is highlighting its impressive research results against several types of treatment-resistant breast cancer. DeoBioSciences’ drug candidate, DBX-31, can selectively target and kill a wide range of tough, treatment-resistant, advanced…
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Excerpt from the Press Release: Agilent Technologies Inc. (NYSE: A) today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered. This…
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– VRDN-001 program remains on track for key proof of concept clinical data in Thyroid Eye Disease patients in the second quarter of 2022 – Excerpt from the Press Release: WALTHAM, Mass., Oct. 14, 2021 (GLOBE NEWSWIRE) — Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company advancing new treatments for patients suffering from serious diseases…
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Excerpt from the Press Release: SAN FRANCISCO, Sept. 29, 2021 /PRNewswire/ — Phil, Inc. announces partnership with Impel NeuroPharma, Inc. (NASDAQ: IMPL) in support of Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) to provide technology-powered patient support and distribution services through Phil’s proprietary workflow to enhance the patient’s access to therapy. Trudhesa is indicated for the acute treatment of…
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