FDA
Excerpt from the Press Release: A Chester County biopharmaceutical company has submitted an application with the Food and Drug Administration to begin human testing of its experimental “antibody cocktail” as a Covid-19 treatment. Exton-based Immunome said Wednesday it expects its antibody cocktail, known as IMM-BCP-01, can neutralize the recently discovered omicron variant. “Immunome designed its…
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Lungs among most common site for metastatic tumors Excerpt from the Press Release: HAYWARD, Calif.–(BUSINESS WIRE)–RefleXion Medical, Inc., a therapeutic oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its biology-guided radiotherapy* (BgRT) for use in treating lung tumors. The breakthrough potential of BgRT lies…
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Excerpt from the Press Release: Pfizer said Friday that it can produce a COVID-19 vaccine for the new virus strain identified in South Africa in “approximately 100 days,” subject to government regulatory approval. The pharmaceutical firm said in a statement to CBS MoneyWatch that its researchers are now conducting tests to see if the company’s existing vaccine is effective…
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Excerpt from the Press Release: KENILWORTH, N.J. & MIAMI–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today provided an update on the MOVe-OUT study of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine for COVID-19. Data are now available from all enrolled participants (n=1433). In this…
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The interventional, multicenter, open-label Phase 2 basket trial will evaluate the safety and efficacy of milademetan in patients with MDM2-amplified advanced solid tumors Excerpt from the Press Release: NEWARK, Calif., Nov. 19, 2021 (GLOBE NEWSWIRE) — Rain Therapeutics Inc. (NasdaqGS: RAIN), (“Rain”), a late-stage company developing precision oncology therapeutics, today announced that the first patient…
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Primary endpoint data expected in Q1 2022 SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (“Better Therapeutics”; NASDAQ: BTTX), a prescription digital therapeutics company developing cognitive behavioral therapy to address the root causes of cardiometabolic diseases, today announced the completion of patient enrollment in its potentially pivotal study to evaluate the safety and efficacy of BT-001 for the…
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Excerpt from the Press Release: Every day, hundreds of thousands of new COVID-19 cases and thousands of new deaths are still being reported worldwide, creating a need for drugs that can combat the disease caused by SARS-CoV-2. Now, new research led by investigators at Harvard Medical School and Boston Children’s Hospital points to a well-known…
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New, Single-arm Phase 3 Study Expected to Initiate in Early 2022 Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, is announcing at its virtual Spotlight Event being held today that, following recent discussions with the…
Read More 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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