FDA
Excerpt from the Press Release: SAN CARLOS, Calif.–(BUSINESS WIRE)–Glycomine, Inc., a biotechnology company focused on developing new therapies for orphan diseases, today announced that the company has received U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for GLM101 for the treatment of PMM2-CDG and has initiated dosing healthy volunteers…
Read More
Only antibody authorized in the US for pre-exposure prophylaxis of COVID-19 Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s EVUSHELD (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, retained neutralizing activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new preclinical data. In this study,EVUSHELD’s Inhibitory Concentration 50 (IC50), a measure…
Read More
– Microbiome data demonstrate the successful engraftment of SER-287 – – Microbiome assessments suggest potential for biomarker-based patient selection – – Company continues to evaluate SER-287 study data, and available preliminary SER-301 Phase 1b study clinical and microbiome data, to inform plans for continued development in ulcerative colitis – Excerpt from the Press Release: CAMBRIDGE,…
Read More
Data demonstrated ONA-XR decreased proliferation in tumors with high PR+ at baseline in early breast cancer Two additional metastatic breast cancer clinical trials in progress also presented Excerpt from the Press Release: PHILADELPHIA, Dec. 09, 2021 (GLOBE NEWSWIRE) — Context Therapeutics Inc. (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments for…
Read More
NRx and Hungary Agree on Regulatory Path for Emergency Use of ZYESAMI Hungary to Serve as First European Nation for the Registrational Phase 2b/3 BriLife COVID Vaccine Trial Excerpt from the Press Release: BUDAPEST, Hungary, Dec. 09, 2021 (GLOBE NEWSWIRE) — NRx Pharmaceuticals (NASDAQ: NRXP) today announced the conclusion of high-level meetings in Hungary that are expected to…
Read More
– Trial to evaluate antigen suppression combined with immunomodulation as a functional cure regimen for chronic HBV – Excerpt from the Press Release: SAN FRANCISCO, Dec. 09, 2021 (GLOBE NEWSWIRE) — Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating novel therapeutic combinations…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More