FDA

Pfizer testing its vaccine against new COVID-19 strain

12/03/2021

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

Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19

11/29/2021

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

Rain Therapeutics Doses First Patient in Phase 2 Basket Trial of Milademetan for MDM2-Amplified Advanced Solid Tumors (MANTRA-2)

11/26/2021

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…

Read More

Better Therapeutics Completes Enrollment of Pivotal Trial for BT-001, a Prescription Digital Therapeutic for Type 2 Diabetes

11/24/2021

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…

Read More

Disulfiram, a treatment for alcoholism, may cut severe SARS-CoV-2 infection, reduce likelihood of dying from COVID-19

11/22/2021

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…

Read More

UroGen Pharma Unveils New Phase 3 Development Plan for UGN-102 at Spotlight Event

11/19/2021

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

Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years

11/10/2021

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,…

Read More

Synthekine Advances IL-2 Partial Agonist, STK-012, into Clinical Investigation for Treatment of Solid Tumors

11/03/2021

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,…

Read More

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)…

Read More

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…

Read More