Clinical News-CliniExpert

Voluntary Withdrawal of Imfinzi Indication in Advanced Bladder Cancer in the US

22 February 2021 -- AstraZeneca today announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic blad

Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women

TOKYO, Feb. 19, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503) (President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline results from the Phase 3 pivotal

Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate

NEW BRUNSWICK, N.J., February 19, 2021 -- Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Hea

Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA

NEW YORK and MAINZ, GERMANY, February 19, 2021 -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to the U.S. Food and Drug Administration (FDA) demon

Novavax Announces Memorandum of Understanding with Gavi for Cumulative Supply to COVAX Facility of 1.1 Billion Doses of COVID-19 Vaccine

GAITHERSBURG, Md., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a Memora

Pfizer and BioNTech Commence Global Clinical Trial to Evaluate COVID-19 Vaccine in Pregnant Women

New York, USA and Mainz, Germany, February 18, 2021 -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the first participants have been dosed in a global Phase 2/3 study to

Efanesoctocog Alfa Granted FDA Fast Track Designation for Treatment of Hemophilia A

February 18, 2021 -- The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for efanesoctocog alfa, previously known as BIVV001 (rFVIIIFc-VWF-XTEN), in patients with hemo

Lilly and Rigel Enter Strategic Collaboration to Develop RIPK1 Inhibitors for the Potential Treatment of Immunological and Neurodegenerative Diseases

INDIANAPOLIS and SOUTH SAN FRANCISCO, Calif., Feb. 18, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced a global exclusive license

Tirzepatide Significantly Reduced A1C and Body Weight in People with Type 2 Diabetes in Two Phase 3 Trials from Lilly's SURPASS Program

INDIANAPOLIS, Feb. 17, 2021 /PRNewswire/ -- Tirzepatide led to significant A1C and body weight reductions from baseline in adults with type 2 diabetes in Eli Lilly and Company's (NYSE: LLY) SURPAS

European Commission Purchases Additional 150 Million Doses of COVID-19 Vaccine Moderna

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 17, 2021 -- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European C

RedHill Biopharma Announces First Patient Dosed in U.S. Phase 2/3 COVID-19 Outpatient Study with RHB-107

TEL AVIV, Israel and RALEIGH, N.C., Feb. 17, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today a

In Vitro Study Published in The New England Journal of Medicine Demonstrates Sera from Individuals Immunized with the Pfizer- BioNTech COVID-19 Vaccine Neutralize SARS-CoV-2 with South African Variant Spike Mutations

New York, NY and Mainz, Germany, February 17, 2021 -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an in vitro study that provides additional data on the capabil