Clinical News-CliniExpert

AstraZeneca Advances Mass Global Rollout of COVID-19 Vaccine Through COVAX

Supply to 142 countries underway as part of the unprecedented effort to bring broad and equitable access to the vaccine AstraZeneca with its partner Serum Institute of India will be the biggest initia

Arena Pharmaceuticals Reports Topline Results from Olorinab Phase 2b CAPTIVATE Clinical Trial

PARK CITY, Utah--(BUSINESS WIRE) -- Mar. 2, 2021 -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced topline results from the randomized, double-blind, placebo-controlled Phase 2b CAPTIVATE

Further Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease

1 March 2021 -- AstraZeneca and FibroGen, Inc. (FibroGen) today announced that the US Food and Drug Administration (FDA) informed FibroGen that it will convene a meeting of the Cardiovascular and Rena

Merck Provides Update on Keytruda (pembrolizumab) Indication in Metastatic Small Cell Lung Cancer in the US

KENILWORTH, N.J.--(BUSINESS WIRE) March 1, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the company is voluntarily withdrawing the U.S. indication for

INOVIO Announces Positive Results from REVEAL 1, a Phase 3 Pivotal Trial Evaluating VGX-3100, its DNA-based HPV Immunotherapy for the Treatment of High-grade Precancerous Cervical Dysplasia Caused by HPV-16 and/or HPV-18

PLYMOUTH MEETING, Pa., March 1, 2021 /PRNewswire/ -- INOVIO, (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infec

FibroGen Provides Regulatory Update on Roxadustat

SAN FRANCISCO, March 01, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN) and its partner, AstraZeneca (LSE/STO/Nasdaq: AZN), today announced that the Cardiovascular and Renal Drugs Advisory Com

Cormedix Receives Complete Response Letter From FDA for Defencath™ Catheter Lock Solution

Berkeley Heights, NJ — March 1, 2021 -- CorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of inf

Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer

BUFFALO, N.Y., March 01, 2021 (GLOBE NEWSWIRE) -- Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies fo

Regeneron Announces Positive Phase 2 Data Evaluating Fel d 1 Antibody Cocktail in Cat-allergic Patients with Mild Asthma

TARRYTOWN, N.Y., Feb. 27, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced detailed results from a Phase 2 proof-of-concept trial evaluating the investigational anti

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic

NEW BRUNSWICK, N.J., February 27, 2021 -- Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA)

Lilly Announces Additional Doses of Neutralizing Antibody Therapy Purchased by U.S. Government to Treat COVID-19

INDIANAPOLIS, Feb. 26, 2021 /PRNewswire/ -- The U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together, Eli Li

Tezepelumab is the First Biologic to Consistently and Significantly Reduce Exacerbations in Broad Population of Severe Asthma Patients

26 February 2021 -- Positive full results from the pivotal NAVIGATOR Phase III trial showed AstraZeneca and Amgen’s tezepelumab demonstrated a statistically significant and clinically meaningful1 redu