U.S. Government Exercises 1st Option for Additional 100 Million Doses of Moderna’s COVID-19 Vaccine Candidate

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Dec. 11, 2020– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. government has exercised its option to purchase an additional 100 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 200 million doses. Of the first […]

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Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 16, 2020– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. Stability […]

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Tezepelumab NAVIGATOR Phase III Trial Met Primary Endpoint of a Statistically Significant and Clinically Meaningful Reduction in Exacerbations in a Broad Population of Patients with Severe Asthma

10 November 2020 — AstraZeneca and Amgen today announced positive results from the NAVIGATOR Phase III trial for the potential new medicine tezepelumab in patients with severe, uncontrolled asthma. NAVIGATOR met the primary endpoint with tezepelumab added to standard of care (SoC) demonstrating a statistically significant and clinically — meaningful1 reduction in the annualised asthma exacerbation rate (AAER) over 52 […]

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Regeneron’s REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients

TARRYTOWN, N.Y., Sept. 29, 2020 /PRNewswire/ —  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits. The ongoing, randomized, double-blind trial […]

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U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis

NEW YORK–(BUSINESS WIRE) September 28, 2020 — Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are dosed based upon […]

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FDA Approves Qdolo

FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain ATHENS, Ga., Sept. 8, 2020 /PRNewswire/ — Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Qdolo™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults for the management of pain severe enough to […]

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Johnson & Johnson to Expand Partnership with U.S. Department of Health & Human Services to Accelerate the Discovery of Potential COVID-19 Treatments

NEW BRUNSWICK, N.J., February 18, 2020 – Johnson & Johnson today announced that its Janssen Pharmaceutical Companies will expand its existing partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services, to seek treatment solutions for COVID-19, the disease caused […]

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Current statin use may lower risk for lethal prostate cancer

(HealthDay)—Current statin use is inversely associated with the risk for lethal prostate cancer, according to a study published online Nov. 21 in Clinical Cancer Research. Emma H. Allott, Ph.D., from Queen’s University Belfast in the United Kingdom, and colleagues prospectively examined statin use and lethal prostate cancer risk in the Health Professionals Follow-up Study. Data were included for 44,126 men […]

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Bladder cancer treatment rejected for routine use on NHS in England

An immunotherapy treatment for some people with bladder cancer, currently available through the Cancer Drugs Fund, has been given an initial “no” for routine use in England. Pembrolizumab (Ketruda) will continue to be available as a treatment option on the NHS until at least January 2020, when the National Institute for Health and Care Excellence (NICE) reviews this initial decision.  In […]

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FDA sends warning letter about foreign OTC drugs to Dollar Tree

Dollar Tree has been sent a warning letter for selling over-the-counter (OTC) drugs made by foreign companies with serious, multiple violations of federal manufacturing laws, the U.S. Food and Drug Administration says. The drugs include Dollar Tree’s Assured Brand OTC drugs and other drug products sold by Dollar Tree Co., which operates stores under the Dollar Tree and Family Dollar […]

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