California Budget Reflects ‘Pandemic-Induced Reality,’ Governor Says

SACRAMENTO, Calif. — The coronavirus pandemic doomed Gov. Gavin Newsom’s ambitious plans last year to combat homelessness, expand behavioral health services and create a state agency to control soaring health care costs. But even as the pandemic continues to rage, California’s Democratic governor said Friday he plans to push forward with those goals in the coming year, due to a […]

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FDA Approves Pediatric Indication for Xeomin (incobotulinumtoxina) for the Treatment of Chronic Sialorrhea

RALEIGH, N.C., December 21, 2020 — Merz Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of patients aged 2 years and older with chronic sialorrhea, or drooling. Xeomin is the first and only FDA-approved neuromodulator with this indication and was granted a priority review […]

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INOVIO Doses First Subject in Phase 2 Segment of its INNOVATE Phase 2/3 Clinical Trial for INO-4800, its DNA Medicine to Prevent COVID-19

PLYMOUTH MEETING, Pa., Dec. 7, 2020 /PRNewswire/ — INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced it has dosed its first subject in a Phase 2 clinical trial evaluating DNA medicine INO-4800, its COVID-19 vaccine candidate, as part of its Phase 2/3 clinical […]

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FDA Approves Oxlumo

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 24, 2020– Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate […]

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Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to […]

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Novavax and Commonwealth of Australia Announce Agreement in Principle for Acquisition of Novavax COVID-19 Vaccine

GAITHERSBURG, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the signing of a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the Company’s COVID-19 vaccine candidate, NVX-CoV2373, for the Australian community. “This arrangement with the Australian Government reflects the importance […]

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Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Evidence of Efficacy in First Interim Analysis from Phase 3 Study

NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE) November 9, 2020 Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns […]

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FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies

TOKYO, Oct. 20, 2020 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP0367/MA-0211 (“ASP0367”) as a potential treatment for primary mitochondrial myopathies (PMM). PMM is a complex mitochondrial disease in which genetic mutations primarily impair the function of […]

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Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

KENILWORTH, N.J.–(BUSINESS WIRE) October 20, 2020 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. In the PNEU-PATH (V114-016) study, healthy adults 50 years of age or older received V114 or PCV13 […]

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Regeneron Confirms that REGN-COV2 Antibody Cocktail Provided to President Trump Under Compassionate Use Request

October 2, 2020 —  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today confirmed that, as announced by the White House Press Secretary, Regeneron provided a single 8 gram dose of REGN-COV2, a cocktail of two monoclonal antibodies, for use by President Trump. REGN-COV2 is an investigational COVID-19 therapy, which was provided in response to an Individual Patient Investigational New Drug (IND) application […]

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