GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps

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Excerpt The FDA has approved GSK’s Nucala (mepolizumab) as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps (CRSwNP). Mepolizumab is the first anti- interleukin-5 therapy to be approved for CRSwNP, which affects over 5 million in the US, caused by raised eosinophil levels resulting in the formation of nasal […]

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IVI Partners with SK Bioscience to Conduct Late Stage Global Clinical Trials of SK Bioscience’s Recombinant Protein Vaccine Candidate (GBP510)

Excerpt The International Vaccine Institute (IVI) will be conducting Phase 3 clinical trials of SK bioscience’s recombinant protein vaccine candidate (GBP510) in Europe and Southeast Asia, with the aim of bringing it to market in 2022. Additionally, IVI has formed a partnership with SK and the Korean National Institute of Health (KNIH) to jointly conduct […]

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SINOVAC Announces Positive Data on Booster Dose of CoronaVac ®

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Excerpt Results from an ongoing phase 2 clinical trial studying immunogenicity, safety, and immune persistence of CoronaVac ® show that while good immune memory is generated after the second dose, a third dose induces a stronger immune response, with an even lower adverse reaction rate after the third dose as compared to the second. A […]

Vigil Neuroscience Completes $90 million Series B Financing to Advance a Pipeline of Microglia-targeted Medicines to Treat Rare and Common Neurodegenerative Diseases

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Excerpt Vigil Neuroscience has secured $90 million in its Series B financing led by Vida Ventures with participation from new as well as existing investors. This will propel the advancement of Vigil’s proprietary microglia-focused medicine line-up for the treatment of neurodegenerative diseases. Development of the antibody, VGL101, and triggering receptor on myeloid cells 2 (TREM2) […]

Lonza to Introduce Drug Product Manufacturing Services in Guangzhou, China

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Lonza announced its plans to invest in establishing drug product manufacturing capabilities at its site in Guangzhou, China. The new investment will fund the installation of an aseptic drug product fill and finish production line at the 17,000 m2 state-of-the-art cGMP mammalian facility. This will significantly expand the site’s capabilities, supporting global and domestic customers […]

Pfizer Blog

Pfizer Announces Positive Top-line Results from Phase 2B/3 of Ritlecitinib in Alopecia Areata

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Excerpt Pfizer announces positive top-line results from the Phase 2b/3 ALLEGRO trial of once-daily ritlecitinib for the treatment of alopecia areata. Ritlecitinib 50 mg and 30 mg showed significantly a greater proportion of patients with 20 percent or less scalp hair loss after 24 weeks of treatment versus placebo, achieving the primary efficacy endpoint of […]

Moderna Announces First Participant Dosed in Pase 1/2 Study of Its Quadrivalent Seasonal Flu mRNA Vaccine

Moderna Announces First Participant Dosed in Phase 1/2 Study of Its Quadrivalent Seasonal Flu mRNA Vaccine

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Excerpt Moderna has dosed the first participants in its Phase 1/2 study of mRNA-1010, the company’s first quadrivalent seasonal influenza mRNA vaccine candidate to enter the clinic. The study will enroll 180 adult participants in the U.S. and targets WHO recommendations for the prevention of influenza, which causes respiratory illnesses and significant economic burdens on […]

VBI Vaccines reports new CPT issued for a 3-Antigen Hepatitis B

VBI Vaccines reports new CPT issued for a 3-Antigen Hepatitis B

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Excerpt The American Medical Association (AMA) Current Procedural Terminology (CPT ® ) Panel has established a unique CPT code for the first 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine, developed by VBI Vaccines. This will differentiate this vaccine from other approved, single-antigen HBV vaccines. The 3-antigen HBV vaccine is approved and commercially available in […]

UNICEF signs COVID-19 vaccine supply agreement with Moderna

UNICEF signs COVID-19 vaccine supply agreement with Moderna

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An Advance Purchase Agreement was signed by the COVAX facility following Moderna’s COVID-19 vaccine’s receipt of a WHO Emergency Use Listing (EUL). Under the long-term supply agreement, UNICEF and its procurement partners will have access to 34 million doses of the vaccine for around 92 countries and territories in 2021 on behalf of the COVAX […]

CDC COVID-19 Study Shows mRNA Vaccines Reduce Risk of Infection by 91 Percent for Fully Vaccinated People

CDC COVID-19 Study Shows mRNA Vaccines Reduce Risk of Infection by 91 Percent for Fully Vaccinated People

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The extended CDC HEROES-RECOVER study, enrolling healthcare workers, first responders, frontline workers, and other essential workers shows that mRNA COVID-19 vaccines authorized by the FDA lower the risk of infection by 91% for fully vaccinated people and 81% for partially vaccinated people. The study is also one of the first to demonstrate that the mRNA […]

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