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Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis

The Pharma Data

We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Source link: [link].

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FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

The Pharma Data

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. Ricks , Lilly chairman and CEO.

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Lilly accelerating baricitinib’s availability in India following receipt of permission for restricted emergency use as a COVID-19 therapy via donations and licensing agreements | Eli Lilly and Company

The Pharma Data

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.

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New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis

The Pharma Data

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. Test patients for latent TB before initiating Olumiant and during therapy. See the full Prescribing Information here.

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U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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Lilly and Incyte’s baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation

The Pharma Data

Vaccinations: Avoid use of live vaccines with baricitinib. See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib. Manage patients according to routine clinical guidelines.