The Pharma Data

OCTOBER 29, 2020

Interim analyses were conducted after patients completed 12 and 36 weeks of treatment, the latter for the primary endpoint of the Phase 2 part of the study. ” In March, the FDA granted Breakthrough Therapy designation to baricitinib for the treatment of AA based on positive Phase 2 results from BRAVE-AA1. .”

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The Pharma Data

MARCH 27, 2022

It is approved in the U.S. and more than 75 countries as a treatment for adults with moderate to severe rheumatoid arthritis and is approved in more than 50 countries, including the European Union and Japan, for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

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Licensing Licensing FDA Approval Disease 40

The Pharma Data

AUGUST 3, 2021

“As additional data from COV-BARRIER become available, it is increasingly evident that treatment with baricitinib may help prevent death in some of the most critically ill COVID-19 patients and that baricitinib represents an important treatment option for this vulnerable group of patients in this constantly evolving pandemic,” said E.

Hospitals 52

Hospitals Licensing Licensing FDA 52

The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. No new safety signals potentially related to the use of baricitinib were identified.

Hospitals 52

Hospitals FDA Laboratories Treatment 52

The Pharma Data

OCTOBER 14, 2020

is a late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). About ImmunityBio ImmunityBio, Inc.

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Vaccine Trials FDA Clinical Trials 52

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine 52

Vaccine FDA Approval FDA Disease 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. In that case, the NDA sponsor applied for two PTEs based on these approvals—one for either U.S.

FDA Approval 59

FDA Approval FDA Production Therapies 59

The Pharma Data

APRIL 8, 2021

“There remains a driving unmet need for treatments with the potential to further decrease mortality for COVID-19 patients,” said co-primary investigator E. These important findings advance our pursuit of treatment options to save lives in hospitalized COVID-19 patients.” Baricitinib-treated patients were 2.7

Hospitals 52

Hospitals FDA Approval Laboratories FDA 52

The Pharma Data

NOVEMBER 10, 2020

SAMI is a renal replacement therapy (RRT) machine manufactured and commercialized by Spectral’s wholly-owned subsidiary, Dialco Medical Inc. ( “Dialco” ). The paper describes the first month of using SAMI as part of UMMC’s PIRRT (Prolonged Intermittent Renal Replacement Therapy) program throughout April 2020.

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Nurses FDA FDA Approval Therapies 52

Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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The Pharma Data

MARCH 4, 2021

Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. There are currently no FDA-approved treatments for AA. AA is the second potential treatment indication in dermatology for baricitinib after AD.

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Trials Treatment Therapies Clinical Trials 52