FDA Law Blog

NOVEMBER 10, 2024

The Clinical Trials Grants Program provides funding for clinical trials that evaluate the safety and efficacy of potential treatments for rare diseases to help move promising treatments through clinical development. This study design is both innovative and efficient, leveraging a single-arm, baseline-controlled design.

Production 69

Production Clinical Development Development Regulation 69

pharmaphorum

OCTOBER 5, 2022

Sanofi has added to its rare disease pipeline by licensing an antibody-RNA conjugate (ARC) for facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder, from US biotech miRecule. The aim will be to identify promising candidates in areas of “unmet patient need.”

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RNA Genetics Dermatology Antibody 105

XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. It leads to partial or complete hair loss on the scalp and other body parts, with patterns varying from patchy bald spots to total scalp or body hair loss.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

The Pharma Data

MAY 1, 2023

Associate Clinical Professor of Dermatology at the University of California San Francisco (UCSF), Director of Medical Dermatology Consultative Services and Patch Testing for the Palo Alto Foundation Medical Group and lead author on the face and hand analysis.

Dermatology 40

Dermatology Medicine Clinical Trials Clinical Trials 40

The Pharma Data

NOVEMBER 4, 2020

TSX: CTX) (OTC US: CRRTF) (“Crescita” or the “Company”), a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house research & development (“R&D”) and manufacturing capabilities, today announced that it has entered into an exclusive agreement with Juyou-Biotechnology Co.

Licensing 40

Licensing Licensing Dermatology Production 40

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

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Development Gene Therapy Engineer Life Science 52

The Pharma Data

AUGUST 19, 2021

2] These genetic alterations result in hyperactivation of the MET receptor with corresponding cancer cell growth. [3] In the METex14 cohort of the Phase 1 CHRYSALIS study, 19 patients with this genetic alteration received intravenous RYBREVANT TM 1050 mg (for patients who weigh <80 kg) or 1400 mg (for patients who weigh ?80

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FDA Approval Dermatology Genetics Development 52