FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs
PharmaTech
DECEMBER 15, 2023
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
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BioPharma Dive
FEBRUARY 20, 2024
Why clinical pharmacology is critical to accelerating drug development, and how it can help drive value in a complex and rapidly evolving landscape.
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WHO INN approves ‘Usnoflast’ as recommended name for ZYIL1 from Zydus
Express Pharma
APRIL 1, 2024
Zydus was the first to establish the Phase 2 proof-of-concept in Cryopyrin-associated periodic syndromes (CAPS) patients [NCT05186051], and published the Phase 2 results in ‘Clinical Pharmacology in Drug Development’.
Zydus begins Phase II trial of ZYIL1, NLRP3 inhibitor in patients with ALS
Express Pharma
OCTOBER 24, 2023
Zydus has established the Phase 2 proof-of-concept in CAPS patients [NCT05186051] and has now published the data in Clinical Pharmacology in Drug Development. In Phase I studies, ZYIL1 was found to be safe and well-tolerated [NCT04731324, NCT04972188].
Zydus receives USFDA approval to initiate Phase II clinical trial of ZYIL1 for Parkinson’s disease
Express Pharma
DECEMBER 18, 2023
The phase-2 data of ZYIL1 in CAPS has now been published in “Clinical Pharmacology in Drug Development”. Zydus has been granted an ‘Orphan Drug Designation’ by the US FDA for ZYIL1 in treatment of patients with CAPS, a rare auto-inflammatory disease.
Allucent to expedite Covid-19 booster vaccines development
Pharmaceutical Business Review
AUGUST 28, 2023
Allucent is engaged in providing comprehensive drug development solutions including consulting, biometrics, clinical operations, and clinical pharmacology across various therapeutic areas. The post Allucent to expedite Covid-19 booster vaccines development appeared first on Pharmaceutical Business review.
Zydus gets Orphan Drug Designation from USFDA for ZYIL1 to treat Cryopyrin Associated Periodic Syndrome
Express Pharma
MARCH 21, 2023
In September 2022, Zydus had announced positive Phase 2 proof-of-concept (POC) study in CAPS patients, and the publication of Phase 1 study results in Clinical Pharmacology in Drug Development, supporting the advancement of ZYIL1 into pivotal clinical trials in CAPS patients.
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