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US FDA approves Pfizer’s migraine nasal spray Zavzpret

Pharmaceutical Technology

It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulations. The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials.

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Danicamtiv, what is the likelihood that the drug will be approved?

Pharmaceutical Technology

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities.

Drugs 100
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Bayer extends clinical development program for finerenone with Phase III study in patients with non-diabetic chronic kidney disease

The Pharma Data

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “If

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Steps to building a more patient-centric industry

pharmaphorum

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.

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10 Key Learnings from Successful Cellular and Gene Therapy Trials for Rare Diseases

XTalks

For rare disease studies where there is little or no clinical trial experience, outcome assessments would have to be validated within a clinical development program. This is important since not all pharmacies and sites are eligible to prepare and administer gene therapy due to biosafety and technical reasons.

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Zepbound, Obesity Version of Eli Lilly’s Mounjaro, Finally Gets FDA Nod

XTalks

XTALKS WEBINAR: The Evolution of the Cardiovascular Clinical Development Landscape and Potential Role of GLP-1 RAs Live and On-Demand: Wednesday, December 6, 2023, at 11am EST (4pm GMT/UK) Register for this free webinar to learn about successful study outcomes in developing GLP1s to new therapeutic areas within cardiovascular medicine and more. “In

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PharmaDrug Enters Definitive Agreement for Acquisition of Sairiyo Therapeutics Inc. Who Recently Received Orphan Drug Designation from FDA for Esophageal Cancer

The Pharma Data

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Persons”, as such term is defined in Regulations under the U.S.

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