FDA grants approval for first breast cancer drug through 'Real-Time Oncology Review'

FDA grants approval for first breast cancer drug through 'Real-Time Oncology Review'

July 19, 2018 The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. The FDA also approved Kisqali in combination with […]

Study raises questions over safety of fast-tracked drug approvals

Study raises questions over safety of fast-tracked drug approvals

“This study of all FDA approvals granted Breakthrough Therapy designation from 2012 through 2017 suggests that pivotal trials supporting these approvals commonly lacked randomisation, double-binding, and control groups, used surrogate markers as primary end points, and enrolled small numbers of patients,” researchers said. “Furthermore, more than half were based on a single pivotal trial.” Source […]

What does it take to get a drug approved by Health Canada?

What does it take to get a drug approved by Health Canada?

Our Reader Score [Total: 0 Average: 0] Clinical trial data for new drugs is often kept under wraps, with minimal information released to the public. One researcher tried to gain insight into the types of trials accepted by Health Canada by examining the characteristics of studies used in its accelerated approval process. In order for […]

Do Breakthrough Therapies Need More Rigorous Evaluation?

Do Breakthrough Therapies Need More Rigorous Evaluation?

A new study published in JAMA reviewed the premarket development and review times of drugs approved between 2012 and 2017 that were granted Breakthrough Therapy designation and found that the crucial studies that supported these approvals lacked key features, including randomization, double-blinding, and control groups. A new study published in JAMA reviewed the premarket development […]

Trials Supporting FDA Approval of Breakthrough Drugs Examined

Trials Supporting FDA Approval of Breakthrough Drugs Examined

July 18, 2018 Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups. HealthDay News — Pivotal trials supporting US Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization, double-blinding, and control groups, according to a research letter […]

PainReform Gets FDA Approval for Phase III Post-Operative Pain Relief Study

PainReform Gets FDA Approval for Phase III Post-Operative Pain Relief Study

HERZLIYA, Israel, July 18, 2018 /PRNewswire/ — PainReform Ltd, developer of a proprietary reformulation technology, has received FDA approval to conduct two pivotal Phase III clinical trials for post-operative pain relief in soft and hard tissue. “This green light from the FDA enables us to progress towards receiving an NDA (New Drug Approval) for the […]

Karyopharm Initiates Rolling Submission of New Drug Application to US Food and Drug Administration for Selinexor as …

Karyopharm Initiates Rolling Submission of New Drug Application to US Food and Drug Administration for Selinexor as …

— Company Plans to Complete Submission During the Second Half of 2018 — NEWTON, Mass., July 18, 2018 (GLOBE NEWSWIRE) — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that the Company has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated […]