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 […]

Smallpox can no longer be used as a bioweapon; new drug gets USFDA approval

Smallpox can no longer be used as a bioweapon; new drug gets USFDA approval

WASHINGTON: The US Food and Drug Administration (FDA) on Saturday approved the first drug with an indication for treatment of smallpox. Smallpox, a contagious and sometimes fatal infectious disease, was declared eradicated in 1980, by the World Health Organization. However, there have been longstanding concerns that smallpox could be used as a bioweapon. TPOXX (tecovirimat) […]

College Station school board OK's new drug testing

College Station school board OK's new drug testing

College Station school board members unanimously approved a policy Tuesday that implements random student drug testing for students in extracurricular activities or who park on campus. The policy will go into effect Oct. 1 and all students in high school who have a parking pass or who participate in school-sponsored extracurricular activities are required to […]

Cancer-treatment drug gets name from Torah

Cancer-treatment drug gets name from Torah

A doctor works with the TOOKAD treatment.. (photo credit: SHEBA BIOTECH) X Dear Reader, As you can imagine, more people are reading The Jerusalem Post than ever before. Nevertheless, traditional business models are no longer sustainable and high-quality publications, like ours, are being forced to look for new ways to keep going. […]

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