Pharmaceutical Technology

APRIL 4, 2023

On April 4, Scorpion Therapeutics announced a collaboration and license agreement with the French dermo-cosmetic and pharmaceutical group Pierre Fabre to codevelop two next-generation epidermal growth factor receptor (EGFR) inhibitors. According to GlobalData’s Pharma Intelligence Centre, Tagrisso is forecasted to have global sales of $8.19

Cosmetics 130

Cosmetics Development Licensing Licensing 130

pharmaphorum

JULY 16, 2021

The deal gives Ipsen worldwide rights to the mid-stage drug – called mesdopetam – and puts the company on the hook for another $335 million in development, regulatory and sales milestones. IRLAB reported first-in-human data with mesdopetam earlier this year that showed the drug was well tolerated in healthy volunteers with twice-daily dosing.

Licensing 89

Licensing Licensing Cosmetics Drugs 89

XTalks

JANUARY 12, 2021

The letter , which was sent on January 4, 2021, stated that several of the company’s products violated section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a) which prohibits the introduction and delivery of new drugs without the Secretary of Health of Human Service’s approval.

Production 93

Production Cosmetics Sales Drugs 93

pharmaphorum

DECEMBER 15, 2022

We’re seeing everything from over-the-counter cold medication to cosmetic injection brands leverage different tiers of influencers. Clinical trial recruitment. Social media can be a powerful tool for improving clinical trial recruitment, a process that has traditionally been notoriously ineffective.

Clinical Trials 103

Clinical Trials Clinical Trials Life Science Marketing 103

XTalks

JANUARY 25, 2023

Brenzavvy’s approval was based on an impressive amount of data collected from 23 clinical trials involving over 5,000 patients with type 2 diabetes. The Federal Food, Drug, and Cosmetic Act (FFDCA) gives the FDA the legal authority to approve drugs for both humans and animals.

FDA Approval 52

FDA Approval Drugs Life Science Cosmetics 52

The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Dermatology 52

FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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Production Drugs FDA Approval Compliance 59