article thumbnail

Amgen readies pivotal MariTide trials; Novo offers discounted Wegovy

BioPharma Drive: Drug Pricing

Elsewhere, Novo started up an online pharmacy and the FDA cleared testing of a base editing therapy for Duchenne. Phase 3 studies for Amgen’s closely watched obesity drug were posted on a federal database.

article thumbnail

Oregon Federal, Court Says PharmacyChecker—Which Helps Americans Find Vetted International Online Pharmacies—Is Legal 

Policy Prescription

LegitScript argued that PharmacyChecker does not have antitrust standing because its business, providing information on the Internet that Americans use to find vetted international online pharmacies and compare their prices, is unlawful. Judge Simon disagreed, writing “PharmacyChecker.com’s business is legal.” ” (Emphasis added).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Manitoba Judge’s Opinion Reveals Different Side of the CanadaDrugs Case

Policy Prescription

It’s important because this case was wrongly used as a pretext to oppose safe personal drug importation and international online pharmacies, which help Americans afford prescription drugs. It seems that the appellant was also told that MHRA would notify the FDA of the situation. Clearly it did so. supply chain.

article thumbnail

CDER’s Office of Compliance Kicks Off Annual Report Season with Rundown of 2023’s Major Public Health Enforcement Initiatives

FDA Law Blog: Biosimilars

OC and CDER continue to use a carrot-and-stick approach with compounders, noting both the creation of the Compounding Quality Center of Excellence and its collaboration with the industry, but also the eleven warning letters FDA sent to drug compounders last year. Drug Supply Chain. Clinical Trials.

article thumbnail

How Pharma-Funded Groups Lie About Personal Drug Imports

Policy Prescription

The Canadian drug supply is pretty safe…” However, standards for a walk-in pharmacy are not applicable to online pharmacies in Canada, which are unregulated and can sell “unlicensed” medications. and licensed by your state board of pharmacy.” Were the statements from PSM’s Executive Director accurate?

article thumbnail

DOJ Investigates $250 Million in U.S. Sales of Counterfeit Drugs Using Fake DSCSA Pedigrees

Policy Prescription

This epic counterfeit drug debacle had nothing to do with the personal importation of less expensive prescription drugs or foreign online pharmacies. pharmacies and wholesalers allegedly flouting the rules. Where’s the FDA? The FDA OCI, however, may very well be working behind the scenes with DOJ.

article thumbnail

New JAMA Article Recommends Personal Drug Importation To Help American Patients Afford Prescription Drugs

Policy Prescription

Harvard doctors and public health experts recommend using the website PharmacyChecker.com to find international online pharmacies to order more affordable prescription drugs for personal importation when domestic savings strategies fail. They offer this advice in a new article in the Journal of the American Medical Association.