Remove Branding Remove Cosmetics Remove Production
article thumbnail

Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025

FDA Law

By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). Mirati) about a healthcare professional branded website for KRAZATI (adagrasib).

article thumbnail

The rise of GLP-1 drugs: Transforming weight loss treatment

Bio Pharma Dive

This shift raises ethical questions around prioritizing supply for diabetes patients versus those seeking treatment for obesity or cosmetic weight loss. The balance is complex, as obesity carries its own serious health risks.

Insiders

Sign Up for our Newsletter

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

article thumbnail

FDA Posts Slate of Seven Warning Letters Following Company Inspections

PharmTech

The warnings encompassed various forms of lack of compliance in the agency’s view, including product mislabeling, false or misleading claims on packaging, and shortfalls in current good manufacturing practice (CGMP) standards found during laboratory inspections.

article thumbnail

ACI’s Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition

FDA Law

The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California.

article thumbnail

Most Favored Nation Pricing is Back – With a Vengeance

FDA Law

It sets forth three directives: HHS shall consider facilitating direct-to-consumer purchasing programs for pharmaceutical manufacturers that sell their products to American patients at the most-favored-nation (MFN) price. What types of drugs are to be covered: brands, generics, biologics, biosimilars, or some combination?

article thumbnail

Novo’s obesity drug has serious warnings and barriers to overcome

World of DTC Marketing

The drug already exists at a lower dose as an anti-diabetic medication under the brand names Ozempic and Rybelsus made by the same pharmaceutical company, Novo Nordisk. Medicare currently doesn’t cover treatments for obesity because it categorizes medications for weight loss as cosmetic, like medications for hair loss.

article thumbnail

Torrent Pharma to acquire Curatio for $245.16m

Pharmaceutical Technology

Holding a presence in the cosmetic dermatology sector, Curatio’s portfolio comprises more than over 50 brands that are commercialised in India. The portfolio includes brands such as Tedibar, Atogla, Spoo, B4 Nappi and Permite. The latest takeover is anticipated to boost the presence of Torrent in the dermatology segment.