Remove Cosmetics Remove Licensing Remove Sales
article thumbnail

Ipsen tries again in Parkinson’s disease with $363m IRLAB deal

pharmaphorum

French drugmaker Ipsen has made another foray into the Parkinson’s disease category, licensing rights to an oral dopamine D3 receptor antagonist from Sweden’s IRLAB for $28 million upfront. . It is due to readout in the first half of next year.

article thumbnail

Everything You Wanted to Know About the Orange Book But Were Too Afraid To Ask

FDA Law Blog

Like all Guidance documents, it starts out with background, explaining that the Orange Book is FDA’s list of drug products approved under the Federal Food, Drug, and Cosmetic Act and contains patent and exclusivity information related to such products.

Insiders

Sign Up for our Newsletter

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

article thumbnail

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

article thumbnail

The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law Blog

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). An area of clarification that we believe will be appreciated by industry concerns sales to a group purchasing organization (GPO).

Drugs 52
article thumbnail

Calamine lotion for chickenpox skin itchiness

Druggist

Nevertheless, calamine lotion is licensed in the UK for symptomatic relief of skin conditions including itchiness. Both products have the same licensed use: symptomatic relief of mild sunburn and relief from other skin conditions. Buy on Amazon Price incl. Some children may find it more soothing and less irritating to the skin.

article thumbnail

Ipsen plans sale of consumer health business for €350m

pharmaphorum

Privately-held Mayoly Spindler is a specialist in gastroenterology and dermato-cosmetic products that has set itself the target of becoming a top 10 European OTC medicines company in the next 10 years. The post Ipsen plans sale of consumer health business for €350m appeared first on. billion takeover of Clementia Pharma in 2019.

Sales 96
article thumbnail

Papa Can You Hear Me? Now You Can Thanks to OTC Hearing Aids

FDA Law Blog

Further, FDA explained that state consumer protection laws can continue to be imposed through any licensing requirements that remain for hearing care professionals, meaning that some consumer protection laws may apply to some OTC hearing aids but not others depending on the seller. In other words, it’s a get-what-you-pay-for type situation.