Cosmetics Licensing Sales 
pharmaphorum
JULY 16, 2021
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.
FDA Law Blog
JULY 26, 2022
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.
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FDA Law Blog
NOVEMBER 1, 2023
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.
FDA Law Blog
JULY 5, 2023
Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance).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).
Druggist
OCTOBER 25, 2020
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.
FDA Law Blog
AUGUST 17, 2022
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.
pharmaphorum
FEBRUARY 11, 2022
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.
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