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STAT+: ‘Skinny labels’ on biosimilar medicines saved Medicare $1.5 billion over a recent five-year period

STAT

billion from 2015 to 2020 — or nearly 5% of the $30.2 The provision is known as skinny labeling , which refers to a move by a company that seeks regulatory approval to market a generic or biosimilar medicine for a specific use, but not for other patented uses for which the brand-name drug is prescribed.

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FDA-Approved Labeling: Is Enough Enough?

The FDA Law Blog

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

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Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

pharmaphorum

The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents. The substance patent expired in 2007.

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FDA Finalizes Guidance Re Enforcement Policy for Homeopathic Drugs

The FDA Law Blog

This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. As we reported previously, here , and here , as a result of the growth of the industry and safety issues, in 2015 FDA started the reevaluation of its regulatory framework for homeopathic products.

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FDA AdCom votes in favour of Lundbeck’s/Otsuka’s Rexulti in AAD

Pharmaceutical Technology

Also known as brexpiprazole, the FDA first approved Rexulti as a treatment for adults with schizophrenia and as an add-on treatment for adults with major depressive disorder in July 2015. He added that there is also a need for FDA-approved products that communicate efficacy and safety on their labels.

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The Guardian view on cystic fibrosis treatments: a rollercoaster ride for the sick | Editorial

The Guardian - Pharmaceutical Industry

Then came Orkambi in 2015 and Symkevi in 2018 – both two-drug combinations. Kaftrio is the latest to be labelled unaffordable for a cash-strapped NHS. The drugs that have caused such a stir are made by the US biotech company Vertex. Since 2020, there has been Kaftrio, which is a triple combination. Continue reading.

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Vertex gets EU okay to treat younger cystic fibrosis patients

pharmaphorum

The new EU approval comes after the FDA approved the expanded label last year, and provides the first treatment option that tackles the underlying cause of CF in patients aged six to 11 with these mutations. Together these drugs cover the CFTR mutations seen in around half of all CF patients.

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