Patents
Eli Lilly’s tirzepatide is expected to be worth $62 billion annually by 2030, according to Evaluate. That valuation would be three times larger than what AbbVie’s blockbuster Humira ever achieved.
Findings that U.S. companies can sue foreign rivals despite limited business operations in the country could dissuade drug developers from targeting the U.S. market, potentially benefiting domestic producers of biosimilars.
The package revives President Donald Trump’s much-maligned Most Favored Nation rule but goes further into the private markets and beyond, leveraging the patent system, drug importation and more.
Jazz is being accused of anti-competitive practices regarding its narcolepsy drug, as generic competitors emerge on the market.
Merck’s new formulation of the mega-blockbuster Keytruda, made in collaboration with Alteogen, could help to keep the drug’s patent cliff at bay.
With Keytruda, the best-selling drug in the world, facing the end of exclusivity in 2028, BioSpace looks at five drugs that have taken the leap off the patent cliff.
Sarepta will update Elevidys’ label after a patient died following treatment; the FDA issues flu vaccine recommendations without advisor input; Trump CDC nominee Dave Weldon pulled at last minute; and FDA decisions expected for Alnylam’s Amvuttra in ATTR-CM and Milestone’s etripamil in tachycardia.
The new formulation of Keytruda, currently under FDA review, is sparking conflict with Halozyme, which makes enzymes that convert intravenous drugs into injectable versions.
SpringWorks Therapeutics sprung out of Pfizer’s storeroom, when a rare disease advocacy group pushed to keep a program for neurofibromatosis alive. This method could work for “every rare disease under the sun,” advocates say.
SpringWorks Therapeutics is the perfect case study for rescuing a discontinued assets. It’s time to repeat the process for every rare disease, experts say.
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