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Patents
The wait for US competition to AbbVie’s Lumigan 0.01% glaucoma brand, launched more than a decade ago, goes on, after Mankind bowed to infringement of a key US patent.
A watershed moment is on the horizon for US biosimilars, with Amgen looking poised to debut competition to Eylea (aflibercept).
With sales projected to peak at nearly $700m a year, Galafold – the first oral monotherapy for people living with the ultra-rare genetic disorder Fabry disease – is a lucrative target for ANDA sponsors. However, Teva, which has just put pen to paper on a patent-litigation settlement agreement, will have to wait more than a decade to roll out its generic product.
MSN Laboratories returned to court to attack more US patents shielding Exelixis’ blockbuster oncology drug Cabometyx. However, as with the first ruling, the Indian firm was met with further disappointment.
Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second.
Patrick Alexandre, Crossject CEO, discusses crucial developments happening for Zeneo, a needle-free injector, functioning intramuscularly to administer medication in a tenth of a second
Otsuka Pharma’s acquisition of Jnana seems like a win for its pipeline, but the Japanese major faced a setback in a Delaware District Court where the judge’s opinion put challenger Lupin closer to a generic to its Jynarque (tolvaptan)
Johnson & Johnson’s actions to promote generic competition and lower the price for its crucial tuberculosis treatment, Sirturo (bedaquiline), have satisfied an investigation launched by South Africa’s Competition Commission.
The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.
US Federal Trade Commission says the policy would enhance its ability to detect reverse payment settlements between pharmaceutical companies that raise antitrust concerns.