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STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

Not long after the patent was awarded, the company leveraged federally funded research and began investigating different forms of the compound, called Revlimid. One expires next year and the other in 2027, well beyond the original patent expiration date.

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ViiV claims $1.25bn settlement from Gilead in HIV patent dispute

pharmaphorum

ViiV claimed the latter compound infringes its patents for dolutegravir and other compounds based on the drug’s chemical scaffold. The dispute centred around Gilead’s triple-drug regimen Biktarvy , which is based on emtricitabine, tenofovir alafenamide and integrase inhibitor bictegravir.

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Nine for 2023, part two: healthcare’s hard problem, the prognosis for diagnosis, and key new pharmacotherapy platforms

pharmaphorum

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. Difficile at the end of November 2022, but in 2023 they will be joined by Seres, which expects an FDA decision in April 2023 on its C.

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Delivery systems for biologics

European Pharmaceutical Review

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 percent through 2027. He was on the faculty of Johns Hopkins Medicine and served as a medical officer with the US/HHS FDA before joining KCR. cited 2024Jan].

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Top Performing Drug of 2021 - Trulicity (February Edition)

PharmaShots

Some of its FDA-approved competitors include: Patents7 Eli Lilly carries big expectations from Trulicity to boost its revenue. In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026).

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Contamination Trends & Proposed Solutions

ISPE

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Pharmaceutical Technology

billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%. However, Invokana is likely to continue to lose market share (forecast 9MM CAGR decline of 14.6%), due to an FDA boxed warning regarding diabetic ketoacidosis and increased risk of lower limb amputations.