STAT

DECEMBER 7, 2023

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.

FDA 114

FDA Compounding Pharmaceutical Companies Pharmaceutical Companies 114

pharmaphorum

FEBRUARY 2, 2022

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.

Compounding 72

Compounding FDA 72

European Pharmaceutical Review

MARCH 4, 2024

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].

FDA 87

FDA Vaccines Immunization Compounding 87

ISPE

MARCH 8, 2023

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.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

Pharmaceutical Technology

JANUARY 10, 2023

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.

Labelling 52

Labelling Compounding Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JANUARY 16, 2023

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.

FDA 98

FDA Pharmaceutical Companies Pharmaceutical Companies Compounding 98

ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” September 2022. 7 March 2023. Regulatory Focus.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52