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Surprise! Amgen's hot KRAS drug seals early FDA approval, winning a shot against 'undruggable' cancer

What was once considered the "Achilles heel" of lung cancer tumors, as Amgen puts it, now has an FDA-approved treatment in the company's KRAS inhibitor, Lumakras. ....

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AstraZeneca's diabetes drug Farxiga nabs coveted kidney disease nod, way ahead of rival Jardiance

Apr 30, 2021 6:40pm
The landmark decision in CKD comes after Farxiga nabbed a first-in-class nod in heart failure patients last year.
AstraZeneca s diabetes med Farxiga stormed the heart failure market with a first-in-class approval last year and in chronic kidney disease, it just left would-be rival Jardiance in the dust.
The FDA late Friday approved Farxiga, also known as dapagliflozin, to treat chronic kidney disease even in patients without diabetes.
With that CKD approval in hand, Farxiga has cemented its lead against Eli Lilly and Boehringer Ingelheim’s SGLT2 rival Jardiance, which isn t expecting data from its kidney disease outcomes trial till 2022. ....

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Roche's arthritis drug Actemra scores FDA nod in rare autoimmune disease after partial clinical win

Mar 5, 2021 11:20am
Roche s Actemra has become the first biologic that the FDA approved for patients with systemic sclerosis-associated interstitial lung disease. (Roche/Genentech)
Missed the primary endpoint of a clinical trial? No problem. We’ll pick the study apart and approve your drug based on a post-hoc subgroup analysis.
That’s what the FDA did in granting Roche’s Actemra a go-ahead in patients with interstitial lung disease (ILD) associated with the rare autoimmune disease systemic sclerosis (SSc).
The approval makes Actemra the first biologic drug cleared by the FDA to slow the decline in pulmonary function in patients with SSc-ILD, Roche’s Genentech said Thursday. ....

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Why did India approve Covaxin, Covishield, not Pfizer, Sputnik V? — Quartz India

This will be a policy hurdle that Johnson & Johnson’s pharmaceutical company, Janssen, will also need to clear for its single-dose vaccine. ....

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Eli Lilly scores FDA nod for COVID-19 antibody cocktail, aims to make 1M doses by midyear

Two weeks after Eli Lilly unveiled data showing its COVID-19 combo of bamlanivimab and etesevimab slashed the risk of death and hospitalization for high-risk patients, the antibody cocktail has won its emergency FDA authorization. The nod squares Lilly up to Regeneron, which till now had the only authorized dual-antibody coronavirus cocktail. ....

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