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An FDA-funded study suggests that different generic levothyroxine products appear equally effective, potentially laying to rest clinical concerns about how switching among them might impact blood levels of thyroid stimulating hormone (TSH). Read More
After resolving drug quality issues, Marinus Pharmaceuticals has resumed screening and recruitment for a phase 3 trial of its investigational drug ganaxolone in refractory status epilepticus (RSE). Read More
AstraZeneca’s complement-5 inhibitor Ultomiris (ravulizumab-cwvz) has shown benefit in people living with a rare degenerative neuromuscular disorder called anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). Read More
AstraZeneca’s blockbuster type 2 diabetes drug Farxiga (dapagliflozin) has already proved its efficacy in treating advanced heart failure. Now, the sodium-glucose cotransporter-2 (SGLT2) Inhibitor is showing promise as a treatment for early heart failure as well. Read More
Medicago’s investigational COVID-19 vaccine, bioengineered in the leaves of a relative of the tobacco plant, was 71 percent effective against any symptomatic cases and 78.8 percent effective against moderate-to-severe COVID-19 disease, researchers have reported. Read More
Amphista Therapeutics has entered into two lucrative partnerships that could potentially net the company more than $2 billion in sales, royalties and performance-based milestone payments. Read More
Tarsus Pharmaceuticals’ a New Drug Application (NDA) for TP-03 (lotilaner ophthalmic solution, 0.25%) later this year based on positive phase 3 results for its investigative treatment for eyelid infections caused by the Demodex mite. Read More
The disappointing results “do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness,” said Pfizer CEO Albert Bourla. Read More
The FDA has placed a clinical hold on the phase 1/2 study of Vertex Pharmaceuticals’ investigational stem cell-derived therapy for type 1 diabetes. Read More
NovoNordisk has reported that its once-a-week form of insulin controlled blood sugar as well as short-acting insulin with a similar rate of hypoglycemic events in a late-stage trial. Read More
Eli Lilly has reported that its investigational once-weekly injectable treatment, tirzepatide, led to significant weight loss in obese and overweight patients in a late-stage study. Read More