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FDA
Otsuka and Lundbeck won approval Friday for Abilify Asimtufii, a long-acting injectable that provides two months of symptom relief in patients with schizophrenia or bipolar I disorder.
As Humira global revenues fall 25%, AbbVie looks to Rinvoq and Skyrizi to fill in the gap. The company also announced it is cutting cystic fibrosis and Crohn’s disease candidates.
FDA
Prevnar 20 is indicated for the prevention of invasive pneumococcal disease and otitis media in children.
In the Phase III SURMOUNT-2 study, Mounjaro reduced body weight by 29.8 lbs. on average in adult type 2 diabetes patients who were overweight or obese.
Longitudinal studies that track patients’ experiences can inform and accelerate the drug approval process for rare diseases.
The joint venture between Walgreens and Prothena to accelerate the approval of an Alzheimer’s treatment is the latest in biotech and retail chain alliances.
The French pharma drops another BTK inhibitor program from Principia and an anti-TNFa from Ablynx.
The leadership shuffle comes as BMS is facing one of the steepest patent cliffs in biopharma, with exclusivity of three of its top drugs lapsing this decade.
To be self-employed in the life sciences, you must have a strong network and background and experience in a relevant area.
While MBAs can reflect positively on job applicants, work experience can often be more valuable, depending on the area.
For people with, or at risk for, SOD1-ALS, the FDA’s approval of Qalsody is an important step toward advancing gene-specific research for this uniformly fatal disease.
FDA
Vowst, the first-ever oral fecal microbiome-based therapeutic, is indicated for preventing C. diff recurrence in adults following antibacterial treatment.
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