In the company’s financial results for 2021 released on May 11, Takeda announced the decision to discontinue the development of TAK-609, a therapeutic for Hunter Syndrome. Additionally, Takeda is collaborating with JCR Pharmaceuticals in another therapeutic attempt for the condition.

Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.

The U.S. Food and Drug Administration expanded the indication of Supernus Pharmaceuticals Inc.’s Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older.

AstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).

The 71st annual American College of Cardiology’s Scientific Session saw several wins – and some “mehs” led by some of biopharma’s largest companies, according to BioSpace.

Interim data from Roche Group member Genentech’s first randomized study of a candidate treatment for extensive-stage small cell lung cancer (ES-SCLC) failed to meet the clinical trial’s co-primary endpoint against the hard-to-treat disease.

Global immunology firm Argenx shared positive topline results from the company’s ongoing study on the use of efgartigimod for generalized myasthenia gravis (gMG). 

Bristol Myers Squibb’s Opdualag – a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion – was approved by the U.S. Food and Drug Administration for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

AstraZeneca’s Fasenra (benralizumab) hit a roadblock in attempting to expand the medicine’s indications when the U.S. Food and Drug Administration issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP). 

Bristol Myers Squibb and Nektar Therapeutics released disappointing news about their joint Phase III PIVOT IO-001 study evaluating a dual therapy of the immunotherapy drug bempegaldesleukin in combination with Opdivo (nivolumab) compared with Opdivo alone to treat unresectable or metastatic melanoma.