Sarepta Therapeutics, a commercial-stage biopharmaceutical company, has announced that the Food and Drug Administration (FDA) has lifted the clinical hold for its Duchenne muscular dystrophy (DMD) micro-dystrophin gene therapy program.
AstraZeneca’s diabetes drug Farxiga (dapagliflozin) has succeeded in a phase 3 cardiovascular (CV) outcomes trial (CVOT) by delivering a statistically-significant reduction in hospitalization for heart failure or CV death in patients with type-2 diabetes (T2D).
Roche’s Tecentriq (atezolizumab) in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) has reduced the risk of disease worsening or death in people with non-squamous and non-small cell lung cancer (NSCLC) in the Phase III IMpower132 study.
Zealand Pharma, a Copenhagen-based biotechnology company, said that a pivotal phase 3 trial evaluating dasiglucagon in patients with severe hypoglycemia in diabetes has achieved primary and key secondary endpoints.
Actelion Pharmaceuticals has announced the results of the first randomized controlled trial in portopulmonary hypertension (PoPH), which showed Opsumit (macitentan) significantly improved pulmonary vascular resistance (PVR) compared with placebo, meeting the primary endpoint of the study.
Pfizer’s Janus kinase (JAK) inhibitors, including PF-06651600 and PF-06700841, have achieved primary efficacy endpoint of improving hair regrowth in patients with moderate to severe alopecia areata (AA) in phase 2a study.
Bristol-Myers Squibb has reported that its oral, selective tyrosine kinase 2 (TYK2) inhibitor BMS-986165, yielded positive results in a phase 2 trial in patients with moderate to severe plaque psoriasis, by reducing the severity of their skin disorder.
Gilead Sciences and Galapagos’ filgotinib has met its primary and all significant secondary endpoints in a phase 3 study of rheumatoid arthritis.
Xspray Pharma, a product development firm with various product candidates in clinical development, has announced positive data from a clinical bioequivalence study with its lead product candidate HyNap-Dasa.
BeiGene's RAF dimer inhibitor, lifirafenib (BGB-283), will be evaluated in combination with SpringWorks Therapeutics’ investigational MEK inhibitor, PD-0325901, in a phase 1b clinical trial in patients with advanced solid tumors.
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