Clinical Trials

FDA lifts clinical hold on Sarepta’s DMD micro-dystrophin gene therapy program

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 Farxiga succeeds in phase 3 cardiovascular outcomes trial

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 plus chemotherapy reduces death risk in lung cancer study

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’s dasiglucagon succeeds in phase 3 trial for severe hypoglycemia

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’s Opsumit improves pulmonary vascular resistance in trial of portopulmonary hypertension

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 JAK inhibitors improve hair regrowth in patients with alopecia areata

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 plaque psoriasis drug BMS-986165 succeeds in phase 2 trial

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, Galapagos’ filgotinib succeeds in phase 3 rheumatoid arthritis study

Gilead Sciences and Galapagos’ filgotinib has met its primary and all significant secondary endpoints in a phase 3 study of rheumatoid arthritis.

Xspray Pharma reports positive clinical data for HyNap-Dasa product candidate

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.