With an eye to continued pipeline expansion, Horizon Therapeutics plc has agreed to pay $45 million up front plus milestones to acquire stealth startup Curzion Pharmaceuticals Inc., the developer of a potential therapy for diffuse cutaneous systemic sclerosis (dcSSc).

Not long after a morning earnings call on March 27 in which Intelgenx Corp. CEO Horst Zerbe said his team was still awaiting word from the FDA on its resubmitted 505(b)(2) application for its acute migraine candidate, Rizaport Versafilm, that news arrived in the form of a complete response letter (CRL), its third following earlier CRLs in February 2014 and April 2019.

Barely a day after its PDUFA date, despite the unfolding COVID-19 pandemic, the FDA has approved Bristol Myers Squibb Co.'s immunomodulator, ozanimod, an oral treatment for adults with relapsing-remitting multiple sclerosis (MS) and active secondary progressive disease branded as Zeposia. The win, a much-anticipated milestone precipitated by the company’s multibillion-dollar acquisition of ozanimod developer Celgene Corp. in November 2019, gives patients a new treatment option amid a growing field of therapies for MS.

Barely a day after its PDUFA date, despite the unfolding COVID-19 pandemic, the FDA has approved Bristol Myers Squibb Co.'s immunomodulator, ozanimod, an oral treatment for adults with relapsing-remitting multiple sclerosis (MS) and active secondary progressive disease branded as Zeposia.

Despite earlier signs it might meet the primary endpoint of a phase III trial testing its ability to terminate supraventricular tachycardia (SVT) episodes in patients with paroxysmal supraventricular tachycardia (PSVT), a short-acting calcium channel blocker tested by Milestone Pharmaceuticals Inc. failed to do so.

Humanigen Inc., the Burlingame, Calif.-based developer of an anti-human-GM-CSF monoclonal antibody for preventing and treating cytokine storms, is urgently working to spin up a phase III trial of the candidate, lenzilumab, for COVID-19 patients whose immune systems have gone into overdrive.

Dragonfly Therapeutics Inc., of Cambridge, Mass., has expanded a strategic collaboration with Merck & Co. Inc. on the development of natural killer (NK) cell engager immunotherapies for oncology to add infectious disease and immune disorders. For $47.5 million up front, it's granting Merck the option to license exclusive rights to candidates developed using its TriNKET cell technology platform.

With medical researchers across the globe adjusting to the far-reaching impacts of COVID-19, commercial and academic trialists are taking action to protect essential studies. Regulators, too, are now joining the effort in a more concerted way, with the FDA issuing new guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic.