Osmotica Pharmaceuticals plc’s amendment earlier this month to the NDA for arbaclofen in spasticity resulting from multiple sclerosis wasn’t enough to quell the concerns of the FDA, which smacked the firm with its second complete response letter (CRL).
Hopes continue to rise as the COVID-19 vaccine beat goes on and Operation Warp Speed (OWS) lives up to its name, with Moderna Inc. netting another U.S. Department of Defense contract worth about $1.97 billion for another 100 million doses – an order that brings to about $6 billion the company’s government contracts for the product, which was granted emergency use authorization (EUA) earlier this month.
Thanks to Myovant Sciences GmbH’s potential $4.2 billion deal with Pfizer Inc. for recently approved Orgovyx (relugolix) in prostate cancer (PC), more physicians are going to be learning about [the compound] faster,” said chief commercial officer Adele Gulfo. “This is going to create huge demand.”
Amsterdam-based Uniqure NV’s regulatory hitch with its highly regarded hemophilia B program had analysts questioning during a conference call what the development might mean for the company’s deal with CSL Ltd.
An evolving COVID-19 treatment paradigm may have foiled Mesoblast Ltd.’s phase III with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS), CEO Silviu Itescu said, but hope remains in pediatric steroid-refractory acute graft-vs.-host disease (GVHD).
The challenging mucositis space chalked up another failure in dusquetide, the innate defense regulator from Soligenix Inc., which fell short in a pivotal, phase III study that enrolled 268 patients to test the small-molecule peptide. “We sort of thought so,” Dawson James analyst Jason Kolbert in a Dec. 22 report, with a neutral rating and no price target.
Amsterdam-based Uniqure NV’s regulatory hitch with its highly regarded hemophilia B program had analysts questioning during a conference call what the development might mean for the company’s deal with CSL Ltd.
An evolving COVID-19 treatment paradigm may have foiled Mesoblast Ltd.’s phase III with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS), CEO Silviu Itescu said, but hope remains in pediatric steroid-refractory acute graft-vs.-host disease (GVHD).
In the second half of November, Black Diamond Therapeutics Inc. gained attention from Wall Street by nominating BDTX-1535 as the firm’s development candidate for glioblastoma multiforme (GBM) and kicked off IND-enabling studies.
