Phase III
The U.S. Food and Drug Administration (FDA) cleared Haifa, Israel-based Pluristem Therapeutics’ Investigational New Drug (IND) application for PLX-R18 to treat acute radiation syndrome (ARS).
Only days after UK-based Mereo BioPharma canceled its plans for an initial public offering (IPO) on the Nasdaq Global Market, Framingham, Massachusetts-based Alzheon dropped its IPO plans.
The first quarter of 2018 for Vertex Pharmaceuticals was highlighted by the U.S. Food and Drug Administration’s February approval of Symdeko, a combination treatment for cystic fibrosis.
Shares of Allergan have been in decline for more than a year and that has created an opening for some investors to begin rattling sabers about change at the company.
Alexion Pharmaceuticals closed out its first quarter plans to seek regulatory approval for its paroxysmal nocturnal hemoglobinuria (PNH) treatment, ALXN1210, which is considered the successor to the company’s blockbuster blood-disorder drug Soliris.
Shares of Denmark-based Saniona are up more than 14 percent on the Stockholm Exchange after the company announced it has been cleared to initiate the second part of a mid-stage trial to develop a treatment for adolescents with Prader-Willi Syndrome.
At the World Medical Innovation Forum, panelists observed that AI can be used to scour old clinical trial data for new applications and possibly take over part of clinical trials in “virtual” models.
Last week, the FDA’s advisory committee review of Eli Lilly and Incyte’s baricitinib for rheumatoid arthritis expressed safety concerns. Not surprisingly, the Arthritis Advisory Committee’s recommendation yesterday was mixed, split right along safety concerns.
Biogen saw a strong first quarter with 11 percent growth in revenues to $3.1 billion, which were spurred by gains in spinal muscular atrophy (SMA) treatment Spinraza and multiple sclerosis treatment Tecfidera.
Urovant Sciences has been busy the past few weeks. In March the company initiated a Phase III trial for an overactive bladder treatment, strengthened its management team and established a U.S. headquarters in Irvine, California.
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