Buoyed by the success of its PAH franchise, Switzerland's Actelion says it has begun a Phase III study of its in-house drug ponesimod for multiple sclerosis.
The litany of clinical trial disasters that has played out at Targacept over the past three years continues this morning with the news that its last remaining pipeline asset failed a Phase I/II study for diabetic gastroparesis. And as has happened so many times before, the biotech's share price took another nasty tumble, dropping 22%.
Pharmalink has stopped a Phase IIb trial of its primary IgA nephropathy treatment early after it met its primary endpoint in a planned interim analysis. The success makes Pharmalink a rare example of a private biotech with an unpartnered, Phase III-ready asset, characteristics that inevitably lead to talk of IPOs and deals.
Given the varying ways that individual ALS patients progress, gradually growing paralyzed and dying in 3 to 5 years, he reasoned, the results from 8 patients after only 12 weeks of treatment, with 4 patients reserved for the placebo arm, couldn't provide a reliable look at efficacy.
Pfizer reported today that it had cut short a Phase III study of palbociclib, recently approved under an accelerated pathway as Ibrance, after clearly demonstrating that it had met its primary endpoint: progression-free survival with a combination of Ibrance plus fulvestrant in women with hormone receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer.
Belgium's Galapagos says that its oral JAK1 inhibitor filgotinib met its primary and other endpoints in a crucial Phase IIb study for rheumatoid arthritis.
In the checkpoint receptors race, Bristol-Myers Squibb is out in front with the biggest and fastest effort, a comeback Merck is in hot pursuit and Roche/Genentech and AstraZeneca are following but still in the front of the pack.
Two Maryland-based companies are racing to get a vaccine for respiratory syncytial virus to market--and one just picked up a regulatory boost.
Two months ago Shire CEO Flemming Ornskov held up the rare liver disease drug SHP625 as a prime example of its most promising development programs. Today, though, Shire was forced to concede that the drug flopped against both the primary and secondary endpoints in the first of several Phase II studies.
Portola Pharmaceuticals has snapped in the last piece to a Phase III program puzzle for its "breakthrough" anti-anticoagulant, painting a clear path to an accelerated regulatory submission later in the year.