Alexion is again having problems with a contract filler, forcing it to recall two more lots of its rare-disease drug Soliris because of visible particles found in vials. It is the second time in about three months that the company has been in this situation.
Alexion Pharmaceuticals has racked up its second breakthrough therapy designation from the FDA, securing a faster track for an early-phase enzyme-replacement treatment targeting an ultra-rare metabolic disorder.
So is Roche going to do some rare disease deals or not? Rumors of a possible buyout of Alexion and BioMarin--alternatively dissed and touted--helped make this one of the big questions for deal watchers. Roche CEO Severin Schwan's answer can now be summarized in one word: Maybe.
Maybe Roche isn't as interested in Alexion Pharmaceuticals as some recent news reports suggest. Roche pharma chief Daniel O'Day told Reuters ' Ben Hirschler that ultra-rare diseases--an Alexion specialty--just doesn't fit its business model.
Amid a major hot streak for biotech stocks, New York Times scribe Andrew Pollack caught up with David Blech, who is heading to prison later this month after making fraudulent trades on drug company stocks. His story has become a cautionary tale in the biotech industry, which once regarded him as a major player.
Biotech companies have set out to keep U.S. tax credits pinned to costs of developing drugs for rare or "orphan" diseases, seeking to escape the mammoth budgetary ax of Congress on Capitol Hill.
If Roche does actually pull the trigger on a rumored bid for Alexion, you can expect analysts to react with some scathing assessments.
If Roche actually comes through with a $22 billion-plus bid for Alexion, the biotech intends to be ready to man the defenses and fight it out for top dollar.
As The Irish Times reports, the company aims to begin shipping the therapy for rare blood disorders from the facility before the end of this year.
Ensemble Therapeutics is putting its discovery engine to work on ultrarare diseases. The Cambridge, MA-based biotech will explore its rapidly growing library of 10 million macrocycles to see what it can whip up for Alexion's pipeline.