The FDA has delayed a decision on Biogen Idec's hemophilia B therapy Alprolix.
Regulus Therapeutics has partnered up with Biogen Idec to identify microRNA biomarkers in the blood of patients with multiple sclerosis, and the California biotech has charted some progress, pocketing a milestone payment and moving toward companion diagnostic development.
The European Medicines Agency Friday granted Tecfidera just what Biogen has been waiting for--a "new active substance" designation, paving the way to even greater sales for the hot product.
A number of drugmakers have been looking to get drugs across the finish line for approval of first-line use in the treatment of chronic lymphocytic leukemia, and Roche's Genentech and Biogen Idec have gotten there first. The FDA today approved their drug Gazyva, a successor to Roche's Rituxan that it hopes will offset some of massive sales that drug generates when it finally succumbs to biosimilar competition.
Just as biosimilar competition creeps up on blockbuster Rituxan, Roche and partner Biogen Idec have won FDA approval for the cancer drug's heir, marking the first success story for the agency's breakthrough drug designation.
Sales for Tecfidera reached $286 million for the quarter, far higher than the $205 million or so that analysts forecast. That revenue mark pushed net profit up 22% to $488 million, up from $398 million last year. It also helped Biogen raise its outlook.
Biogen Idec's MS pill Tecfidera has had no problem taking the market by storm since its launch in April. And armed with new reimbursement data, analysts now say more revenue growth is on the way: An already-broad reimbursement base should help Tecfidera, a drug expected to hit peak sales of $3.78 billion, as it competes with rival pills from Novartis and Sanofi.
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When a 59-year-old woman who had used Biogen Idec's Tecfidera died in July, the company said it was investigating but declared it was unlikely her death was tied to its new multiple sclerosis pill. Now the company says her doctor has made the determination the drug is not to blame.