Few productivity metrics in biopharma measure up to the annual rate of new drug approvals. So now that the FDA has come through with only 13 novel approvals in the first half of the year, well off the pace of 39 new approvals in 2012, there's some handwringing going on.
A report from BioPharm Insight noted that a patient on Biogen Idec's new multiple sclerosis drug Tecfidera had died, prompting a quick drop of about 3% in the biotech group's stock price, which recovered to about even later in the day.
Biogen Idec seized U.S. approval for its new oral multiple sclerosis drug, Tecfidera, already touted as a sure blockbuster.
Just days ahead of a big-time FDA decision on its oral multiple sclerosis pill, Biogen Idec grabbed the endorsement of a European Union authority for approval of Tecfidera as a first-line therapy.
The budget cuts required by sequestration may have added a big question mark to every FDA deadline on the schedule, but there are four big developers holding their breath right now in anticipation of a formal marketing decision on their experimental drugs.
With $4 billion of Copaxone revenue on the line, it's no surprise to find Teva waving a red flag to the FDA as Biogen Idec gets down to the regulatory wire with its closely watched competitor BG-12. The big generics company filed a petition with the FDA demanding an advisory committee meeting to inspect what it has called potentially "serious safety risks."
Industry watchers argue that Scangos deserves kudos for the success of the biotech powerhouse since his tenure began, Forbes editor Matthew Herper writes in a feature on the chief executive's impact.
Novartis is touting a new data analysis suggesting that early treatment with its multiple sclerosis drug Gilenya can ward off relapses--and even prevent the loss of brain volume that often plagues MS patients. It's just one of the studies Novartis hopes will support increased use of its MS pill, the first oral therapy for the disease when it was launched last year.
Three contenders in the oral multiple sclerosis drug race have spotlighted their rival therapies this week. Biogen Idec, which revealed analysis from two Phase III studies of its blockbuster hopeful BG-12, is providing the new data points as the biotech heavyweight seeks approval of the oral med in the U.S. and Europe.
The Holy Grail of every big R&D organization on the planet remains finding and developing blockbuster drugs. Breaking into the 10-figure club can be a defining moment in any researcher's career. It may not make it on the tombstone--here lies John T. Researcher, he developed a billion-dollar therapy--but it would be an understandable desire. Despite rumors to the contrary, the blockbuster is far from dead. Here are 15 hopefuls that are alive and kicking >>