Reuters has the "exclusive" this morning that the FDA may approve Merck's PD-1 immuno-oncology superstar pembrolizumab for melanoma some weeks ahead of the October 28 PDUFA date. Then again, they may not, but it's looking good, according to the wire service.
The executive team here at the rapidly expanding headquarters of Novo Nordisk doesn't pull many punches. CEO Lars Rebien Sørensen is a competitive sort who tends to be blunt, aggressive and forward-thinking; projecting a confident attitude that is reflected by the rest of the execs and right down the line to 40,000 rank-and-file employees around the world.
Analysts at Silicon Valley Bank have been crunching the numbers on biotech investing, and they have found that a group of busy corporate venture arms has fundamentally changed the landscape for startups and the entire field of early-state drug development--with some big implications for the current crop of industry upstarts.
If you look at the biosimilars market as a global whole, the sum total of revenue generated by the follow-on crowd just barely crossed into blockbuster territory in 2013, according to a new study from Allied Marketing Research. But that $1.3 billion base is expected to swell to $35 billion by 2020 as new products penetrate the market in North America, Europe and Asia.
Close to four years ago, Reata Pharmaceuticals scored one of the biggest packages of upfront and near-term cash the industry had seen at that point. AbbVie signed up to partner on its chronic kidney drug bardoxolone by dangling $450 million in quick cash, and then came back a year later to get the full portfolio of follow-up drugs at Reata for another $400 million upfront.
Whether it's in Boston, Chicago, Philadelphia or Washington, DC, the centerpiece of the annual BIO convention is always the same: a sprawl of interconnecting cubicles and makeshift corridors where would-be dealmakers shake hands, make promises and hope to form pacts that'll turn their strategic plans into reality.
Convening in San Francisco for the annual conference of the American Diabetes Association this weekend, drugmakers angled for the spotlight in a field made up mostly of similar treatments with small differentiations that could spell the difference between blockbuster sales and also-ran status.
If Orexigen wins FDA approval for its weight loss drug NB32 (which used to be called Contrave) by tomorrow's long-awaited PDUFA date--and the odds are in its favor--look for the biotech and its pharma partner Takeda to barrel into a huge obesity market that has provided a chilly reception for a pair of rivals.