Biogenerics get an unlikely ally — the Bush administration
The push to create a regulatory framework for generic versions of biotech drugs fizzled last year in Congress, as legislators seemed to lose interest after failing to attach the measure to a major FDA reform bill. But now it’s back, and has gained some unlikely friends in the Bush administration.
The FY2009 federal budget, compiled by the administration’s Office of Management and Budget, for the first time explicitly proposes giving the FDA authority to regulate biogenerics…. Continue Reading
Life sciences briefing: Tuesday, Jan. 22, 2007
TODAY’S HEADLINES:
Teva acquires protein-therapeutic maker CoGenesys for $400M (release)
ViewRay takes in $25M for MRI radiation-therapy guidance (release)
NovaMed, Chinese clinical-research outfit, receives $14M (release)
Progentix Ortho raises first funding round (release)
Medical imaging co. Point Biomedical recaps with $25M (VentureWire)
Lumidigm takes in $7M for optical-fingerprint ID systems (VW)
Medical-software co. Compressus aims to close $14M round (VW)
Channel Medical Partners aims for $150M med-tech fund (VW)
Spinal-implant maker Scient’x names Michael Huggins as CEO (release)
Specialty pharma Cardiokine names Manuel Worcel as… Continue Reading
Biogenerics: The bad arguments just won’t stop
It’s always fascinating to see just how entitled biotechnology investors feel about the outsized rewards the industry bestows whenever one of their long-shot companies finally strikes it rich — not to mention how thoroughly that sense of entitlement seems to muddle their thinking.
Case in point for the moment is Steve Burrill, CEO of the life-science VC firm that bears his name, and in most respects a sage and intelligent man. Yet here he is… Continue Reading
Biotech’s double standard on biogenerics
(UPDATED: See below.)
Yesterday, the WSJ Health Blog cited a WSJ story as evidence that “biogenerics” — that is, generic versions of biotech drugs, which currently don’t exist — need to be treated with caution. Unfortunately, that post missed a much more important point about biogenerics: The double standard that the biotech industry holds when it comes to determining whether different batches of biotech drugs are equivalent or not. The subject is still widely misunderstood, thanks in… Continue Reading
Roundup: Biogenerics bill in limbo, clashing data on health IT benefits, the RNAi boom, and more
House-Senate confrontation set over biogenerics – Late last month, a key group of senators reached agreement on legislative provisions that would authorize copycat versions of biotech drugs, which are typically complex proteins manufactured by genetically engineered cells (see details here and here). These provisions would finally put biotech drugs — which don’t face cut-rate competition once their key patents expire — on a par with traditional pharmaceuticals, and have been a long time in coming. They’re… Continue Reading
“Generic” biologics: Another biotech battle begins
(Note: This item has been copied over to the Life Sciences page from its original location on the VentureBeat main page. To view it in its original context, with comments, click here.)
A second legislative fight for the biotech industry is shaping up in Washington over whether to give the Food and Drug Administration authority to approve “generic” versions of biotechnology drugs whose patents have expired.
Measures that would grant FDA that authority, introduced separately in the… Continue Reading