An FDA advisory panel wants to limit the use of testosterone drugs for safety reasons--and the proposed restrictions would shrink sales significantly. That's not good news for AbbVie, the market leader, and other drugmakers that have been riding a surge of testosterone growth.
As if the merger-happy pharmaceutical industry didn't have enough to worry about, what with the federal government threatening to crack down on companies that flee overseas to lower their taxes, now there's another set of stakeholders protesting these so-called tax inversions: pension funds.
Partners Biogen Idec and AbbVie are touting late-stage results for their new, monthly multiple sclerosis treatment, preparing to hand in regulatory applications next year and contend in a crowded market.
Even as the FDA is questioning the widespread use of testosterone-boosting drugs for men, the Federal Trade Commission has sued AbbVie and Teva Pharmaceutical Industries for keeping a generic of one out of their reach for years. It is one of the first actions brought by the FTC since the Supreme Court last year said that so-called pay-for-delay deals are not inherently illegal.
While the outside world still has little idea what Google's biotech Calico is planning, AbbVie has seen enough to convince it to commit at least $250 million to the startup.
Hot on the heels of its $805 million development deal with Infinity, AbbVie Pharmaceuticals has followed up today with a plan to partner with Google's closely watched biotech upstart Calico on a new research operation that will cost up to $1.5 billion to get started.
AbbVie has agreed to hand over $275 million upfront to Infinity Pharmaceuticals in exchange for rights to develop and commercialize duvelisib, its oral PI3k-delta/gamma inhibitor for blood cancers. And the blockbuster-size deal for Infinity's lead program comes with $530 million in potential milestones.
AbbVie's waiting for FDA approval on a hepatitis C combo therapy. OraSure makes a rapid test to detect the virus. And professional truck drivers in the U.S. are more than 5 times as likely as other Americans to have it.
Gilead Sciences convinced an panel of arbitrators that rival Roche had no legitimate claims on Sovaldi, its record-setting hepatitis C treatment, but the antiviral pioneer still faces patent spats with a host of challengers looking to cash in on next-generation combo therapies for the disease.
U.S. drugmakers have embraced the tax inversion strategy with open arms as of late, buying up foreign companies right and left and hauling overseas to take advantage of their lower rates. But U.S. officials are looking to stop them in their tracks--an intent that has some pharma investors worried.