Anderson, 50, has been with the company for 10 years. His most recent position was head of North American commercial operations. Prior to taking on that job in July 2016, he was global product strategy chief for the parent company, Roche (RHHBY). He joined Genentech in 2006 as vice president of immunology sales and marketing. He also directed the company’s bio-oncology business unit.
Mr. Eisenberg has worked within the life sciences for over 20 years and has been on the board of directors, at Xenetic, since July 2016. Prior to joining the board at Xenetic, Mr. Eisenberg had over 17 years’ experience working various positions at Noven Pharmaceutical. He finally held the position of president and CEO before leaving. He had also experience working for Ivax Pharmaceuticals for three years.
A Chicago doctor who took kickbacks from Big Pharma in exchange for prescribing antipsychotic meds is facing some prison time. A U.S. District judge sentenced Dr. Michael Reinstein to 9 months in federal prison after finding that Reinstein accepted payments from companies such as Teva Pharmaceuticals ($TEVA) and Ivax Pharmaceuticals for promoting the drugs to elderly patients.
One of the more memorable lines from the original Star Wars Trilogy is uttered in Return of the Jedi when Luke Skywalker surrenders himself to Darth Vader on the Forest Moon of Endor. Luke tries to convince Vader to return to the Light Side of the Force, saying that he feels the “good” within Vader. Vader, however, rebuffs the attempt at conversion, saying “You don’t know the power of the dark side! I must obey my master.” nnPutting aside the light versus dark allegory, those lines sum up quite well the power of pediatric exclusivity (and its statutory master), particularly as it relates to Orange Book-listed patents. And it’s a power that is often overlooked . . . at least initially, until the full force of pediatric exclusivity comes to bear on an ANDA or 505(b)(2) applicant. Indeed, we’ve seen a few instances over the past year where pediatric exclusivity has crept up on an unsuspecting applicant to block final approval of an ANDA. Consider, for example, the cascading periods of pediatric exclusivity applicable to various patents that were (and some that still are) listed in the Orange Book for NEXIUM (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg. Although there is no 180-day exclusivity block on ANDA approval, only one ANDA sponsor, Ivax Pharmaceuticals, Inc., currently has approval of an application – ANDA 078003. FDA approved that application after the sponsor obtained a waiver of pediatric exclusivity from the NDA sponsor, and which pediatric exclusivity became operative upon expiration of a patnet to which it attached (see our previous post here). Other ANDA sponsor have apparently not been as fortunate. nnIn light of this incident and others, we thought it would be a good time to review a couple of the ins and outs outs of pediatric exclusivity. We also refer to several of our previous posts on some interesting pediatric exclusivity topics – here, here, and here.
US drug company buys EirGen for $135m
Ivax`s (Tolterodine Tartrate 1Mg, 2Mg) Approved in USA for Overactive Bladder