|Biotech Due Diligence||
Novartis $NVS, through its Sandoz generics unit, is one of the leading biosimilars players worldwide. They also have collaborations with Momenta Pharma $MNTA around generic versions of LOVENOX (enoxaparin) and COPAXONE. Here are some highlights from their recent 1q-2013 conference call (c/o SeekingAlpha). Note there was no substantive discussion on either the enoxaparin program or their ALK inhibitor LDK378, which is covered extensively on our HSP90 Central site.
Actavis $ACT (renamed from Watson Pharma $WPI after merger) is one of numerous companies pursuing biosimilars, in collaboration with Amgen $AMGN. Here are there recent comments from the 1q-2013 earnings call (c/o SeekingAlpha). Note that their commercialization deal with Antares Pharma $ATRS for GELNIQUE was not discussed.
See below for recent comments from Teva Pharmaceuticals $TEVA and Baxter International $BAX relevant to Momenta Pharmaceuticals $MNTA - specifically their generic COPAXONE program for MS and their biosimilars partnership, respectively.
Antares Pharma $ATRS has a number of product partnerships with Teva Pharmaceuticals $TEVA based around a series of parenteral injection devices. These deals have been shrouded in secrecy and also littered with delays over the years. Recently though Teva briefly addressed the Epi-pen program on their 1q-2013 conference call (excerpt via SeekingAlpha).
Just curious to know your confidence level in the FDA's ability to approve EpiPen, an AB-rated EpiPen in 2015?
So, just to your second on question on EpiPen, I will let you know we had a settlement with Mylan and we have an entry date in 2015. The trial Is progressing well.
Don't Take Your Vitamins
Paul Offit (New York TImes)
Profiles in Long-Termism: Sarepta Therapeutics CEO Chris Garabedian
Luke Timmerman (Xconomy)
Be sure to head over to our SRPT home page for extensive coverage of Sarepta and their DMD drug eteplirsen from investing, scientific, and patient perspectives.
Legislation would Create New Incentives, Penalties to Compel Reporting of Trials Results
Alec Gaffney (Regulatory Focus)
I can count on one hand the number of listings I have seen on Clinicaltrials.gov that had the "required" results published - hopefully the situation will be improved somehow.
Master protocol’ aims to revamp cancer trials
Heidi Ledford (Nature)
FDA Issues Final Orphan Drug Regulations
Michelle Butler (FDA Law Blog)
Opinion recap: No patent on natural gene work
Lyle Denniston (SCOTUS Blog)
Solid summary of the Myriad Genetics MYGN patent case ruling re BRCA1/BRCA2.