Repros Therapeutics Inc.'s first pivotal study, called ZA-301, with the hypogonadism therapy Androxal (enclomiphene) hit both of its primary endpoints – testosterone and sperm count – in the intent-to-treat population, as mandated by the FDA, and CEO Joseph Podolski said the $2 billion demand for such therapies could get bigger than the market for erectile dysfunction drugs.
Ziopharm Oncology Inc.'s Phase III trial with the alkylating agent palifosfamide for first-line, metastatic soft tissue sarcoma failed to meet the primary endpoint of progression-free survival (PFS), but the company – shifting its efforts to synthetic biology programs partnered with Intrexon Corp. – will continue to follow patients' overall survival (OS) rates.
Having taken one step forward, Idenix Pharmaceuticals Inc. got pushed one back when the U.S. Patent and Trademark Office (USPTO) appeals board flipped a decision made earlier that favored Idenix over Gilead Pharmaceuticals Inc. in an interference dispute over patents related to hepatitis C virus (HCV) drugs.
Although Cerulean Pharma Inc.'s farthest-along trial with nanoparticle-based, camptothecin-loaded CRLX101 missed its endpoint in a Phase IIb trial against advanced non-small-cell lung cancer (NSCLC), a handful of other studies are ongoing and all have "a very strong biological rationale underpinning" them, said Oliver Fetzer, president and CEO of the Cambridge, Mass.-based firm.
Moderna Therapeutics Inc.'s major win, in the form of a $240 million up-front licensing deal with battered AstraZeneca plc for technology still at the preclinical stage, put the spotlight on messenger RNA therapy (mRNA) and sparked guesswork about whether the wager by the pharma giant can bring enough revenue soon enough.
Amgen Inc.'s $1 billion buyout in 2011 of BioVex Group Inc., which brought aboard the melanoma therapy then known as OncoVex, may be paying off, but analysts are waiting for overall survival (OS) Phase III data before they start jumping up and down about the compound, now called talimogene laherparepvec, or T-VEC.
Affymax Inc.'s stock-ravaging decision to let go 75 percent of its employees after the voluntary recall of Omontys (peginesatide) puts the spotlight ever more strongly on safety with regard to erythropoiesis-stimulating agents, and could bode well for Amgen Inc.'s anemia franchise.
India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong.
Dry-eye syndrome (DES) was not the first indication that OphthaliX Inc. planned to tackle with its first-in-class A3 adenosine receptor agonist CF101, though a 24-week, 236-patient, placebo-controlled Phase III trial is already enrolled, from which data are expected to spill out by the fourth quarter of this year.
India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong.
