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Biopharmaceutical news and analysis from Elsevier Business Intelligence:
Japan’s Takeda Pharmaceuticals has inked an option agreement with Resolve Therapeutics for a pre-clinical lupus drug. The deal provides Resolve with $8 million upfront and Takeda has the right to option the compound after Phase Ib, effectively providing an exit for the small biotech’s shareholders.
The antibiotic company Optimer announced it is reviewing strategic options and that CEO Petdro Lichtinger has been replaced by Chairman Henry McKinnell. Multiple anti-infective rivals looking to beef up their portfolios with a commercial asset could drive a competitive process.
Vertex announced the start of a two-trial pivotal Phase III program for its cystic fibrosis combo consisting of Kalydeco and lumacaftor (VX-809) on Feb. 26. The two studies will investigate a pair of doses of lumacaftor with the FDA-approved dose of Kalydeco for safety and efficacy over a 24-week period.
Zogenix expects brief delay in decision on hydrocodone-only Zohydro ER for chronic pain; the drug’s user fee date is March 1.
Tivozanib Will Face Challenging Survival Data At ODAC Review FDA's
Oncologic Drugs Advisory Committee will consider the tyrosine kinase inhibitor
for advanced renal cell carcinoma at a May 2 meeting. Aveo has attributed a
negative overall survival trend in the TIVO-1 study to a crossover design and
use of post-progression therapies among patients randomized to the comparator
Royalty Pharma’s $11 per-share bid for Elan is too low, according to Elan’s management and industry analysts. But will investors, anxious about the company’s planned buying spree, opt for a safe exit or trust management to execute the long-term strategy?
New understanding of the spectrum of CNS disorders and rising interest from biotechs have revealed new targets, new biomarkers and new opportunities to treat the fast-acting and deadly neurodegenerative disease. Add to that an open stakeholder forum hosted by FDA Feb. 25 that could clarify regulatory and clinical expectations, and the tide may be turning on amyotrophic lateral sclerosis.
Kadcyla Positioned For Wide Use In Metastatic Breast Cancer Roche is set to launch T-DM1 at the price of $9,800 a month, similar to cost of the preferred first-line regimen, which includes a combination of its own Perjeta and Herceptin. Drug was tested mostly in second-line HER-2 positive mBC, but labeling allows first-line treatment in a subset of patients at high risk.
The European Medicines Agency has knocked back Vivus Inc.’s Qsiva (phentermine/topiramate) for the treatment of obesity for a second time. The decision from the Committee for Medicinal Products for Human Use is likely to delay EU approval of the drug by at least two years.
Financings of the Fortnight takes note of pending IPOs and a largely self-financed Series C round by San Diego’s Elcelyx. Plus news on recent financings by Jounce Therapeutics, Retrophin and e-Therapeutics.
Receptor tyronsine kinase-focused Kolltan Pharmaceuticals looks to move into a new stage as it readies its first candidate for an IND and names a Chief Business Officer, Jane Henderson. Although Kolltan once had an option arrangement with Celtic Therapeutics, the company says its technology now is unencumbered by any options or partnerships.
Compounding pharmacy association says its position on non-traditional manufacturing is “not a major departure” from previous statements.