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Coming in Friday's "The Pink Sheet" DAILY

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.

Latest News From "The Pink Sheet" DAILY - Antibiotic Play Optimer Looks At Options

Securities Fraud Class Action Suits Could Grow After Amgen's Supreme Court Loss Supreme Court rules 6-3 that plaintiffs do not need to prove that a company's misrepresentations were material at the class certification stage; investors allege Amgen misrepresented the safety of Aranesp and Epogen.

Coming In Thursday's "The Pink Sheet" DAILY - Optimer Explores Its Options

The antibiotic company Optimer announced it is reviewing strategic options and that CEO Petdro Lichtinger has been replaced by Chairman Henry McKinnell.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.

Latest News From "The Pink Sheet" DAILY - Aveo's Tivozanib Faces ODAC May 2

Aveo's 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 arm.

Latest News From "The Pink Sheet" DAILY - Royalty Pharma Makes A Play For Elan

For Elan Investors, A Choice Between A Sure Thing Or A High-Risk Play 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 certain exit or trust management to execute the long-term strategy?

Coming In Tuesday's "The Pink Sheet" DAILY - Royalty Pharma Makes A Move For Elan

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?

Save the Date!

Scientific Advances Increase Potential For Drugs To Treat ALS

Article preview from "The Pink Sheet"-  February 25 , 2013

 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.

Latest News From "The Pink Sheet" DAILY - Roche's Kadcyla Clears FDA

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.

Coming In Monday's "The Pink Sheet" DAILY - EMA Panel Again Rejects Vivus' Obesity Drug Qsiva

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.

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Latest News From "The Pink Sheet" DAILY - GPhA Objects To Amgen Push To Restrict Biosimilar Substitution

Biosimilar Diplomacy By Other Means: GPhA CEO Calls Out Amgen Guest During speech to the group's annual meeting, GPhA President Ralph Neas says he is disappointed that Amgen, which is among the firms attending the gathering, is pushing biosimilar substitution restrictions in state legislatures.