Xarelto Acute Coronary Syndromes Claim Faces Data Quality Hurdle / FDA will ask its cardio-renal advisory committee whether missing data in J&J/Bayer’s ATLAS study affects the interpretability of rivaroxaban’s demonstrated efficacy in acute coronary syndromes. The panel also will be asked whether the agency should pre-specify clinical trial standards for data quality to reduce the problems associated with missing data in CV outcomes studies. / “The Pink Sheet” DAILY May 21, 2012

DaVita Shifts Its Business Model With HealthCare Partners Acquisition / Dialysis provider DaVita acquires one of the largest independent physician associations, HealthCare Partners, for $4.4 billion in cash and stock, as well as earn-outs. / “The Pink Sheet” DAILY May 21, 2012

P&G Spinout Spins Off Another Company, While Looking To Partner Mid-Stage Oral Anemia Candidate / Akebia will sell off, partner or possibly bring AKB-6548 – thought to be a safer erythropoietin stimulator than currently available injectables – through Phase III, while its spinout, Aerpio, will focus on clinical development of candidates for diabetic macular edema and inflammatory bowel disease. / “The Pink Sheet” DAILY May 21, 2012

Prosonix Extends Series B Financing, Plans Generic Fluticasone Filing / Prosonix receives an extra $9 million for its Series B round as it changes business strategy from contract research to the development of generic respiratory products, based on a novel particle-engineering technology for inhaled powders. / “The Pink Sheet” DAILY May 21, 2012

OraSure In-Home HIV Test’s Promise Outweighs Risks, Panel Concludes / FDA’s Blood Products Advisory Committee endorses OraSure’s OraQuick in-home HIV test in a unanimous 17-0 vote on May 15. If approved, OraQuick would be the first-ever over-the-counter test for HIV that can be performed entirely in the home by untrained users. / “The Pink Sheet” DAILY May 21, 2012

User Fee Amendments In Senate Filed, But Track-And-Trace Remains Off The Map / System standards could be included in the manager’s amendment, which was not complete May 18. A cloture vote could come late May 21, which would delay the start of floor debate. / “The Pink Sheet” DAILY May 18, 2012

FDA Performance Assessments Include Drug Review Clock Sometimes, GAO Says / Government Accountability Office report finds that meeting PDUFA review goals is not an explicit element in CDER non-executive level employees’ performance plans. However, CDER Director Janet Woodcock’s performance plan includes an express reference to PDUFA performance goals, reflecting a “buck stops here” level of accountability. / “The Pink Sheet” DAILY May 18, 2012

Sign Of The Times: Late-Stage Cancer Vaccines On Display At ASCO / Vindicated by the approvals of Provenge and Yervoy, a host of therapeutic cancer vaccines is working through late-stage trials with the regulatory finish line in sight, and some of those companies will be presenting data at the American Society of Clinical Oncology meeting in Chicago June 1-5. / “The Pink Sheet” DAILY May 18, 2012

Osiris Prochymal Gets Green Light In Canada; FDA Filing Is Next / World’s first approval for a stem cell treatment is milestone for Maryland-based Osiris Therapeutics, but the product’s patient population is small and further studies are required. / “The Pink Sheet” DAILY May 18, 2012

Financings Of The Fortnight Parses Federal Funding For Roche/Genentech Alzheimer’s Candidate / Plus news on recent financing activity by Arena, OncoMed, Egalet and Dynavax. / “The Pink Sheet” DAILY May 18, 2012

BMS Dives Deeper Into China With First Discovery Partnership / BMS doubling down in China with discovery deal with Beijing’s Tsinghua University and plans to ramp up in diabetes and hepatitis. / “The Pink Sheet” DAILY May 18, 2012

Medication Adherence Improves With eRx Growth – Surescripts / With more than 50% of office-based physicians electronically prescribing, Surescripts is estimating that the benefit to the health care system from eRx could reach $240 billion over the next 10 years. / “The Pink Sheet” DAILY May 17, 2012

Ra Pharma Aims For Oral Peptide Drugs Using Synthetic Amino Acids / Just out of stealth mode, privately held biotech closes second tranche of $27 million Series A financing and announces first drug program will pursue an oral kallikrein inhibitor for prevention of hereditary angioedema. / “The Pink Sheet” DAILY May 17, 2012

Alkermes After Elan: A Slow Start But A Maturing Pipeline / As it continues its transformation into a drug development company, Alkermes says it is meeting its own expectations, but analysts are disappointed, at least in the short term. / “The Pink Sheet” DAILY May 17, 2012

Zithromax Cardiovascular Safety Label Revision May Resemble Levaquin / FDA is reviewing a large study published in the New England Journal of Medicine, and strengthened warnings about cardiovascular risk may be on the way for all azithromycin products. / “The Pink Sheet” DAILY May 17, 2012

Value-Based Pricing Could Boost Global Applicability Of NICE Appraisals / Value-based pricing will start in the U.K. in January 2014 for newly launched products, with prices taking into account innovation and societal benefit as well as NICE's usual clinical and cost-effectiveness analysis, U.K. Health Secretary Andrew Lansley tells NICE's annual conference. / “The Pink Sheet” DAILY May 17, 2012

NICE Price: Zytiga On Track In England After Discount / Janssen’s decision to offer the NHS a discount for its oral prostate cancer treatment Zytiga appears to have paid off, giving the drug a boost and head start over potential rivals in the EU. / “The Pink Sheet” DAILY May 17, 2012

User Fee Bill Reemerges In Senate With Minor Tweaks, But More Changes Expected / The new bill includes a provision requiring FDA to consider foreign clinical trial data when making approval decisions and more patient participation in drug development meetings. A cloture vote could come as soon as May 17 with floor debate possibly beginning next week, Sen. / “The Pink Sheet” DAILY May 16, 2012

Antibiotic Exclusivity’s Latest Push: Distressing Resistance Data From The VA / A Pew-funded study found growing use of “last-stand” antibiotics in VA hospitals as resistant pathogens spread. Researchers say the pending GAIN Act will help address some of the economics of convincing drug makers to invest in development of new antibiotics, but other financial – as well as regulatory and scientific challenges – will remain. / “The Pink Sheet” DAILY May 16, 2012

Small Companies Turning To CDER Ombudsman For Help With Drug Approvals / While the CDER ombudsman dealt with far fewer complaints overall in 2011 than in 2010 due to administrative changes, smaller companies are increasingly asking for help in certain key areas of drug development. / “The Pink Sheet” DAILY May 16, 2012