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; Company Will Double R&D / 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

Pfizer’s Biosimilar Program: A MAB Dash After Biocon Deal Ends / Following the breakup in March of its insulin biosimilars deal with Biocon, Pfizer confirms plans to develop monoclonal antibody biosimilars on its own, and has put its first candidate, rituximab, into Phase 1 testing. / “The Pink Sheet” DAILY May 16, 2012

Cardinal’s Dik Acquisition Aims To Grow Independent Pharmacy Ties, Generic Rx Sales / Cardinal agrees to purchase regional distributor Dik Drug, bringing in business with about 500 independent retail pharmacies and high generic drug volume. / “The Pink Sheet” DAILY May 16, 2012

Regional Firms Must Compete With Multinationals At Home And Away / Regional firms have to face multinationals coming into small and emerging markets, says an Alkaloid AD Skopje exec, but they need to venture into new markets themselves. While multinationals have the benefit of large budgets and proven strategies, smaller companies can more effectively identify and predict key local behavior. / “The Pink Sheet” DAILY May 16, 2012

Alzheimer’s Research To Be More Collaborative, Better Funded Under National Plan / Most of the additional money will help support two trials – one for insulin as a treatment and one for crenezumab as a preventative. The Obama administration formally launched its national Alzheimer’s plan in the midst of a two-day meeting that underscored how little researchers know about the disease. / “The Pink Sheet” DAILY May 15, 2012

Cornerstone Buys EKR Therapeutics To Expand Hospital Growth Strategy / Cornerstone gains two commercial products for the acute-care hospital setting, Cardene and Retavase, with the acquisition of EKR Therapeutics for $125 million upfront and potential milestones. / “The Pink Sheet” DAILY May 15, 2012