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

Benlysta And Fampyra Fail to Make Headway As IQWiG Tightens Comparator Screw / Germany’s health technology evaluator’s rejection of GSK’s Benlysta and Biogen Idec’s Fampyra could force companies to design separate trials for authorization and HTA assessment. / “The Pink Sheet” DAILY May 15, 2012

Pixuvri’s Conditional EU Approval Could Herald The Rise Of Staggered Approval / CTI’s conditional EU approval for its non-Hodgkin B-cell lymphoma drug Pixuvri goes against the run of the drug in the US, but reinforces the idea that staggered approvals are on the way in Europe. / “The Pink Sheet” DAILY May 15, 2012

ESAs And Transfusions In Dialysis Patients: Watching For The Tipping Point / A study from the U.S. Renal Data System contributes to concerns that decreasing use of erythropoiesis-stimulating agents like Amgen’s Epogen in dialysis patients can lead to a significant increase in the need for blood transfusions. / “The Pink Sheet” DAILY May 15, 2012

PDL Aims To Acquire New Royalty Assets Before Current Licenses Expire / PDL BioPharma has been preparing for the expiry of key patents by making a few hires and reconfiguring its business, with plans to use remaining cash either to purchase new royalty bearing assets or, failing that, to wind up the business. / “The Pink Sheet” DAILY May 14, 2012

Ventrus Reports Positive Phase III, But Warns Again That FDA May Want Second Study / After announcing positive results from a Phase III European study of topical diltiazem for anal fissures, Ventrus cautions that a new study including Americans may be needed for FDA approval. The company says that if it gains approval, it may price the therapy on a par with recently cleared Rectiv from ProLactan. / “The Pink Sheet” DAILY May 14, 2012

CBO Says Senate User Fee Package Will Decrease Direct Spending / While drug development incentives will increase federal health care program spending, other provisions designed to allow lower-cost drugs on the market faster are expected to reduce costs. / “The Pink Sheet” DAILY May 14, 2012