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

Big Pharma Insiders Pessimistic About Pricing Going Forward / Pricing and market access continue to be trends that plague big pharma, even as patent expirations and lagging new drug launches create harder circumstances for companies. / “The Pink Sheet” DAILY May 14, 2012

Gaming 340B: Sen. Grassley Wants Answers On How A Hospital Bends Drug Discount Rules / The ranking member on the Senate Judiciary Committee sends a letter to the University of Alabama Hospital seeking details on how it has changed the admission status and treatment of patients to get 340B drug discounts for patients who would not have been eligible otherwise. / “The Pink Sheet” DAILY May 14, 2012

Device Firms Seek More Exemptions, Pricing Flexibility For Oncoming Excise Tax / Written comments were due May 7 on the Internal Revenue Service’s proposed regulation to implement a 2.3% excise tax on device sales in the lead-up to a May 16 public hearing. / “The Pink Sheet” DAILY May 14, 2012

Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns / Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early. / “The Pink Sheet” DAILY May 11, 2012

Dificid Launch On Path To Success / Optimer Pharmaceuticals’ antibiotic Dificid is on track to exceed one-year targets agreed upon with co-promotion partner Cubist. / “The Pink Sheet” DAILY May 11, 2012

Seeking Turnaround, Myrexis Taps Two New Execs / Rather than pursue a sale, Myrexis will obtain revenue-generating drugs that it feels are underperforming in other hands. Until it chooses an asset to acquire, it will operate as a virtual company. / “The Pink Sheet” DAILY May 11, 2012