Germany’s Berlin Airports chief executive has been dismissed, following a personnel reshuffle by the airport operator’s supervisory board.Newly elected chairman of the supervisory board, Brandenburg state governor Matthias Platzeck, said directors decided at a meeting Wednesday to dismiss chief executive Rainer Schwarz with immediate effect, the Centre for Aviation reported.“The supervisory board meeting today demonstrated the common will of the three shareholders, the German government, Berlin and Brandenburg, to haul the company back out of the deep water it is currently in: we are all pulling together,” Mr Platzeck said.“Over the coming months, we aim to put complete our appraisal of the situation at Berlin Brandenburg Airport the most important project for the future of eastern Germany, so that we can then establish a realistic and reliable schedule for the successful completion of all outstanding work on the airport through to its opening.”Officials said the new airport, which has suffered numerous delays in the past, would not open in October this year, as planners and builders are struggling with technical problems, including a complex fire safety system.Airport planning chief Horst Amann said the airport was unlikely to be ready for business next year, “perhaps rather 2015,” ZDF television reported.Berlin Brandenburg Airport was originally scheduled to open in late 2011. Source = e-Travel Blackboard: P.T Management overhaul following airport opening delays.
The Wall Street Journal: Alkermes Shares Surge On Favorable Data For Depression Drug Alkermes PLC said its depression drug helped patients not responding to standard treatments, news that added more than $3 billion to the company’s market value in after-hours trading. The company said that in a late-stage trial, its ALKS 5461 treatment significantly improved depression scores in patients who had an inadequate response to standard therapies. The most commonly reported adverse events associated with the treatment were nausea, dizziness and fatigue. (Beckerman, 10/20) Gilead Presses For Exclusivity On HIV Drug After Judge’s Ruling That FDA Policy Is ‘Capricious’ Gilead wants the agency to retroactively grant it five years of exclusive marketing. Meanwhile, groups say the gaps in Food and Drug Administration’s biosimilar policies are creating untenable situations. Politico Pro: Groups Press FDA For Biosimilar Policy, Resources FDA must move faster to develop policies for cheaper versions of biologic medicines, and Congress should provide more resources to enable faster agency review, a broad array of health care groups told FDA. Gaps in FDA policy on biosimilars are creating challenging situations for states, providers and health insurers who must deal with already approved biosimilars, the agency was told at a Thursday meeting on a recently announced user fee agreement. The groups said the agency should finalize its guidance on key biosimilar policies — such as how to name and label treatments, and when biosimilars can be considered “interchangeable” with their brand counterparts — ahead of deadlines specified in that agreement. (Karlin-Smith, 10/20) Stat: Gilead Asks FDA To Expand Exclusivity For A Key HIV Drug In the latest development in a heated battle between Gilead Sciences and the US Food and Drug Administration, the company petitioned the agency this month to retroactively grant five years of exclusive marketing for an HIV medicine. And the drug maker argues that it otherwise faces lost sales and added expense from fending off a pending generic threat to its Stribild medication. The move follows a complicated legal battle in which Gilead challenged an FDA policy toward so-called fixed-dose combination drugs, which consist of two or more chemical entities. At stake are untold amounts of revenue as Gilead and other drug makers have battled the agency over its policy, which a federal judge recently ruled is “arbitrary and capricious.” (Silverman, 10/20) This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription. And in other pharmaceutical news —