Category Archives: Supply Chain

Drug Shortages Continue to Plague Health Care System

Despite notable successes in preventing and mitigating short supplies of important medicines, the drug shortage crisis still disrupts medical treatment and gives drug manufacturers a bad name. The Food and Drug Administration is doing a better job of identifying potential shortage situations and implementing relief strategies, but many supply problems continue to limit treatment options […]
Also posted in FDA, Legal, Manufacturing, Safety | Tagged , , , , , , | Leave a comment

Big Pharma's Second Life

Can big pharma solve its fixed cost problem by going virtual? Not entirely, but drug companies can get more out of their CRO partners by treating them less like avatars and more like equals, according to conference-goers at a CBI event in The Triangle. The problem with overbearing project mangers on the sponsor side of […]
Also posted in Biotech, People, R&D, Strategy | Tagged , , , , , | Leave a comment

The Little Orphan That Could: How Alexion is Going Global

Since the initial FDA approval of its flagship orphan drug Soliris in 2007, Alexion Pharmaceuticals has done well for itself as a small biotech firm that focuses on ultra-rare disease. So well in fact, that instead of partnering, the company has taken global expansion into its own hands. Apart from a pipeline that includes asfotase […]
Also posted in Biotech, Global, Manufacturing, Market Access, Orphan Drugs, Strategy | Tagged , , , , , , , , | Leave a comment

Congress Clarifies Drug Compounding, Tracking Policies

Public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation. After months of public hearings and negotiations, Democrat and Republican leaders of the House […]
Also posted in FDA, Legal, Manufacturing, Regulatory, Safety, Strategy, Technology | Tagged , , , , , , , , , , , , , | Leave a comment

Court Ruling Threatens Drug Shortage Remedy

The Food and  Drug Administration may no longer be able to alleviate shortages in vital drugs by permitting the import of unapproved medicines following a decision by the Court of Appeals for the District of Columbia. The ruling of July 23, 2013 also raises broader questions about when and how FDA can “exercise regulatory discretion” […]
Also posted in Anti-counterfeiting, FDA, Safety | Tagged , , , , , , | 1 Comment
  • Categories

  • Meta