• Regulatory NewsRegulatory News

    Swedish Regulators Halt Imports from AstraZeneca’s Indian API Plant

    European imports from AstraZeneca’s now-closed terbutaline sulphate active pharmaceutical ingredient (API) manufacturing facility in Bangalore, India were halted by Sweden’s Medical Products Agency after failed validation runs, according to a recent notice in EudraGMDP. “The concerned API-batches or finished product containing the API should not be imported to the EEA [European Economic Area],” the agency said. “All API batches manufactured during the year 2014 are conce...
  • Regulatory NewsRegulatory News

    Are the Days of FDA Approving 'Basically Everything' Falling by the Wayside?

    In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week. FDA's drug review process has long been recognized as the gold standard globally (FDA even mentioned that gold standard moniker in congressional testimony ) and as recently as 2008, ...
  • Regulatory NewsRegulatory News

    Indian Manufacturer Seeks Compulsory License for Type II Diabetes Drug Saxagliptin

    An Indian manufacturer has filed the third-ever compulsory license application in India for AstraZeneca's type II diabetes drug saxagliptin, SpicyIP reports. Background Compulsory licensing is a legal provision that allows for the licensing of intellectual property rights without the rights holder's consent. The power to grant these licenses is seen by some countries, especially low- and middle-income ones, as a powerful tool to ensure important drugs are available a...
  • House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations

    • 08 May 2012
    An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt to discover what went on between the Obama administration and the pharmaceutical industry during negotiations on the Patient Protection and Affordable Care Act in 2010, reports Bloomberg . Members of the House Energy and Commerce Committee oversee the healthcare sector, ...
  • NIH Launches New Program to Share Drug Compounds

    • 04 May 2012
    The National Institutes of Health's (NIH) new National Center for Advancing Translational Sciences (NCATS) said it will launch a new pilot program to partner with a number of pharmaceutical manufacturers in an effort to look for new uses for some of their existing compounds. NCATS, currently under the temporary leadership of Thomas Insel , was formed in late 2011 to spur the development of new therapies by focusing on ways to bridge the so-called "valley of death" betwe...
  • AstraZeneca CEO Out as New J&J CEO Takes the Helm

    • 26 April 2012
    Two life sciences giants are experiencing transitions in leadership, as AstraZeneca's Chief Executive Office David Brennan announced he was relinquishing his position effective immediately and incoming Johnson & Johnson (J&J) CEO Alex Gorsky assumes his position at the company on 26 April. Rumors of Brennan's departure have been brewing for some time, but finally came to a head after the firm announced a 19% decrease in first-quarter profits, reports Reuters . T...
  • AstraZeneca Sues FDA to Halt Generic Seroquel

    Pharmaceutical manufacturer AstraZeneca filed a lawsuit on 13 March seeking an injunction against the US Food and Drug Administration (FDA) to bar it from allowing generic versions of its blockbuster antipsychotic drug Seroquel to be marketed in the US. FDA denied two Citizen Petitions from AstraZeneca on 9 March that requested FDA delay market entry for any generic products not containing the exact warnings contained on the reference listed drug (RLD). FDA said in its...
  • Petitions to Delay Generic Seroquel Denied

    Two petitions from pharmaceutical manufacturer AstraZeneca that could have delayed market competition to its flagship line of antipsychotic drugs were denied by the US Food and Drug Administration (FDA) on 9 March. AstraZeneca's Citizen Petitions requested that FDA delay market entry for generic products if those products omitted warnings about the risk of developing hyperglycemia. FDA required AstraZeneca to include such warnings on Seroquel and Seroquel XR (quetiapine ...