• Biopharmaceutical Manufacturer Admits Faulty Data Reporting, Blames Contractor

    • 24 September 2012
    Biologics manufacturer Peregrine Pharmaceuticals' has informed its investors that its second-line lung cancer drug bavituximab, for which the company just released phase IIb data showing evidence of efficacy, is plagued by faulty data it says is the result of poor work by a third-party clinical trials contractor. In its 24 September release, Peregrine said it discovered the deficient data when preparing for an end-of-phase II meeting with the US Food and Drug Administrat...
  • European Commission: Non-EU Reference Product OK for EU Biosimilars

    The European Commission plans to allow the use of a reference product not authorized in the EU in support of a biosimilar application, according to a  speech  delivered by Health and Consumer Policy Commissioner Dalli at the 18thEuropean Generic Medicines Association Annual Conference. Dalli announced "that after careful analysis of the scientific and regulatory elements, the European Commission will revise its interpretation" of existing EU law. The details o...
  • FDA Warning Letter Cites Company for Breaking HCT/P Regulations

    A warning letter sent to the company Young Medical Spa by the US Food and Drug Administration (FDA) cites the company for violating minimal manipulation regulations governing the use of human cells, tissues or cellular and tissue-based products (HCT/Ps). FDA's warning letter specifically cites Young's Owner and Medical Director Thomas E. Young for removing, reprocessing and injecting patients with their own adipose tissue (lipoaspirate), from which Young isolated stem ce...
  • New Biologic Sterility Regulation Issued by FDA

    The US Food and Drug Administration (FDA) is announcing its amendment of existing sterility test requirements for biological products, which it said will provide greater flexibility for manufacturers and encourage the use of cutting-edge technologies to assure the safety of biological products. In its 2 May Federal Register posting entitled Amendments to Sterility Test Requirements for Biological Products , FDA said its rule is "intended to promote improvement and i...
  • BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort

    An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL). The analysis, which tracked NDA and BLA submissions made between 2005 and 2010, shows a 55% approval rate for first-round submissions. The total approval rate jumped nearly 20% to 74.6% after ...