Articles By Cyndi Root

  1. Weekly FDA Enforcement Report For Drugs 10/22/14 10/27/2014

    The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for October 15, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls.

  2. Foundation Medicine Licenses Assays To WuXi PharmaTech 10/27/2014

    Foundation Medicine has licensed assays for targeted cancer treatments to WuXi PharmaTech. The move, announced in a press release, allows WuXi to meet the growing need in China for comprehensive genomic profiling in clinical trials for treatments addressing oncology indications.

  3. Lexicon Licenses Telotristat Etiprate For Carcinoid Syndrome To Ipsen 10/24/2014

    Lexicon Pharmaceuticals has licensed telotristat etiprate to Ipsen for exclusive global marketing outside of the United States, Canada, and Japan.

  4. Enanta Drops AbbVie Co-Development Of Hepatitis C Drugs 10/24/2014

    Enanta Pharmaceuticals has decided not to continue co-developing hepatitis C virus (HCV) drugs with AbbVie.

  5. Sucampo Extends Global Rights To Takeda For Amitiza, Constipation Treatment 10/24/2014

    Sucampo Pharmaceuticals has extended further Amitiza (lubiprostone) development and marketing rights to Takeda.

  6. CRO GVK BIO Repurposes Takeda's Failed Compounds To Identify Novel Indications 10/24/2014

    GVK Biosciences, a contract research organization (CRO) in Asia, has agreed to repurpose Takeda’s failed compounds in search of new indications.

  7. CRO PPD, Sellas Partner On Zolpidem And WT1 Cancer Vaccine 10/23/2014

    Sellas Life Sciences Group announced in a press release that it has partnered with Pharmaceutical Product Development (PPD), a contract research organization (CRO), to develop Sellas’ Zolpidem for central nervous indications and its WT1 cancer vaccine.

  8. CRO Domainex, Auspherix Partner On Anti-Infectives 10/23/2014

    Domainex, a contract research organization (CRO), and Auspherix have partnered to develop new drugs for antibiotic resistant bacterial infections.

  9. Patent Expirations Encourage Lilly To Streamline Manufacturing Activities 10/22/2014

    Eli Lilly has decided to close its Guayama, Puerto Rico manufacturing site by the end of 2015 due to the impact of patent expirations. Paul Ahern, Ph.D., SVP of Global Active Pharmaceutical Ingredient and Dry Products Manufacturing at Lilly, stated the company evaluated its pipeline and concluded that, due to patent expirations, competition would grow for those medicines and reduce Lilly’s sales.

  10. CDMOs Cook, Patheon FDA-Approved To Manufacture Halozyme's Hylenex 10/22/2014

    Cook Pharmica and Patheon, contract development and manufacturing organizations (CDMOs), have received Food and Drug Administration (FDA) approval to manufacture Halozyme Therapeutics’ Hylenex recombinant (hyaluronidase human injection).