Articles By Cyndi Root

  1. NIH, NSF Collaborate To Find Markets For Biomedical Research Innovations 7/7/2014

    The National Institutes of Health (NIH) announced in a press release that it will provide its researchers training, in collaboration with the National Science Foundation (NSF), to evaluate biomedical innovations for commercial potential. I-Corps instructors with biomedical business experience will work closely with federally funded personnel with the goal of turning NIH innovations into applied health technologies. Slated to participate in the pilot program are award grantees from NIH institutes, including the National Cancer Institute (NCI). Michael Weingarten Director of the NCI SBIR Development Center, said, “I-Corps will help teach NIH-funded start-ups how to build scalable business models around new technologies they’re developing for the detection and treatment of disease.”

  2. NIH Awards Sorrento $2.6 Million For Bispecific Antibodies 7/7/2014
    Sorrento Therapeutics announced in a press release that the National Institutes of Health (NIH) has provided funding for the development of bispecific antibodies. Two small business grants from the NIH will allow Sorrento to use its antibody conjugation technology platform to develop antibodies for two of the NIH’s anti-bacterial immunotherapies. Sorrento's pipeline also shows promise in anti-infectives and auto-immune diseases.
  3. Boston Strategics Licenses E6201 Oncology Drug From Eisai 7/7/2014
    Boston Strategics Corporation (BSC) announced in a press release that it has entered a licensing agreement with Eisai. The new partnership allows BSC to develop and commercialize Eisai’s E6201, an oncology drug, worldwide.
  4. Gilead Seeks New Indication In Japan For Sovaldi In Genotype 2 HCV 7/3/2014

    Gilead Sciences announced in a press release it has requested that the Pharmaceutical and Medical Devices Agency (PMDA) of Japan approve its New Drug Application (NDA) for Sovaldi (sofosbuvir). The nucleotide analog polymerase inhibitor treats chronic hepatitis C virus (HCV) infection. Gilead’s NDA is for sofosbuvir with ribavirin (RBV) in patients with genotype 2 HCV infection. The NDA is Gilead’s first in Japan and if approved, Sovaldi would be the first drug marketed by Gilead in Japan.

  5. Weekly FDA Enforcement Report For Drugs And Biologics 6/18/14 6/26/2014

    The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for June 18, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification. 

  6. Weekly FDA Enforcement Report For Drugs And Biologics 6/11/14 6/16/2014
    The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for June 11, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs and by Classification.
  7. Lonza Invests In Single-Use For Swiss Manufacturing Facility 6/13/2014
    Lonza announced in a press release that it plans to invest in the infrastructure at its manufacturing facility in Visp, Switzerland. Some technology and facility improvements to its Antibody Drug Conjugate (ADC) clinical manufacturing facility are already complete as the construction occurred in the spring over a seven-week period. The improvements allow for new ADC products and more capacity. The second phase is underway and will allow for faster changeover times between manufacturing campaigns.
  8. FDA Accepts Expanded Label For Teva's Azilect In Parkinson's Disease 6/12/2014
    Teva Pharmaceutical Industries announced in a press release that the Food and Drug Administration (FDA) has approved a new indication for Azilect (rasagiline tablets). The medication for Parkinson’s disease (PD) was previously approved as a monotherapy or as an adjunct to levodopa (LD). The new label allows dopamine agonists (DAs) as an adjunct, giving physicians more flexibility in using the drug alone or with other medications. Teva states that the expanded label reinforces growing evidence that Azilect is effective in all stages of PD.
  9. Merck Reformulates Isentress And Seeks New Indication In HIV-1 6/11/2014
    Merck announced in a press release that its Phase III trial of reformulated Isentress (raltegravir) has enrolled its first patient. The ONCEMRK trial is assessing once-daily raltegravir (1200 mg once daily), known as reformulated raltegravir (MK-0518), combined with Truvada (tenofovir/emtricitabine) vs. raltegravir (400 mg, not reformulated) twice daily in combination with Truvada in HIV-1 infected, treatment-naive participants. Researchers hypothesize that reformulated raltegravir is not inferior to standard raltegravir.
  10. Biosimilars To Erode Biologics Market, GlobalData Reports 6/11/2014

    GlobalData, a market analysis company, announced in a press release that biosimilars will erode the branded biologic therapy market beyond 2019. The report, titled “PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market,” provides analysis of the market and reasons for the shift, including patent expirations and redefined regulatory requirements.