Articles by Suzanne Hodsden

  1. FDA Issues New Guidance For Neoadjuvant Breast Cancer Therapies 10/13/2014

    Regulatory Affairs Professionals Society (RAPS) reports that the FDA has issued a guidance allowing the agency to consider pathological complete response (pCr) as a surrogate endpoint in phase 3 clinical trials for high-risk breast cancer neoadjuvant therapies.

  2. EU To Meet, Make Decisions About Clinical Trial Transparency Legislation 10/1/2014

    EU legislation requiring complete transparency of clinical trial data was passed in 2012 and was set to be implemented in January of this year. In the meantime however, it has suffered several delays as the EMA struggles to reconcile the aspirations of the law with concerns about innovation incentive and privacy.  The EMA recently announced it has scheduled another meeting to discuss its new transparency policy on October 2, Euractiv reported earlier this week.

  3. Bausch & Lomb and Nicox's Glaucoma Treatment Succeeds In Phase 3 Clinical Trial 9/29/2014

    Latanoprostene bunod, brand name Vesneo, a collaboration between Valeant subsidiary Bausch & Lomb and Nicox, has hit its primary endpoint in phase 3 clinical trials and its New Drug Application could hit the FDA’s desk by mid-2015.

  4. FDA Panel Unanimously Rules To Restrict Testosterone Drugs 9/23/2014

    A panel of experts has offered its opinion to the FDA suggesting that the agency take measures to restrict the advertising and prescribing of testosterone medications.

  5. New Biologic Treatments Expected to Grow Rheumatoid Arthritis Drug Market to $18.2B 9/19/2014

    Decisions Resources Group (DRG) released a report which projected an increase in the rheumatoid arthritis (RA) market from $14 billion to $18 billion by 2023. The group attributes this increase to research advances in new alternative biologic treatments, specifically oral Janus kinase (JAK) inhibitors and non tnf-alpha biologics.

  6. UK Pharma Doctors: Clinical Transparency Is Good For Science 9/3/2014

    The Faculty of Pharmaceutical Medicine (FPM) of the Royal Colleges of Physicians of the United Kingdom released the results of a study, which found an overwhelming majority of U.K. pharma doctors and industry experts are in favor of greater transparency in clinical trials.

  7. New Collaboration Explores Wearable Devices For Parkinson's Research 8/15/2014

    The Michael J. Fox Foundation (MJFF) and Intel announced a collaboration which would design wearable devices capable of monitoring the motor symptoms of Parkinson’s Disease (PD). This information would then be uploaded and stored in the cloud so it would be widely available to researchers.

  8. FDA To Consult Patients In Ongoing Development of Female Sexual Disorder Drugs 8/15/2014

    Under the fifth authorization of the Prescription Drug User Fee Act (PDUFA) in 2012, the FDA expressed commitment to making patients a greater part of the agency’s regulatory process and has already conducted meetings with patients suffering from a range of diseases which, as yet, have no effective treatment. Under pressure from Women’s groups, the FDA announced that female sexual disorder (FSD) is set to become the eleventh patient-focused meeting conducted by the agency.

  9. Cedars-Sinai Opens Stem-Cell Research Clinic for Cardiac Patients 8/13/2014

    Cedars-Sinai Heart Institute has opened the doors of a brand new clinic specializing in regenerative medicine for cardiac patients. The institute hopes that this new clinic will become a research hub that will both recruit patients for clinical studies and direct them towards other facilities and clinical trials, depending on the patients’ needs.

  10. Has The FDA Sacrificed Safety For Speed? 8/8/2014

    As the Ebola crisis rages on in West Africa, the FDA is under increased pressure to rush their approval of potential cures and ‘stands ready” to work with pharmaceutical companies. However, a new study has been published in Health Affairs that suggests the FDA’s commitment to speed comes at the cost of patient safety.