Articles By Cyndi Root

  1. Bristol-Myers Squibb Withdraws NDA For Asunaprevir-Daclatasvir In HCV 10/8/2014

    Bristol-Myers Squibb (BMS) is withdrawing its New Drug Application (NDA) for asunaprevir in combination treatment with daclatasvir for the treatment of HCV genotype 1b patients.

  2. New Report Reveals FDA-Approved New Molecular Entities: 1827-2013 10/7/2014

    A new report was recently published on Drug Discovery Today highlighting the  Food and Drug Administration’s history of New Molecular Entity (NME) approvals from 1827-2013. The authors of the study state that, as of 2013, the FDA has approved 1,453 drugs, not counting generic versions. According to Regulatory Affairs Professional Society (RAPS), which released a feature on the report, there was a decrease in the number of companies with approved NMEs, which it attributes to increasing mergers and acquisitions.

  3. EMA Enacts New Plan To Enhance Data Transparency 10/7/2014

    The European Medicines Agency (EMA) has enacted a new policy, effective January 1, 2015, compelling pharmaceutical companies to publicize clinical data from trials supporting regulatory applications for new medicines following the EMA's decision about the drug. The agency publicized its decision in a press release, stating that the policy goes into effect well before the EU’s Clinical Trial Regulations in 2016. The EMA expects the new policy to benefit patients and increase trust in the agency’s decisions. Additionally, the rules will benefit researchers as they access data sets, avoid duplication of trials, and develop new medicines faster.

  4. Multiple Myeloma Research Foundation, Industry Partners Start Clinical Trials 10/1/2014

    The Multiple Myeloma Research Foundation (MMRF), the Multiple Myeloma Research Consortium (MMRC), and industry partners have started new clinical trials to investigate treatments for multiple myeloma patients.

  5. EMA Seeks Patient Input In Drug Submission Review Process 10/1/2014

    The European Medicines Agency (EMA) is seeking patient input in the drug review process. The patient-centric pilot project, announced in a press release, will incorporate assessments from patients on the benefits and risks of medicines during Committee for Medicinal Products for Human Use (CHMP) evaluations.

  6. FDA Approves Two Gilead HIV Drugs, Elvitegravir And Cobicistat 9/26/2014

    Gilead has two new Food and Drug Administration (FDA) approved HIV drugs. Announced in an FDA email update, the approvals come on the heels of positive results of a study that used both agents as part of a drug cocktail. The drugs, Vitekta (elvitegravir) and Tybost (cobicistat), have already been approved by the European Medicines Agency (EMA).

  7. NIH Establishes Rheumatoid Arthritis And Lupus Network, Grants $6 Million 9/25/2014

    The National Institutes of Health (NIH) has awarded $6 million to 11 research groups to study rheumatoid arthritis (RA) and lupus. The grants establish the Rheumatoid Arthritis and Lupus (AMP RA/Lupus) Network, part of the Accelerating Medicines Partnership (AMP) launched in February 2014. The AMP grants, announced in a press release, are funded by the NIH along with industry partners, including AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Sanofi, and Takeda. The grantees were selected through a competitive process and funding was awarded on Sept. 24, 2014.

  8. NIH Commits $10 Million To Investigate Role Of Gender In Clinical Studies 9/24/2014

    The National Institutes of Health (NIH) has pledged $10 million to 82 grantees to investigate gender in clinical studies.

  9. Amgen Submits BLA To FDA For Blinatumomab Immunotherapy In Leukemia 9/24/2014

    Amgen has applied to the FDA for a Biologics License Application (BLA) for blinatumomab, an investigational immunotherapy.

  10. Life Science Industry Increasing Remote Access To Trial Master Files 9/23/2014

    A life science industry survey by Veeva Systems reveals that remote access to Trial Master Files (TMF) is increasing. The survey, announced in a press release, states that 16 percent of TMF owners are currently allowing health authorities remote access to their eTMF. However, 32 percent plan to allow remote access in 2015.