Articles By Cyndi Root

  1. TG Therapeutics, BCRP Partner For Ibrutinib Combo Clinical Trial 12/5/2014

    TG Therapeutics has partnered with the Blood Cancer Research Partnership (BCRP) and the Dana-Farber Cancer Institute (DFCI), the lead institute of the BCRP, to study a combination of TGR-1202 and ibrutinib in B-cell malignancies.

  2. FDA Removes Clinical Hold On Flexion's FX006 Phase Osteoarthritis 2b Trial 12/5/2014

    Flexion Therapeutics announced in a press release that the Food and Drug Administration (FDA) has lifted the clinical hold on the FX006 trial in patients with moderate to severe osteoarthritis (OA) pain.

  3. FDA Accepts Ipsen's BLA For Dysport To Treat Upper Limb Spasticity 12/4/2014

    Ipsen Biopharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has accepted its supplemental Biological License Application (sBLA) for Dysport (abobotulinumtoxinA).

  4. FDA Denies Bristol-Myers Squibb's Daclatasvir For HCV, Citing Asunaprevir Withdrawal 12/3/2014

    Bristol-Myers Squibb (BMS) says that the Food and Drug Administration (FDA) has denied its daclatasvir New Drug Application (NDA). The denial comes on the heels of BMS’ withdrawal of asunaprevir for consideration.

  5. BioMarin Acquires Prosensa, Duchenne Muscular Dystrophy Products 12/2/2014

    BioMarin Pharmaceutical has acquired Prosensa Holding N.V. and its rare disease candidate drisapersen for Duchenne muscular dystrophy (DMD). The companies announced the deal in a press release, stating that the definitive agreement is for stock shares worth approximately $680 million.

  6. FDA Releases Clinical Trial Data In Drug Trials Snapshot Pilot Program 11/26/2014

    The Food and Drug Administration (FDA) continues its mission to make clinical trials more transparent with the launch of a pilot program called Drug Trials Snapshot.

  7. FDA Grants Orphan Drug Status To Avaxia, Immunomedics, ChemoCentryx 11/26/2014

    The Food and Drug Administration has moved decisively to find treatments for rare diseases, granting Orphan Drug status to three companies and their pharmaceutical agents.

  8. Apellis Acquires Potentia, APL-2 For Macular Degeneration 11/26/2014

    Apellis Pharmaceuticals has entered into an agreement to acquire Potentia Pharmaceuticals, the company from which Apellis was spun out.

  9. HHS, NIH, FDA Propose New Rules To Enhance Clinical Trial Transparency 11/24/2014

    Federal agencies in the U.S. have proposed new rules to promote clinical trial transparency. The National Institutes of Health (NIH) announced the rules in a press release, stating that the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) regarding reporting requirements.

  10. CRO Ricerca Biosciences Acquired By Main Market Partners 11/24/2014

    Main Market Partners has acquired Ricerca Biosciences, a contract research organization (CRO) from Concord, Ohio. The deal, announced in a press release, was struck on November 14, 2014 when Ricerca’s Board of Directors approved the sale.