Articles By Estel Grace Masangkay

  1. Sanofi Division Winthrop US Launches Generic Eloxatin 8/13/2014

    Sanofi announced that its generic division, Winthrop U.S., has launched the generic version of Eloxatin (oxaliplatin injection).

  2. Access And Norgine Enter Licensing Agreement For MuGard In EU 8/11/2014
    Emerging biopharmaceutical firm Access Pharmaceuticals announced that it has signed into an exclusive licensing partnership with European specialty pharmaceutical company Norgine for the marketing of MuGard in EU.
  3. Alvogen Acquires SK Firm Dream Pharma For $187M 8/8/2014

    U.S. based pharmaceutical company Alvogen announced that it has acquired South Korean company Dream Pharma through its subsidiary Kunwha Pharmaceuticals. The transaction will result in the biggest generics drugmaker in South Korea.

  4. Oxygen To Work With ICL On Levosimendan For Organ Failure 8/8/2014

    Oxygen Biotherapeutics, a pharmaceutical company specializing on critical care products, will partner with Imperial College London to supply additional funding in an ongoing Phase III trial investigating levosimendan in cardiac surgery patients at risk of low cardiac output syndrome (LCOS).

  5. UM Researchers Use Breath In New Anti-Counterfeit Drug Label 8/8/2014

    Researchers at the University of Michigan have developed a new kind of high-tech label that only needs a breath to verify whether a drug product is authentic or not.

  6. Eli Lilly Updates Jentadueto Label To Include Phase 4 Data 8/7/2014

    Eli Lilly announced that it has successfully updated the label of its Type 2 diabetes drug Jentadueto to include the latest data from a Phase IV trial showing significant blood glucose reductions. Jentadueto (linagliptin and metformin hydrochloride) is a combination tablet indicated for adults with Type 2 diabetes for improvement of glycemic control when treatment with the two drugs is appropriate. The drug can be used in conjunction with proper diet and exercise to control blood sugar in T2D patients.

  7. FDA OKs Hovion API Plant Inspection 8/6/2014

    The U.S. Food and Drug Administration (FDA) revealed the results of its inspection this month of the drug manufacturing and processing plants for international company Hovione.

    Active Pharmaceutical Ingredient (API) development and manufacturing firm Hovione announced that its Irish plant had passed a pre-approval inspection by the U.S. Food and Drug Administration (FDA). The FDA conducted a 5 day inspection of the facility located in Cork, Ireland and found the site to be compliant with guidelines and principles of Good Manufacturing Practices (GMP).

  8. NeuroDerm Parkinson's Drug Eligible For EU Centralized Procedure 8/5/2014

    NeuroDerm, a clinical stage pharmaceutical company focused on central nervous system (CNS) products, announced that the European Medicines Agency (EMA) pronounced eligibility of its Parkinson’s drug ND0612H for the European Union Centralized Procedure.

    ND0612H is a high dose form of liquid levodopa/carbidopa (LD/CD) administered subcutaneously and continuously by a belt pump. The drug is intended to reduce the motor challenges that occur in the advanced stages of Parkinson’s disease through regular administration of high therapeutic levodopa plasma levels.

  9. Bayer Bags EU Approval For Cancer Drug Stivarga 8/5/2014

    The European Commission has granted approval to Bayer HealthCare’s oncology drug Stivarga (regorafenib) for the treatment of patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who have progressed or shown intolerance to prior treatment with imatinib and sunitinib.

  10. Sanofi And Regeneron To Use Priority Review Voucher For Alirocumab 8/4/2014

    Collaborators Sanofi and Regeneron announced that they plan to leverage a U.S. Food and Drug Administration (FDA) rare pediatric disease priority review voucher for their Biologics License Application (BLA) for alirocumab. The voucher will qualify the BLA for an expedited 6 month review with the agency instead of the traditional 10 months.