Articles By Cyndi Root

  1. Raleigh, Wake County Invest In Xellia's Lyophilized Vial Manufacturing Site 9/18/2014

    The Wake County Board of Commissioners announced in a press release that it has joined the city of Raleigh, NC in investing in Xellia Pharmaceuticals’ manufacturing site. The facility, acquired from Fresenius Kabi in July, is dedicated to lyophilized (freeze-dried) vial manufacturing.

  2. Merck's Odanacatib Reduced Fracture Risk In Postmenopausal Osteoporosis 9/18/2014

    Merck announced in a press release that data from a Phase III trial of odanacatib in postmenopausal women with osteoporosis met its primary endpoint of reducing fractures. The company presented the results on the cathepsin K inhibitor at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Houston, Texas. Merck plans to use the data to support its New Drug Application (NDA) to the Food and Drug Administration (FDA) in 2015. Dr. Keith Kaufman, VP of Clinical Research in the Diabetes and Endocrinology unit at Merck, said, “Merck believes the currently available data support a favorable benefit/risk profile for odanacatib.”

  3. Dragonfly Malware Could Lead To Drug Counterfeiting 9/18/2014

    Belden, a communications and electronics company, warned the pharmaceutical industry in a press release that the Dragonfly (Havex) malware is a threat. Previously, the malware was thought to be targeting the energy sector, but further analysis revealed that the cyberattack threatens pharmaceutical Intellectual Property (IP).

  4. Gilead Licenses Generic Sovaldi To Hetero, Mylan, Ranbaxy, 4 Others 9/16/2014

    Gilead Sciences announced in a press release that it has licensed Sovaldi (sofosbuvir) to seven Indian companies. The non-exclusive licensing agreements with generic pharmaceutical manufacturers allows developing countries access to the drug for Hepatitis C.

  5. Weekly FDA Enforcement Report For Drugs 9/10/14 9/15/2014

    The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for September 10, 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 Classification.

  6. Ireland Supports Pharmaceutical Manufacturing Sector With New Technology Center 9/15/2014

    The University of Limerick (UL) announced in a press release that it has launched a new Technology Center to support Ireland’s pharmaceutical manufacturing sector. Funded by the State, the Pharmaceutical Manufacturing Technology Centre (PMTC) will gather members of industry and academia to address contemporary manufacturing issues. UL states that the industry employs over 25,000 people and contributes €40 billion in exports to the Irish economy. The center will address cost competitiveness and patent expiry issues, as well as seek to improve Ireland’s position as a global hub for manufacturing. Dr. Mary Shire, VP of Research at UL, said, “Ireland has one of the best reputations globally in pharmaceutical manufacturing and it’s important that we continue to support the sector so we attract further investment and retain existing investments.”

  7. CDMO ProBioGen Invests €20 million In Manufacturing Expansion 9/15/2014

    ProBioGen, a contract development and manufacturing organization (CDMO) announced in a press release that it intends to invest €20 million in its biopharmaceutical manufacturing enterprise. CEO Dr. Wieland Wolf made the announcement to ceremony guests in Berlin, Germany. The funds are to be used in GMP (Good Manufacturing Practice) manufacturing of biopharmaceuticals. The company also intends to build two bioreactors and increase staff from 75 to 150. Dr. Wolf said, "With an investment of around 20 million euros, we will strengthen our market position.”

  8. Kinex Completes Acquisition Of CDMO QuaDPharma 9/12/2014

    Kinex Pharmaceuticals announced in a press release that it has completed the acquisition of contract development and manufacturing organization (CDMO) QuaDPharma. The New York State manufacturing facility also engages in analytical and support services for the pharmaceutical industry. Rand Capitol and others have been funding QuaDPharma. Allen Grum, CEO of Rand Capital, said, “Kinex was one of their first customers and as part of this transaction Rand is now a shareholder in Kinex.”

  9. Soligenix Acquires Phase III Clinical Oncology Candidate SGX301 9/10/2014

    Soligenix announced in a press release that it has acquired SGX301 (synthetic hypericin), currently entering phase III trials. The photodynamic therapy is a Food and Drug Administration (FDA) designated Orphan Drug for the treatment of cutaneous T-cell lymphoma (CTCL). The drug was developed at New York University Medical Center with the Yeda Research and Development Company, the commercial arm of the Weizmann Institute of Science in Rehovot, Israel. Solgenix acquired all Intellectual Property (IP) right, preclinical data, and clinical data supporting other indications, such as psoriasis.

  10. FDA Approves Keryx's Ferric Citrate For Hyperphosphatemia 9/10/2014

    Keryx Biopharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has approved Ferric Citrate (previously Zerenex). The new, oral iron-based treatment is for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The approval was based in part on Phase III trials showing that Ferric Citrate reduced serum phosphorus levels to well within the KDOQI guidelines from the National Kidney Foundation to a range of 3.5 mg/dL to 5.5 mg/dL. The approval included stipulations and warnings, but the company plans to bring the product to market within 12 weeks.