October 2014

  • AstraZeneca receives approval for Bydureon Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
  • USFDA grants marketing approval for Pleximmune, a laboratory blood test which helps to predict risk of a transplant rejection, known as Acute Cellular Rejection (ACR) in patients below 21 years who have undergone liver or small bowel transplants.
  • Sivextro (tedizolid phosphate), a new antibacterial drug has been approved for treating adults with skin infections caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis.
  • The CardioMEMS HF System, a device that measures and monitors the pulmonary artery (PA) pressure and heart rate in certain heart failure patients has been approved by USFDA. The System consists of an implantable PA sensor, delivery system, and Patient Electronics System.
  • The U.S. Food and Drug Administration approved Belsomra (suvorexant), a drug for treatment of insomnia.
  • Research shows that the occurrence of micro RNA (miRNA) biomarkers in blood helps to predict the development of severe osteoarthritis (OA) of the knee or hip.
  • Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent which helps determine the extent of spread of squamous cell carcinoma in the head and neck region obtains US FDA approval.
  • The first vaccine against meningococcal disease caused by Neisseria meningitides receives approval from U.S. Food and Drug Administration.
  • Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] has been approved by FDA for the treatment of bleeding episodes in adults with hemophilia A (acquired Factor VIII deficiency), a rare, but potentially life threatening, bleeding disorder caused by the development of antibodies (immune system proteins) directed against the body’s own FVIII.
  • The U.S. Food and Drug Administration approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF), a condition in which the lungs become progressively scarred and patients experience shortness of breath, cough, and have difficulty participating in everyday physical activities.