Domestic pharmaceutical companies are actively developing combination drugs, government data showed.
Shire Plc is seeking to fend off generic competition to its on-the-rise Gattex drug from Endo Pharmaceuticals Inc.’s Par Pharmaceutical Co.
Amlodipine and Valsartan Tablets, Glipizide Extended-Release Tablets, Dexamethasone Tablets, Argatroban Injection, Fluphenazine Decanoate Injection, Meropenem Injection, Mycophenolate Mofetil Injection, Levothyroxine Sodium Injection; Shire-NPS Pharmaceuticals, Inc. v. Par Pharmaceutical et al.
Scottish cost regulators have approved funding for five new therapies on the NHS, offering new treatment options for a range of conditions.
FDA Confirms Paragraph IV Patent Challenge of Gattex (Teduglutide) Injection
The National Institute for Health and Care Excellence has published draft guidelines rejecting NHS funding for Shire’s Revestive as a treatment for short bowel syndrome (SBS).
Gattex (Teduglutide): Shire-NPS Pharma v. AmbioPharm & Par Pharmaceutical
Shire (LSE: SHP, NASDAQ: SHPG) today announced that the European Commission has granted extension of Market Authorization for Revestive®* (teduglutide) 5 mg powder and solvent for solution for injection for the treatment of patients aged one year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of the approval of Revestive[®*] (teduglutide) 5 mg powder and solvent for solution for injection in paediatric patients (aged one to 17 years) with short bowel syndrome (SBS). Teduglutide is an analogue of human glucagon like peptide 2 (GLP-2) that enhances key structural and functional adaptations in the intestinal mucosa.[i]