Soma Pharmacy Blognews

Inspirion Delivery Technologies completes Pre-IND meeting with the FDA Inspirion Delivery Technologies, LLC (“IDT”) announced today that last week the Company completed a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to determine the clinical and regulatory pathway to advance its abuse deterrent, extended release formulation of oxycodone.

Emergent BioSolutions receives NIAID funding support for dmPA7909 anthrax vaccine candidate Emergent BioSolutions Inc. announced today that it was awarded a cooperative agreement from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to further the development of one of Emergent’s advanced anthrax vaccine candidates known as dmPA7909.

Amicus Therapeutics to initiate Phase 1 study of AT2220 Amicus Therapeutics today announced it plans to initiate a Phase 1 study of AT2220 (1-deoxynojirimycin HCl), its investigational drug in development for the treatment of Pompe Disease.

Caraco enters into a consent decree with the FDA regarding its drug manufacturing operations Caraco Pharmaceutical Laboratories, Ltd. announced today that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company’s drug manufacturing operations. The decree provides a series of measures that, when satisfied, will permit Caraco [...]

FDA approves Mylan Pharmaceuticals’ Carbidopa and Levodopa tablets Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

Sun Pharma Global issues notice to Labopharm regarding its generic versions of Ryzolt Labopharm Inc. today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 100, 200 and 300 mg generic [...]

Orphan drug designation for pixantrone applied by Cell Therapeutics Cell Therapeutics, Inc. (“CTI”) announced today that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL.

IDRI and Academia Sinica sign Memorandum of Understanding On behalf of The Lilly TB Drug Discovery Initiative, the Infectious Disease Research Institute (IDRI) today signed a Memorandum of Understanding (MOU) with Academia Sinica, a research institution based in Taiwan, to collaborate in target-based screening for the discovery of new tuberculosis (TB) drugs.

Mellow Hope granted H1N1 license by SFDA The issuer’s China based operating subsidiary Mellow Hope through its exclusive business partner Zhejiang Tianyuan Bio-pharmaceutical Co., Ltd has been granted H1N1 license on September 24, 2009 by SFDA (China Authority) http://eng.sfda.gov.cn/eng. Mellow Hope is the exclusive agent of Zhejiang Tianyuan Bio-pharmaceutical Co., Ltd for International marketing and [...]

Treating Mild Diabetes During Pregnancy Beneficial Lorenda Donaugh, top, who was treated for gestational diabetes during her pregnancy, is seen with… Lorenda Donaugh, top, who was treated for gestational diabetes during her pregnancy, is seen with her two-week-old daughter Adelynn at their Westerville, Ohio, residence Tuesday, Sept.