Pharmaceuticals - Generic / Specialty
Biomarin Pharmaceutical Inc:Says the U.S. Food and Drug Administration has approved VIMIZIM for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).
Shire Plc:Says that the US Food & Drug Administration (FDA) has approved the production of VPRIV drug substance (velaglucerase alfa for injection) in Shire's manufacturing facility at 400 Shire Way, Lexington, Massachusetts, US.Says the facility was previously approved by the European Medicines Agency (EMA) for production of VPRIV drug substance.
Kyung Dong Pharmaceutical Co., Ltd:Says received a patent on Feb. 14, for a process for the preparation of solifenacin or salt there of and novel intermediates used in the process.
Sun Pharmaceutical Industries Ltd:Says the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Temodar, Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg.
Health Canada approves Aegerion Pharmaceuticals Inc' JUXTAPID capsules for treatment of homozygous familial hypercholesterolemia
Aegerion Pharmaceuticals Inc:Says that Health Canada has granted a Notice of Compliance approving JUXTAPID.Says Health Canada has granted JUXTAPID as an adjunct to a low-fat diet and other lipid-lowering drugs, with or without LDL apheresis, to reduce low-density lipoprotein cholesterol in adult patients with homozygous familial hypercholesterolemia.
Biomarin Pharmaceutical Inc announces selection of NAGLU fusion protein drug development candidate bmn 250 for treatment of sanfilippo B
Biomarin Pharmaceutical Inc:Says that it has selected a new drug development candidate, BMN 250, a fusion of alpha-N-acetyglucosaminidase (NAGLU) with a peptide derived from insulin-like growth factor 2.The BMN 250 is for the treatment of Sanfilippo B syndrome or Mucopolysaccharidosis type IIIB (MPS IIIB).Says it has initiated IND-enabling studies and expects to initiate clinical studies with BMN 250 in mid-2015.Data on the NAGLU fusion protein will be presented at the Lysosomal Disease Network's (LDN) 10(th) Annual WORLDSymposium being held Feb 11-13 in San Diego, California.
Celgene Corp:Says Health Canada has approved POMALYST oral therapy in combination with dexamethasone, for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed, who have received at least two prior treatment regimens and have demonstrated disease progression on their last regimen.POMALYST received priority review status by Health Canada due to the high unmet medical need that exists and the clinical value that the treatment brings to patients and physicians.The Health Canada approval of POMALYST was based on the MM-003 pivotal study, which was published in The Lancet Oncology in Oct 2013.POMALYST is expected to be commercially available in Mar.POMALYST is a trademark of the company.
Zhejiang Huahai Pharmaceutical Co Ltd:Says received drug supplementary approval for its losartan potassium tablets 0.1g.Says state medical permit for the losartan potassium tablets 0.1g is H20143030.
Shenzhen Neptunus Bioengineering Co Ltd:Says its wholly owned subsidiary, a bio engineering company, passed the new Goods Manufacturing Practice (GMP) recognition for its tablet, hard capsule, granules, powder, medicinal tea, syrup, mixture, oral liquid, fluid extract, oral solution, tincture, liniment, film agent, pill and enema.Says the recognition is valid until Jan. 25, 2019.