US-based clinical stage biopharmaceutical firm Heat Biologics has filed an investigational new drug application (NDA) with the US Food and Drug Administration (FDA) for its second product candidate, HS-410, which will be evaluated in ...
Mylan Pharmaceuticals, a subsidiary of Mylan, has introduced Voriconazole for oral suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND for oral suspension. The US Food and Drug Administration (FDA) has granted a ...
Tags: Mylan, Antifungal Drug
Mystic Pharmaceuticals has received notices of allowance from the China Patent Office and the Japan Patent Office for its 'Deep Draw Container Forming Method' and 'Combination Unit Dose Dispensing Container' patent applications ...
Tags: Drug Delivery Platforms, Medicine
The US Food and Drug Administration (FDA) has approved US-based StemCells’ investigational new drug (IND) application for clinical testing of its HuCNS-SC human neural stem cells as a treatment for spinal cord injury. StemCells is ...
Tags: Spinal Cord Injury, Medicine
Canadian regulatory authority Health Canada has approved Valeant Pharmaceuticals International subsidiary Valeant Canada's new drug submission of Jublia for the treatment of onychomycosis. Jublia is designated for the treatment of mild to ...
Tags: Fungal Drug, Medicine
CureDuchenne has launched a new drug discovery and development initiative to identify and develop a pipeline of therapies to treat Duchenne muscular dystrophy. The initiative, dubbed CureDuchenne Ventures, is based on the company's ...
Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer, has obtained two separate orphan drug designations from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its investigational, oral medication ...
Tags: Drug Designations, Medicine
The US Food and Drug Administration (FDA) has accepted to review AstraZeneca's new drug application (NDA) for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridaemia. Omthera Pharmaceuticals, ...
US-based Mystic Pharmaceuticals has secured two Notices of Allowance from the US Patent Office for its Unit Dose Drug Delivery Platform and Piercing Device for Drug Delivery Systems patent applications. According to the company, the new ...
Health Canada has accepted to review Sunovion Pharmaceuticals Canada's (Sunovion) new drug submission (NDS) for eslicarbazepine acetate for use as a once-daily adjunctive therapy for the treatment of partial-onset seizures in patients aged ...
Powder characterization specialist Freeman Technology has expanded its global team with the appointment of Patrick van Barneveld to the new role of product manager for Central Europe. Operating from Almelo, The Netherlands, van Barneveld ...
Tags: Construction, Decoration
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics' GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle cell ...
The European Medicines Agency (EMA) has granted an orphan drug status to US-based clinical-stage biotechnology company GlycoMimetics’ GMI-1070 (rivipansel sodium), designed to treat vaso-occlusive crisis (VOC) in patients with sickle ...
Tags: Orphan Drug, Cell Drug
Activaero has entered into research collaboration with Italian pharmaceutical firm Chiesi Farmaceutici to develop an effective solution to treat patients with cystic fibrosis (CF). Under the deal, Activaero will offer its flow and volume ...
Reporters learnt from the China Food and Drug Administration (CFDA) that the government agency has approved Ginsenoside CK of Zhejiang Hisun Pharmaceutical Co., Ltd. (SHSE: 600267) to enter clinical test phase. Ginsenoside CK has ...