Merck Serono has entered into a collaboration agreement to provide strategic, scientific and medical support in the development and commercialization of Auxogyn's proprietary Early Embryo Viability Assessment (Eeva) test. The Eeva test, ...
Tags: Eeva test, non-invasive computerized test, embryo selection
Pfizer and Ligand Pharmaceuticals have announced the FDA acceptance of bazedoxifene/conjugated estrogens (BZA/CE) new drug application (NDA) for review. The BZA/CE is an investigational therapy developed by Wyeth Pharmaceuticals to tackle ...
Tags: estrogens NDA, Pharmaceuticals, FDA, menopausal symptoms
Theravance has commenced Phase 2b study desined to evaluate varying doses of TD-4208 in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Theravance leveraged its multivalent approach of drug design to ...
Tags: drug, long-acting medicines, long-acting muscarinic antagonist
Janssen Research & Development has submitted a New Drug Application (NDA) to the US FDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes. ...
Janssen Biotech and Janssen Biologics are seeking approval for Stelara in the US and Europe for the treatment of active psoriatic arthritis. A supplemental biologics license application (sBLA) was submitted to the FDA and a Type II ...
Israel-based Protalix BioTherapeutics has signed an agreement with Pfizer to continue managing the development activities of Gaucher disease drug Elelyso. According to the clinical development agreement, Protalix will continue to manage ...
Tags: Protalix, Pfizer, Gaucher disease drug
Teva Women's Health, a US-based subsidiary of Teva Pharmaceutical Industries, has announced FDA acceptance of its Quartette new drug application (NDA). The company is seeking approval to manufacture and market Quartette ...
Tags: ethinyl estradiol tablets, market Quartette, contraceptive products
PharmaPros has signed a deal for its study management technology, Dataflow Manager, with an undisclosed pharmaceutical company. The pharmaceutical company will leverage the platform for performance-based trial management processes, to ...
Tags: PharmaPros, pharmaceutical, management technology, Dataflow Manager
Biopharmaceutical company Protalix BioTherapeutics has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical trials of PRX-102. The Company is planning to ...
Tags: Protalix BioTherapeutics, investigational new drug, IND, PRX-102
Omeros has filed an investigational new drug application (IND) with the FDA for OMS824, the compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders. OMS824 targets and inhibits an enzyme ...
Tags: new drug application, FDA, OMS824
US Food and Drug Administration (FDA) has approved Pfizer's Bosulf (bosutinib) to treat adult patients with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) (CML) with resistance to prior therapy. Bosulif is a ...
Tags: bosulf, bosutinib, kinase inhibitor, Philadelphia chromosome-positive
The US Food and Drug Administration (FDA) has granted fast track designation to Alvine Pharmaceuticals' ALV003 for the potential treatment of celiac disease. Alvine is at present conducting Phase 2 trials with ALV003, an orally ...
Tags: ALV003, treatment of celiac disease, orally administered mixture
Ironwood Pharmaceuticals, Bionomics' licensee, has submitted an investigational new drug (IND) application to the FDA to begin IW-2143 clinical trial. The trial will further evaluate pharmacokinetic profile of the anti-anxiety drug ...
Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval to use the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as ...
Tags: investigational drug bedaquiline, multi-drug resistant tuberculosis
EquinoxO2 Medical has announced development and distribution of its new HALO XP negative pressure wound therapy (NPWT) pump system, HXP2000. The light weight, portable HALO XP pump system, which combines advanced technology with ...
Tags: clinical development, HALO XP pump system, chronic wound