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
Biopharmaceutical company Zalicus has received the US FDA approval for its supplemental new drug application (sNDA) for the 32 mg dose strength of Exalgo(hydromorphone HCl) Extended-Release Tablets (CII). Exalgo is used to treat moderate ...
Tags: Exalgo Extended-Release Tablets, around-the-clock opioid analgesia
Aerial BioPharma, a biopharmaceutical company, has won FDA orphan drug designation for its narcolepsy drug in development. The issuance of designation from the FDA follows the completion of a Phase IIa study in which N05 demonstrated ...
NeuroTherapeutics Pharma (NTP), a biopharmaceutical company, has licensed and deployed the Dotmatics informatics platform. According to NTP, the requirement for an informatics system, to manage the chemistry and related data, made the ...
Tags: NeuroTherapeutics Pharma, NTP, Dotmatics informatics platform
pSivida has signed a funded technology evaluation agreement with a biopharmaceutical company to evaluate pSivida's Tethadur protein/antibody delivery technology in the field of ophthalmology. Tethadur, which uses an injectable, ...
Jazz Pharmaceuticals is closing the sale of its women's health business to Meda, a specialty pharmaceutical company, for $95m in cash. The products listed in the sale are Elestrin, Gastrocrom, Natelle One, AVC Cream , Gesticare DHA and ...
Tags: women's health business, Elestrin, Gastrocrom, Natelle One, AVC Cream
RayBiotech has signed a master services agreement with a West Coast-based biopharmaceutical company to provide custom services in the area of preclinical research diagnostic testing. RayBiotech will leverage its antibody array ...
Tags: company cooperation, clinical technology, clinical service
S1 Biopharma, an early-stage biopharmaceutical company, has announced its foray into male sexual health with S1P-205, the drug in development to treat Hypoactive Sexual Desire Disorder (HSDD) in males. With the development of S1P-205, the ...
Tags: S1 Biopharma, male sexual health, S1P-205, drug
Bristol-Myers Squibb, a biopharmaceutical company, has terminated the development of BMS-986094, an investigational NS5B nucleotide for the treatment of hepatitis C. Based on an ongoing assessment of patients in a Phase II study that the ...
Tags: BMS-986094, Bristol-Myers, hepatitis C, NS5B nucleotide
Clinical-stage biopharmaceutical company Omeros Corporation said that it has discovered the proteins that activate the alternative pathway of the complement system as part of the company's mannan-binding lectin associated serine protease-2 ...
Tags: complement system, protease-2(MASP-2)program, pro-inflammatory protein
Clinical stage biopharmaceutical company, Tocagen, has entered into a partnership agreement with MRI Interventions and Brainlab. Under the collaboration, Tocagen will use MRI Interventions' ClearPoint neuro intervention system at selected ...
Clinical-stage biopharmaceutical company OXiGENE's acute myelogenous leukemia (AML) drug candidate, OXi4503, has received FDA orphan drug status. The second-generation anticancer agent with a dual-mechanism vascular disrupting feature ...
Insmed, a biopharmaceutical company developing inhalation therapeutics for patients suffering from orphan lung diseases, has named Will Lewis as president and chief executive officer. Lewis has also been appointed to the company's board ...
Rockwell Medical, a fully-integrated biopharmaceutical company, has received a new patent for Soluble Ferric Pyrophosphate (SFP) formulation for iron-delivery in hemodialysis patients from the Canadian Intellectual Property Office. ...
AbGenomics International, a biopharmaceutical company, has obtained FDA agreement on Its Phase 2 clinical trial plans of the novel autoimmune therapeutic candidate, AbGn-168H. The current Phase 2 AbGn-168H trial will be a multicenter, ...
Tags: FDA approval, psoriatic, clinical trial, pharmaceutical product