US-based biopharmaceutical company Spring Bank Pharmaceuticals has closed a $10.5m Series A financing round from Brock Securities with Gilford Securities as a participator. The firm is planning to invest the fund in its Phase I clinical ...
Biopharmaceutical company Amarin has submitted a Supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA), seeking approval for the marketing and sale of its Vascepa(R) (icosapent ethyl) capsules. Vascepa is ...
Tags: Amarin, Vascepa Capsule, FDA
Belgium-based biopharmaceutical company UCB has signed a research deal with ConfometRx for the discovery of new drugs. Under the deal, UCB and ConfometRx will leverage structural biology to gain insight into G-protein coupled receptor ...
Tags: drug discovery, biopharmaceutical, UCB
Biopharmaceutical company Gilead Sciences has issued a voluntary recall of one lot of Vistide (cidofovir injection) at user level due to incidence of particulate matter in few vials. The recalled lot of the product was distributed to ...
Specialty biopharmaceutical company Santarus has announced the commercial launch of ulcerative colitis therapy, Uceris (budesonide) extended release tablets. Uceris that contains a locally acting glucocorticosteroid, budesonide, in a ...
Tags: Santarus, Uceris, ulcerative colitis therapy
Biopharmaceutical company Gilead Sciences has completed the acquisition of YM BioSciences. A Gilead subsidiary acquired all YM's outstanding common shares as per the terms of a plan of arrangement. Thus, YM has become a wholly-owned ...
Tags: Gilead Sciences, YM BioSciences, acquisition
Clinical stage biopharmaceutical company Apogenix's Apocept (APG101) has won FDA orphan drug designation to treat myelodysplastic syndromes (MDS). Apogenix also announced the commencement of Apocept Phase I trial in MDS patients in ...
Tags: FDA, orphan drug, biopharmaceutical
US-based biopharmaceutical company Hyperion Therapeutics has announced that it has gained approval from US Food and Drug Administration (FDA) for its RAVICTI (glycerol phenylbutyrate) liquid drug. RAVICTI used for treating Urea Cycle ...
Tags: FDA, drug, biopharmaceutical company
The US Patent and Trademark Office (USPTO) has granted a notice of allowance (NOA) to biopharmaceutical company Amarin for its claims related to Vascepa and FDA-approved MARINE indication. The NOA, which is issued based on patent ...
Tags: NOA, Vascepa capsules, biopharmaceutical
Shire, a specialty biopharmaceutical company, is set to purchase US-based biotechnology company Lotus Tissue Repair. Under the purchase, Lotus Tissue Repair's intravenous protein replacement therapy, which is in late pre-clinical ...
Tags: Shire, biopharmaceutical company, US, Lotus Tissue Repair
Gilead Sciences, a biopharmaceutical company, has submitted a new drug application (NDA) to the FDA for HIV integrase inhibitor elvitegravir for the treatment-experienced patients. The company provided 96-week data from a pivotal Phase ...
pSivida, a developer of sustained release drug delivery products, has entered into an agreement with a biopharmaceutical company for the evaluation of its Tethadur protein/antibody delivery technology. Designed for use in the field of ...
Biopharmaceutical company AstraZeneca has announced agreement with the US Food and Drug Administration (FDA) with regard to FASLODEX (fulvestrant) Injection label changes. The labeling update includes results and a Kaplan-Meier plot of ...
Tags: FASLODEX Injection label, AstraZeneca, prescription medicines
Multinational biopharmaceutical company Celgene has received US Food and Drug Administration (FDA) approval for Abraxane, which is aimed to treat locally advanced or metastatic non-small cell lung cancer in combination with carboplatin in ...
Tags: Abraxane, lung cancer, Multinational biopharmaceutical company Celgene
GlaxoSmithKline (GSK), Ligand Pharmaceuticals' partner, has gained FDA priority review status for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection. ...
Tags: GlaxoSmithKline, GSK, promacta, thrombocytopenia