Industry News

- Read more about Biocon's Rosuvastatin Calcium tablets receive Europe's approval
Biocon Ltd., announced that it has received European approvals for its Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets, a generic equivalent of Crestor® tablets, indicated for hyperlipidemia or mixed dyslipidemia.
- Read more about Clovis Oncology Rociletinib NDA scheduled for presentation at upcoming FDA ODAC
Clovis Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016.
- Read more about Optovue’s AngioVue imaging system receives FDA clearance
Optovue announced FDA clearance and immediate U.S. commercial availability of the AngioVue™ Imaging System, a groundbreaking technology that provides a non-invasive way to visualize abnormal blood vessels in the retina to help physicians determine an appropriate course of treatment.
- Read more about Guerbet receives FDA 510k clearance for the OptiOne™ single-head contrast delivery system
Guerbet announced that it has received 510K clearance from the US Food and Drug Agency (FDA) for its OptiOne™ Single-Head Contrast Delivery System, featuring advanced multi-purpose functionality for CT imaging procedures.
- Read more about RedHill Biopharma announces successful PK study With BEKINDA™ 12 mg and submission to FDA of IBS-D Phase II study Protocol
RedHill Biopharma Ltd, announced the successful completion of a first-in-man pharmacokinetic (PK) study of BEKINDA™ 12 mg formulation, intended to be administered in the Phase II study for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). RedHill further announced the submission to the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) protocol for the Phase II clinical study with BEKINDA™ 12 mg for IBS-D, planned to be initiated in the coming weeks, subject to final preparations.
- Read more about Astrazeca and Eli Lilly joined to discover treatment of CKD
AstraZeneca and its global biologics research and development arm, MedImmune, have entered into a collaboration with the University of Michigan and Eli Lilly to identify new therapeutic targets for the treatment of chronic kidney diseases (CKD).
- Read more about Second Phase 3 Study of Alkermes antipsychotic drug
Alkermes plc. initiated second of two core phase 3 studies for ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.
- Read more about EMA accepts Sandoz application for pegfilgrastim biosimilar
Sandoz, a Novartis company and the global leader in biosimilars, announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen’s EU-licensed Neulasta®* (pegfilgrastim) – a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product.
- Read more about Aurobindo Pharma receives USFDA approval for Levofloxacin in Dextrose Injection
Aurobindo Pharma Limited announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 500 mg/100 mL (5 mg/mL), and 750 mg/150 mL (5 mg/mL), single-use containers. The product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin® (Levaquin in 5 % Dextrose) by Janssen Pharmaceuticals, Inc.
- Read more about ABBVIE announces positive top-line results from second phase 3 study investigating Elagolix
AbbVie, in cooperation with Neurocrine Biosciences, Inc., announced positive top-line results from the second of two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer pain from endometriosis.