Oral drug delivery systems developer Oramed Pharmaceuticals has submitted a pre-Investigational New Drug (pre-IND) seeking approval from the US Food and Drug Administration (FDA) to commence a trial on its orally ingestible exenatide ...
Researchers at A*STAR’s Genome Institute of Singapore (GIS) have identified potential targets for therapeutic drugs against aggressive breast cancer. Working in collaboration with local and international institutions, GIS scientists ...
Tags: therapeutic drugs, Medicine
Daiichi Sankyo Company has decided to expand its collaborative drug discovery program with universities and research institutions based in Japan, Take a New challenge for Drug diScovery (TaNeDS) Global Program, to Germany, Switzerland and ...
Tags: Daiichi Sankyo, Medicine
Dr Reddy's Laboratories, an India-based pharmaceutical company, has introduced Donepezil Hydrochloride tablets 23mg in the US on 26 July 2013. The launch follows the approval of an abbreviated new drug application (ANDA) for the drug by ...
Tags: Drug Aricept, Generic Equivalent
Mylan Pharmaceuticals and Orion have entered into a settlement and license agreement, which dismisses the parties pending litigation related to Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US FDA for the generic ...
Tags: Mylan, Orion, Generic Version
Biopharmaceutical development company Chelsea Therapeutics has announced the US FDA acceptance of Northera (droxidopa) new drug application (NDA) resubmission to treat symptomatic neurogenic orthostatic hypotension (NOH). The company is ...
Specialty pharmaceutical company Iroko Pharmaceuticals has announced the FDA acceptance for New Drug Application (NDA) filing of lower dose submicron Indomethacin, a non-steroidal anti-inflammatory drug. The proposed indication of the ...
Tags: FDA Acceptance, NDA Filing
Mylan Pharmaceuticals has introduced Norethindrone Tablets USP, 0.35mg, which is the generic version of Watson Laboratories' (now Actavis) Nor-Q.D. tablets, 0.35mg for 28-day cycle, for the prevention of pregnancy in the US. The ...
Tags: Generic Contraceptive Pill, Mylan
Mylan Pharmaceuticals, Mylan's US subsidiary, has launched one of the first generic versions of Abbott's Trilipix Capsule in the US. Known as Fenofibric Acid Delayed-release Capsules, 45mg and 135mg is indicated for patients with mixed ...
The USFDA has cleared Actavis' abbreviated new drug application (ANDA) for Lamotrigine orally disintegrating tablets, 25mg, 50mg, 100mg and 200mg. A generic version of GlaxoSmithKline's Lamictal ODT, the antiepileptic drug is indicated ...
Specialty pharmaceutical company Actavis has won FDA approval for abbreviated new drug application (ANDA) of generic equivalent to Endo Health Solutions' Opana ER. Oxymorphone Hydrochloride extended-release tablets, which is available in ...
Tags: FDA, ANDA, Generic Opana ER
GlaxoSmithKline (GSK) and Theravance have withdrawn license application for the use of inhaled drug fluticasone furoate (FF) and vilanterol (VI), with proposed brand name of Relvar Ellipta, as treatment for chronic obstructive pulmonary ...
Tags: Japan, GSK, Relvar License
Janssen Research & Development is seeking FDA approval for use of ibrutinib in the treatment of previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). The ...
Tags: FDA Approval, Janssen
The US FDA has accepted to review Bristol-Myers Squibb Company and Pfizer's Eliquis (apixaban) supplemental new drug application for prophylaxis of deep vein thrombosis (DVT) subsequent to hip or knee replacement surgery. The application ...
Tags: Drug Application, Medicine
Cha Bio&Diostech, a South Korean partner of Pluristem Therapeutics, has filed its first investigational new drug (IND) application for Pluristem’s PLacental eXpanded (PLX) cells with the Korean Food and Drug Administration (KFDA). ...
Tags: PLX Cells, Cha Bio&Diostech