Canadian biopharmaceutical firm Aeterna Zentaris has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its ghrelin agonist, macimorelin acetate (AEZS-130), a novel orally-active small molecule. The ...
Tags: Aeterna Zentaris, Medicine
US-based pharmaceutical firm Zogenix has entered into a development and option agreement (D&O Agreement) with Altus Formulation (Altus) to develop abuse deterrent formulations of Zohydro ER (hydrocodone bitartrate) extended-release ...
Tags: Zogenix, Zohydro ER
The US Food and Drug Administration (FDA) has approved Roche's new drug Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy for treatment of patients with chronic lymphocytic leukemia (CLL) who have not previously been ...
Tags: Combination Vaccine, Medicine
Janssen-Cilag (Janssen), a subsidiary of Johnson & Johnson pharmaceutical firm, has submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug ibrutinib for the ...
Tags: Blood Cancer Medicine, Medicine
GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA dry powder ...
Tags: Asthma Treatment, Medicine
Netherland-based injectable drug delivery products producer InnoCore Pharmaceuticals has signed an exclusive license and collaboration agreement with Allergan (AGN), to develop new medicines for ophthalmic diseases. The deal will see the ...
Tags: injectable drug, Innocore
Ranbaxy Laboratories has secured approval from India's Central Drugs Standard Control Organisation (CDSCO) to manufacture and sell 'Synriam' to treat uncomplicated malaria caused by Plasmodium vivax parasite in adult patients. Phase III ...
Tags: Ranbaxy Laboratories, Drug Synriam
Amarin, a biopharmaceutical company, has announced the outcome of the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee for the use of Vascepa (icosapent ethyl) capsules in the treatment of high ...
AMAG Pharmaceuticals has received a notice of three-month extension from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection to be used for intravenous (IV) therapy. ...
Tags: AMAG Pharma, Intravenous Use
US-based biopharmaceutical company MannKind has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking marketing authorization for its AFREZZA inhalation powder, indicated to improve glycemic control ...
Tags: Insulin Application, biopharmaceutical company MannKind
Santen Pharmaceutical, a manufacturer of ophthalmic and anti-rheumatic pharmaceuticals, has introduced TAPROS MINI ophthalmic solution 0.0015%, indicated for glaucoma and ocular hypertension. TAPROS MINI ophthalmic solution contains ...
Allegro Ophthalmics has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to commence two Phase II clinical studies of integrin peptide therapy ALG-1001. The new trials, ...
Tags: Eye Disease Patients
InSite Vision Incorporated (INSV) has reported that the US District Court for the District of New Jersey upheld all four of the patents protecting AzaSite, an azithromycin 1% ophthalmic solution, in a patent infringement lawsuit against ...
US-based specialty pharmaceutical firm Par Pharmaceutical has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for clonidine hydrochloride (HCl) extended-release (ER) ...
Tags: Par Pharmaceutical, Medicine
Optivia Biotechnology has secured a $1.8m two-year Phase II small business innovation research (SBIR) grant, from the National Institute of Mental Health (NIMH) of the National Institutes of Health (NIH). The federal grant is expected to ...