Health Canada has suspended the Establishment Licence of Chemi Pharmaceutical of Mississauga, Ontaria, Canada, after noticing inaccurate testing results during an inspection. Health Canada has also started enquiring the company's ...
Kaneka has unveiled KANEKA KanCapA, a new protein A chromatography resin to purify therapeutic antibodies. Protein A chromatography resin is widely used to produce antibodies due to its high affinity and excellent selectivity for ...
Pharmaceutical Product Development (PPD) has selected Sparta Systems' TrackWise quality management software to centralize the management of its global quality and compliance processes including audits and corrective and preventive actions. ...
Supernus Pharmaceuticals has received approval from the FDA for its Oxtellar XR, a new once-daily extended release formulation of oxcarbazepine. Oxtellar XR is an antiepileptic drug used as an adjunct therapy to treat partial seizures in ...
Tags: oxcarbazepine, FDA approval, partial seizure, pharmaceutical product
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Astellas Pharma Europe's Betmigatm (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency ...
Tags: symptomatic treatment of urgency, pharmaceutical product
Kyowa Hakko Kirin, Orexo's partner, has filed a new drug application (NDA) seeking Japanese approval for KW-2246 as cancer pain medication. The sublingual formulation of fentanyl earlier gained approval in US, EU and Canada as cancer ...
Tags: new drug application, cancer pain medication, pharmaceutical product
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application (ANDA) of Trospium Chloride Extended-release Capsules. Watson anticipates beginning the shipment of the ...
Tags: FDA, Trospium Chloride Extended-release Capsules, pharmaceutical product
The European Commission (EC) has granted marketing authorization to Pfizer's INLYTA (axitinib) oral therapy, designed to treat adult patients with advanced renal cell carcinoma (RCC). INLYTA, a kinase inhibitor, is designed to ...
Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary ...
Pharmaceutical Product Development (PPD) has entered into a license agreement to use Tessella and Berry Consultants' adaptive trial design solution. Comprised of a suite of programs, the FACTS solution has built-in facilities for ...
Tags: trial design solution, company cooperation, clinical program
The US FDA has granted fast track status to Soligenix's SGX203 for the treatment of pediatric Crohn's disease. SGX203 contains an active corticosteroid, beclomethasone 17,21-dipropionate (BDP), that targets local inflamed tissue. ...
The US Food and Drug Administration (FDA) has accepted to review Ferring Pharmaceuticals' new drug application (NDA) of controlled release misoprostol vaginal insert (MVI) for decreasing time to vaginal delivery in women with an unfavorable ...
The US Food and Drug Administration (FDA) has approved Eisai's non-competitive AMPA glutamate receptor antagonist for patients who continue to have seizures despite being on other prescription medications for epilepsy. The drug, ...
Jazz Pharmaceuticals, a specialty pharmaceutical company, has announced the issuance of new formulation patent for Xyrem (sodium oxybate) oral solution. Xyrem (sodium oxybate) oral solution is the FDA approved product for the ...
Tags: xyrem, cataplexy, patent, pharmaceutical product
The USFDA has approved Watson Laboratories' abbreviated new drug application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm. Lidocaine is an amide-type local anesthetic agent and is suggested to ...