US-based Avanir Pharmaceuticals (AVNR) has entered into a settlement agreement with the US unit of Indian drugmaker Wockhardt to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking ...
Tags: Avanir Pharma, Medicine
The US Food and Drug Administration (FDA) has scheduled a meeting on 03 October 2013 to discuss QRxPharma's Moxduo new drug application (NDA) for the treatment of moderate to severe acute pain. The meeting is aimed at focusing on ...
Tags: Acute Pain Drug
Japanese drugmaker Otsuka Pharmaceutical has agreed to acquire Astex Pharmaceuticals for $866m in an all-cash tender offer. Under the deal, Astex's fragment-based drug design technology called 'PYRAMID' will be integrated into Otsuka, ...
The US Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo Health Solutions' subsidiary Endo Pharmaceuticals to the new drug application (NDA) for its testosterone undecanoate injection ...
Tags: Aveed Injection, Medicine
Clinical-stage biopharmaceutical company Pharmacyclics' new drug application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, has been accepted by the US FDA for two B-cell malignancy indications. ...
Tags: Solvay Group, Medicine
Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar ...
Tags: New Drug Application, FDA
Biomedical engineers from The Johns Hopkins University have partnered with clinicians to create new therapeutic eye injections for a type of central vision loss caused by blood vessel growth at the back of the eye. The new drug, with a ...
The US Patent and Trademark Office (USPTO) has granted a patent to Atlantic Pharma for its SMART/Script abuse deterrent drug delivery system. Designed to thwart dose dumping of orally delivered prescription opioids, the new drug delivery ...
Tags: Atlantic Pharma, Medicine
Mylan has obtained FDA approval for its supplemental abbreviated new drug application (sANDA) for the generic version of GSK's WELLBUTRIN XL, bupropion hydrochloride extended-release tablets USP (XL), 300mg. Bioequivalence study results ...
Tags: FDA Approval, drug application
Avanir Pharmaceuticals has settled pending patent litigation concerning Sandoz's abbreviated new drug application (ANDA) to market generic versions of Avanir's Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) capsules. Under the ...
Tags: Avanir Pharmaceuticals
ANI Pharmaceuticals has signed a binding letter of intent with Sofgen Pharmaceuticals to develop and market an oral soft gel prescription product indicated for cardiovascular health. Development, manufacturing and regulatory activities of ...
Pharmaceutical marketing, research and development company Breckenridge Pharmaceutical has signed a deal to acquire certain assets of Pernix Therapeutics' subsidiary, Cypress Pharmaceuticals, for $30m. The assets included in the agreement ...
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee has recommended approval of Bayer’s oral soluble guanylate cyclase (sGC) stimulator, riociguat, in two forms of pulmonary ...
Tags: FDA Advisory Committee
Perrigo Company has received final FDA approval for abbreviated new drug application for generic equivalent to cutivate lotion, 0.05% and begins immediate shipment of the product. Cutivate Lotion 0.05% (fluticasone propionate lotion, ...
Naurex has announced the issuance of new US patent for selective NMDA receptor partial agonist, GLYX-13, covering methods of treating major depressive disorder through 2030. In a Phase II trial, GLYX-13 demonstrated considerable safety, ...