Breckenridge Pharmaceutical Inc., of Boca Raton, Fla., entered into a development agreement with Welding GmbH & Co., of Hamburg, Germany, and SK Chemicals, of Seoul, South Korea, to develop and market an undisclosed drug candidate with potential U.S.-branded sales of approximately $500 million

Metreleptin, a recombinant analogue of human hormone leptin, was developed by San Diego-based Amylin Pharmaceuticals Inc., which was acquired in a joint buyout by BMS and AstraZeneca last year. (See BioWorld Today, July 3, 2012

Mylan Inc., of Pittsburgh, said its subsidiary Mylan Pharmaceuticals Inc...Oramed Pharmaceuticals Inc., of Jerusalem, said the FDA cleared the company's investigational new drug application for its flagship product, an oral insulin capsule called ORMD-0801 for early Type II diabetes

Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., signed a three-year agreement with the California Institute for Quantitative Biosciences (QB3) to evaluate life sciences start-up companies with the goal of advancing early stage technologies and therapeutics

Mylan Inc., of Pittsburgh, said subsidiary Mylan Pharmaceuticals Inc...The product is the generic version of Puerto Rico-based IPR Pharmaceuticals Inc.'s Zomig Tablets and is indicated for the acute treatment of migraine with or without aura in adults

In 2009, Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., updated its license agreement with Novartis related to canakinumab and a second antibody program using Regeneron's interleukin-1 Trap technology

Sucampo Pharmaceuticals Inc., of Bethesda, Md., said the FDA approved its prostone-based therapy Amitiza (lubiprostone) as the first oral treatment of opioid-induced constipation (OIC) in patients with chronic, noncancer pain

Amylin Pharmaceutical Inc., of San Diego, (later acquired by Bristol-Myers Squibb Co. with help from AstraZeneca plc) is the subject of a three-defendant lawsuit along with Merck & Co

Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said the FDA accepted for filing and granted priority review to its new drug application (NDA) for oral investigational compound riociguat in chronic thromboembolic pulmonary hypertension (CTEPH) that is inoperable or persistent or recurrent CTEPH after pulmonary endarterectomy and pulmonary arterial hypertension...Rafarma Pharmaceuticals Inc., of Terbuny, Russia, and Sandy, Utah, said it registered ceftriaxone, a third-generation cephalosporin

Covis Pharmaceuticals Inc., of Cary, N.C., disclosed an agreement today to distribute in the U.S. Nilandron (nilutamide), Plaquenil (hydroxychloroquine), Rilutek (riluzole), Uroxatral (alfuzosin hydrochloride) and Kayexalate (sodium polystyrene sulfate

Noven Pharmaceuticals Inc., of Miami, said it confirmed that it filed an abbreviated new drug application seeking approval to market its rivastigmine transdermal system in 4.6 mg/24 hours and 9.5 mg/24 hours dosage strengths

The FDA approved Invokana (canagliflozin) by Janssen Pharmaceuticals Inc., part of Johnson & Johnson, of New Brunswick, N.J., for Type II diabetes

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, and Eli Lilly and Co., of Indianapolis, submitted a new drug application for sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for Type II diabetes in adults

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, said a new perspective from the FDA stated the agency has not changed its recommendations regarding Pradaxa (dabigatran etexilate mesylate) capsules, following the November 2012 Mini-Sentinel evaluations

Actavis' ANDA product is a generic version of Endo Pharmaceuticals Inc.'s Fortesta (testosterone 2% gel), which is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

Sunovion Pharmaceuticals Inc., of Marlborough, Mass., said the FDA accepted for review its new drug application (NDA) for Stedesa (eslicarbazepine acetate) for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in patients 18 years and older with epilepsy

Mylan Inc., of Pittsburgh, said subsidiary Mylan Pharmaceuticals Inc...The FDA denied a Citizens Petition filed by Reckitt Benckiser Pharmaceuticals Inc., of Richmond, Va., presenting pediatric exposure data for products containing buprenorphine, and recommending that the FDA adopt more stringent packaging standards and increased educational interventions

Lupin Ltd., of Mumbai, India, said its subsidiary, Lupin Pharmaceuticals Inc., received approval for Suprax (cefixime) for oral suspension, 500 mg/5mL from the FDA

Cumberland Pharmaceuticals Inc., of Nashville, Tenn., partnered with Sandor Medicaids Pvt Ltd., of Hyderabad, India, to commercialize Caldolor (ibuprofin) injection in India for treatment of pain and fever...Sucampo Pharmaceuticals Inc., of Bethesda, Md., and R-Tech Ueno Ltd., of Tokyo, said Rescula (unoprostone isopropryl) eye drops were launched in the U.S