Company Drug Indication Algeta ASA Xofigo Castration-resistant prostate cancer Genentech Inc. Tarceva Metastatic non-small-cell lung cancer Genentech Inc. Actemra Polyarticular juvenile idiopathic arthritis Raptor Pharmaceutical Corp. Procysbi Nephropathic cystinosis

We decided, once we got FDA approval for thalidomide, not to go international because we didn't want to be known as 'the thalidomide company,' so we waited until we got our successor compound

and certain other territories from Basel, Switzerland-based Novartis AG for $60 million up front, and additional payments of at least $75 million over the next several years, plus milestone payments prior to FDA approval...Upon FDA approval, Questcor will pay another milestone to Novartis, plus royalties based on net sales in the U.S. The products are approved for autoimmune and inflammatory diseases outside the U.S., but have not been approved in the U.S

Proceeds also will support commercial launch of Resure Sealant following FDA approval of the device

plc, of Dublin, Ireland, bought into the respiratory franchise shared by Theravance Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK), acquiring for $1 billion a 21 percent stake in Theravance's future royalty streams from four drugs that are partnered with GSK. (See BioWorld Today, May 14, 2013.) One of the compounds in the deal, Breo (fluticasone furoate and vilanterol inhalation powder), which is administered using the Ellipta inhaler, recently won FDA approval as a

3SBio Inc., of Shenyang, China, said it completed its merger with Decade Sunshine Ltd., an exempted company with limited liability incorporated under the laws of the Cayman Islands. The firm also requested that trading of its American depositary shares on Nasdaq be suspended, while it works to delist its registered securities. Addex Therapeutics SA, of Geneva, completed a previously announced restructuring, and Bharatt Chowrir stepped down effectively immediately as CEO and as director of

Genervon Biopharmaceuticals LLC, of Pasadena, Calif., said it received FDA approval for an amyotrophic lateral sclerosis (ALS) Phase IIa trial for GM604, which has been found to modulate more than 80 ALS-related gene targets (efficacy and target biomarkers) interactively and dynamically, through up to 12 pathways and 22 biological processes

GlaxoSmithKline plc, of London, has received FDA approval for Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced melanoma

Biovail provided $10 million up front, and pledged as much as $20 million in potential development milestone payments that would come along the path through FDA approval, plus $35 million if certain sales-based milestones are met

In addition, at this time, we are still aware that Seaside plans to pursue FDA approval pending the results of the placebo-controlled studies

FDA approval of NGX-1998, and $3M if net sales reach $100M

Linzess gained FDA approval last year for use in irritable bowel syndrome...NPS gained FDA approval of lead candidate Gattex (teduglutide [rDNA origin]) for short bowel syndrome late last year and is developing Natpara (rhPTH [1-84]) for adult hypoparathyroidism

Xenoport severed its marketing ties with London-based GSK last fall after a legal skirmish over the drug's modest sales following FDA approval for RLS in 2011 and in PN a year later

The drug has not gained FDA approval. (See BioWorld Today, Jan. 31, 2012

And More Algeta ASA and partner Bayer AG disclosed FDA approval for Xofigo (radium Ra 223 dichloride) in castration-resistant prostate cancer, Astellas Pharma Inc

Algeta ASA and partner Bayer AG disclosed FDA approval Wednesday for Xofigo (radium Ra 223 dichloride) in castration-resistant prostate cancer, with the agency's nod coming three months ahead of the Aug. 14 PDUFA date

One of them, Breo (fluticasone furoate [FF] and vilanterol inhalation powder), which is administered using the Ellipta inhaler, has just gained FDA approval as a daily maintenance therapy for relieving airflow obstruction in patients with chronic obstructive pulmonary disease (COPD

One of them, Breo (fluticasone furoate [FF] and vilanterol inhalation powder), which is administered using the Ellipta inhaler, has just gained FDA approval as a daily maintenance therapy for relieving airflow obstruction in patients with chronic obstructive pulmonary disease (COPD