|Raptor Offers Update on PROCYSBI; FDA Approves Alexza's ADASUVE|
|By Staff and Wire Reports|
|Friday, 21 December 2012 19:18|
Raptor Pharmaceutical Corp. (Nasdaq: RPTP) announced that the U.S. FDA will require additional time to complete its review of the New Drug Application ("NDA") for RP103 (PROCYSBI™), for the potential treatment of nephropathic cystinosis. In a notice received today from the FDA, the initial Prescription Drug User Fee Act ("PDUFA") goal date has been extended from January 30, 2013 to April 30, 2013. The three month extension is a standard extension period.
The FDA exercised its option to extend the PDUFA goal date to provide more time to complete the review of information submitted within three months of the PDUFA date. The agency has not asked for additional studies.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced the U.S. FDA approved ADASUVE® (loxapine) Inhalation Powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. ADASUVE combines Alexza's proprietary Staccato® delivery system with the antipsychotic drug, loxapine.
The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in rapid systemic delivery and absorption of a drug. See below for Important Safety Information about ADASUVE, including Boxed Warnings.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the Company has completed the acquisition of Neuronex, Inc., a privately held company developing a nasal spray formulation of diazepam.
Celgene Corporation (NASDAQ: CELG) today announced its presentation at the 31st Annual J.P. Morgan Healthcare Conference on January 7, 2013 at 11:00a.m. E.T. will be webcast live and will be available in the investor relations section of the company’s Web site at www.celgene.com.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval for the use of ENTEREG® (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease.
Genomic Health, Inc. (Nasdaq: GHDX) today announced that Kim Popovits, Genomic Health's Chairman, Chief Executive Officer, and President will present at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 7 at 1:30 p.m. Pacific Time (PT).
iBio, Inc. (NYSE MKT: IBIO) announced today the appointment of Seymour Flug to the iBio Board of Directors and the addition of Andrea Corcoran, as Senior Vice President, Finance and Strategy, a newly created position on the iBio leadership team.
IDEXX Laboratories, Inc. (NASDAQ, IDXX) announced today that the Commissioners of the U.S. Federal Trade Commission ("FTC") have preliminarily approved the consent agreement previously reached between the Company and the staff of the FTC Bureau of Competition.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") today announced that its patented MyMedicalRecords Personal Health Record (PHR) will be featured in the ng Connect Telepresence collaboration being unveiled at the 2013 Consumer Electronics Show January 8-11 in Las Vegas in the Alcatel-Lucent Booth #31412.
ShangPharma Corporation (NYSE: SHP) (the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that the Company has entered into a definitive Agreement and Plan of Merger (the "Merger Agreement") with ShangPharma Holdings Limited ("Holdings"), ShangPharma Parent Limited ("Parent") and ShangPharma Merger Sub Limited ("Merger Sub"), pursuant to which Parent will acquire the Company for US$0.50 per ordinary share or US$9.00 per American Depositary Share, each representing eighteen ordinary shares ("ADS").
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced surpassing the primary endpoint in the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor.
Vycor Medical, Inc. (OTCBB: VYCO) announced today that Richard Denness will resign as the Company's CEO effective December 31, 2012, and as a member of the Board of Directors effective immediately.
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that Paul Bisaro, Watson's President and Chief Executive Officer, will provide an overview and update of the Company's business at the 31st Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2013 at 7:30 am PST (10:30 am EST) at the Westin St. Francis Hotel, San Francisco, California.
YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM) today announced that the Supreme Court of Nova Scotia has granted an interim order, setting, among other things, December 31, 2012 as the record date associated with the previously announced plan of arrangement.