|FDA Postpones Panel for Glaxo's COPD; FDA Panel Sees Risk in Osteoporosis Drug|
|By Staff and Wire Reports|
|Tuesday, 05 March 2013 20:24|
The Food and Drug Administration said it has postponed a meeting of outside advisers scheduled for March 7 to review a drug developed by GlaxoSmithKline Plc (NYSE:GSK) and Theravance Inc (NASDAQ:THRX) for chronic obstructive pulmonary disease (COPD).
The agency did not officially give a reason for the postponement but it comes as a major snowstorm bears down on the Northeastern United States, including Washington D.C., where the panelists were due to meet.
The agency said it would post briefing materials related to the drug, to be called Breo if approved in the United States, no later than two days before the next meeting, once announced.
A panel of federal health experts says a long-established bone strengthening drug should no longer be used by women because there is little evidence it works and it may actually increase the risk of cancer.
The FDA panel voted 12-9 that the risks of the inhalable osteoporosis drug outweigh its benefits when used to treat brittle bones. The drug, known chemically as calcitonin salmon, has been prescribed for osteoporosis in postmenopausal women since the 1980s. Currently, Novartis (NYSE:NVS) and Upsher-Smith market the drug in nasal spray form as Miacalcin and Fortical, respectively.
But health authorities around the world have been reviewing the drug's safety after two recent studies showed a slightly higher rate of cancer among patients taking calcitonin pills. The drug is also available as an injection to treat other conditions, including excess calcium in the blood.
The European Medicines Agency concluded last July that calcitonin should no longer be used to treat osteoporosis, due to the drug's cancer risk.
An internal FDA memo released ahead of Tuesday's meeting said it's difficult to draw a direct link between the drug and cancer. However, "the potential for a cancer risk with calcitonin salmon therapy cannot be ignored. The majority of all calcitonin salmon trials showed an increased risk estimate."
A narrow majority of panelists voted against continued use of the drug, pointing out that the drug has not been shown very effective at preventing bone fractures.
3DIcon Corporation (OTCBB: TDCP) (the "Company"), a developer of three-dimensional projection display technologies, today announced that its CEO, Mr. Mark Willner, has issued a new Technology Update Letter to shareholders.
Abattis Bioceuticals Corp. (OTC PINK: ATTBF) (CNSX: FLU), announces it has signed a Letter Of Intent for a multimillion dollar supply agreement with Cromogen Biotechnologies to purchase Cannabidiol or "CBD's" for the use of creating infused products to be sold in the US Natural Health Product Market(s).
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation, heart failure and other cardiovascular diseases, today announced a 6-for-1 reverse split of its common stock.
Array BioPharma Inc. (NASDAQ: ARRY) and Global Blood Therapeutics today announced a multi-target drug discovery collaboration agreement to identify small molecule lead compounds targeting chronic blood-based diseases.
Biomass Secure Power Inc. (OTC:Pinksheet: "BMSPF") (the "Company") is pleased to provide shareholders with an update on the status of lease option at the Port of Greater Baton Rouge. The Company has set up a wholly owned subsidiary in the State of Louisiana to hold the pellet plant project, namely Biomass Power Louisiana L.L.C.
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S., announced today that it will host a conference call and live audio webcast at 4:30 p.m. EDT on Tuesday, March 12, 2013 to report its fourth quarter and full year 2012 financial results and provide a corporate update.
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Zoledronic Acid Injection (4 mg/5 mL), a bioequivalent generic version of Zometa® (zoledronic acid) 4 mg/5 mL Injection in the US market on March 4, 2013, following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Zoledronic Acid Injection (4 mg/5 mL).
EasyMed Services Inc. (CNSX:EZM) (PINKSHEETS:EMYSF) (MUN:EY6) ("EasyMed" or the "Company") announces the launch of a new smartphone application for its International Medical Passport on the Android platform.
Eli Lilly and Company (NYSE: LLY) will conduct a conference call for the media and investment community to provide a pipeline update for its diabetes business on Monday, June 24, 2013.
Endo Health Solutions (Nasdaq: ENDP) today announced that Alan Levin, chief financial officer, will present a corporate overview at the Cowen and Company 33rd Annual Health Care Conference on Wednesday, Mar. 6, 2013, at 10:00 a.m. Eastern Time.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) will be presenting at the Barclays 2013 Global Healthcare Conference in Miami, FL. on March 12, 2013 at 4:15 p.m. ET/1:15 p.m. PT. Kurt Gustafson, Chief Financial Officer of Halozyme Therapeutics, will provide a corporate overview.
MedeFile International, Inc. (OTCQB: MDFI), a leader in Internet-enabled Personal Health Record (iPHR) management solutions, today announced that the Company was among 15 award recipients of the Allscripts Open App Challenge, announced yesterday at the Healthcare Information and Management Society's (HIMSS) Annual Conference in New Orleans.
Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that its Phase I/II DCVax-Direct clinical trial for all inoperable solid tumor cancers is planned to begin within approximately the next sixty days.
Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC) (NASDAQ: ONCY) today announced that it has completed patient enrollment in a Phase 2 clinical trial evaluating intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumours (REO 016).
PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent application covering the company's long-acting CTP-enhanced human growth hormone (hGH-CTP).
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the fourth quarter and year ended December 31, 2012.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today that Edward Lanphier, Sangamo's president and CEO, will provide an update on the progress of Sangamo's ZFP Therapeutic®development programs and an overview of the company's business strategy at 4:45 pm ET on Wednesday, March 13, 2013, at the Barclays Global Healthcare Conference which will be held in Miami.
Sigma-Aldrich Corporation (NASDAQ: SIAL) today announced that its custom manufacturing and services business unit, SAFC (www.safcglobal.com), is expanding its line of PharmaGrade products with the addition of 20 raw materials for biopharmaceutical manufacturing.