FDA Modifies Hold On Tekmira's Ebola Application; Catalyst Pharma Partners Provides Updates On Progress of Phase 3 Firdapse Study Print E-mail
By Staff and Wire Reports   
Monday, 11 August 2014 19:31
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 11, 2014.
Tekmira Pharmaceuticals (NASDAQ: TKMR) saw 27,193,600 shares change hands as shares rose $3.10 or 15.0 percent to $23.80 Thursday, after the company said a Food and Drug Administration action may enable the use of the company's TKM-Ebola drug for individuals infected with Ebola virus.

The FDA modified its full clinical hold on the company's Investigational New Drug Application for the treatment to a partial clinical hold, according to Tekmira, which said it received "verbal confirmation" from the agency.

"We are carefully evaluating options for use of the drug within accepted clinical and regulatory protocols," Tekmira Chief Executive Mark Murray said.

The hold had been placed July 3 when the FDA sought additional data as well as protocol changes to assure the safety of volunteer subjects.

Published preclinical studies looked promising for the treatment, which is being developed under a $140 million contract with the U.S. Department of Defense.

Tekmira was priced during Friday's pre-market session at $16.52, up 15.7 percent.

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Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX)
, a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today provided an update on the progress of its Phase 3 study of FirdapseTM (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). The last patient has completed the blinded portion of the study and top-line data remains on track to be reported later this quarter. A total of 38 patients completed the 3 month treatment period and were successfully randomized to either receive FirdapseTM or placebo. All patients who were randomized elected to continue in 2-year open label follow-up.

If the company obtains positive results from its Phase 3 study, the company intends to submit a request to the FDA for a pre-NDA meeting and to initiate the steps necessary to seek regulatory approval of FirdapseTM. This would likely include the initiation of a rolling NDA submission to the FDA by early-2015.

The FirdapseTM Phase 3 trial utilizes a randomized, double-blind, placebo-controlled, discontinuation design. The trial is being conducted at sites in the United States and Europe. Following enrollment, patients were treated with open label drug for a minimum of 91 days, and then randomized to either continue on FirdapseTM or be discontinued to placebo over a 2-week period. Following the randomization phase of the trial, patients were then eligible to receive open label FirdapseTM treatment for a two-year follow-up period, to obtain additional long term safety data.


Also Monday:



Achaogen, Inc. (Nasdaq:AKAO)
, a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, today reported financial results for the quarter ended June 30, 2014.

Air Methods Corporation (Nasdaq:AIRM)
, the global leader in air medical transportation, today announced that David Richardson has been appointed as senior vice president of eastern air medical services.

Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L)
, a leading designer and manufacturer of rapid diagnostic screening and testing products, will hold a conference call on Tuesday, August 12, 2014, at 10:30 a.m. Eastern Time to discuss its results for the second quarter and six months ended June 30, 2014.

Athersys, Inc. (Nasdaq:ATHX)
today announced its financial results for the three months ended June 30, 2014.

Cellular Dynamics International, Inc. (Nasdaq:ICEL),
a developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, today reported financial results for the second quarter and six months ended June 30, 2014.

Ekso Bionics Holdings, Inc. (OTCQB:EKSO),
a robotic exoskeleton company, announced today that Nathan Harding, chief executive officer and co-founder, will present at the Canaccord Genuity 34th Annual Growth Conference on Wednesday, August 13, 2014 at 5:00 p.m. Eastern time at The InterContinental Hotel in Boston, MA.

Foundation Healthcare, Inc. (OTC Markets:FDNH)
, which focuses on the development and management of surgical hospitals and related ancillary services, announced today the appointment of Travis Crenshaw to the position Chief Information Officer.

FutureWorld (OTCQB: FWDG)
, the leading provider of advanced solutions to the Cannabis industry globally, with its subsidiary CB Scientific, announce today that they are on schedule to meet forecasted expectations for new and patentable products to be revealed in upcoming industry shows!

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the quarter ended June 30, 2014 and provided a business update.

ICU Medical, Inc., (Nasdaq:ICUI)
, a leader in innovative medical devices used in infusion therapy, oncology and critical care applications, today announced financial results for the second quarter and six months ended June 30, 2014.

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today announced it submitted a New Drug Submission (NDS) to Health Canada seeking approval for the company's investigational drug, ATX-101 (deoxycholic acid), as an injectable treatment for the reduction of submental fat.

MedAssets, Inc. (Nasdaq:MDAS)
, a healthcare performance improvement company, will visit the NASDAQ MarketSite in Times Square.

MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of nonalcoholic fatty liver disease (NAFLD).

MTBC (Nasdaq:MTBC)
, a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions, today announced that the company will release the results for its second quarter ended June 30, 2014 before the market opens on Wednesday, August 27, 2014.

Ocera Therapeutics, Inc. (Nasdaq:OCRX),
a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced its financial results for the second quarter ended June 30, 2014.

Prosensa Holding N.V. (NASDAQ: RNA)
, the biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, today announced that an affiliate of CureDuchenne, a US national nonprofit organization dedicated to finding a cure for Duchenne Muscular Dystrophy (DMD), will provide Prosensa with up to €5 million by means of convertible promissory notes to support the company and accelerate the development and patient access of much needed DMD therapies.

Relypsa, Inc. (Nasdaq:RLYP)
, a biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2014.

Repros Therapeutics Inc.® (Nasdaq:RPRX)
today announced financial results for the second quarter ended June 30, 2014.

Swisher Hygiene Inc. (Nasdaq:SWSH)
, a leading service provider of essential hygiene and sanitizing solutions, announced today results for the three and six months ended June 30, 2014.

Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today reported its financial results and corporate update for the second quarter ended June 30, 2014.

uniQure N.V. (Nasdaq:QURE)
, a leader in human gene therapy, today announced the acquisition of InoCard GmbH, an innovative, early-stage biotechnology company focused on the development of gene therapy approaches for cardiac disease.

Zafgen, Inc. (Nasdaq:ZFGN)
, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity, today announced that Thomas Hughes, Ph.D., Chief Executive Officer, is scheduled to present a company overview at the 34th Annual Canaccord Genuity Growth Conference.



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