|Wright Medical Group Announces Deal with FDA Office of Device Evaluation; Shares of Intercept Pharma Rise|
|By Staff and Wire Reports|
|Monday, 10 March 2014 19:58|
Wright Medical Group, Inc. (NASDAQ: WMGI) announced it has reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the Pre-Market Approval application (PMA) for Augment^® Bone Graft in lieu of proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the week of May 19, 2014. The agreement with ODE remains subject to final approval by the FDA appeal authority. That approval is expected shortly.
The PMA amendment, which the company expects to submit on or about March 31, 2014, will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment. The company intends to renew the DRP process if the PMA amendment fails to result in a reversal of ODE's previous not approvability determination.
Commenting on this development, Robert Palmisano, president and chief executive officer, stated, “Since inception of the DRP process, Wright and ODE were encouraged by the FDA Ombudsman to continue discussing alternative ways to resolve the dispute. These discussions proceeded slowly but gathered steam in recent days as the timeline for DRP submissions grew nearer. The result is something we consider to be a good mechanism for moving forward.”
Palmisano continued, “While this development is cause for somewhat greater optimism than we have thus far had reason to embrace, it is important to reiterate that the parties' positions are still far apart and there is no guarantee this PMA amendment will result in an approval for Augment Bone Graft. Nevertheless, we are pleased we were able to work collaboratively with FDA to identify a path forward that does not require new clinical studies to get to the next approvability determination.”
On Monday, Bank of America released a bullish note on Intercept Pharmaceuticals (NASDAQ: ICPT). Shares trended higher throughout the session, spiking over the $440 level just minutes before the bell. The stock closed up nearly 8 percent.
Analyst Rachel McMinn believes the company should see FDA and EU regulators' support on using reversal of steatohepatitis, with no fibrosis progression, as surrogate histologic endpoint. Intercept's endpoint is to approve non-alcoholic steatohepatitis (NASH) drugs for the pre-cirrhotic population, according to the BofA analyst.
McMinn believes that regulators will need Phase 3 studies for approval, but regulators won't require CV outcomes data prior to approval.
Amarantus Bioscience Holdings, Inc. (OTC:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, announced today that it has closed on its previously announced Warrant Solicitation, which the Company elected to increase in size from $3.0M to $3.6M due to oversubscriptions.
Anavex Life Sciences Corp. (OTCQB:AVXL), a clinical stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's, diseases of the central nervous system (CNS) and various types of cancer, today announced the findings of a research report published in the current issue of peer-reviewed scientific journal Neuroscience Letters.
Apricus Biosciences, Inc. (Nasdaq:APRI) announced today that it will host a conference call on Monday, March 17, 2014, at 5:00 p.m. ET to discuss recent corporate highlights and its fourth quarter and year-end 2013 financial results.
Bionomics Limited (ASX:BNO) (ADR:BMICY) CEO and managing director Dr Deborah Rathjen will present a company update at the renowned 26th Annual ROTH Conference in Dana Point, California Monday, March 10, 2014 at 11am PDT at The Ritz Carlton.
BG Medicine, Inc. (Nasdaq:BGMD) announced today that galectin-3 testing has been recognized for the first time in the newly issued 2014 Indian Consensus Document on Cardiac Biomarkers published by the Cardiological Society of India.
Caliber Imaging & Diagnostics (OTCQB:LCDX), formerly Lucid, Inc., has named Anthony J. Roberto as East Coast Sales Manager, a newly created position.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that veteran pediatric pathologist R. Weslie Tyson, M.D. (Wes), has been hired as Chief Medical Officer, effective April 8, 2014.
Elite Pharmaceuticals, Inc. (OTCBB:ELTP) today announced the expansion of intellectual property protection surrounding the Company's abuse deterrent technology with the issuance of Canadian Patent Number 2,521,655 titled "Abuse-Resistant Oral Dosage Forms and Method of Use Thereof".
Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it will issue its financial results for the Fourth Quarter of 2013 on Tuesday, March 25, 2014, after the close of the market.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research, has named Ronald Aplin to Vice President Global Operations and Quality, effective immediately.
Hemispherx Biopharma, Inc. (NYSE MKT:HEB), announced that after more than a week in trial, a federal jury in Atlanta took only an hour to determine there was no merit to a brokerage firm's claim that Hemispherx owed the firm over $6 million for commissions from private sales of stock in 2009.
I.D. Systems, Inc. (Nasdaq:IDSY), a leading provider of wireless M2M asset management solutions, has received a series of purchase orders, valued in excess of $800,000, to deploy its PowerFleet® wireless vehicle management system (VMS) on fleets of lift trucks at multiple distribution centers of a Fortune 100 company.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced it has submitted a Marketing Authorization Application to the European Medicines Agency, seeking the approval of Zerenex™ (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease, including dialysis- and non-dialysis dependent CKD.
MRI Interventions, Inc. (OTCQB:MRIC), a commercial stage medical device company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart, announced today its fourth quarter and full year product revenues for 2013.
MRI Interventions, Inc. (OTCQB:MRIC) today announced that its Board of Directors has elected medical device executive Timothy T. Richards to the Board.
MRI Interventions, Inc. (OTCQB:MRIC) announced today that it has entered into a purchase agreement with certain accredited investors for a private placement of securities.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC, an internationally recognized contract development and manufacturing organization, announced today that PCT has expanded both its Allendale, NJ and Mountain View, CA current Good Manufacturing Practice facilities to significantly increase its engineering and process development laboratories, and controlled environment space available for client needs.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the appointment of John J. Trizzino to the position of Senior Vice President, Commercial Operations, effective March 10, 2014.
Healthcare organizations can now analyze labor efficiency across multiple care settings using enhanced analytics from Premier, Inc. (Nasdaq:PINC).
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced that it will release fourth quarter and full year 2013 financial results after market close on Thursday, March 13, 2014.
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer today announced the commercial availability of its expanded KRAS assay, a mutation detection test that provides broader coverage of KRAS mutations, including those in regions of the gene not previously examined.
RestorGenex (OTCBB:SMDID) announced today that it has named Stephen M. Simes as its Chief Executive Officer, to lead the company. Mr. Simes formerly served as vice chairman, president, and CEO at BioSante Pharmaceuticals, Inc., a publicly held pharmaceutical company focused on developing products for women's and men's health and oncology that merged with ANI Pharmaceuticals, Inc. in 2013.
StemCells, Inc. (Nasdaq:STEM) announced today that Martin McGlynn will present at the 2nd Annual Regen Med Investor Day, Wednesday, March 26, 2014, at 3:30 pm EDT at the Metropolitan Club, One East 60th Street, in New York City.