Dyax Receives FDA Approval to Expand Use of KALBITOR®; IntegraGen Announces Agreement with Pfizer to Evaluate Proprietary Hepatocellular Carcinoma Molecular Signature Print E-mail
By Staff and Wire Reports   
Thursday, 03 April 2014 20:36
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 2, 2014.
Dyax Corp. (NASDAQ: DYAX)
today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for KALBITOR (ecallantide), a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema (HAE) attacks, to include patients 12 years of age and older. With this approval, KALBITOR is the first and only subcutaneous therapy available to treat acute attacks of HAE in patients 12 years of age and older. KALBITOR is also the only therapy that is not purified from human plasma that has been approved to treat this patient group.

The FDA approval of this label expansion for KALBITOR is supported by the results from two previously completed Phase 3 placebo-controlled clinical studies, known as EDEMA3® and EDEMA4® as well as the results of study DX-88/19, which was ongoing at the time of the original approval of KALBITOR. The efficacy and safety profile observed in pediatric patients 12 years of age and older is similar to the adult population.

“KALBITOR has an established track record in the HAE marketplace and this FDA approval for the expanded use in pediatric patients is an important achievement for both Dyax and the children and families who are affected by this disease,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “We remain committed to providing access to novel therapeutics and first-class patient services to the HAE community.”

About KALBITOR (ecallantide) KALBITOR is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of HAE in patients 12 years of age and older. KALBITOR, which was discovered and developed by Dyax, was the first subcutaneous treatment available in the U.S. for treating acute HAE attacks. Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and HAE.



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IntegraGen, a leading player in the development and marketing of molecular diagnostic testing in oncology and autism, announced today that it has entered into an agreement with Pfizer Inc. (NYSE:PFE) that provides Pfizer access to evaluate the company’s proprietary molecular signature for hepatocellular carcinoma. The 56-gene molecular signature covered by the agreement is intended to predict the clinical prognosis of patients with hepatocellular carcinoma and subcategorize patients into six separate classifications based on the molecular characteristics of their liver tumors.

“We are pleased to have our molecular signature evaluated by one of the world’s leading pharmaceutical companies,” said Dr. Bernard Courtieu, IntegraGen’s Chief Executive Officer. “The use of our molecular signature may help to identify specific patient populations who would benefit from Pfizer’s experimental compounds, if approved by regulatory authorities. We are also extremely appreciative of the research conducted by Professor Jessica Zucman-Rossi which led to the development of this molecular signature with the continued support of the French League Against Cancer Program ‘Cartes d’Identité des Tumeurs®’ (CIT).”

Terms of the agreement were not disclosed.


Also Thursday:


ACETO Corporation (Nasdaq:ACET),
a global leader in the marketing, sale and distribution of products for Human Health, Pharmaceutical Ingredients and Performance Chemicals, today announced that Rising Pharmaceuticals Inc., its finished dosage form generics subsidiary, is launching the 10/12.5mg, 20/12.5mg and 20/25mg strengths of Benazepril/HCTZ, the authorized generic of Validus' Lotensin HCT®.

Amyris, Inc. (Nasdaq:AMRS)
announced that it is entering into a collaborative research and development agreement with BASF SE (XETRA:BAS).

Applied Genetic Technologies Corporation (Nasdaq:AGTC)
announced today the closing on April 1, 2014 of its initial public offering of 4,166,667 shares of its common stock at an initial public offering price of $12.00 per share, and the exercise in full by the underwriters of their option to purchase 625,000 additional shares of common stock, which closed on April 3, 2014.

Apricus Biosciences, Inc. (Nasdaq:APRI)
, a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced that the Ministry of Health of Luxembourg has granted national phase approval to Vitaros®, Apricus' novel topical on-demand treatment for erectile dysfunction ("ED").

Bottomline Technologies (Nasdaq:EPAY)
today announced the general availability of the Healthcare 5.1 platform, enhancing eCapture, eSignature, and On-Demand forms functionality.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based diagnostics, announced today that a poster highlighting preliminary results of a study in clear cell Renal Cell Carcinoma (ccRCC) will be presented at the 105th Annual Meeting of the American Association of Cancer Research ("AACR"), which will be held in San Diego, California April 5-9, 2014.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
announced today that data from preclinical studies evaluating the anti-tumor activity of the antibody-drug conjugate (ADC) CDX-014 will be presented at the American Association of Cancer Research (AACR) Annual Meeting 2014 in San Diego, California, April 5-9.

Cempra, Inc. (Nasdaq:CEMP)
today announced the presentation of a late-breaking abstract entitled "Anti-NASH Effects of Solithromycin in NASH-HCC Mouse Model," at 9:15 a.m. EDT, May 6, at Digestive Disease Week (DDW®) 2014 in Room S105A at McCormick Place in Chicago.

Cytomedix, Inc. (OTCQX:CMXI),
a leading developer of biologically active regenerative therapies, and its wholly owned subsidiary, Aldagen, Inc., announced today the receipt of a notice of allowance for U.S. divisional patent application 12/966,401 with claims covering methods of use of ALDH bright cells in the treatment of neurological damage arising from an ischemic stroke.

EDAP TMS SA (Nasdaq:EDAP)
, the global leader in therapeutic ultrasound, announced today financial results for the fourth quarter and year ended December 31, 2013, and provided an update on recent strategic developments.

Galena Biopharma (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark J. Ahn, Ph.D., President and Chief Executive Officer will present a corporate update at the 13th Annual Needham Healthcare Conference.

LHC Group, Inc. (Nasdaq:LHCG)
, a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that it has acquired the assets of a home health and hospice provider in the Certificate of Need (CON) state of West Virginia and signed a definitive purchase agreement to acquire the assets of a home health and community-based service provider in the CON state of North Carolina.

Medical Marijuana Inc. (OTC Pink:MJNA)
is pleased to announce that its subsidiary company, HempMedsPX™, will participate in the Americans for Safe Access (ASA) 2nd Annual National Medical Cannabis Unity Conference, Navigating Medical Cannabis in the Mainstream, in Washington D.C.

MRI Interventions, Inc. (OTCQB:MRIC)
today announced that its ClearPoint® Neuro Intervention System will be on exhibit at the 2014 Annual Meeting of the American Association of Neurological Surgeons (AANS) April 7-9, 2014, in San Francisco, California.

Nanosphere, Inc. (Nasdaq:NSPH)
, a company enhancing medicine through targeted molecular diagnostics, today announced that that an overview of the Company's business and commercial strategy will be given at the 13th Annual Needham Healthcare Conference, being held at the Westin Grand Central Hotel in New York City from April 8-9, 2014.

NanoString Technologies, Inc. (Nasdaq:NSTG)
, a provider of life science tools for translational research and molecular diagnostic products, today announced that it has entered into a term loan agreement with Capital Royalty L.P. and certain of its affiliates.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today the appointment of Dr. Adel Nada as Vice President, Immunotherapy.

Rango Energy, Inc. (OTCBB:RAGO)
announced today that it would effect a name change to Verde Science, Inc., in order to facilitate the Company's transition to providing legal licensed medical marijuana production and services.

Response Genetics, Inc. (Nasdaq:RGDX)
, a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced that it has signed agreements with six additional health plans across 10 states bringing the Company's total national contracted membership to more than 174 million lives.

UPS (NYSE: UPS)
today held a ribbon-cutting ceremony in the state of Mexico, celebrating the addition of three healthcare-dedicated facilities to address high growth medical device and pharmaceutical consumption markets throughout Latin America.



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