Biopharmaceutical News and Research

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Auxilium doses first patient in CCH Phase 2b study for treatment frozen shoulder syndrome

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in the EU, today announced that its partner Auxilium Pharmaceuticals, Inc. has dosed the first patient in its Phase 2b study of collagenase clostridium histolyticum for the treatment of frozen shoulder syndrome (adhesive capsulitis).

16 Dec 2013

Retrophin to acquire privately-held company, Kyalin Biosciences

Retrophin, Inc. today announced that it will acquire privately-held Kyalin Biosciences, Inc., an early-stage company based in San Diego, CA, that is developing therapies targeting the core symptoms of autism and related conditions.

12 Dec 2013

Emergent BioSolutions enters into definitive agreement to acquire Cangene

Emergent BioSolutions Inc.announced that it has entered into a definitive agreement with Cangene Corporation (TSX: CNJ) under which Emergent will acquire all of the outstanding common shares of Cangene in an all-cash transaction valued at $3.24 per share on a fully diluted basis for an aggregate purchase price of $222 million.

12 Dec 2013

Palo Alto Medical Foundation, El Camino Hospital to explore collaborative partnerships to improve community health

El Camino Hospital and the Palo Alto Medical Foundation today announced that following the return of its delegation to India as part of Mayor Ed Lee's SF Bangalore Sister City Initiative, the organizations will be exploring memoranda of understanding (MOU) with local Indian hospitals, healthcare organizations and technology companies.

12 Dec 2013

First patient enrolled in Otonomy's pivotal Phase 2b study of OTO-104 for Meniere's disease

Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced enrollment of the first patient in its pivotal Phase 2b study of OTO-104 for the reduction of vertigo in patients with unilateral Meniere's disease.

11 Dec 2013

GW Pharmaceuticals receives U.S. patent for treating glioma

GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 12/996,124, a patent which covers the use of cannabinoids for treating glioma.

11 Dec 2013

Navidea receives Fast Track designation for Lymphoseek injection

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.

11 Dec 2013

Computational predictive toxicology services available in SafeBridge Consultants

SafeBridge Consultants, Inc., a division of Trinity Consultants, Inc., Dallas, TX, with offices in Mountain View, CA, New York, NY, and Liverpool, UK, announces the availability of computational predictive toxicology services to the biopharmaceutical and chemical industry.

10 Dec 2013

Arrowhead reports Phase 1 study data on ARC-520 for treatment of chronic hepatitis B infection

Arrowhead Research Corporation, a biopharmaceutical company developing targeted RNAi therapeutics, today announced that COO and Head of R&D, Bruce Given, M.D., presented data on the Phase 1 clinical study of ARC-520, the company's clinical candidate for the treatment of chronic hepatitis B infection, at the HepDART 2013 conference being held on The Big Island, Hawaii.

9 Dec 2013

Kolltan Pharmaceuticals signs license agreement with University of Toronto for novel anti-KIT antibodies

Kolltan Pharmaceuticals, a privately held biopharmaceutical company, today announced the Company has signed a license agreement with the University of Toronto for novel anti-KIT receptor tyrosine kinase antibodies identified in the laboratories of Dr. Sachdev Sidhu at the University of Toronto and the laboratory of Dr. Joseph Schlessinger of Yale University.

6 Dec 2013

Auxilium Pharmaceuticals' XIAFLEX gets FDA approval for treatment of Peyronie's disease

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has approved XIAFLEX (collagenase clostridium histolyticum, or CCH), an in-office, biologic for the treatment of Peyronie's disease. XIAFLEX is the first and only FDA-approved treatment proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy.

6 Dec 2013

Eli Lilly reports edivoxetine Phase III program did not meet primary endpoint for major depressive disorder

Eli Lilly and Company (NYSE: LLY) announced today that results from three studies of edivoxetine did not meet the primary study objective of superior efficacy in depression after eight weeks of treatment.

6 Dec 2013

Soligenix initiates SGX942 Phase 2 study for treatment of oral mucositis

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it has initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating SGX942, a first-in-class innate defense regulator, as a treatment for oral mucositis in patients undergoing chemoradiation therapy for head and neck cancer.

5 Dec 2013

Alvotech to invests $250M in the development of biosimilar monoclonal antibodies

Alvotech, a powerful new player in the field of biopharmaceuticals, today announced plans to invest $250 million in the development and manufacturing of a portfolio of biosimilar monoclonal antibodies.

5 Dec 2013

Enrollment opens for IMO-8400 Phase 1/2 trial in patients with Waldenström's macroglobulinemia

Idera Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing a novel therapeutic approach for the treatment of autoimmune diseases and genetically defined forms of B-cell lymphoma, today announced that enrollment is open for a Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström's macroglobulinemia, following acceptance of its Investigational New Drug application by the U.S. Food and Drug Administration.

5 Dec 2013

FDA accepts ARCA biopharma's Gencaro IND application for atrial fibrillation

ARCA biopharma, Inc., a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that the Company's Gencaro Investigational New Drug application for atrial fibrillation has been accepted by the U.S. Food and Drug Administration and is now active.

4 Dec 2013

EMD Serono's TocopheRx to focus on development of oral FSH agonists for infertility treatment

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today the creation of TocopheRx, a Boston-based spin-off company resulting from the Entrepreneur Partnership Program launched by Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, in April 2012.

3 Dec 2013

Soligenix initiates orBec Phase 2 study for GI manifestations of chronic GVHD

Soligenix, Inc., a clinical stage biopharmaceutical company focused on developing products to treat serious inflammatory diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics, announced today that it has initiated a Phase 2, randomized, double-blind, placebo-controlled study evaluating orBec (oral beclomethasone 17,21-dipropionate or BDP) as a treatment for the gastrointestinal manifestations of chronic Graft-versus-Host disease.

2 Dec 2013

JHL Biotech installs GE Healthcare's FlexFactory biomanufacturing platform at Hsinchu plant in Taiwan

GE Healthcare Life Sciences and JHL Biotech today announced that GE Healthcare has completed installation of its FlexFactory biomanufacturing platform at JHL Biotech's Research Center and manufacturing plant in Hsinchu, Taiwan.

2 Dec 2013

Visterra gets $8.1M in proceeds from upsized and final closing of Series A financing round

Visterra, Inc., a developer of novel therapeutics to prevent and treat major infectious diseases, today announced that it has received $8.1 million in proceeds from an upsized and final closing of its Series A financing round. The company also announced that it has deepened its executive management team by appointing two industry veterans to newly created roles, which follows the recent appointment of Brian Pereira, M.D. as President and Chief Executive Officer of Visterra this past summer.

2 Dec 2013

Biopharmaceutical News and Research

Auxilium doses first patient in CCH Phase 2b study for treatment frozen shoulder syndrome

Retrophin to acquire privately-held company, Kyalin Biosciences

Emergent BioSolutions enters into definitive agreement to acquire Cangene

Palo Alto Medical Foundation, El Camino Hospital to explore collaborative partnerships to improve community health

First patient enrolled in Otonomy's pivotal Phase 2b study of OTO-104 for Meniere's disease

GW Pharmaceuticals receives U.S. patent for treating glioma

Navidea receives Fast Track designation for Lymphoseek injection

Computational predictive toxicology services available in SafeBridge Consultants

Arrowhead reports Phase 1 study data on ARC-520 for treatment of chronic hepatitis B infection

Kolltan Pharmaceuticals signs license agreement with University of Toronto for novel anti-KIT antibodies

Auxilium Pharmaceuticals' XIAFLEX gets FDA approval for treatment of Peyronie's disease

Eli Lilly reports edivoxetine Phase III program did not meet primary endpoint for major depressive disorder

Soligenix initiates SGX942 Phase 2 study for treatment of oral mucositis

Alvotech to invests $250M in the development of biosimilar monoclonal antibodies

Enrollment opens for IMO-8400 Phase 1/2 trial in patients with Waldenström's macroglobulinemia

FDA accepts ARCA biopharma's Gencaro IND application for atrial fibrillation

EMD Serono's TocopheRx to focus on development of oral FSH agonists for infertility treatment

Soligenix initiates orBec Phase 2 study for GI manifestations of chronic GVHD

JHL Biotech installs GE Healthcare's FlexFactory biomanufacturing platform at Hsinchu plant in Taiwan

Visterra gets $8.1M in proceeds from upsized and final closing of Series A financing round

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