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Auxilium seeks FDA approval for XIAFLEX sBLA to treat multiple Dupuytren's contracture cords concurrently

Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, today announced the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration requesting approval of XIAFLEX (collagenase clostridium histolyticum, or CCH) for the treatment of multiple Dupuytren's contracture cords concurrently.

20 Dec 2013

PeptiDream signs Collaboration and License Agreement with Lilly

PeptiDream Inc, a Tokyo-based biopharmaceutical company, announced that they have entered into a Collaboration and License Agreement with US-based Eli Lilly and Company on 19 December 2013.

20 Dec 2013

MicuRx announces initiation of global clinical development program for MRX-I compound

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced the initiation of a global clinical development program for its lead compound MRX-I, a novel oxazolidinone antibiotic for treatment of Gram-positive infections including methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci.

20 Dec 2013

Merck and CNIO sign agreement to collaborate in area of cancer drug development

The Spanish National Cancer Research Centre (CNIO) and the German chemical and pharmaceutical company Merck today signed an agreement in Madrid to collaborate in the area of cancer drug development.

19 Dec 2013

Merck signs license agreement with CNIO for cancer drug development

Merck Serono, the biopharmaceutical division of Merck, today announced that a license agreement has been signed with the Spanish National Cancer Research Centre in Madrid in the area of cancer drug development. The global agreement will build upon CNIO research discoveries to encourage the development and commercialization of new compounds in the field of oncology.

18 Dec 2013

BioLineRx enrolls first patient in BL-7010 Phase 1/2 trial for treatment of celiac disease

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today enrollment of the first patient in a Phase 1/2 trial of BL-7010, for the treatment of celiac disease. The first patient was enrolled at Tampere Hospital in Finland, a world-leading site for celiac disease research. Results are expected in mid-2014.

18 Dec 2013

Navidea seeks FDA approval for marketing Lymphoseek Injection for SLN detection

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that it has submitted a Supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval for the marketing and sale of Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer, an indication for which Lymphoseek was also granted Fast Track designation earlier this month.

17 Dec 2013

Preclinical data shows BGB324 as potential treatment option for Chronic Myeloid Leukemia

BerGenBio AS, an oncology biopharmaceutical company, announces that preclinical data demonstrating that BGB324 has potential application as a novel treatment for Chronic Myeloid Leukemia, was presented in a poster at the Annual Meeting of the American Society of Hematology, which took place on December 7-10, 2013.

17 Dec 2013

Targacept reports top-line results from TC-5619 Phase 2b trial for negative symptoms in schizophrenia

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced top-line results from a Phase 2b clinical trial of TC-5619 as an augmentation therapy for the treatment of negative symptoms of schizophrenia.

17 Dec 2013

BioLineRx reports promising initial results from Phase 2 trial of BL-8040 in AML patients

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today promising initial results for its BL-8040 drug candidate in a Phase 2 clinical trial for patients with relapsed or refractory acute myeloid leukemia (AML).

16 Dec 2013

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

Biopharmaceutical News and Research

Auxilium seeks FDA approval for XIAFLEX sBLA to treat multiple Dupuytren's contracture cords concurrently

PeptiDream signs Collaboration and License Agreement with Lilly

MicuRx announces initiation of global clinical development program for MRX-I compound

Merck and CNIO sign agreement to collaborate in area of cancer drug development

Merck signs license agreement with CNIO for cancer drug development

BioLineRx enrolls first patient in BL-7010 Phase 1/2 trial for treatment of celiac disease

Navidea seeks FDA approval for marketing Lymphoseek Injection for SLN detection

Preclinical data shows BGB324 as potential treatment option for Chronic Myeloid Leukemia

Targacept reports top-line results from TC-5619 Phase 2b trial for negative symptoms in schizophrenia

BioLineRx reports promising initial results from Phase 2 trial of BL-8040 in AML patients

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

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