Biotherapeutics News and Research

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CSL Behring to receive 2012 EURORDIS Award for pioneering work

CSL Behring is the recipient of a 2012 EURORDIS Award for its pioneering work in developing and manufacturing therapies used to treat rare and serious medical conditions.

2 Mar 2012

IDRI launches LEISH-F3 + GLA-SE Phase 1 trial for kala-azar

The first clinical trial of a new vaccine for visceral leishmaniasis (VL) has been launched by the Infectious Disease Research Institute (IDRI), a Seattle-based nonprofit that develops products to prevent, detect, and treat diseases of poverty. The Phase 1 trial is taking place in Washington State, with a companion Phase 1 trial planned in India, an epicenter of the disease.

23 Feb 2012

Oxygen Biotherapeutics to commence study to determine efficacy of Dermacyte in relieving Histamine induced pruritus

Oxygen Biotherapeutics, Inc. has announced that enrollment for the company’s first dermatological study will begin later this month at St. John’s Medical College Hospital in Bangalore, India. The company received formal approval from the hospital’s Ethics Review Board in December. This study is the first of a series of trials scheduled for 2012 to explore the efficacy of Dermacyte to treat a variety of dermatological conditions, such as allergic contact dermatitis, psoriasis and acne.

9 Jan 2012

Lundbeck invests in Ossianix to focus on biotherapeutics for CNS disorders

Ossianix, Inc. today announced a strategic investment by H. Lundbeck A/S in the form of a Convertible Promissory Note. The proceeds from Lundbeck's investment is expected to allow Ossianix to generate biopharmaceuticals for the treatment of nervous system disorders by utilizing Ossianix's proprietary single domain antibody platform modeled on the shark vNAR structure.

3 Jan 2012

Pfizer, Karo Bio partner to develop RORgamma modulators for autoimmune diseases

Karo Bio AB has entered into a research collaboration agreement with Pfizer Inc., to discover and develop novel small molecule RORgamma modulators for the treatment of autoimmune diseases.

26 Dec 2011

PDUFA goal date of NDA for Protalix's taliglucerase alfa extended

Protalix BioTherapeutics, Inc., announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.

6 Dec 2011

Pfizer acquires Excaliard

Pfizer Inc. announced today that it has completed its acquisition of Excaliard Pharmaceuticals, Inc., a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis, more commonly referred to as skin scarring.

3 Dec 2011

Pfizer enters definitive agreement to acquire Excaliard

Pfizer Inc. and Excaliard Pharmaceuticals, Inc. announced today that they have entered into a definitive agreement under which Pfizer will acquire Excaliard, a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis, more commonly referred to as skin scarring. The acquisition is expected to close before the end of the year.

22 Nov 2011

MIT, Pfizer announce new location for CVMED and Neuroscience research units

Pfizer Inc. and the Massachusetts Institute of Technology (MIT) today held the official groundbreaking of the new location of Pfizer's Cardiovascular, Metabolic and Endocrine Diseases (CVMED) and Neuroscience research units at 610 Main Street, Cambridge, MA.

22 Nov 2011

Jennerex commences enrollment in JX-594 Phase 2b trial for HCC

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic virus products for cancer, together with its international commercialization partners, today announced that enrollment has been initiated and the first patient has been randomized in a Phase 2b clinical trial called TRAVERSE.

4 Nov 2011

GSK, Alnylam collaborate to apply VaxiRNA technology for influenza vaccine production

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has formed a collaboration with GlaxoSmithKline (GSK) focused on Alnylam's VaxiRNATM technology for certain GSK vaccine products, including influenza. VaxiRNA is a new RNAi technology for the enhanced production of viruses used in the manufacture of vaccine products. GSK, a leading vaccine manufacturer, is the first company to form a collaboration accessing this new platform.

2 Nov 2011

Zymeworks announces completion of $8.1M financing

Zymeworks Inc., a privately held biotherapeutics company focused on the development of best-in-class antibody and next generation protein-based therapeutics, today announced the completion of a financing totaling $8.1 million.

22 Sep 2011

Hengrui, Shanghai ChemPartner enter strategic development partnership for monoclonal antibodies

ShangPharma Corporation, a leading China-based pharmaceutical and biotechnology research and development outsourcing company, and Jiangsu Hengrui Medicine Co., Ltd., a leading Chinese pharmaceutical company, today announced that Shanghai ChemPartner, a wholly owned subsidiary of ShangPharma, and Hengrui have entered into a strategic partnership for the development of novel therapeutic monoclonal antibodies.

15 Sep 2011

OBT, Seattle Genetics form strategic collaboration to discover novel ADCs for cancer

Seattle Genetics, Inc. and Oxford BioTherapeutics today announced that they have formed a strategic collaboration to jointly discover novel antibody-drug conjugates (ADCs) for cancer.

14 Sep 2011

EBD Group, MassBio announce plenary sessions program for BioPharm America 2011

EBD Group and MassBio today announced the plenary sessions program for BioPharm America 2011, being held at the Westin Boston Waterfront Hotel, September 7-9.

20 Aug 2011

FDA accepts Protalix taliglucerase alfa NDA resubmission for review

Protalix BioTherapeutics, Inc., announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) in February 2011.

17 Aug 2011

Pfizer, UC San Diego sign research agreement to drive innovation in drug discovery

In an innovative collaboration designed to speed the process of drug discovery, Pfizer, Inc. and the University of California, San Diego Health Sciences announced today that UC San Diego has joined the ranks of other top-tier life science research institutions across the country as part of Pfizer's Centers for Therapeutic Innovation.

9 Aug 2011

SynCo Bio commences release of drug products after expansion of Class A zone

SynCo Bio Partners B.V., one of the leading GMP contract manufacturers of biopharmaceuticals today announced that its aseptic filling facility is again fully operational and SynCo has produced and released the first drug product batches for its clients after the expansion of its Class A zone.

4 Aug 2011

Positive results from Jennerex JX-594 proof-of-concept trial on metastatic melanoma

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, today announced that positive results from a proof-of-concept clinical trial using JX-594 to treat patients with metastatic melanoma were published in the peer-reviewed journal Molecular Therapy.

2 Aug 2011

RXi expands intellectual property portfolio with additional NeuVax patents

RXi Pharmaceuticals Corporation, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, announced today that it expanded its patent portfolio with additional patents covering worldwide rights to develop and commercialize NeuVax.

14 Jul 2011