Biopharmaceutical News and Research

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Circassia: House dust mite allergy treatment meets primary endpoint in phase II clinical study

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced successful results from a phase II clinical study of its house dust mite allergy treatment (House Dust Mite-Synthetic Peptide Immuno-Regulatory Epitope [HDM-SPIRE] based on Circassia’s ToleroMune technology).

12 Sep 2013

Kiadis five-year follow-up phase I/II clinical study confirms long-term safety, efficacy of ATIR

Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, announced today that the five-year follow-up of patients with high-risk malignancies from its Phase I/II clinical study confirms long-term safety and efficacy of ATIR™ over a broad dose range.

12 Sep 2013

Ventana gets CFDA approval for VENTANA ALK immunohistochemistry assay

Ventana Medical Systems, Inc., a member of the Roche Group, today announced the approval of the VENTANA ALK immunohistochemistry assay by the Chinese Food and Drug Administration as a companion diagnostic to aid in the identification of patients for Pfizer's CFDA-approved oncology product XALKORI (crizotinib).

12 Sep 2013

Berg receives Drug Discovery Technology Innovation Award for agnostic approach to drug discovery

Berg, a biopharmaceutical company committed to uncovering health solutions through a data-driven, biological research approach, was recognized today with the 2013 North American Drug Discovery Technology Innovation Award at the Frost & Sullivan Growth, Innovation and Leadership Awards Gala, the annual event by the global research organization that highlights the most promising new innovative technology across sectors.

12 Sep 2013

Developing Analytical Techniques for Biotherapeutics

News-Medical talks to Dr. Lewis about the development of analytical equipment for a new era of drug development that goes beyond small molecule synthesis.

From Malvern Panalytical 11 Sep 2013

Paragon Bioservices awarded 2013 CMO Leadership Award for Quality and Reliability

Paragon Bioservices, a contract manufacturing organization whose expertise is the process development and manufacturing of biopharmaceuticals, announced today that it has been awarded the 2013 CMO Leadership Award for Quality and Reliability.

10 Sep 2013

Hospira announces EC approval of Inflectra, Europe's first biosimilar mAb therapy

Hospira, the world's leading provider of injectable drugs and infusion technologies, today announced the European Commission (EC) approval of Inflectra™ (infliximab), Europe's first biosimilar monoclonal antibody (mAb) therapy. Inflectra has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis.

10 Sep 2013

$Pivotal Study Supports Use of IMNOVID®▼ Pomalidomide in Patients with Relapsed or Refractory Multiple Myeloma$

Pivotal Study Supports Use of IMNOVID®▼ Pomalidomide in Patients with Relapsed or Refractory Multiple Myeloma

The Lancet Oncology published this week findings from a study, which showed that the new oral therapy IMNOVID®▼ (pomalidomide), used in combination with low-dose dexamethasone demonstrated a significant survival advantage over high-dose dexamethasone alone, in patients with relapsed and refractory multiple myeloma (rrMM).1

5 Sep 2013

ThromboGenics, Bicycle to develop and commercialize novel drugs for ophthalmic diseases

ThromboGenics NV, a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that it has entered into a collaboration and license agreement with Bicycle Therapeutics to develop and commercialize novel drugs inhibiting a specific target for the treatment of ophthalmic diseases, such as diabetic macular edema.

5 Sep 2013

Esperion Therapeutics reports positive results from ETC-1002 Phase 2a study for LDL-C treatment

Esperion Therapeutics, Inc., a clinical-stage biopharmaceutical company, today announced positive top-line results from a Phase 2a study of ETC-1002 when added to statin therapy in patients with elevated levels of low density lipoprotein cholesterol (LDL-C or "bad cholesterol").

4 Sep 2013

Apitope successfully completes ATX-MS-1467 Phase I trial in relapsing MS patients with positive results

Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, today announced completion with positive results of its second Phase I clinical trial of ATX-MS-1467.

3 Sep 2013

Imaxio's pro-immunogenic technology used in tuberculosis vaccine phase I clinical study

Imaxio, a biopharmaceutical company specializing in vaccines and genomics, announces today that IMX313, its proprietary pro-immunogenic technology, has been administered for the first time in humans in a tuberculosis vaccine phase I clinical study. The trial is being conducted by the Jenner Institute at Oxford University, England.

3 Sep 2013

Debiopharm starts Debio 1347 phase I study in patients with advanced solid tumors

Debiopharm Group, the Swiss-based global biopharmaceutical company that focuses on the development of prescription drugs that target unmet medical needs including oncology, today announced the start of a phase I, open label multicenter study of a selective FGFR 1, 2, 3 inhibitor, Debio 1347 (CH5183284) in patients with advanced solid tumors.

2 Sep 2013

FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has notified the Company that it is extending the Prescription Drug User Fee Act goal date for the Company's supplemental biologics license application for XIAFLEX (collagenase clostridium histolyticum) for the treatment of Peyronie's disease from September 6, 2013 to December 6, 2013.

28 Aug 2013

Laureate Biopharma collaborates with Dyax to develop new treatment candidate for HAE

Laureate Biopharma is pleased to announce its successful collaboration with Dyax Corp. for process development and cGMP production of a new treatment candidate for hereditary angioedema.

26 Aug 2013

CeBiTec researchers successfully sequence genome of Chinese hamster

Genome researchers from Bielefeld University's Center for Biotechnology (CeBiTec) headed by Professor Dr. Alfred P-hler have succeeded in sequencing the genome of the Chinese hamster. The Chinese hamster supplies the cell cultures used by the pharmaceutical industry to produce biopharmaceutical products such as antibodies used in medicine.

26 Aug 2013

Shire extends existing partnership with Santaris Pharma in rare genetic disease space

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that its long term partner, Shire has extended the existing partnership in the rare genetic disease space.

23 Aug 2013

Navidea Biopharmaceuticals signs SPA agreements with FDA for NAV5001 Phase 3 program

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that it has reached agreement with the U.S. Food and Drug Administration for two special protocol assessments for the Company's pivotal Phase 3 program with NAV5001 as an aid in the differential diagnosis of Parkinsonian Syndromes from non-Parkinsonian tremor.

23 Aug 2013

MicuRx Pharmaceuticals raises $25 million in Series B financing

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced it raised $25 million in Series B financing. Led by BVCF, a private equity and growth fund specializing in the life sciences industry, the round also includes existing investors Morningside Group and Devon Park Bioventures.

22 Aug 2013

Tel-Aviv Stock Exchange approves new listing of OPKO's common stock

OPKO Health, Inc. (NYSE: OPK), a multi-national biopharmaceutical and diagnostics company, today announced that the Tel-Aviv Stock Exchange ("TASE") has approved the new listing of OPKO's common stock on the TASE beginning on August 21, 2013, under the ticker symbol OPK. OPKO's common stock will thereafter be listed on both the NYSE in the United States and the TASE in Israel.

19 Aug 2013

Biopharmaceutical News and Research

Circassia: House dust mite allergy treatment meets primary endpoint in phase II clinical study

Kiadis five-year follow-up phase I/II clinical study confirms long-term safety, efficacy of ATIR

Ventana gets CFDA approval for VENTANA ALK immunohistochemistry assay

Berg receives Drug Discovery Technology Innovation Award for agnostic approach to drug discovery

Developing Analytical Techniques for Biotherapeutics

Paragon Bioservices awarded 2013 CMO Leadership Award for Quality and Reliability

Hospira announces EC approval of Inflectra, Europe's first biosimilar mAb therapy

Pivotal Study Supports Use of IMNOVID®▼ Pomalidomide in Patients with Relapsed or Refractory Multiple Myeloma

ThromboGenics, Bicycle to develop and commercialize novel drugs for ophthalmic diseases

Esperion Therapeutics reports positive results from ETC-1002 Phase 2a study for LDL-C treatment

Apitope successfully completes ATX-MS-1467 Phase I trial in relapsing MS patients with positive results

Imaxio's pro-immunogenic technology used in tuberculosis vaccine phase I clinical study

Debiopharm starts Debio 1347 phase I study in patients with advanced solid tumors

FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX

Laureate Biopharma collaborates with Dyax to develop new treatment candidate for HAE

CeBiTec researchers successfully sequence genome of Chinese hamster

Shire extends existing partnership with Santaris Pharma in rare genetic disease space

Navidea Biopharmaceuticals signs SPA agreements with FDA for NAV5001 Phase 3 program

MicuRx Pharmaceuticals raises $25 million in Series B financing

Tel-Aviv Stock Exchange approves new listing of OPKO's common stock

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