Medical Tidbits,U.S. FDA ACCEPTS FOR PRIORITY REVIEW sNDA FOR EISAI’S ANTICANCER AGENT LENVATINIB SEEKING APPROVAL FOR RENAL CELL CARCINOMA

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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) submitted by its U.S. subsidiary Eisai Inc. for Eisai’s in-house developed novel anticancer agent lenvatinib mesylate (generic name, “lenvatinib”) for use in the treatment of advanced or metastatic renal cell carcinoma, and granted the sNDA Priority Review status. read more

Immunovia AB: Immunovia and the University of Liverpool enter into a collaboration in a prospective clinical study

LUND, Sweden & LIVERPOOL, England–(BUSINESS WIRE)–Immunovia and the University of Liverpool enter into collaboration to validate early detection blood test for pancreatic cancer in a prospective clinical study. In line with Immunovia´s strategy to deliver the first validated test for early diagnosis of pancreatic cancer, the company announced today that the first European site participating in its prospective clinical study for the early diagnosis of pancreatic cancer will be the National Institute for Health Research (NIHR) Pancreatic Biomedical Research Unit, based at the Royal Liverpool University Hospital. Designed to validate Immunovia´s blood test, IMMray™ PanCan-d, the study will run for three years across sites in both the US and Europe, starting in the second half of 2016.

 

 

Baxalta Granted EU Marketing Authorization for ONCASPAR (pegaspargase) as a Component of Combination Therapy in Acute Lymphoblastic Leukaemia (ALL)

BANNOCKBURN, Ill.–(BUSINESS WIRE)–Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that the European Commission has granted Marketing Authorization for use of ONCASPAR as a combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients. read more

Zymeworks Announces the Successful Achievement of a Milestone with Lilly in Bi-Specific Antibody Therapeutics Collaboration

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. today announced the successful achievement of a research milestone in its collaboration with Eli Lilly and Company in the development of a novel immune-modulating bi-specific antibody using Zymeworks’ proprietary Azymetric™ platform. In accordance with the terms of the licensing and collaboration agreement, Zymeworks is to receive an undisclosed milestone payment from Lilly. read more

MOLOGEN AG: First combination trial with MGN1703 and a checkpoint inhibitor in collaboration with MD Anderson

BERLIN–(BUSINESS WIRE)–The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) today announced that it has entered into a collaboration agreement with The University of Texas MD Anderson Cancer Center (MD Anderson). The agreement relates to a phase I trial with MOLOGEN’s immunomodulator lefitolimod (MGN1703) in combination with the immunotherapy Yervoy® (ipilimumab) in patients with advanced solid malignancies. This is the first time that lefitolimod (MGN1703) will be evaluated in combination with a checkpoint inhibitor. Should MGN1703 succeed in augmenting the efficacy of immune checkpoint blockade, the potential applications of the compound could be broadened. This study has been initiated based on the idea that the combination of these two immunotherapies could have synergistic effects by a broader activation of the immune system. read more

Acorda to Acquire Biotie Therapies

ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it entered into an agreement to acquire Biotie Therapies Corp. (Nasdaq Helsinki BTH1V; NASDAQ: BITI) for €23.5680 per ADS in cash, or the equivalent of $25.60 per ADS based on an exchange rate of 1.0864 U.S. dollars to euros, which values Biotie at approximately $363 million. read more

Expansion of Oxitec’s Vector Control Solution in Brazil Attacking Source of Zika Virus and Dengue Fever after Positive Program Results

OXFORD, England and GERMANTOWN, Maryland, Jan. 19, 2016 /PRNewswire-HISPANIC PR WIRE/ — Intrexon Corporation (NYSE: XON), a leader in synthetic biology, today announced its subsidiary Oxitec and Piracicaba City Hall have expanded the ‘Friendly Aedes aegypti Project’ in Piracicaba, Brazil following strong results for controlling the Ae. aegypti mosquito population, the primary vector for dengue, chikungunya and Zika virus outbreaks around the world. In preparation of this growing program and to meet increasing demand for its proprietary vector control solution, Oxitec is initiating a new mosquito production facility in Piracicaba that will have capacity to protect over 300,000 people.

U.S. Patent & Trademark Office Issues Notice of Allowance for Can-Fite’s Sexual Dysfunction Drug CF602

PETACH TIKVA, Israel, Jan. 19, 2016 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today announced the United States Patent and Trademark Office has issued a Notice of Allowance for a patent titled, “A3 Adenosine Receptor Allosteric Modulators”. This composition of matter patent protects the use of Can-Fite’s proprietary A3 Adenosine Receptor (A3AR) modulator including the preparation of its pharmaceutical compositions and its use in patients across all therapeutic indications. Can-Fite is currently developing this invention for the treatment of sexual dysfunction with its next-generation drug, CF602.  read more

Biotest Pharmaceuticals Corporation Announces the Appointment of Kedrion Biopharma Inc. as the exclusive distributor of its IGIV product, Bivigam® in the US

BOCA RATON, Fla., Jan. 19, 2016 /PRNewswire/ — Biotest Pharmaceuticals Corporation (BPC), is pleased to announce the appointment of Kedrion Biopharma Inc. (Kedrion) as exclusive U.S. distributor of its IGIV product, BIVIGAM®.  BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid], the most recent entrant into the U.S. immunoglobulin market, is approved for the treatment of patients with Primary Humoral Immunodeficiency (PI). The seven year cooperation agreement (including a two years wind-down period) will strengthen the position of BIVIGAM in the U.S. market. read more

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