Medical Tidbits,VIBERZI™ (eluxadoline) Phase III Trial Results Published in The New England Journal of Medicine

pharmaceutical industry

DUBLIN, Jan. 21, 2016 /PRNewswire/ — Allergan plc (NYSE: AGN) announced today the publication of the positive results of the Phase III trials of VIBERZITM C IV (eluxadoline) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in the January 21 issue of The New England Journal of Medicine (NEJM). The trial results are from two Phase III randomized, multi-center, multi-national, double-blind, placebo-controlled trials (Studies 1 and 2). IBS-D is a functional bowel disorder commonly characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 15 million patients in the U.S. read more

Galapagos and Gilead Complete Closing of Their Global Collaboration for Filgotinib

MECHELEN, Belgium & FOSTER CITY, Calif.–(BUSINESS WIRE)–Galapagos NV (Euronext & NASDAQ: GLPG) and Gilead Sciences, Inc. (NASDAQ: GILD) announced today the closing and entry into force of their global license and collaboration agreement on filgotinib.

Under the terms of the agreement, the closing of this transaction triggers an upfront license fee payment of $300 million by Gilead to Galapagos. In addition, Gilead has made a $425 million (or €392 million) equity investment in Galapagos by subscribing for new shares at a price of €58 per share, including issuance premium. As a result, Gilead now owns 6,760,701 ordinary shares of Galapagos, representing 14.75 percent of the currently outstanding share capital of Galapagos read more

vasopharm Announces EUR 20 Million Fundraising to Progress Treatment for Traumatic Brain Injury

WÜRZBURG, Germany, January 21, 2016 /PRNewswire/ —

Phase III registration study of VAS203 to commence in H1 2016

vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebrovascular diseases, today announced it has successfully raised EUR 20 million of new capital.  The financing was co-led by existing investors Entrepreneurs Fund, Heidelberg Capital Private Equity and new investor, UK based Fort Rock Capital. Existing investors Bayern Kapital and funds advised by Hanseatic Asset Management LBG also participated in the round. Dr Mario Alberto Accardi, Venture Partner at Fort Rock Capital will be joining the Board of the company as a Non-Executive Director.

Asterias Biotherapeutics Announces Completion of Transfer of AST-VAC2 Manufacturing Process to Cancer Research UK as Milestone Towards Initiating Phase 1/2 Clinical Trial 

FREMONT, Calif., Jan. 21, 2016 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), announced that it has completed the transfer of its manufacturing processes to produce AST-VAC2 to Cancer Research UK.

AST-VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) AST-VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase permits enhanced stimulation of immune responses to the protein. The AST-VAC2 dendritic cells instruct the immune system to generate responses against telomerase which will target tumor cells. read more

Celltrion and Medidata Team Up to Transform Global Clinical Trials for Biosimilars

NEW YORK & SEOUL, Korea–(BUSINESS WIRE)–Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, and Korean biopharmaceutical company Celltrion (KOSDAQ:068270) today announced that the Seoul-based organization has adopted Medidata’s industry-leading technology platform. A global leader in biosimilars R&D, Celltrion will rely on the Medidata Clinical Cloud® to enhance the speed, efficiency and accuracy of its clinical trials. read more

Moberg Pharma is contemplating a potential bond issue and updates financial targets

STOCKHOLM, January 21st, 2016. Moberg Pharma AB (OMX: MOB) announces that the company intends to issue a bond and has engaged Carnegie Investment Bank and Swedbank as financial advisors. The issue proceeds are intended to be used for general corporate purposes, including accretive add-on acquisitions.

Moberg Pharma’s strategy is to generate returns to shareholders by profitable growth of strategic brands, value creating acquisitions and commercialization of pipeline assets. Moberg Pharma’s long-term financial goal is to achieve an EBITDA margin of at least 25 percent.

To enable future growth, Moberg Pharma intends to make significant investments during 2016, focusing on strengthening brand platforms for the company’s strategic brands in the U.S., increased international distribution, acquiring additional brands and initiating Phase III studies for MOB-015. As a consequence of decided investments and initiatives, the EBITDA margin in 2016 will be lower than the previously communicated margin of at least 25 percent. The long-term financial goal of achieving an EBITDA margin of at least 25 percent remains.

PENTAX Europe GmbH Acquires the Remaining Shares of PENTAX Italia S.r.L. from Movi S.p.A.

HAMBURG, Germany–(BUSINESS WIRE)–PENTAX Europe GmbH has acquired the remaining stock of PENTAX Italia S.r.L. from Movi S.p.A. This further investment by PENTAX Europe GmbH into the Italian healthcare market strengthens PENTAX Medical’s position in Italy and will bring enhanced customer and professional education services to its Italian customers.

Established in 2007, PENTAX Italia was co-owned by PENTAX Europe GmbH and Movi S.p.A., an Italian distributor of healthcare products. PENTAX Italia has increased its sales of endoscopy products and services over this time, leading to PENTAX Europe GmbH’s decision to acquire full ownership

UVLrx™ European Launch: Targeting 14th Annual Aesthetic & Anti-Aging Medicine World Congress

MONTE CARLO, Monaco–(BUSINESS WIRE)–After a successful North American debut last month at the American Academy of Anti-Aging Medicine (A4M) in Las Vegas, UVLrx Therapeutics™ is pleased to announce the official European launch of its intravenous light therapy treatment system, the model UVL1500, at this year’s 14th Aesthetic & Anti-Aging Medicine World Congress (AMWC) from March 31st to April 2nd. Under the scientific supervision of the World Society of Interdisciplinary Anti-Aging Medicine (WOSIAM), the conference will attract over 10,000 physicians and researchers from more than 120 countries who are interested in the role of prevention in global aesthetic and anti-aging management. At the Congress, UVLrx Therapeutics™ will highlight the clinically proven benefits of light wavelengths utilized by its UVLrx™ Treatment System* for reducing inflammation, a key issue facing the entire $300 billion global industry today.

OncoGenex Announces Update on Phase 2 Spruce Trial in Previously Untreated Metastatic Non-Small Cell Lung Cancer

BOTHELL, Wash. and VANCOUVER, British Columbia, Jan. 20, 2016 /PRNewswire/ — OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that data from the Phase 2 Spruce™ trial evaluating the combination of apatorsen with carboplatin and pemetrexed in patients with untreated metastatic non-small cell lung cancer (NSCLC) did not reach the statistical significance required to demonstrate a progression-free survival (PFS) benefit. A potential PFS benefit was observed in patients with high baseline serum Hsp27 status when treated with apatorsen. The study is ongoing and overall survival results are expected in the second half of 2016. read more

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