Medical Tidbits, Medtronic First to Receive FDA Approval for MR-Conditional Implantable Cardioverter Defibrillator System

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IV Drip

DUBLIN – Sept. 14, 2015 – Medtronic plc (NYSE: MDT) today announced that it has received the first U.S. Food and Drug Administration (FDA) approval for an implantable cardioverter defibrillator (ICD) system for use with magnetic resonance imaging (MRI) scans. The Medtronic Evera MRI(TM) SureScan® ICD System is approved for MRI scans on any part of the body without positioning restrictions, which means that patients in the U.S. who depend on life-saving ICDs also now have access to MRI scans if and when they need them. The newly approved system, which will be commercially available this month, includes the Evera MRI ICD and Sprint Quattro® Secure MRI SureScan® DF4 leads, which must be used together to be considered MR-conditional. read more

Bayer to Showcase Data from Growing Oncology Franchise at ECC2015 in Vienna

WHIPPANY, N.J., Sept. 14, 2015 /PRNewswire/ — Bayer HealthCare Pharmaceuticals Inc. announced today that data from its growing oncology portfolio will be presented at the 2015 European Cancer Congress (ECC2015), September 25 – 29, in Vienna, Austria. These data include further analyses from the CONSIGN and CONCUR trials of Stivarga® (regorafenib) tablets in previously treated metastatic colorectal cancer (mCRC) patients, and findings from the Phase III ALSYMPCA trial and the U.S. expanded access program (EAP) of Xofigo® (radium Ra 223 dichloride) injection in patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastatic disease. read more

Amgen Highlights Key Clinical Data To Be Presented At European Cancer Congress 2015

THOUSAND OAKS, Calif., Sept. 14, 2015 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced it will present data from its oncology portfolio and pipeline at the European Cancer Congress 2015 (ECC 2015), Sept. 25 – 29, 2015, in Vienna.  read more

BioLife Solutions CryoStor® Commercial Grade Freeze Media Embedded in TC Biopharm ImmuniCell® Clinical Trial for Various Cancers  

BOTHELL, Wash., Sept. 14, 2015 /PRNewswire/ — BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers (“BioLife” or the “Company”), today announced that UK-based TC Biopharm Ltd, a developer of anti-cancer immunotherapies, has incorporated the Company’s CryoStor clinical and commercial grade freeze media in its manufacturing and clinical delivery processes of ImmuniCell, a novel T cell based immunotherapy targeting various cancers. read more

Dexcom G5® Mobile Continuous Glucose Monitoring System Receives CE Mark

SAN DIEGO, Sept. 14, 2015 /PRNewswire/ — Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System has received CE Mark (Conformite Europeenne) and will be available in several European countries in the coming weeks. This revolutionary new system from Dexcom will be introduced to healthcare professionals and diabetes association delegates at the European Association for the Study read more

Mundipharma and Medical Developments International announce a new alliance for the commercialisation of Penthrox® in Europe

CAMBRIDGE, England & VICTORIA, Australia–(BUSINESS WIRE)–Mundipharma International Corporation Limited (Mundipharma) and Medical Developments International Limited (ASX:MVP) today announced that they have entered into a License, Development and Commercialisation Agreement for Penthrox® (low dose methoxyflurane) in Europe, as a self-inhaled analgesic for the treatment of emergency pain. read more

PeptiDream Announces Peptide Discovery Collaboration Agreement with Sanofi

TOKYO–(BUSINESS WIRE)–PeptiDream Inc., a public Tokyo-based biopharmaceutical company (“PeptiDream”)(TOKYO:4587) today announced a multi-target discovery and optimization collaboration with Sanofi, Paris, France (“Sanofi”)(Euronext: SAN). Under the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology to generate macrocyclic/constrained peptides against multiple targets of interest selected by Sanofi. Sanofi will have the right to develop and commercialize all therapeutic peptides resulting from the collaboration. PeptiDream will receive an undisclosed upfront payment, research funding and will be eligible for payments associated with the achievement of certain preclinical and clinical development milestones. In addition, PeptiDream is eligible to receive royalties on sales of any products that arise from the collaboration. read more

Mylan Commences Offer to Acquire Perrigo

Mylan’s Compelling Offer Represents One of the Industry’s Highest Multiples to Date

HERTFORDSHIRE, England and PITTSBURGH , Sept. 14, 2015 /PRNewswire/ –Mylan N.V. (NASDAQ: MYL) today announced that it has officially commenced its formal offer to acquire all outstanding ordinary shares of Perrigo Company plc (NYSE: PRGO; TASE). Under the terms of the offer, Perrigo shareholders will receive $75 in cash and 2.3 Mylan ordinary shares for each Perrigo ordinary share. Perrigo shareholders will own approximately 40% of the combined company upon completion of the transaction.

Mylan’s Executive Chairman Robert J. Coury commented, “With the overwhelming support of Mylan shareholders, today we officially are taking our offer directly to the Perrigo shareholders. We are highly confident that the majority of Perrigo shareholders will support this full and compelling offer, particularly in the absence of any competing interest in this asset and the significant uncertainties, execution risk and lengthy timetable associated with Perrigo’s standalone strategy.

 

 

 

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