Medical Tidbits,Celprogen Introduced Novel Small Molecules CEP2005 & CEP2010 That Activate and Stimulate Human Cardiac Stem Cells for Repair of Heart Tissue after a Cardiac Arrest.

TORRANCE, Calif.–(BUSINESS WIRE)–Celprogen Inc., a leader in the Stem Cell Research and Therapeutics industry for the development of stem cell technologies for regenerative medicine, today announced that they have synthesized two small molecules that are able to activate the resident cardiac stem cell pool to accelerate cardiac repair after a Cardiac Arrest. The actual mechanism of action is not yet worked out, but the molecular recruitment of cardiac stem cells is well documented and established in their in-house 3D human cardiac cell culture models. These molecules are being presented at the Annual Cell Biology Meeting in San Diego on Dec. 14, 2015 at B1410, 1:30PM to 3:00PM, Location: ASCB Learning Center, Exhibit Halls D-H, San Diego Convention Center. The gene expression profile of cardiac stem cell markers were increased 5-6 folds above non treated hearts in 3D culture system and also in-vivo mouse and rat models. The abstract is titled: “Novel 3D Primary Human Cardiomyocyte Culture System for Evaluation of Candidate Drug Related Cardiac Safety Profile.” read more

New England Journal of Medicine Publishes Groundbreaking Study Demonstrating Benefits of Pulmonx’s Medical Device for Emphysema

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Pulmonx Corporation, a leader in interventional pulmonology, announced online publication today of results from the independent, randomized, controlled STELVIO trial in the New England Journal of Medicine. The trial demonstrated statistically and clinically significant outcomes in lung function, exercise capacity and quality of life in severe emphysema patients identified with the Chartis® System, Pulmonx’s proprietary assessment system, and treated with the Zephyr® Endobronchial Valve (EBV), when compared to those receiving standard medical management. read more

Karus Therapeutics Announces Strategic Collaboration with The University of Texas MD Anderson Cancer Center

OXFORD, England–(BUSINESS WIRE)–Karus Therapeutics (‘Karus’), a leader in the development of innovative medicines with breakthrough potential in the treatment of hematological cancers and solid tumor immunotherapy, today announced that it has entered into a strategic pre-clinical and clinical collaboration with The University of Texas MD Anderson Cancer Center. The collaboration will include both of Karus’s lead cancer candidates, KA2237 and KA2507. read more

BioInvent in-Licenses Cutting Edge Technology to Pave the Way for More Efficacious Cancer Treatments

BioInvent International (STO:BINV) today announced that it has gained access to novel technology for making highly efficacious immune stimulatory antibodies to combat cancer. This initiative continues BioInvent’s long standing research collaborations with the University of Southampton. The precise shape of an antibody makes a critical difference to how it can stimulate the body’s immune system to fight cancer. A key research team at University of Southampton, supported by Cancer Research Technology, has been able to engineer antibodies that will be locked into the particular shape (called a locked B structure) that is most potent, making them much stronger immune stimulators than previous drugs. This achievement has recently been thoroughly described in the renowned scientific journal Cancer Cell.[1]

Boston Scientific,Voluntary Recall of Chariot™ Guiding Sheath

MARLBOROUGH, Mass., Dec. 9, 2015 /PRNewswire/ — Boston Scientific (NYSE: BSX) has voluntarily recalled the Chariot™ Guiding Sheath globally. These devices are intended for the introduction of interventional devices during peripheral vascular procedures, and were recalled on November 19th due to the risk of shaft separation. The U.S. Food and Drug Administration (FDA) has classified the action as a Class-1 recall. read more

A recall has been issued for eVent Medical LS, 5i, or 7i Inspiration Ventilators.  eVent Medical is recalling the LS, 5i, or 7i Inspiration ventilators because a faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm.  If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.  The company has received one report of this issue occurring, with no injuries and no deaths.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm475862.htm

Lilly and Merck Expand Immuno-Oncology Collaboration Adding Abemaciclib and KEYTRUDA® Combination Trial

INDIANAPOLIS and KENILWORTH, N.J., Dec. 10, 2015 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced another immuno-oncology collaboration that will evaluate abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck’s KEYTRUDA® (pembrolizumab) in a Phase I study across multiple tumor types. Based on the Phase I trial results, the collaboration has the potential to progress to Phase II trials in patients who have been diagnosed with either metastatic breast cancer or non-small cell lung cancer (NSCLC).  read more

Multiple Scientific Presentations at the San Antonio Breast Cancer Symposium Highlight the Clinical Utility of the Myriad myRisk(TM) Hereditary Cancer Gene Panel Test

Data Support Expanding the Role of Multi-Gene Panel Testing in Breast Cancer

SALT LAKE CITY, Dec. 9, 2015 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced it will highlight three scientific presentations related to its myRisk Hereditary Cancer test at the 2015 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. Data include results from studies that advance the understanding of hereditary cancer testing using multi-gene panels to evaluate patients at risk for or diagnosed with breast cancer. read more

Medtronic Announces FDA Approval for the Only Full-Body MR Conditional Deep Brain Stimulation Systems

DUBLIN – December 9, 2015 – Medtronic plc (NYSE: MDT) today announced that systems within its Activa®portfolio of Deep Brain Stimulation (DBS) neurostimulators have received FDA approval for full-body Magnetic Resonance Imaging (MRI)* under specific conditions of use. Medtronic’s MR Conditional DBS systems are the only approved for full-body MRI scans. This approval expands access to MRIs, making it safe for patients receiving Medtronic DBS Therapy to also receive this important diagnostic standard of care. Additionally, this approval applies to individuals receiving new Medtronic DBS systems and to an estimated 43,000 people in the U.S. already receiving Medtronic DBS Therapy as long as updated MRI guidelines are followed.*read more

Evotec Receives Important Pre-Clinical Milestones as Part of Its Multi-Target Alliance with Bayer HealthCare

HAMBURG, Germany–(BUSINESS WIRE)–Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) announced today that its multi-target collaboration with Bayer HealthCare (“Bayer”) has reached two important pre-clinical milestones for the transition of two projects from the alliance portfolio into late-stage discovery and pre-clinical development for the treatment of endometriosis. read more

ERYTECH Wins the European Small and Mid-Cap Award in the Most Innovative Newcomer Category

ERYTECH Pharma  (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP & OTC US: EYRYY), the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other maligna

ncies with unmet medical needs, announced today that it received yesterday evening the “European Small and Mid-Cap” award in the “Most Innovative Newcomer” category by the Federation of European Stock Exchanges. read more

Astellas Announces Publication of CRESEMBA® (Isavuconazonium Sulfate) Pivotal Phase 3 Study Results in The Lancet  PRNewswire/ –Astellas today announced that results from the pivotal Phase 3 SECURE trial evaluating CRESEMBA®(isavuconazonium sulfate) in adult patients with invasive aspergillosis were published in The Lancet. The article, titled “Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial,” appears in the December 9th online issue and will appear in a future print issue of The Lancet.  read more

Sinovac Obtains Clinical Trial Approval for Sabin-IPV Candidate

/PRNewswire/ — Sinovac Biotech Ltd. (NASDAQ:SVA), a leading provider of biopharmaceutical products in China, today announced that the Company has obtained approval to begin human clinical trials on its Sabin Inactivated Polio Vaccine (or “sIPV”) candidate. read more

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