Medical Tidbits,Medtronic IN.PACT Admiral DEB Receives CE Mark for Treatment of AV Access In Patients with End-Stage Renal Disease

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Medtronic plc (NYSE:MDT), a global leader in medical technology, services and solutions, today announced that the IN.PACT® Admiral® drug eluting balloon (DEB) (also known as the IN.PACT Admiral drug-coated balloon (DCB) in non-European markets) has received CE (Conformité Européene) Mark for arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.  read more

Medtronic and Chengdu Sign Insulin Pump Manufacturing Agreement

Help Expand Access to Advanced Diabetes Therapies in China

DUBLIN and CHENGDU, China – January 11, 2016 – Medtronic plc (NYSE:MDT), the global leader in medical technology, has formed a partnership with the Chengdu municipal government to manufacture and deploy advanced diabetes therapies in Chengdu, China.

As part of the agreement, Medtronic will invest in a manufacturing facility for a next generation sensor augmented pump system with SmartGuard(TM) technology to help provide better diabetes management for the growing diabetes population in China. In addition, Medtronic will partner with the Chengdu government to enable people with diabetes in Chengdu and the broader Sichuan province to access this new, locally produced technology with software displayed in Chinese language. read more

Mylan Confirms FDA Submission of ANDA for Generic Advair Diskus

HERTFORDSHIRE, England and PITTSBURGH, Jan. 11, 2016 /PRNewswire/ — In advance of its upcoming presentation at the J.P. Morgan Annual Healthcare Conference tomorrow, Mylan N.V. (NASDAQ, TASE: MYL) today confirmed that it submitted its abbreviated new drug application (ANDA) for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder to the U.S. Food and Drug Administration (FDA) in Dec. 2015. This product is the generic version of GlaxoSmithKline’s Advair Diskus®, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).  read more

NCCN Awards Grants to Three Researchers to Investigate Volasertib in Hematologic Malignancies

The NCCN Oncology Research Program has awarded three research grants to investigate the safety and effectiveness of volasertib in hematologic malignancies.

FORT WASHINGTON, PA — The National Comprehensive Cancer Network ® ( NCCN ® ) Oncology Research Program ( ORP ) has awarded three grants to investigators from NCCN Member Institutions to scientifically evaluate and define the safety and clinical effectiveness of the investigational compound volasertib in the treatment of hematologic malignancies. These grants are made possible through funding from Boehringer Ingelheim, Inc . read more

Neurovive Pharmaceutical: NeuroVive enters strategic collaboration with University of Pennsylvania

NeuroVive Pharmaceutical AB (publ), the mitochondrial medicine company, announces that it has entered into a research partnership with University of Pennsylvania to enhance NeuroVive’s traumatic brain injury (TBI) research and development program. The research partnership will focus on an important unsolved problem in the medical field: nerve cell protection following moderate to severe brain trauma. The agreement between University of Pennsylvania and NeuroVive represents the expanding footprint beyond Europe into the US and will further advance the company’s understanding of and presence in the US market.

Zambon Launches Xadago® (Safinamide) in Switzerland for Patients with Parkinson’s Disease

MILAN–(BUSINESS WIRE)–Zambon S.p.A., an international pharmaceutical company strongly committed to the central nervous system (CNS) therapeutic area, and its partner Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, today announced the launch of Xadago® (safinamide) in Switzerland, the second market after Germany. Swissmedic approved Xadago® (safinamide) on Nov. 12 as add-on therapy to levodopa (L-dopa) alone or in combination with other therapies for patients with Parkinson’s disease (PD) in mid-to late-stage and motor fluctuations. read more

Provectus Biopharmaceuticals Confirms First Patients Dosed in Trials of PV-10 for Melanoma

KNOXVILLE, Tenn.–(BUSINESS WIRE)–Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,, a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus”), today confirmed that patients have been dosed in both its Phase 3 clinical trial of PV-10, Provectus’ novel investigational drug for cancer, for Stage III locally advanced cutaneous melanoma and its Phase 1b/2 clinical trial of PV-10 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with Stage IV melanoma. In addition, the Company confirmed that it continues to enroll patients in all of its active oncology studies. read more

US Biotech Company, Calysta Inc., to Open Its First R&D and Market Introduction Facility in the UK

January 12, 2016 03:01 AM Eastern Standard Time

TEESSIDE, England–(BUSINESS WIRE)–Located at the Centre for Process Innovation (CPI), Teesside, Calysta will develop the production process for FeedKind™ protein, a new fish feed ingredient to reduce the aquaculture industry’s use of fishmeal. FeedKind™ protein – a natural, safe, non-GMO sustainable fish feed ingredient – is approved for sale in the European more

Evotec Achieves Important Milestone in TargetAD Collaboration with Janssen in Alzheimer’s Disease

HAMBURG, Germany–(BUSINESS WIRE)–Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) today announced the achievement of an important milestone in its TargetAD collaboration with Janssen Pharmaceuticals, Inc. (“Janssen”) for the transition of a project into further drug discovery process. This milestone was reached in 2015 which will be recognised in the financial year 2015. read more

Ionis Pharmaceuticals Completes Target Enrollment for Nusinersen Phase 3 Study, CHERISH, in Children with Spinal Muscular Atrophy

Ionis Earns $2.15M Milestone Payment from Biogen as Nusinersen Advances

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that it has earned a milestone payment of $2.15 million from Biogen for completing the target enrollment of the Phase 3 CHERISH study. The study is designed to support marketing approval of nusinersen in children with spinal muscular atrophy (SMA).   read more
BioLineRx Announces Collaboration with MSD to Investigate the Combination of KEYTRUDA (pembrolizumab) and BL-8040 in Pancreatic Cancer 

BioLineRx Ltd. (NASDAQ/TASE: BLRX) today announced a collaboration with MSD, known as Merck in the US and Canada, to support a Phase 2 study investigating BioLineRx’s BL-8040 in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic pancreatic cancer. The study is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of this combination in patients with metastatic pancreatic adenocarcinoma. BioLineRx will hold a conference call to discuss the collaboration today, January 12, 2016, at 10:00 am EST. To access the conference call, please dial 1-888-281-1167 from the U.S. or +972-3-918-0610 internationally. The call will also be available via live webcast through BioLineRx’s website . A replay of the conference call will be available approximately two hours after completion of the live conference call. To access the replay, please dial 1-888-326-9310 from the U.S. or +972-3-925-5904 internationally. The replay will be available through January 15, 2016.

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