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FDA holds trials of Cellectis’ cell therapy after patient death

US regulators have placed on hold studies of French drugmaker Cellectis’ CAR-T therapy following a patient fatality.
- Source: news.open-medical
- 591
- September 6, 2017
BPDCN CAR–T Clinical Trials Company Insight CRS
Takeda and Noile-Immune Biotech Collaborate to Advance Next Generation CAR-T Cell Therapy Effective for Solid Tumors

A collaboration to develop next generation chimeric antigen receptor T cell therapy (CAR-T) (RELATED: Kite begins EU trial of CAR–T therapy) was announced by Takeda Pharmaceutical Company Limited (TSE: 4502) and Noile-Immune Biotech Inc..
- Source: Takeda
- 907
- September 6, 2017
antigen CAR–T Market Views receptor therapy
FDA approves Adherium’s new inhaler monitoring device

The US Food and Drug Administration (FDA) has cleared Adherium for its new inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler.
- Source: medicaldevices-business-review
- 585
- September 5, 2017
Company Insight FDA inhaler respiratory
Amgen Ventures Invests in GNS Healthcare to Advance Applications of its REFS™ Causal Machine Learning and Simulation AI Platforms

GNS Healthcare (GNS), a leading precision medicine company, today announced that it has raised an additional $6 million in equity from Amgen Ventures with participation from existing investor Alexandria Real Estate Equities. The funds will be used to further develop the company's REFS™ causal machine learning and simulation platform and solutions across drug discovery & development, value-based drug solutions, care management, and health system business optimization. With this investment, Amgen Ventures joins other leading biopharma companies Celgene and Zambon Pharmaceuticals, leading health plans Regence Blue Cross Blue Shield (Cambia Health Solutions), and Horizon Blue Cross of NJ and provider Heritage Provider Network, in addition to Mitsui, GHO Capital, and Fort Rock Capital as shareholders of GNS.
- Source: Prnewswire
- 578
- September 5, 2017
Market Views platform solution
FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterized by cycles of remission and relapse.
- Source: biospace
- 573
- September 5, 2017
cancer FDA follicular lymphoma New Approvals sBLA
Apollo Endosurgery gets CE-Mark for managed weight loss system

Apollo Endosurgery has received CE-Mark for its ORBERA365 Managed Weight Loss System allowing commercialisation in the European Union (EU) and member countries of the European Economic Area.
- Source: medicaldevice-network
- 918
- September 4, 2017
CE EU New Approvals weight loss
Hologic introduces new Brevera breast biopsy system

Medical technology firm Hologic has introduced new Brevera breast biopsy system with CorLumina imaging technology in the US.
- Source: diagnosticimaging.medicaldevices-business-review
- 511
- September 4, 2017
breast biopsy Company Insight
LabCorp completes $1.2B Chiltern buy

Diagnostics company LabCorp (NYSE:LH) said today that it has closed its $1.2 billion acquisition of contract research organization Chiltern International.
- Source: drugdeliverybusiness
- 674
- September 4, 2017
acquisition Clinical Market Views oncology
2nd International Conference on Pediatric Neurology

Pediatric Neurology 2017 will focus on the latest and exodus innovations in all areas of Pediatric neurology research which offers exclusive opportunity for investigators across the globe to meet, network, and perceive new scientific innovations. This year's annual congress highlights the theme, "Channelizing the novel ideas for treating Pediatric Neurological Disorders" which reflects the innovative progress in Pediatric Neurology research.
- Source: drugs
- 603
- September 1, 2017
Exhibitions & Activities Pediatric Neurology
Stent Tek Closes Series A Investment Round for its ePATH AVF Device, Aiming to Improve Vascular Access for Hemodialysis

Stent Tek, a medical device company that is developing a minimally invasive catheter system for dialysis patients, announced today it has successfully closed a Series A funding round with investments from two institutional investors.
- Source: infomeddnews
- 414
- September 1, 2017
dialysis Market Views Stent Tek

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