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Smiths updates recall for Medfusion syringe pumps

Smiths Medical has amended an urgent medical device recall that it first issued in August for its Medfusion syringe pump model series 3500 and 4000.
- Source: Drug Delivery Business
- 799
- January 19, 2018
Company Insight medical device syringe pump
Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL

Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review.
- Source: Novartis
- 403
- January 18, 2018
DLBCL New Approvals sBLA
EU nod for Shire’s longer-acting haemophilia A therapy

Shire’s Adynovi has been approved for use in Europe for on-demand and prophylactic use in patients 12 years and older with the rare bleeding disorder haemophilia A.
- Source: Pharmatimes
- 534
- January 18, 2018
Adynovi haemophilia A New Approvals
TAI Diagnostics Closes $10M Financing and Establishes Collaboration Agreement with United Therapeutics

TAI Diagnostics, Inc., focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, announced the final closing of a $10 million Series A preferred equity financing. The company has now raised over $21 million since its inception. The proceeds of this financing will support on-going research and development of TAI’s innovative cell-free DNA (cfDNA) transplant monitoring technology, clinical studies, and the upcoming commercial launch of its post-transplant monitoring assays performed by its CLIA and CAP accredited reference laboratory.
- Source: drugdu
- 469
- January 18, 2018
health Series TAI’s innovative cell-free DNA
Pfizer, Foundation Medicine to develop companion diagnostics for oncology treatments

Pfizer has collaborated with Foundation Medicine for the development of companion diagnostics (CDx) for its oncology portfolio.
- Source: invitrodiagnostics.medicaldevices-business-review
- 629
- January 18, 2018
Company Insight oncology Pfizer
This Company’s AI-Fueled Tech Is About to Bring Digital Health Care to Millions

Digital health firm HealthTap and Bupa, a health care provider that offers both insurance and medical services to millions around the world, are teaming up in a massive strategic partnership that could make “digital end-to-end” medical services a widespread reality, HealthTap CEO Ron Gutman stated in an early interview previewing the arrangement.
- Source: Fortune
- 453
- January 18, 2018
AI Company Insight digital health
3D Printing Goes Legit with FDA Guidance

The FDA guidance does give potential 3D medical device manufacturers a path to follow to prepare for FDA approval.
- Source: HealthTech Insider
- 623
- January 18, 2018
3D printing FDA medical device products Policy
Study shows wearables lack clinical impact, but researchers haven’t lost hope

New research shows that wearables and remote patient monitoring technology have a limited impact on clinical outcomes. But digital health researchers aren't ready to abandon the promise of mobile technology.
- Source: FierceHealthcare
- 571
- January 18, 2018
digital health mHealth Researches wearables
Afatinib Approval Expanded for Rare Lung Cancer Treatment

Boehringer Ingelheim announced the approval of a new indication for afatinib (Gilotrif), as the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
- Source: Raredr
- 710
- January 17, 2018
afatinib DNA FDA New Approvals NSCLC
AstraZeneca’s PARP inhibitor gains market edge with breast cancer approval

AstraZeneca still enjoys the perks of being first to market with its PARP inhibitor. Lynparza (olaparib) sales were $81 million from July to September, whereas net revenues were $16.8 million and $39.4 million for Clovis Oncology Inc.'s Rubraca (rucaparib) and Tesaro Inc.'s Zejula (niraparib), respectively.
- Source: Biopharmadive
- 584
- January 17, 2018
inhibitor Lynparza New Approvals

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