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FDA Grants Breakthrough Device Designation to Polyganics’ Liver and Pancreas Sealant Patch

Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, announced that the US Food and Drug Administration (FDA) has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch. The Liver and Pancreas Sealant patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which currently no approved or cleared alternatives exist.
- Source: polyganics
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- March 15, 2018
bioresorbable medical devices FDA New Approvals Polyganics
Patient death forces FDA to slap a hold on study using combo from Advaxis, AstraZeneca — biotech’s shares plunge

The FDA has slapped a clinical hold on a combo therapy using Advaxis’$ADXS axalimogene filolisbac along with AstraZeneca’s approved PD-L1 Imfinzi following the death of a patient in their Phase I/II trial.
- Source: endpts
- 633
- March 15, 2018
AstraZeneca cervical cancer Company Insight FDA
IMMUTEP ENTERS INTO CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT WITH MSD

Immutep Limited (ASX:IMM) (IMMP) (“Immutep” or the “Company”) has announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary, to evaluate the combination of Immutep’s lead immunotherapy product candidate eftilagimod alpha (“efti” or “IMP321”) with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a new clinical trial that will evaluate the combination in several different solid tumours.
- Source: finance.yahoo
- 639
- March 14, 2018
Company Insight immunotherapy keytruda
Busy Sanofi takes a pass on one of Alnylam’s rare disease drugs, FDA offers ‘breakthrough’ status for PhIII

A couple of months after Sanofi $SNY and Alnylam $ALNY retooled their RNAi collaboration so that the French pharma giant could concentrate on their hemophilia therapy while giving up rights to the biotech’s patisiran, the two partners are also going their separate ways on a late-stage drug for rare cases of primary hyperoxaluria type 1.
- Source: Endpts
- 584
- March 14, 2018
hemophilia lumasiran New Approvals RNAi
New Data Presented at MDA Clinical Conference Show Benefit in Motor Function for Infants, Teens and Young Adults Treated With SPINRAZA® (nusinersen)

Biogen (BIIB) today announced new interim Phase 2 results from NURTURE, the ongoing open-label, single-arm study evaluating the efficacy and safety of SPINRAZA® (nusinersen) among pre-symptomatic infants with spinal muscular atrophy (SMA). In NURTURE, all infants treated with SPINRAZA were alive, did not require permanent ventilation and showed improvement in motor function and motor milestone achievements as of July 5, 2017, compared to the disease’s natural history. This study, along with a case series demonstrating SPINRAZA’s effectiveness among teens and young adults, will be presented at the Muscular Dystrophy Association (MDA) Clinical Conference on March 11-14, 2018, in Arlington, Virginia.
- Source: finance.yahoo
- 2,248
- March 14, 2018
Biogen Clinical Trials SMA SPINRAZA
New Late-Breaking Study Finds Wearable Electrocardiogram (ECG) Monitoring Patch Can Detect Atrial Fibrillation Earlier and More Efficiently than Routine Care

Janssen leads in cardiovascular innovation using real-world data to detect asymptomatic atrial fibrillation Home-based clinical study underscores the game-changing role of digital technology in future of health care
- Source: jnj
- 804
- March 14, 2018
AFib ECG Janssen Johnson & Johnson
Fitbit unveils new tracker for kids, new smartwatch for adults

Come this spring adults won’t be the only ones with their own line of Fitbit trackers. The company recently announced a new set of products including the Fitbit Ace, which is a tracker designed for children 8 years old and up, as well a much anticipated new smartwatch, the Fitbit Versa.
- Source: MobiHealthNews
- 597
- March 14, 2018
Company Insight digital health Fitbit wearables
Human gut-on-a-chip could replace radiation testing on animals

An organ-on-a-chip model of the human gut could offer a better prediction of the effect of radiation exposure on humans than animal testing.
- Source: Verdict Medical Devices
- 564
- March 14, 2018
medical device medtech Researches
CFDA Continues to Expand Oversea Inspection

On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good Manufacturing Practice.
- Source: drugdu
- 692
- March 14, 2018
CFDA medical device products Policies
Medical device industry may see up to 5% growth

Moody’s Investors Service has upgraded the financial outlook for the medical products and device industry from stable to positive, predicting that “continued product innovation” and synergies from acquisitions will drive growth of earnings before interest, depreciation and amortization (EBITDA) of between 4 and 5 percent over the next 12 to 18 months.
- Source: HealthExec
- 492
- March 13, 2018
Market Views medical device products

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