Search Results for “EC” – Page 542 – media

AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

In clinical studies, more than half of patients receiving risankizumab achieved complete skin clearance (PASI 100) at one year (52 weeks) (1) The Biologics License Application is supported by four Phase 3 studies of more than 2,000 patients with moderate to severe plaque psoriasis (1-3) Risankizumab is an investigational compound designed to selectively inhibit IL-23 by binding to its p19 subunit and is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12-week dosing (4)
- Source: prnewswire
- 627
- April 27, 2018
AbbVie FDA New Approvals plaque psoriasis
As FDA’s Pre-Cert plan takes shape, worries emerge about overreach

Yesterday morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work.
- Source: MobiHealthNews
- 609
- April 27, 2018
FDA medical device products Policies
FDA to expedite review of IDx-DR, a breakthrough AI diagnostic system

IDx, a privately held AI diagnostics company, announced today that it has filed its De Novo submission to the FDA for IDx-DR, an AI-based system for the autonomous detection of diabetic retinopathy — a leading cause of blindness. The FDA has granted IDx-DR with a “Breakthrough Device” designation, which means the submission will receive expedited review.
- Source: prweb
- 659
- April 26, 2018
blindness diabetic retinopathy FDA IDx-DR New Approvals
Fresenius dumps its $4.3B Akorn buyout, and a ‘legal battle royale’ could come next

Akorn has filed a complaint in Delaware Chancery Court asking Fresenius to follow through on the pair's buyout agreement. A year after inking its $4.3 billion Akorn buyout agreement, Fresenius intends to scrap the deal. Akorn, though, isn’t having it, and analysts say a “legal battle royale” could be on the horizon.
- Source: fiercepharma
- 623
- April 26, 2018
acquisition Series
Lilly and China’s NCCD announce collaboration to advance scientific understanding and care for people living with diabetes and cardiovascular disease

Collaboration between China's National Center for Cardiovascular Diseases and Lilly aims to improve care for people living with Type 2 diabetes in China - The Lilly and NCCD collaboration will address four strategic areas to advance scientific understanding and medical education related to diabetes and cardiovascular disease
- Source: prnewswire
- 522
- April 26, 2018
Company Insights CVD Eli Lilly NCCD
ResearchKit Study to Test Smartphones’ mHealth Value in Eye Studies

Novartis is launching an mHealth app on Apple's ResearchKit platform to determine whether smartphones are reliable enough for use in ophthalmology studies.
- Source: mHealth Intelligence
- 649
- April 26, 2018
mHealth Researches
Steth IO launches digital stethoscope housed within smartphone case

On Tuesday, Bothell, Washington-based Steth IO announced the launch of its smartphone-based digital stethoscope.
- Source: MobiHealthNews
- 840
- April 26, 2018
FDA medtech mHealth New Approvals
Urotronic gets OK for advanced trial to treat narrowed urethras

Plymouth-based medical device maker Urotronic is ramping up clinical research on its Optilume drug-coated balloon to treat men with narrowed urethras, accelerating the data-gathering process for its novel device.
- Source: StarTribune
- 1,911
- April 26, 2018
FDA medical device medtech Researches
Takeda reaches preliminary deal to buy Shire for close to $65B

Takeda has upped its offer to buy Shire $SHPG for a mix of stock and cash worth close to $65 billion, which is good enough for the Lexington, MA-based biotech to extend the deadline on their talks to May 8 after determining they were close to finalizing a pact.
- Source: endpts
- 661
- April 25, 2018
Lexington Market Views Shire Takeda
Autolus announces license agreement with UCL Business PLC for clinical-stage product candidate in development for the treatment of B-cell malignancies

- A CD19 CAR with novel targeting properties designed to reduce cytokine release syndrome –
- Source: autolus
- 578
- April 25, 2018
B-cell malignancies Market Views T-cell therapies

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