Newscast – Page 84 – media

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
- 698
- 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
- 661
- 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
- 560
- 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
- 676
- April 26, 2018
mHealth Researches
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
- 1,945
- 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
- 691
- 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
- 608
- April 25, 2018
B-cell malignancies Market Views T-cell therapies
FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate. While the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.
- Source: prnewswire
- 712
- April 25, 2018
baricitinib Eli Lilly New Approvals RA
UCB snags an NDA-ready epilepsy drug from Proximagen in $370M deal

UCB is beefing up its pipeline of epilepsy drugs with an NDA-ready therapy from Proximagen. The Belgian company has agreed to buy their nasal spray therapy USL261, designed as a rescue therapy for acute repetitive seizures, for $150 million in cash and another $220 million in sales and regulatory milestones.
- Source: endpts
- 609
- April 25, 2018
acute repetitive seizures Market Views Proximagen UCB
‘Orangeworm’ hacking campaign hits X-ray and MRI machines

Malware from a newly disclosed hacking campaign has infected the networks of multinational health care companies, including some X-ray and MRI machines, cybersecurity firm Symantec warned Monday.
- Source: CyberScoop
- 761
- April 25, 2018
cybersecurity Market Views

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.