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Ultragenyx and Kyowa Kirin Announce FDA Approval of Crysvita® (burosumab-twza) for the Treatment of Children and Adults with X–Linked Hypophosphatemia (XLH)

First Approved Therapy for XLH in the U.S.; Only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease
- Source: globenewswire
- 951
- April 19, 2018
biopharmaceutical FDA New Approvals rare and ultra-rare diseases
Shire——FDA approves VONVENDI® for perioperative management of bleeding in adult patients with von Willebrand disease

Cambridge, Ma. -- Shire plc, the global biotechnology leader in rare disease, today announced the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (recombinant)], a recombinant von Willebrand factor (rVWF) treatment for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD).
- Source: 4-traders;
- 591
- April 19, 2018
New Approvals rVWF VONVENDI VWD
FDA medical device plan zeros in on cybersecurity, public-private partnership

The agency released a five-point plan outlining regulatory changes to bolster medical device safety, including requiring manufacturers ensure devices can be updated and patched.
- Source: HealthcareIT News
- 628
- April 19, 2018
cybersecurity digital health FDA Policies
Artificial pancreas is a safe and effective treatment for type 1 diabetes

Use of an artificial pancreas is associated with better control of blood sugar levels for people with type 1 diabetes compared with standard treatment, finds a review of the available evidence published by The BMJ today.
- Source: MedicalXpress
- 629
- April 19, 2018
diabetes digital health Researches
CSIRO spinout Coviu brings the doctor to you

Silvia Pfeiffer started Coviu with CSIRO colleague Nathan Oehlman in 2015, and it is now in use by 1100 healthcare professionals, with 160 of them paid subscribers to the software-as-a-service platform at $20 a month. More than 20,000 patients have been remotely consulted to date via the platform, which is browser-based and does not require a download.
- Source: Financial Review
- 595
- April 19, 2018
Company Insights digital health Telemedicine
What to do if you are rejected by your client

If you are in sales, you have probably encountered this all-too-familiar situation of being rejected without any clear reasons, but it’s necessary to keep in touch with your clients and wait for another opportunity.
- Source: Ddu
- 5,955
- April 18, 2018
client Ddu College
Will Facebook’s data-scraping woes bleed into healthcare and pharma?

Another internet data scandal—this time Facebook and Cambridge Analytica—has consumers buzzing about the safety of their personal information. Will people become more nervous about sharing their healthcare data in its wake?
- Source: fiercepharma
- 583
- April 18, 2018
Facebook pharma
Common Sensing Secures $6.6M Series A Investment Round to Support Injectable Medicines

Common Sensing , an evidence-based, data-driven injectable-medicine healthcare company, announced the close of a $6.6 million USD Series A financing. The round was led by Waterline Ventures. New World Health, Royal Philips (NYSE: PHG; AEX: PHIA), and Haselmeier joined the round as well. The funds will be used to accelerate Common Sensing's manufacturing and commercial operations for Gocap™, an IP-protected dose monitoring solution enabling patients and providers to better utilize injectable medicine, including insulin, fertility medications, growth hormones, and others.
- Source: 4-traders.
- 607
- April 18, 2018
Gocap™ injectable medicine Market Views Series
XBiotech In-licenses Anti-NY-ESO-1 Antibody Targeting Advanced Cancer

XBiotech USA, Inc. (NASDAQ:XBIT) announced today that it has obtained an exclusive, worldwide license from CT Atlantic AG (CTA), a Swiss biotechnology company. Under the terms of the license agreement, XBiotech will use its proprietary manufacturing technology to advance the development of the True HumanTM anti-NY-ESO-1 monoclonal antibody, 12D7.
- Source: Forextv
- 892
- April 18, 2018
12D7 antibody Market Views
Kineta to Collaborate on the Development of a Novel Non-Opioid Pain Therapy with Genentech

Kineta Chronic Pain, LLC, a subsidiary of Kineta, Inc., today announced that it has entered into an exclusive option and license agreement with Genentech, a member of the Roche Group, to develop Kineta’s α9/α10 nicotinic acetylcholine receptor (nAChR) antagonists for the treatment of chronic pain.
- Source: Kinetabio
- 478
- April 18, 2018
chronic pain Market Views nAChR

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