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Leading CROs, Veeva team up for open tech on trials

Six big contract research companies, alongside Veeva Systems, are for the first time coming together to develop open technology standards aimed at “transforming clinical trial ops” to speed up development.
- Source: fiercebiotech
- 592
- March 30, 2018
Clinical Trial CRO
Third Rock debuts immunometabolism startup Rheos with $60M launch round

Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
- Source: pharmacompass
- 646
- March 30, 2018
financing immune Market Views
Merck KGaA adopts Medisafe medication adherence tool for patients with chronic conditions

Patients can access their record through a code for their iPhone. The idea is to help patients better understand their medical history, improve the quality of interactions with their physicians and family members, and make more informed decisions about their care.
- Source: MedCityNews
- 585
- March 30, 2018
Company Insights digital health EHR
Alnylam Presents New Clinical Results from the APOLLO Phase 3 Study of Patisiran at the 16th International Symposium on Amyloidosis

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced that the Company presented new results from the APOLLO Phase 3 study of patisiran, an investigational, RNAi therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis at the 16th International Symposium on Amyloidosis (ISA), being held March 26-29, 2018 in Kumamoto, Japan. In addition, the Company presented new data from the Phase 1 study of ALN-TTRsc02, an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis.
- Source: biospace
- 596
- March 30, 2018
ATTR amyloidosis Clinical Trials hereditary ATTR
Bigfoot brings in $55M Series B to propel integrated diabetes platform

This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval(PMA) from the FDA.
- Source: MedCityNews
- 828
- March 30, 2018
Company Insights diabetes FDA funding
FDA clears Medtronic’s smartphone-connected CGM for MDI users

Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016.
- Source: mobihealthnews
- 823
- March 30, 2018
FDA Guardian Connect insulin Medtronic New Approvals
China’s Adagene raises $50M to take anticancer antibodies into the clinic

Sequoia China has powered Adagene to a $50 million series C round. The investment positions the Chinese antibody discovery shop to move the most advanced assets in its oncology pipeline into human testing.
- Source: FierceBioTech
- 618
- March 30, 2018
Clinical Trials Company Insights oncology
Mylan Introduces Symfi™ Triple Combo Once-Daily HIV Treatment in the U.S.

Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
- Source: finance.yahoo
- 551
- March 29, 2018
HIV-1 New Approvals Symfi™
Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia

Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
- Source: Novartis
- 640
- March 29, 2018
FDA New Approvals Ph+ CML-CP Tasigna®
U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review

Bristol-Myers Squibb Company (BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation.
- Source: drugdu
- 596
- March 29, 2018
FDA MBS New Approvals Opdivo

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