Search Results for “FDA” – Page 169 – media

A healthcare startup to improve dose management for injectable drugs raises $6.6M

The FDA confirmed in a March 16, 2012 communication released to Bloomberg News that the vaginally placed pelvic mesh product known as the Prolift, sold by Johnson & Johnson subsidiary Ethicon, Inc. since March, 2005, was initially marketed without any clearance or approval from the FDA.
- Source: Med City News
- 511
- April 16, 2018
Company Insights digital health
ARKAY Therapeutics Submits Investigational New Drug (IND) Application for RK-01, a First-in Class ‘Beta-cell-centric’ Drug Combination Product for Type 2 Diabetes

First Human Proof-of-Concept (PoC) Trial to Test the Superiority of RK-01 over Metformin in Type 2 Diabetes Patients with Inadequate Glycemic Control.
- Source: Pipelinereview
- 509
- April 13, 2018
New Approvals type 2 diabetes
Cellectis Snags $164 Million in IPO to Advance CAR-T Programs

Today the company has found some sure financial footing that will support its efforts through the remainder of the year. The company secured $163.7 million in an initial public offering. The funding will be used to continue the development of Cellectis’ off-the-shelf CAR-T products and drive them toward regulatory approval.
- Source: biospace
- 667
- April 13, 2018
CAR-T therapies Series
Illumina and Loxo Oncology to Partner on Developing Next-Generation Sequencing-Based Pan-Cancer Companion Diagnostics

Illumina, Inc. (Nasdaq: ILMN) and Loxo Oncology (Nasdaq: LOXO) today announced a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication.
- Source: Illumina
- 496
- April 12, 2018
larotrectinib Market Views
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer

Application based on results from Phase 2 CheckMate -142 study
- Source: investors.bms
- 606
- April 11, 2018
Bristol-Myers Squibb FDA New Approvals Opdivo
Eidos Therapeutics completes $64M Series B financing

Funding supports Phase 2 clinical trials of AG10, a potential best-in-class therapy for transthyretin amyloidosis, and ongoing preparation for Phase 3 clinical trials
- Source: prnewswire
- 584
- April 10, 2018
amyloidosis Series transthyretin
Ferring Acquires Innovative Biotechnology Company and Microbiome Pioneer Rebiotix Inc.

Ferring Pharmaceuticals* and Rebiotix Inc. today announce that they have agreed to the acquisition of Rebiotix by Ferring. This acquisition brings together two innovative healthcare companies that share a common commitment to exploring and understanding the human microbiome to develop new solutions for patients.
- Source: Businesswire;
- 591
- April 9, 2018
acquisition CDI Market Views non-antibiotic
China pushes generics over brands with another round of new pharma policies

In a potential threat to foreign drugmakers profiting on innovative drugs, the Chinese government on Tuesday issued a new policy package—including tax breaks—to promote generics.
- Source: fiercepharma
- 569
- April 8, 2018
generics polices
Adherium receives OTC clearance for AstraZeneca’s Symbicort inhaler

Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort.
- Source: MobiHealthNews
- 795
- April 7, 2018
COPD FDA New Approvals
Singapore’s Aslan stalks $86M IPO to fund cancer pipeline

Aslan wants to list on the U.S. exchange under the ASLN symbol.
- Source: fiercebiotech
- 541
- April 5, 2018
Aslan Market Views varlitinib

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