Tag: US pharma

ROMEG Reports FDA Approval for Gout Flares Solution

ROMEG Therapeutics, an innovative drug development company focused on alternative formulations to better meet clinical and patient needs, today announced that the U.S. Food and Drug Administration (FD...

Big Pharma Answered for High Prices

U.S. senators called drug pricing practices “morally repugnant” and told drug company executives they do not want to hear them blame others for the high prices, taking an aggressive stance at a Senate...

CMS Proposed Coverage of New Form of Cancer Therapy

Proposed decision would provide nationwide consistency in CMS’s coverage of the innovative new cancer therapy, to improve patient access and ensure appropriate evidence generation. The Centers for ...

Leading Manufacturer Choose Paperless Validation

ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Solutions (VLMS), announced that a New Jersey-based leading contract manufacturer of pharmaceutical drugs has chosen Val...

PhRMA Criticize Damaging Price Control in Some Countries

The Pharmaceutical Research and Manufacturers of America (PhRMA) urged the Office of the United States Trade Representative (USTR) to take immediate action to address serious and growing market access...

Big Pharma to Testify in High Drug Pricing Case

While congressional scrutiny on drug pricing is nothing new, the prospect of some of the pharmaceutical industry's highest-profile CEOs testifying on the issue will make for a must-watch event. In ...

Biocept Launches RUO Liquid Biopsy Kits

Biocept, Inc., a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, ann...

US Tries First Digital Oncology Drugs

Cancer patients in the US are trialling digital oncology drugs for the first time, collecting data on patients in a bid to improve outcomes and help adherence. The new technology from Proteus Digit...

TrakCel and Quick Partner for Cell and Gene Therapies Tracking

On Jan. 17, 2019, TrakCel, a UK-based developer of cell and gene therapy supply-chain tracking and orchestration systems software, and The Quick Life Science Group, a US-based provider of time- and te...

AstraZeneca and Ironwood’s IBS-C Drug Approved in China

Ironwood Pharmaceuticals’ irritable bowel syndrome treatment Linzess has gained approval in China, opening up a market of up to 14m adults with the condition. The good news coincides with big chang...

Generic for Alzheimer’s and Parkinson’s Approved by FDA

The U.S. Food and Drug Administration (FDA) approved Bridgewater, NJ-based Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to A...

GE Healthcare and VUMC to Develop New DIagnostic Tools for Cancer Treatment

New diagnostic tools will be developed by GE Healthcare and Vanderbilt University Medical Centre (VUMC) to help make cancer immunotherapies safer and more accurate. As part of a five-year partnersh...

AbbVie and Tizona to Develop Antibody for Cancer Treatment

AbbVie, a research-based global biopharmaceutical company, and Tizona Therapeutics, Inc., a privately held immunotherapy company, announced on Jan. 3, 2019 that they have entered into a global, strate...

FDA Granted Priority Review Non-Opioid for Postoperative Pain

Heron Therapeutics, Inc., a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient...

First FDA Approved ANDA for OHPC Injections in MDV

Slayback Pharma LLC announced today that the U.S. Food and Drug Administration granted approval of its abbreviated new drug application ("ANDA") for Hydroxyprogesterone Caproate Injection, USP 1,250 m...

FDA Approved Rare Blood Disease Drug

The US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab) injection for use in the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare and...