Brian Gragnolati, CEO of Atlantic Health System, said that "there's a war going on between providers and payers right now." In his view, payers “are doing everything they can” not to pay providers for the care they deliver. He said insurers have greatly increased their rate of denials and are extremely reluctant to take on risk in value-based contracts.
Celldex drug barzolvolimab has mid-stage results in a chronic inflammatory skin disease that top those of an approved Genentech drug and two experimental Novartis therapies. The biotech is preparing to advance its drug to Phase 3 testing in 2024.
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The restructuring of cardiovascular drugmaker Amarin means the layoff of about 30% of staff. Sales of Vascepa, the company’s only commercialized product, have suffered as generic versions gain traction in the market.
The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.
PTC Therapeutics plans to talk to regulators about regulatory submissions for sepiapterin after the drug met the main goal of a Phase 3 study. The small molecule is a potential treatment for phenylketonuria, a rare enzyme deficiency.
Quest Diagnostics is acquiring liquid biopsy company Haystack Oncology. The startup’s technology is used for identifying cancer patients who need adjuvant therapy.
The TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development.
GSK acquired global rights to Brexafemme, a novel antifungal from Scynexis that is approved for treating vaginal yeast infections. The deal also gives GSK the chance to commercialize the drug in other indications.
Type 1 diabetes patients now have a new therapeutic option for the autoimmune disorder. Provention Bio drug Tzield has received FDA approval for delaying the onset of the most severe stage of this chronic disease.
Taiho Oncology’s cancer drug Lytgobi is the third FDA-approved therapy for bile duct cancer driven by FGFR2 genetic alterations. The accelerated approval for Taiho’s drug follows regulatory nods for products from Incyte and QED Therapeutics that address the same genetic signature.
A Merck HIV drug placed under multiple full and partial clinical holds last year is now clear to resume testing. As part of a modified plan, Merck will test a lower dose of its experimental drug, islatravir. The pharma giant is also dropping tests of the drug for HIV prevention.
This eBook, in collaboration with Care Logistics, details how hospitals and health systems can facilitate more effective decision-making by operationalizing elevated awareness.
Rocket Pharmaceuticals is acquiring Renovacor, a gene therapies developer whose lead program addresses a particular genetic mutation that leads to a type of heart failure. The all-stock deal gives Rocket the opportunity to expand its reach in genetically driven cardiac diseases.
BeCare Link has developed software that enables the traditional in-person multiple sclerosis assessment to be done remotely on a patient’s own mobile device. The startup was named the winner of MedCity’s recent Pitch Perfect contest.
Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.
PMV Pharmaceuticals has its first clinical data showing that its lead therapeutic candidate can hit p53, a tumor-suppressing protein long thought to be undruggable. After reporting the preliminary data during ASCO, PMV said it plans to continue the Phase 1 study with the goal of advancing to Phase 2 early next year.
Becton Dickinson is getting into pharmacies with a more than $1.5 billion acquisition of Parata Systems, maker of robotics technologies that automate pharmacy tasks. The deal comes two months after BD completed the spinoff of its diabetes business as a separate, publicly traded company.