New Jersey
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Amarin Restructures, Charting Course That Braces for Generic Competition
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.
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After Second FDA Rejection, Intercept Abandons NASH Drug and Restructures
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.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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PTC Posts Positive Phase 3 Data, But Comparison to BioMarin Is Less Clear
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.
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Quest Expands in Cancer Testing With $300M Haystack Oncology Acquisition
Quest Diagnostics is acquiring liquid biopsy company Haystack Oncology. The startup’s technology is used for identifying cancer patients who need adjuvant therapy.
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GSK Strikes Another Antimicrobial Deal, Paying $90M for Scynexis’s Brexafemme
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.
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Provention Wins FDA Approval for First Drug to Delay Type 1 Diabetes Progression
Type 1 diabetes patients now have a new therapeutic option for the autoimmune disorder. Provention Bio drug Tzeild has received FDA approval for delaying the onset of the most severe stage of this chronic disease.
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FDA approves Taiho drug for rare bile duct cancer with certain genetic signature
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.
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Merck HIV drug trials paused by FDA will resume under modified plan
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.
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Rocket Pharma stocks up on cardiac gene therapies with $53M Renovacor acquisition
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.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Devices & Diagnostics, Artificial Intelligence, BioPharma
INVEST Pitch Perfect winner: BeCare Link brings MS assessments to patients’ homes
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.
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After initial failure, Intercept Pharma feels new data can get NASH drug approval
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.
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PMV’s ASCO data show signs of drugging ‘undruggable’ p53 protein across tumor types
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.
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Becton Dickinson buys into pharmacy automation with $1.5B Parata acquisition
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.
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100% survival in clinical test puts Rocket Pharma gene therapy on course to FDA
A Rocket Pharmaceuticals gene therapy for the rare immune disorder leukocyte adhesion deficiency-I has met the survival goals of a pivotal study, paving the way for regulatory submissions that the company expects to file in early 2023.
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Aiming to make better mRNA vaccines, BioNTech strikes up alliance with Matinas
Oral delivery of messenger RNA is one of the capabilities of Matinas BioPharma’s technology. BioNTech will explore that feature among others under a new research alliance with Matinas, a clinical-stage biotech that also has an ongoing collaboration with Genentech.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
