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In an interview with Pharm Exec Associate Editor Don Tracy at Financial Times’ US Pharma and Biotech Summit, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses the use of artificial intelligence and machine learning in drug development.

This is the second accelerated approval the FDA has granted to Bristol Myers Squibb’s chimeric antigen receptor T-cell therapy in the past few months.

Unlike for individuals or entities providing or receiving services related to in vitro fertilization (IVF), the Alabama IVF Act does not grant immunity to manufacturers, but it limits damages for their violations to the cost of an IVF cycle.

The NABIP expressed frustration at CMS’ statement for placing blame on brokers and agents and not acknowledging evidence that switches were made by automated programs.

Novo Holdings is expected to acquire 60% of Single Use Support, with the remaining shares being held by Danaher and the company founders.

Roche’s human papillomavirus solution is reportedly one of the first of its kind to be available in the United States.

In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora discusses ways that cell and gene therapy developers can follow examples from the commercialization and distribution of orphan drugs.

The joint venture aims to address unmet needs in the treatment of mood and anxiety disorders through novel neuroplastogens.

In the Phase IIIa FRONTIER 2 trial, participants aged 12 years and older administered Mim8 showed significant and superior reduction of treated bleeding episodes.

Dupixent has previously been approved for adults with chronic rhinosinusitis with nasal polyposis whose condition is inadequately controlled.

Study findings indicated that psilocybin can reduce the symptoms of depression, with response and remission rates showing significant support.

Led by Decheng Capital, the successful round of funding also included participation from investors such as Cormorant Asset Management, Surveyor Capital, and the Foundation for Prader-Willi Research.

The National Institute for Public Employee Healthcare Policy attributed the importance to the rising cost of health care.

The collaboration is a part of a broader strategy to combat cardiometabolic and rare diseases.

Strategic financing from Oaktree Capital Management and OMERS Life Sciences is expected to support the US launch of ensifentrine, Verona’s promising chronic obstructive pulmonary disease treatment.

The new care center will offer primary care services to uninsured and underinsured patients in the Wilmington, North Carolina, area.

In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora, discusses the unique challenges that developers of cell and gene therapies need to plan for when building their channel strategy.

A Harvard Business School Healthcare Alumni Association Q&A with Dorie Clark, Instructor of Executive Education at the Columbia Business School.

Joint venture aims to develop up to 10 new cell and gene therapy products targeting areas with high unmet medical needs.

RxLink will incorporate Cost Plus’ prices into its drug pricing platform MedMap.

The catheters approved by the FDA include the Plato 17, a DMSO-compatible microcatheter, and the Socrates 38, an aspiration catheter specifically designed for treating ischemic strokes.

In this Pharmaceutical Executive video interview, Jesse Mendelsohn, senior vice president at Model N, discusses how more granular insights into channel, tracing, and chargeback data can help drugmakers make smarter provider and payer contracting decisions.

Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients.

Significant findings included a 100% biochemical recurrence-free rate at 24 months post-surgery in patients with high-risk localized prostate cancer.

Acceptance of the application was based on promising results from the Phase III CheckMate -67T study, which displayed noninferiority between the oral and intravenous formulations of Opdivo.

Batra will lead the company’s clinical strategy.

Dr. Lewis used the AI-powered device on a patient with severe lumbar stenosis.

In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora, offers a synopsis on what questions cell and gene therapy developers need to answer to inform their distribution strategy.