Don Tracy, Associate Editor

Approval for the Phase III protocol of LAE002 Plus LAE001 come as a result of posiive Phase II data, which showed promising benefits for metastatic castration-resistant prostate cancer (mCRPC) patients.

Under terms of the agreement, Nona Biosciences is expected to receive an upfront payment of $19 million, with the potential of up to $585 million in milestones.

In an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses best-case scenarios for health policy amid the 2024 presidential election.

In an interview with Pharm Exec Associate Editor Don Tracy, Carmen Villar, VP, ESG & Corporate Citizenship, Gilead Sciences discusses new skills that members of generation Alpha will bring to the pharma industry and potential struggles that they may face.

Moving forward, Durect plans on incorporating feedback from the FDA in the design of a Phase III trial.

In an interview with Pharm Exec Associate Editor Don Tracy, Tala Fakhouri, at Financial Times’ US Pharma and Biotech Summit, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses whether the FDA plans on restricting the use of AI and what the future could look like when it comes to machine learning.

Approval of Yesafili represents Biocon’s entrance into the US ophthalmology market, following previous approvals in Europe and the UK.

In an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses the upcoming United States presidential election and the potential impact that it could have on the pharma industry.

Investment from the Alzheimer’s Drug Discovery Foundation (ADDF) aims to support the development of Coya 302, a therapeutic candidate for the treatment of frontotemporal dementia (FTD).

In an interview with Pharm Exec Associate Editor Don Tracy, Carmen Villar, VP, ESG & Corporate Citizenship, Gilead Sciences discusses the changes expected in the pharma industry that will come with the entry of younger professionals.

Imdelltra (tarlatamab-dlle) is the first T-cell engager therapy approved for extensive stage small cell lung cancer.

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.

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.

In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora discusses the process of coming up with innovative order-to-cash solutions to help maximize market reach.

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 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.

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.

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

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.