Pharmaceutical Executive Daily: September 12, 2025
September 12th 2025In today’s Pharmaceutical Executive Daily, we cover the president’s call to lower drug costs for patients, the compliance and operational pressures facing pharmaceutical manufacturers, and a White House plan to restrict treatments discovered in China.
Influence of Pharmacologic Options on Clinical Practices
September 12th 2025Helen Sabzevari, PhD, president and CEO of Precigen, explains how Papzimeos transforms clinical practice by establishing the first FDA-approved standard of care for recurrent respiratory papillomatosis (RRP), shifting treatment from repeated surgeries to an immunotherapy that addresses the root HPV infection, with future plans to expand into pediatric populations and redosing strategies.
Setting Precedents for Rare Disease Therapies
September 11th 2025Helen Sabzevari, PhD, president and CEO of Precigen, reflects on how Papzimeos sets an important precedent for rare disease therapies, with its broad FDA label for all adult patients with recurrent respiratory papillomatosis (RRP) highlighting the potential for earlier intervention to prevent irreversible damage and establish new standards of care.
Characterizing Disscussions with Regulators Around Clinical Data
September 10th 2025Helen Sabzevari, PhD, president and CEO of Precigen, discusses the FDA’s decision to grant full approval to Papzimeos without requiring a confirmatory trial, highlighting how strong safety, efficacy, and durability data supported a broad label for all adult patients with recurrent respiratory papillomatosis (RRP).
Key Factors in Papzimeos' FDA Approval in Adults Patients with Recurrent Respiratory Papillomatosis
September 9th 2025Helen Sabzevari, PhD, president and CEO of Precigen, explains how Papzimeos, developed using the company’s AdenoVerse platform, became the first FDA-approved therapy for adult patients with recurrent respiratory papillomatosi.
Recurrent Respiratory Papillomatosis Treatments Before Papzimeos
September 9th 2025In this video interview, Helen Sabzevari, PhD, president and CEO of Precigen, discusses the background of Recurrent Respiratory Papillomatosis treatments that led to Papzimeos becoming the first FDA-approved therapy for Recurrent Respiratory Papillomatosis.
Pharmaceutical Executive Daily: September 8, 2025
September 8th 2025In today’s Pharmaceutical Executive Daily, we review the wave of pharmaceutical layoffs shaping 2025, highlight the latest Pharm Exec Top 50 company rankings, and cover BioNTech and Duality Biologics’ clinical trial success with BNT323.
Pharmaceutical Executive Daily: September 5, 2025
September 5th 2025In today’s Pharmaceutical Executive Daily, we will recap the top stories of the week, exploring the current state of the GLP-1 market, review major pharmaceutical layoffs shaping 2025, and cover Pfizer’s response to political pressure on COVID-19 vaccine safety evidence.
Pharmaceutical Executive Daily: September 4, 2025
September 4th 2025In today’s Pharmaceutical Executive Daily, we cover political pressure on Moderna and Novavax to release COVID-19 vaccine evidence, a deep dive into the evolving GLP-1 market, and Sanofi’s share decline following disappointing Phase III results for Amlitelimab.