Andy Studna

New FDA guidance signals a major shift for CAR-T development, calling for randomized trials with standard-of-care control groups and clear evidence of superiority over existing therapies, while simultaneously easing REMS requirements to reduce logistical burdens for treatment centers and patients.

Twelve former FDA leaders have publicly challenged the agency’s proposed overhaul of vaccine approvals, sparked by an internal memo linking child deaths to COVID-19 vaccination, arguing the changes threaten evidence-based standards, weaken immunobridging practices, and risk eroding public trust.

The approval of AstraZeneca’s Imfinzi in combination with perioperative FLOT chemotherapy marks the first immunotherapy regimen for resectable gastric and gastroesophageal junction cancers, delivering a 22% overall survival benefit and establishing a new standard of care.

FDA approval of Itvisma, the first gene replacement therapy for adolescents, teens, and adults with SMA, is backed by Phase III data showing meaningful gains in motor function and a consistent safety profile across previously untreated and previously treated patients.

The Supreme Court has ruled 5-4 to allow the Trump administration’s NIH funding cuts to continue, impacting more than 1,700 medical research grants in areas including heart disease, HIV/AIDS, Alzheimer’s disease, and mental health.

For the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer, patritumab deruxtecan did not meet statistical significance for overall survival in the HERTHENA-Lung02 trial.

In patients with first-line metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitors, Trodelvy (sacituzumab govitecan-hziy) achieved a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy.

In a post-hoc analysis from the Phase III ARANOTE trial, new results show metastatic castration-sensitive prostate cancer patients treated with Nubeqa plus ADT experienced a clinically meaningful improvement in health-related quality of life and delayed pain progression.

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.

Based on additional results from the Phase III PSMAfore clinical trial, the therapy is now approved for use prior to chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer.

Former Chief Oncology Officer and Executive Vice President, Chris Boshoff, MD, PhD, will assume the role and lead all R&D functions including oncology.

Biktarvy approved for expanded indication to include patients with HIV who have suppressed viral loads with known or suspected M184V/I resistance.

Pivmecillinam has already been approved in Europe to treat uncomplicated urinary tract infections.

New analysis for 2023 shows signs of post-pandemic recovery; breast cancer remains most studied disease area.

A commentary by former FDA Commissioner Scott Gottlieb, MD, addresses uncertainty regarding how the FDA will regulate new technologies, such as artificial intelligence.

Proposed acquisition would have given IQVIA a market-leading position in healthcare advertising.

In-depth study outlines the top five reasons biopharma products miss launch forecasts.

Pharma industry stakeholders must develop actionable roadmaps to prioritize the areas in which the use of generative artificial intelligence can create the greatest benefits.

Ongoing phase 1 dose-escalation trial of KO-2806 (FIT-001) for the treatment of patients with KRASG12C-mutated non-small cell lung cancer expected to begin dosing patients in combination with adagrasib by mid-2024.

Exagamglogene autotemcel (exa-cel) has shown the potential to be a landmark therapy in preventing episodes of excruciating pain among patients with sickle cell disease.

Ushering in a novel class of drugs that attacks HIV at multiple stages of replication.

How the pivot to corporate development became a natural fit for the once-destined scientist. (The story of Natasha A. Hernday, chief business officer of Seagen and a 2023 Emerging Pharma Leader.)

An evolving job market has forced life sciences companies to respond.

An entrepreneurial quest to transform oncology treatment.

Fast riser in biotech strategy execution seizes on opportunities in immunotherapy.

Standard for reaching patients shifts with influx of new technology in post-COVID world.

Looking Back at 2011–2014.

Hopeful new standard of care for advanced prostate cancer capitalizing on momentum.

Script change from destined life in research to wild pace of biotech pays off.