Patient Access

The Trump administration is expected to announce a new round of voluntary MFN drug-pricing agreements with midsize biotech companies as soon as August 31.

A recent study of more than 15,000 adults over 55 with obesity found that sustained Zepbound use was associated with up to 38% lower monthly healthcare costs at 12 months compared with untreated matched controls.

FDA approved Imaavy (nipocalimab-aahu) as the first-ever treatment specifically indicated for warm autoimmune hemolytic anemia in patients ages 12 and up.

James LaValle, chair of the International Peptide Society, notes how the advisory committee's favorable vote on peptides for the 503A Bulks List was a meaningful step without constituting approval.

FDA has approved Regeneron's Pasatru ,the first treatment for fibrodysplasia ossificans progressiva in adults.

ADVI’s associate director of market access policy strategy discusses how 340B grew to $100 billion, lost its safety-net purpose, and became a compliance nightmare when the IRA arrived.

FDA has granted accelerated approval to Zenbexus plus daratumumab and Hyaluronidase-fihj and dexamethasone for multiple myeloma after at least one prior line of therapy.

In today's Pharmaceutical Executive Daily, a new report finds U.S. rare disease biotech investment rebounding after FDA's Priority Review Voucher program renewal, President Trump signs an executive order narrowing the recommended childhood vaccine schedule, and BeOne Medicines and Revolution Medicines announce a multi-part oncology collaboration.

President Trump signs an executive order shrinking the recommended childhood vaccine schedule from 18 diseases to 11, and calls for the MMR shot to be split into three separate injections.

In today's Pharmaceutical Executive Daily, Amazon Pharmacy launches a GLP-1 delivery service for eligible Medicare patients, Tarsus Pharmaceuticals agrees to acquire Alkeus Pharmaceuticals for $450 million to advance a Stargardt disease therapy, and FDA grants accelerated approval to Replimune's Tudriqev in combination with nivolumab for advanced melanoma.

Amazon Pharmacy is now delivering GLP-1 weight management medications to eligible Medicare patients.

FDA has granted accelerated approval to Replimune's Tudriqev plus nivolumab for anti-PD-1-refractory unresectable advanced cutaneous melanoma.

FDA has approved Takeda's Orzeyful as the first oral orexin receptor 2 agonist for narcolepsy type 1 in adults.

An FDA advisory panel voted to recommend six of seven unapproved peptides for compounding access, raising concerns about its newly appointed members.

FDA has approved Viatris' Gwyn Lo as a once-weekly low-dose estrogen contraceptive patch, offering women with a BMI below 30 a non-invasive hormonal contraception option.

LucyRx’s chief commercial officer explains why the traditional two-bucket approach to GLP-1 coverage, which focuses on diabetes and weight loss, leaves high-risk populations without access.

BioMarin and n-Lorem Foundation have partnered to develop the first ASO therapy targeting ReNU syndrome.

FDA has approved Otsuka's Simtriyo as the first norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD.

An FDA advisory panel voted narrowly to recommend four unapproved peptides, BPC-157, KPV, TB-500, and MOTS-c.

Chief commercial officer Susan Thomas from LucyRx explains why coverage isn’t a one-size-fits all problem.

LucyRx’s chief commercial officer Susan Thomas discusses the impact that only looking at immediate cost impact has on certain indications.

Susan Thomas, chief commercial officer at LucyRx, explains the areas where GLP-1 coverage still lacks.

In today's Pharmaceutical Executive Daily, FDA grants emergency use authorization for Seegene's multiplex PCR assay, a Pfizer medical lead makes the case for continued antiviral use among Covid-19 high-risk patients, and Nuvation Bio's CEO discusses the company's oncology pipeline and philosophy of developing better drugs rather than more of them.

FDA has granted Emergency Use Authorization to Seegene USA's Allplex multiplex PCR assay, making it the first U.S.-authorized test to simultaneously detect and differentiate HSV-1, HSV-2, VZV, and monkeypox virus in a single reaction.

Dr. Gurinder S. Sidhu, senior medical director and U.S. Antiviral Medical Lead, Pfizer, discusses how Covid-19 remains a serious threat to the roughly 75% of American adults who qualify as high-risk, and pushes back against clinician complacency.