PharmExec

Pharmaceutical Executive Daily: FDA Approves New Dosing Schedule for Rybrevant Faspro

In today’s Pharmaceutical Executive Daily, the FDA approves a monthly dosing schedule for Rybrevant Faspro, HHS Secretary ...
PharmExec

HHS Secretary of Health RFK Jr. Revises Agency’s Leadership Team: Report

HHS Secretary Robert F. Kennedy Jr. reorganized senior leadership at the department to streamline management and advance the ...
PharmExec

FDA Approves Monthly Dosing Schedule for Rybrevant Faspro

FDA approved a simplified, once-monthly dosing schedule for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) when used in combination with Lazcluze (lazertinib) as a first-line treatment for ...
PharmExec

Delivering Actual Value: Q&A with Sandy Tammisetty

Sandy Tammisetty, VP of Veeva Services Practive Group at Conexus Solutions, spoke with Pharmaceutical Executive about where AI implementation is working for the pharma industry, and where it doesn’t ...
PharmExec

Complex Challenges Arising from Pricing Reforms: Q&A with Jesse Mendelsohn

Pharmaceutical Executive recently spoke with Jesse Mendelsohn, SVP at Model N, about the complications that can arise from companies entering into drug pricing agreements with the government. This ...
PharmExec

You Can Just (Not) Do Stuff: FDA’s Power to De-Bottleneck Early-Stage Clinical Trials

What’s been overlooked is that the FDA already has the power to fix this. Without new legislation, pilot programs, or years ...
PharmExec

Pharmaceutical Executive Daily: Disc Medicine Receives CRL from FDA for Bitopertin

In today’s Pharmaceutical Executive Daily, the FDA issues a Complete Response Letter for Disc Medicine’s bitopertin in EPP, ...
PharmExec

Edwards Life Sciences Lifts Anti-Copycat Policy

Edwards Lifesciences withdrew its global anti-copycat policy, prompting European Union antitrust regulators to close an investigation that began with dawn raids back in 2023. The European Commission ...
PharmExec

Edwards Life Sciences Lifts Anit-Copycat Policy

Edwards Lifesciences withdrew its global anti-copycat policy, prompting European Union antitrust regulators to close an investigation that began with dawn raids back in 2023. The European Commission ...
PharmExec

FDA Issues CRL to Disc Medicine for Eythropoietic Protoporphyria Treatment Bitopertin

Disc Medicine received a Complete Response Letter (CRL) from FDA for its New Drug Application (NDA) for bitopertin as a treatment for erythropoietic protoporphyria (EPP), delaying a potential ...
PharmExec

How to Bring a Breakthrough Rare Disease Product to Patients in Record Time: Q&A with Brian Laird

After starting his career as a pharmacist, Brian Laird decided to focus on the business-side of healthcare. He recently joined EVERSANA as its president of Patient Services, where uses his experience ...
PharmExec

Scaling Medical Digital Transformation in Global Pharma While Ensuring Local Fit

Scaling without losing local relevance requires humility, trust, and a willingness to relinquish the illusion that control ...