PharmExec

Pharmaceutical Executive Daily: FDA Initiates Review of Moderna’s Seasonal Influenza Vaccine

In today’s Pharmaceutical Executive Daily, the FDA begins reviewing Moderna’s seasonal flu vaccine under a revised regulatory approach, Eli Lilly signs a $100 million licensing agreement with CSL for ...
PharmExec

From Sun Belt Boom to Biotech Hub: Why Southern Florida’s Moment has Arrived

The broader Miami-Fort Lauderdale-West Palm Beach metro produced $533.7 billion in GDP in 2023, a nearly 9% year-over-year increase. 3 Migration continues to rise with a reported 123,471 new residents ...
PharmExec

Eli Lilly Enters $100 Million Licensing Agreement with CSL Limited for Clazakizumab

Exclusive licensing grants Lilly development and commercialization rights for clazakizumab beyond ESKD-related cardiovascular prevention, while CSL retains the ESKD cardiovascular events indication.
PharmExec

FDA Initiating Review of Moderna’s Seasonal Flu Vaccine Following Revised Regulatory Approach

On the heels of a Type A meeting with FDA’s Center for Biologics and Research (CBER), Moderna’s seasonal influenza vaccine ...
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 administration’s health policy priorities.
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 ...
Opinion
PharmExecOpinion

Brian Finrow

Brian Finrow is a former Cooley securities lawyer and co-founder/CEO of Lumen Bioscience, a clinical-stage biotechnology company in Seattle. Without new legislation, pilot programs, or years of ...
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, ...