PharmExec

What Impact will FDA's ANDA Prioritization Pilot have on the Global Supply Chain?

Marcel Botha, CEO of 10XBeta, discusses FDA’s new pilot authorization program for abbreviated new drug applications (ANDA) ...
PharmExec

What Impact will DTC Programs have on Generic Drug Prices?

PE: What impact will DTC programs have on generic drug prices? O’Dell: Not much today, but generics are not completely immune ...
PharmExec

GSK Enters $745 Million Worldwide Exclusive License Agreement with Empirico for Clinical-Stage First-In-Class Oligonucleotide Candidate

Shortly following the announcement of its acquisition of Syndivia’s ADC, GSK entered into a worldwide exclusive license ...
PharmExec

Roundup: Pharma Funding Continues with Financing Rounds and Public Offering Price Announcements

Zag Bio announced the company’s launch with a $80 million financing round, which includes a recently closed Series A ...
PharmExec

Pharmaceutical Executive Daily: Organon CEO Kevin Ali Resigns

In today’s Pharmaceutical Executive Daily, we cover the resignation of Organon CEO Kevin Ali following an internal investigation tied to Nexplanon sales, GSK’s $357 million agreement with Syndivia to ...
PharmExec

FDA Expands Indication for Merck’s Winrevair in Pulmonary Arterial Hypertension

The FDA has updated the label for Merck’s Winrevair (sotatercept-csrk) following results from the Phase III ZENITH trial, confirming the therapy’s ability to reduce the risk of clinical worsening ...