Legal & Regulatory

Pembrolizumab (Keytruda) plus fluoropyrimidine- and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction cancer approved by FDA after being found to lower the risk of metastasis or death.

Bristol Myers Squibb’s repotrectinib (Augtyro) approved by FDA to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Patients with kidney failure administered chronic hemodialysis who received DefenCath showed a statistically significant lower incidence of catheter-related bloodstream infections.

Exparel was initially approved in 2011 for single-dose infiltration into a surgical site.

The Flowflex COVID-19 Antigen Home Test is the first over-the-counter rapid antigen test for SARS-CoV-2 to gain FDA 510(k) marketing clearance by the FDA.

Conference presentation explores groundbreaking topics impacting the pharma industry.

Fruquintinib (Fruzaqla) is a significant new therapy for patients who have had limited options to treat metastatic colorectal cancer.

Conference session discusses the drivers, practical considerations, success factors, and landscape for next-generation pharmacy innovation.

Ayala Pharmaceuticals’ AL102 is a gamma secretase inhibitor being studied to treat patients with desmoid tumors.

Surge acted as a precursor for the RSV-marketed drug landscape in 2023, says GlobalData.

Value is attributed to the rise in counterfeit cases and ongoing regulations surrounding anti-counterfeit packaging.

Pharma Commerce converges on Nation's Capital for HDA Traceability Seminar.

The agency differentiates between software that has a notable impact on the effectiveness and safety of drug use.

PBM transparency and data reporting requirements are likely to be part of a larger healthcare bill that Congress will work on this fall.

Pharma Commerce provides a synopsis of the presentation.

Biopharma company now required to seek approval before attempting further buyouts.

Attendees meet to discuss operational issues related to traceability implementation.

Session offers information on industry readiness, plus an overview of a phase implementation recommendation.

Pharma Commerce provides a summary of conference breakout session.

Delay to allow agency to consider other ways of solving the issue, filing says.

Illinois Governor JB Pritzker signed into a law a bill prohibiting PBM retaliation against pharmacists who disclose information during government proceedings.

In the midst of providing DSCSA support, the SaaS provider is awarded for being a fast-growing, private US company.

Company will focus on its managed access services.

Offering provides assistance through the post-approval lifecycle of drugs.

Pharma Commerce team attends DIA's Annual Meeting for the first time.

Company is seeking monetary damages from the alleged violation.

How the ‘fight-for-the-dollar’ is coming and likely will impact the bundled pricing of industry stakeholders.

Agency claims union would threaten a monopoly on programmatic advertising space.

Micah Litow, Kalderos’ president and COO, discusses the importance of identifying and resolving noncompliant discount requests, along with addressing the gross-to-net gap for drug manufacturers.

The legislation’s deadline for compliance is knocking on the door. Pharma Commerce offers a synopsis of how the Drug Supply Chain Security Act has progressed over the past decade.