News

Accord BioPharma's 420 mg strength Hercessi (trastuzumab-strf), a biosimilar to Herceptin, gains FDA approval to treat HER2-overexpressing breast cancer and gastric cancer.

Drug shortages, including critical antibiotics, fever medications, and cancer treatments, highlight global supply chain issues and the need for improved health policies to prevent medication bottlenecks.

FDA fast tracks Sun Pharma and Moebius Medical’s MM-II treatment for osteoarthritis knee pain, with Phase III clinical trials planned to expedite a potential approval.

The manufacturing line producing the company’s branded form of nirsevimab-alip has been approved by the FDA.

It’s essential for commercial success, but presents its share of obstacles.

A study aims to determine whether there are disparities in burden and treatment across neighborhoods, and if socioeconomic position, race, ethnicity have an impact.

A cross-sectional study investigates changes in Medicare Advantage enrollment among Medicare beneficiaries with end-stage renal disease in the first two years of the Act.

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, discusses the WEE request process itself, while also providing her thoughts on other sessions that have garnered her attention.

The parties’ want to provide customers with a “one-stop-shop,” with the hopes that their services will be easier to navigate.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

A pooled analysis of the SWIFT-1 and SWIFT-2 trials found 54% reduction in exacerbation rates over 52 weeks in patients with severe asthma with type 2 inflammation treated with depemokimab.

The company boosts its healthcare logistics services by agreeing to purchase Frigo-Trans and its sister company BPL.

The project is funded by Scottish Enterprise, and aims to boost commercial manufacturing of injectable drug product.

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, offers advice to pharma manufacturers for successfully applying digital solutions to their patient support programs.

The enhancement—which complements the CDMO’s adeno-associated viral vector services—will be utilized at the company’s advanced therapies site in Stevenage, UK.

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption.

This year’s conference—taking place in Washington, DC— will prioritize the tackling of business, economic, and healthcare policy obstacles when it comes to decision marking and net revenue optimization.

In the second part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, discusses the best practices that compliance teams should consider as the end of the stabilization period approaches this November.

The project features several enhancements, including a new 67,000 square-foot warehouse at its HQ.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

How can industry stakeholders ensure the quality and supply chain security of existing product?

The 8,000 square-foot facility—located within the wholesaler’s Le Vergne distribution center— is expected to help tackle cell and gene therapy logistical challenges.

The company also participated in the coalition’s pilot inspection program, making it the first CDMO to do so.

The 3PL plans to convert all its trucks to electric by 2027.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.

The joint venture aims to disrupt pathological lncRNA interactions with RNA-binding proteins using NextRNA’s platform.

Session uncovers distributors’ experiences with the Waiver, Exception, or Exemption request process, and how these affect the overall supply chain.

The agency provides an update surrounding the Act’s implementation efforts.

The new vials of Zepbound are available through a new self-pay pharmacy channel, priced over 50% lower than other incretin medications for obesity.

Ryan Sevek, the supplier’s CFO, will become president.