HEALTH & LIFE SCIENCES NEWS
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
HEALTH & LIFE SCIENCES NEWS
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
contract research organizations
Subscribe to contract research organizations's Posts

This Week in 340B: June 17 – 23, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation. Get more details on these 340B cases and all other material 340B cases pending in federal and state courts with the 340B Litigation Tracker.

Issues at Stake: Contract Pharmacy; Rebate Model; HRSA Audit Process

  • In five cases challenging Tennessee, Hawaii and Utah state laws governing contract pharmacy arrangements:
    • Tennessee: In one case, amici filed an amicus curiae brief in opposition to plaintiff’s motion for preliminary injunction and in a second case, the plaintiff filed a motion for preliminary injunctive relief and the defendant filed a motion to dismiss.
    • Hawaii: In one case, the plaintiff filed a motion for preliminary injunction.
    • Utah: In three cases, the plaintiffs filed oppositions to the defendants’ motion to dismiss and replies in support of plaintiffs’ motions for preliminary injunctive relief.
  • In two appealed cases against the government related to rebate models, the court granted appellant’s motion to consolidate the cases with other similarly situated cases, and consolidated two additional cases as cross-appeals.
  • In three appealed cases against the government related to rebate models, the appellants filed opening briefs.
  • In two cases related to the HRSA audit process, the court granted defendants’ motion [...]

    Continue Reading



read more

Opportunities in Outsourced Pharmaceutical Services

Pharmaceutical outsourcing has emerged as a robust—and rapidly growing—subsector of the life sciences industry. As the push for efficiency continues, more pharmaceutical, biotech and medtech companies are turning to contract research organizations (CROs), contract development organizations, medical affairs outsourcing and other service providers for help bringing products to market, manufacturing and distributing products, and improving quality. This trend is creating exciting new opportunities for investors in this burgeoning space.

Several factors are driving this growth in pharmaceutical services outsourcing:

  • Pharma companies are becoming more comfortable with outsourcing. Of outsourced service providers, CROs have the highest penetration, with approximately 50 percent of clinical trials outsourced. Other areas of outsourcing are far less penetrated, however, offering ample opportunity for investment. Consider researching opportunities in health economics or outcomes research market access, for example.
  • The current health care/pharma environment is rich for pharma outsourcing. Biotech is thriving: capital is readily available, and the US Food and Drug Administration regulatory environment for approval of new products is favorable. On the pharmaceutical front, ongoing consolidation has fostered an efficiency mindset. And across the health care and life sciences space, big data is being harnessed in new ways that make outsourcing easier and more efficient than ever.
  • We are in a period of great market fragmentation. The market is starting to skew toward earlier stage rather than big pharma companies. Trials also are increasingly designed with an emphasis on subpopulations and advanced analytics (such as specialty drugs targeted to specific genotypes). Traditional pharma often lacks [...]

    Continue Reading



read more

STAY CONNECTED

TOPICS

ARCHIVES

Chambers 2021 Top Ranked
U.S. News Law Firm of the Year 2022 Health Care Law
LEgal 500 EMEA top tier firm 2021
Legal 500 USA top tier firm