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Expert Analysis

• CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits

  

  Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.

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  Running Marathons Makes Me A Better Lawyer

  

  After almost five years of running marathons, I’ve learned that both the race itself and the training process sharpen skills that directly translate to the practice of law, including discipline, dedication, endurance, problem-solving and mental toughness, says Lauren Meadows at Swift Currie.

• 3 Takeaways From Recent Cyberattacks On Healthcare Cos.

  

  For the healthcare industry, the upward trend in styles of cyberattacks, costs, and entities targeted highlights the critical importance of proactive planning to help withstand the operational, legal and reputational turmoil that can follow a data breach, say attorneys at Troutman Pepper.

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  Law School's Missed Lessons: Supporting A Trial Team

  

  While students often practice as lead trial attorneys in law school, such an opportunity likely won’t arise until a few years into practice, so junior associates should focus on honing skills that are essential to supporting a trial team, including organization, adaptability and humility, says Lucy Zelina at Tucker Ellis.

• FAR Rewrite May Cloud Key Gov't Contract Doctrine

  

  The Trump administration's government procurement overhaul, under which sections of the Federal Acquisition Regulation are eliminated by default, is bound to collide with a doctrine that allows courts to read omitted clauses into government contracts if they represent long-standing pillars of federal procurement law, say attorneys at Rogers Joseph.

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  Adapting To Private Practice: From US Attorney To BigLaw

  

  When I transitioned to private practice after government service — most recently as the U.S. attorney for the Eastern District of Virginia — I learned there are more similarities between the two jobs than many realize, with both disciplines requiring resourcefulness, zealous advocacy and foresight, says Zach Terwilliger at V&E.

• Most-Favored Nation Drug Pricing Could Shake Up US Pharma

  

  Recent moves from the executive and legislative branches represent a serious attempt to revive and refine the first Trump administration's most-favored-nations model for drug pricing, though implementation could bring unintended consequences for pharmaceutical manufacturers and will likely draw significant legal opposition, say attorneys at Morgan Lewis.

• The Ins And Outs Of Consensual Judicial References

  

  As parties consider the possibility of judicial reference to resolve complex disputes, it is critical to understand how the process works, why it's gaining traction, and why carefully crafted agreements make all the difference, say attorneys at Pillsbury.

• How Focus On Menopause Care Is Fueling Innovation, Access

  

  Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.

• Opinion

  The BigLaw Settlements Are About Risk, Not Profit

  

  The nine Am Law 100 firms that settled with the Trump administration likely did so because of the personal risk faced by equity partners in today's billion‑dollar national practices, enabled by an ethics rule primed for modernization, says Adam Forest at Scale.

• Neb.'s Cannabis Regulatory Void Poses Operational Risks

  

  With the Nebraska Legislature recently declining to advance any cannabis legislation, leaving the state without a regulatory framework for voter-passed initiatives, the risks of operating without clear rules will likely affect patients, providers and caregivers, says John Cartier at Omnus Law.

• Del. Dispatch: A Look At Indemnification Notice Provisions

  

  The Delaware Supreme Court's recent decision in Thompson Street Capital Partners v. Sonova U.S. Hearing Instruments serves as a reminder that noncompliance with contractual requirements for an indemnification claim notice may result in forfeiture of the indemnification right, depending on both the agreement language and the circumstances, say attorneys at Fried Frank.

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  Brazilian Jiujitsu Makes Me A Better Lawyer

  

  Competing in Brazilian jiujitsu – often against opponents who are much larger and younger than me – has allowed me to develop a handful of useful skills that foster the resilience and adaptability necessary for a successful legal career, says Tina Dorr of Barnes & Thornburg.

• FDA Commissioner Speech Suggests New Vision For Agency

  

  In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.

• AG Watch: Texas Expands Use Of Consumer Protection Laws

  

  In recent years under Attorney General Ken Paxton, Texas has demonstrated the breadth of its public interest authority by bringing actions in areas not traditionally associated with consumer protection law, including recent actions involving sports and public safety, say attorneys at Kelley Drye.