Breaking News: Amgen-Horizon Partnership Gains Momentum, Top 10 Medications Enter IRA Price Talks, Workforce Changes, and More Unveiled!

In a whirlwind week of regulatory developments, the stage was set for high-stakes battles in the pharmaceutical world. On Friday, the Federal Trade Commission granted Amgen the green light for its audacious $27.8 billion Horizon therapeutics acquisition. But it wasn’t all smooth sailing – this clearance came with a twist. Amgen was sternly cautioned against bundling its products with Horizon’s Tepezza or Krystexxa, a move the FTC argued could stifle competition in the industry.

Then, on Tuesday, the Biden administration unleashed a game-changing announcement, revealing the inaugural roster of ten drugs that would be thrust into intense Medicare price negotiations with pharmaceutical giants. This groundbreaking initiative, birthed from the pages of the Inflation Reduction Act (IRA), marked the opening salvo in a fierce battle to save the federal government an estimated $25 billion in drug costs.

The initial selection of ten drugs unveiled by Medicare did little to shock the industry, encompassing a range of treatments for ailments such as diabetes and cancer. However, the numbers spoke volumes. A staggering $50 billion was attributed to these medications from mid-2022 to mid-2023, with Johnson & Johnson’s trio—Imbruvica, Stelara, and Xarelto—commanding the lion’s share at over $11 billion. Mara Goldstein, the insightful managing director of Mizuho Securities, hinted at a twist in the tale, suggesting that many of these drugs might soon lose their exclusive status, with J&J already bracing for Stelara biosimilars in 2025, just as Medicare negotiations kick in during 2026.

In a fierce showdown, AbbVie faced mounting pressure from eight Humira biosimilars, with Amgen’s Amjevita leading the charge after its debut in January 2023. Not to be underestimated, Alvotech re-entered the ring, resubmitting its BLA to the FDA in pursuit of an interchangeability designation for their high-concentration biosimilar version of AbbVie’s Humira, despite two prior setbacks.

Meanwhile, after the FDA’s recent rejection of zuranolone in treating major depressive disorder, Sage Therapeutics orchestrated a dramatic strategic overhaul. A seismic 40% workforce reduction was announced, with the aim of funneling resources towards bolstering their commercial team, a critical move in support of zuranolone’s launch for postpartum depression, bearing the brand name Zurzuvae. The pharmaceutical world is undeniably in the throes of a riveting transformation.

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