HIKMA PHARMACEUTICALS

Hikma Pharmaceuticals and Celltrion Inc. have signed exclusive licensing agreements to bring six biosimilar treatments to the Middle East and North Africa region.

Amgen and Accord BioPharma reached a settlement agreement on July 16, 2025, resolving patent litigation over Accord's denosumab biosimilar INTP23, with Accord agreeing to delay U.S. market entry until October 1, 2025.

Hikma Pharmaceuticals received FDA approval for TYZAVAN™, the first ready-to-infuse vancomycin formulation that requires no preparation, targeting critical sepsis treatment where survival rates decrease by 15% after 87-113 minutes.

Hikma Pharmaceuticals USA announces a $1 billion investment by 2030 to expand its US manufacturing and R&D capabilities for generic medicines.

Amgen filed three separate BPCIA patent infringement lawsuits in late June 2025 against companies developing denosumab biosimilars, including Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon.

Bio-Thera Solutions has dosed the first patient in a pivotal phase 3 trial for BAT8006, an antibody-drug conjugate targeting folate receptor α for platinum-resistant ovarian cancer treatment.

Novo Nordisk permanently forfeited Canadian patent protection for semaglutide after failing to pay a routine $450 maintenance fee in 2019, clearing the path for generic competitors.

Hikma Pharmaceuticals has acquired Novugen's FDA-approved ANDA for trametinib tablets, the generic version of Mekinist®, with 180 days of US market exclusivity upon launch.

Jazz Pharmaceuticals will pay $145 million to settle allegations of anti-competitive practices related to its narcolepsy drug Xyrem, while denying all wrongdoing in the class action lawsuit.

Health Canada has approved KLOXXADO® (naloxone HCl) Nasal Spray 8 mg for treating known or suspected opioid overdoses in adults, providing a higher-dose alternative to existing treatments.