JAZZ PHARMACEUTICALS FRANCE

Ziihera, the first FDA-approved dual HER2-targeted bispecific antibody for HER2+ (IHC 3+) BTC, is now available in the U.S. It is recommended by the NCCN Guidelines as a category 2A treatment option for BTC, based on a 52% objective response rate and median duration of response of 14.9 months from the HERIZON-BTC-01 trial. Continued approval may depend on verification of clinical benefit in a confirmatory trial.

Jazz Pharmaceuticals to host a webcast on December 11, 2024, to discuss Ziihera® (zanidatamab-hrii), a chemotherapy-free dual HER2-targeted bispecific antibody for biliary tract cancer (BTC), approved by the FDA on November 20, 2024.

Jazz Pharmaceuticals to host a webcast on Dec 11, 2024, to discuss Ziihera® (zanidatamab-hrii), a chemotherapy-free dual HER2-targeted bispecific antibody for biliary tract cancer (BTC), approved by the FDA on Nov 20, 2024.

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Neuropsychiatric research is experiencing a resurgence driven by high unmet medical needs, personalized medicine, and novel mechanisms of action. New treatments like SIRT6 activators and GLP-1 agonists target fundamental disease causes. AI advancements aid in early drug candidate evaluation, while subpopulation studies focus on personalized medicine. Objective measures of disease progression, such as digital technologies and biomarkers, are replacing traditional subjective scales. This shift towards personalized medicine aims to improve treatment efficacy and tolerability for neuropsychiatric disorders.

Jazz Pharmaceuticals (JAZZ) posted Q3 top-and-bottom-line beats, projecting 2024 earnings above expectations, driven by sales growth from Xywav and Epidiolex. The company received accelerated approval for Ziihera, a treatment for HER2-positive biliary tract cancer, and anticipates phase 3 PFS results on Zanidatamab. JAZZ trades at a discount to peers, making it attractive for value investors.

Avextra Portugal launches an in-house breeding program to develop proprietary cannabis varieties with specific cannabinoid and terpene profiles, aiming for consistency and scalability in pharmaceutical production. Led by industry experts, the program uses 5,000 seeds over two years, with 600 already germinated, focusing on stable cannabinoid output, terpene selection, cultivation environment optimization, and extraction efficiency. This initiative aligns with Avextra’s commitment to advancing safe and effective cannabis-based medicines.

AstraZeneca terminated OUD drug AZD4041 development due to drug-drug interaction with antifungal itraconazole. Despite challenges, non-opioid medications are under development, but efficacy data is lacking. Opioid agonist therapies are expected to drive $1.75 billion in sales by 2033, reflecting patient preference and lack of alternatives. KOLs view OUD as a relapsing-remitting disorder, naturally inclined towards opioid use, making non-opioid treatments only adjunctive. The market lacks effective non-opioid therapies, but a strong profile could disrupt the OUD market.

FDA approves Roche’s PATHWAY anti-HER2/neu (4B5) test for biliary tract cancer, identifying patients eligible for targeted therapy ZIIHERA, potentially improving clinical outcomes.