AstraZeneca

AstraZeneca’s AZD1390 joins GBM AGILE, a Phase 2/3 adaptive platform trial for glioblastoma, targeting newly diagnosed patients; recruitment starts Q2 2025. GBM AGILE aims to rapidly identify effective therapies through adaptive randomization and a seamless phase 2/3 design, potentially enabling new drug applications. AZD1390, an ATM kinase inhibitor, shows promise in preclinical and Phase I trials as a radiosensitizer.

EMA states two doses of anti-COVID vaccines are necessary for adequate protection against the Delta variant. Emphasis on accelerating vaccination campaigns and ordering additional doses to prevent new variant emergence. Combination of two doses from different manufacturers deemed safe and effective. Early to determine future need for additional doses due to insufficient data on vaccine protection duration.

Novartis acquires Kate Therapeutics for $1.1B, Barclays predicts challenging 2025 for European pharma, Trump picks surgeon Martin Makary to lead FDA, Novartis partners with Ratio Therapeutics for up to $745M, Kyowa Kirin pays Kura Oncology $330M upfront for leukemia drug rights, global measles cases rise 20% to 10.3 million, Brookfield considers €7B bid for Grifols, Bavarian Nordic's 2025 order book reaches €320M, FDA supports REGENXBIO's Duchenne muscular dystrophy gene therapy, Merck's subcutaneous Keytruda matches infused version, Syndax Pharmaceuticals secures FDA approval for Revuforj, Aclaris Therapeutics licenses 2 antibodies from Biosion for over $40M upfront, Sandoz to cut 10% of workforce in France, Incyte halts testing and discontinues drugs, Sage Therapeutics discontinues dalzanemdor, Johnson & Johnson and Merck announce job cuts in China, Samsung Biologics signs $668M contracts, FDA grants accelerated approval to Jazz Pharmaceuticals' Ziihera, Lexicon Pharmaceuticals cuts 60% of workforce, Halozyme withdraws €2B bid for Evotec, mpox epidemic overwhelms hospitals in Kinshasa.

Tango Therapeutics reports Q3 2024 financials, highlighting progress in PRMT5 inhibitor TNG462 clinical trials, including positive data in pancreatic and NSCLC. The company plans to advance TNG462 into combination trials with RAS(ON) inhibitors and other treatments, expecting enrollment in 1H 2025. TNG908 trial enrollment is halted to focus on TNG462. Tango also announces the appointment of Dr. Maeve Waldron-Lynch as SVP, Head of Clinical Development.

The neurodegenerative disorder therapeutics market is projected to grow from $18.53 billion in 2023 to $28.33 billion in 2028 at a CAGR of 9.0%, driven by factors like aging population, rising prevalence of neurodegenerative disorders, and strategic collaborations among pharmaceutical companies.

RDIF and Hetero to produce over 100 million Sputnik V Covid-19 vaccine doses annually in India, starting early 2021. Phase III trials ongoing in multiple countries, with over 1.2 billion doses requested globally. Efficacy of Sputnik V shown to be over 95%, with a dose cost of less than USD 10.

FDA approved zolbetuximab-clzb (Vylov) plus chemotherapy for HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma, addressing unmet need in PD-L1–low/HER2-negative patients. Routine CLDN18.2 testing is crucial for targeted therapy in previously non-targetable populations.

The FDA approved acoramidis (Attruby) for transthyretin amyloid cardiomyopathy (ATTR-CM), reducing cardiovascular death and hospitalization. Acoramidis, an orally-administered TTR stabilizer, showed a 42% reduction in mortality and recurrent hospitalization events at Month 30 in a phase 3 trial.

Perrigo received FDA approval for store brand OTC equivalent of Nexium 24HR (esomeprazole magnesium) capsules. A patent litigation settlement with AstraZeneca allows the product to launch in late September 2017, offering a high-quality, value alternative to Nexium 24HR, with annual retail sales exceeding $300 million.

Novartis raised mid-term sales guidance, Pfizer's Hympavzi approved in EU for hemophilia, AstraZeneca's Tagrisso recommended for EGFR-mutated lung cancer, J&J and Lilly report positive study data.