WORLD HEALTH ORGANIZATION

Novo Holdings completes $16.5B Catalent Pharma Solutions buyout. Merck pays $112M upfront for obesity pill. Ottimo Pharma raises $140M for cancer therapy. Novo Nordisk invests $1.2B in Denmark factory. Angitia Biopharmaceuticals raises $120M for musculoskeletal candidates. Novartis closes MorphoSys sites, laying off 330. SiteOne Therapeutics secures $100M for non-opioid pain drugs. Novo Nordisk's obesity drug underperforms. Bristol Myers Squibb invests $100M in BioArctic's Alzheimer antibodies. Sudan's healthcare collapses. Tonix Pharmaceuticals files NDA for fibromyalgia drug. Neurocrine Biosciences wins FDA approval for Crenessity. Edgewise Therapeutics discusses accelerated approval for Becker muscular dystrophy. FDA places partial hold on PepGen's Duchenne therapy. Checkpoint Therapeutics' immunotherapy approved. WHO opens Academy in Lyon. GSK's Jemperli earns FDA Breakthrough status. Sanofi's duvakitug shows remission in ulcerative colitis. Sandoz agrees to $275M settlement over drug pricing. Pfizer projects 2025 earnings. Mesoblast's Ryoncil approved as 1st MSC therapy for graft-vs-host disease.

Pitt announces the Vijayalakshmi Innovation Center in Women’s Health Analytics and Research (VIHAR), an AI-based global initiative aimed at improving women’s health care. Funded by a $10 million pledge from Vishnu Vardhan and Harsha Vardhini, VIHAR will focus on creating a comprehensive female digital health twin and reducing health disparities. The center will be led by Vanathi Gopalakrishnan and build on progress from the Pattern Recognition from Biomedical Evidence (PRoBE) laboratory.

Philanthropists Ginny L. Clements and Tom Rogers commit $2 million to the Sarver Heart Center at the University of Arizona College of Medicine – Tucson to establish a cardiovascular research institute. The center aims to raise $75 million, with a $25 million challenge gift contingent on raising $50 million over five years. The institute will focus on heart health, disease prevention, and treatment, aiming to become a leader in cardiovascular research.

CanSino Biologics Inc. initiated Phase I/II trials for its Recombinant Poliomyelitis Vaccine (CS-2036) in Indonesia, enrolling the first trial patient. CS-2036, a non-infectious polio VLP vaccine, leverages the company's protein structure design and VLP assembly technology, offering good safety and immunogenicity. The trials aim to assess CS-2036's safety and immunogenicity in infants and toddlers.

The Pediatric Clinical Trials Market is projected to grow from US$ 20.1 Billion in 2023 to US$ 33.0 Billion by 2033, with a CAGR of 5.0%. North America led in 2023 with a 39.10% share. Challenges include ethical concerns, limited recruitment, and high costs. Innovations like adaptive trials and digital technologies are enhancing efficiency.

Breckenridge Pharmaceutical Inc announced FDA approval for its Methadone hydrochloride injection, 200 mg/20 mL, to be launched immediately. The product is for managing severe pain requiring extended opioid treatment and temporary opioid dependence in non-oral medication patients. This launch aligns with the company's strategy to expand in the institutional channel and enhance its portfolio, reflecting commitment to innovation and growth in healthcare.

LimmaTech Biologics AG announced FDA Fast Track designation for LBT-SA7, a multivalent toxoid vaccine candidate to prevent skin and soft tissue infections caused by Staphylococcus aureus. The designation aims to expedite development and review, addressing urgent medical needs. LBT-SA7, targeting over 1 million annual deaths from S. aureus, will undergo Phase 1 trials in the U.S. to assess safety and immunogenicity, with results expected in 2025.

The U.S. is supporting global mpox response with $500M and 1M vaccine doses, focusing on vaccine distribution, testing, and treatment in affected countries like the DRC. Domestically, the U.S. is prepared for clade I and II mpox cases with early detection, increased clinician education, and widely available vaccines. The risk to the general public remains low.

Two studies in the New England Journal of Medicine show 6 months of levofloxacin preventive treatment in household contacts of MDR-TB patients resulted in non-significant TB incidence reductions. A meta-analysis found a 60% relative reduction in TB incidence with levofloxacin, though it increased musculoskeletal adverse events. The WHO now strongly recommends 6 months of daily levofloxacin for contacts exposed to MDR or rifampicin-resistant TB.

Chikungunya virus outbreaks are prevalent in tropical regions; WHO confirms mosquito-transmitted CHIKV outbreaks in 115 countries. PAHO reports 421,000 CHIKV cases and 211 fatalities in the Americas in 2024. Bavarian Nordic's CHIKV VLP vaccine candidate, targeting ages 12+, awaits potential EU approval in H1 2025 and U.S. FDA approval in 2025. The vaccine offers rapid onset of protection within two weeks and is delivered in pre-filled syringes for ease of use.