NOVARTIS

Propionic acid deficiency may contribute to multiple sclerosis (MS) pathology. Propionate shows beneficial effects on immune, peripheral, and central nervous systems in MS patients, potentially improving outcomes when used with immune-modulating therapy. Further large clinical trials are necessary to evaluate its efficacy and safety.

Leqvio (inclisiran) received FDA approval in 2021 for LDL-C reduction, following European approval in 2020. Novartis acquired inclisiran through a $9.7 billion deal and has since seen increased demand. In 2023, sales reached $355 million, up 217% from 2022, and are projected to hit $3.4 billion by 2030. Inclisiran works by reducing PCSK9 levels to enhance cholesterol processing. Novartis invested CHF 70 million in a dedicated siRNA production facility, which began operations in 2022, aiming to optimize production and reduce environmental impact.

DelveInsight's follicular lymphoma pipeline report highlights 50+ companies developing 55+ therapies, including key players like Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, and others. Promising therapies such as Parsaclisib, TQ-B3525, and Tafasitamab are in various clinical trial phases. Notable events include Incyte's acquisition of tafasitamab rights and Janssen's collaboration with CBMG for CAR-T therapies.

The Global KRAS Inhibitor Market is projected to grow from US$ 108.1 million in 2023 to US$ 186.4 million by 2033, driven by targeted cancer therapies and rising interest in KRAS mutations. North America leads with a 42.3% market share, while lung cancer dominates the cancer type segment. Recent FDA approvals and clinical trial successes, such as Nested Therapeutics' novel KRAS inhibitor, highlight the market's potential. High development costs and macroeconomic factors pose challenges, but growing cancer prevalence and rising collaborations offer opportunities.

Teva Pharmaceutical Industries Limited's TEVA stock declined 10% despite strong Q3 results, driven by underwhelming guidance. The company's branded drugs Austedo and Ajovy are key growth drivers, with expected sales of $1.6 billion and $500 million in 2024, respectively. Teva's generics and biosimilars pipeline is robust, with several launches expected by 2027. The company resolved opioid litigation for $4.25 billion, and its stock valuation is attractive, making it a potential buying opportunity for long-term investors.

Obe-cel (Aucatzyl) CAR T-cell therapy demonstrated durable remissions in 77% of patients with relapsed or refractory B-cell ALL in the FELIX trial, with 55% achieving complete remission. Median event-free survival was 11.9 months, and overall survival was 15.6 months. Obe-cel showed low severe toxicity, supporting its safety and efficacy.

Pharmaceutical companies conduct most clinical trials in countries where they plan to market products, often neglecting low and middle-income countries (LMICs), particularly in sub-Saharan Africa. This exclusion limits access to life-saving treatments and therapies for patients in these regions. The Access to Medicine Foundation report highlights a gap in product registration in Africa, with 43% of innovative products approved in the past five years not registered in any African countries. The report calls for pharmaceutical companies to prioritize equitable access and work with local partners to build research capabilities in LMICs.

Novartis receives EC approval for Kisqali (ribociclib) to treat early breast cancer at high risk of recurrence. Kisqali, a CDK inhibitor, is now approved in combination with an aromatase inhibitor for HR+/HER2- EBC patients. The approval is based on the Phase 3 NATALEE trial, showing a 25.1% reduction in disease recurrence risk with Kisqali plus endocrine therapy compared to endocrine therapy alone.

The global pharmaceutical CDMO market was valued at USD 184.90 billion in 2024 and is projected to reach USD 368.70 billion by 2034, driven by a CAGR of 7.2%. Key players include Pfizer, Biocon Biologics, and Thermo Fisher Scientific. Services offered by CDMOs include antibody production and vaccine development, operating under GMP and cGMP standards. The Asia Pacific region leads with a 42.4% market share, while Europe is expected to grow at a CAGR of 7.7%.