Amgen, Inc.

Two new drugs, an siRNA and an oral agent, reduced Lp(a) by 80% in phase II studies. Zerlasiran, the siRNA, lowered Lp(a) by 85% over 36 weeks, while muvalaplin, the oral agent, reduced Lp(a) by 70% with a traditional assay and over 85% with an intact assay. Both therapies offer potential for treating cardiovascular disease, with muvalaplin providing an oral alternative to injectables.

Muvalaplin, an oral drug, significantly reduced lipoprotein(a) (Lp[a]) by 70% in a traditional blood test and 85.5% in a new test, according to a phase 2 study presented at the 2024 AHA Scientific Sessions. The drug, developed by Eli Lilly, targets Lp(a), a genetically driven variant of LDL cholesterol linked to cardiovascular disease, with no current treatments. Muvalaplin disrupts the bonding of apo(a) to apoB, preventing Lp(a) formation, and also reduced oxidized phospholipids. The study involved doses of 10 mg, 60 mg, and 240 mg over 12 weeks, with 97% of participants achieving Lp(a) levels below 125 nmol/L. Phase 3 trials and cardiovascular outcomes trials are next steps before market potential.

Amgen presents new data on UPLIZNA for IgG4-RD and KRYSTEXXA for uncontrolled gout at ACR Convergence 2024, highlighting reduced disease activity and shorter infusion times.

OpenAI collaborates with Broadcom and TSMC for custom AI chips, Leonardo and Rheinmetall form joint venture for European tank production, drug makers race for GLP-1 breakthroughs, Rio Tinto to acquire Arcadium Lithium, big tech continues data center buildouts, Tesla unveils Cybercab and robovan.

Pharmaceutical Outsourcing releases documentary 'Transforming Drug Development: Accelerating Clinical Trials through Patient-Centric Innovations and Technological Breakthroughs,' exploring how patient-centric approaches and technology are revolutionizing drug development.

Teprotumumab-trbw (Tepezza) approved by FDA in 2020 for thyroid eye disease (TED) shows promising real-world outcomes, reducing need for retreatments and orbital decompression surgeries. A study by Ugradar et al. found a 24% retreatment rate among 119 patients, with age being the only significant factor for retreatment. Another study by Topilow and Kikkawa showed a decline in orbital decompression surgeries post-teprotumumab treatment, indicating its effectiveness as a less invasive option for many TED patients.

Samsung Bioepis received a positive opinion from the EMA's CHMP for marketing authorization of Obodence and Xbryk, biosimilars of Amgen’s Prolia and Xgeva. The company expects final EC approval within two to three months, allowing the products to enter the European market. Clinical trials demonstrated equivalence in efficacy and safety to the reference drugs.

Sarilumab more effective than methotrexate in enabling steroid taper in polymyalgia rheumatica patients, according to ACR Convergence 2024 data.

Pharma companies race to develop weight-loss pills as effective as injectables like Ozempic, Wegovy, Mounjaro, and Zepbound. Novo Nordisk, Eli Lilly, Viking Therapeutics, and others report promising trial results. GLP-1 drugs, while revolutionary, require weekly injections and face supply issues. Dozens of new weight-loss medications are in development, aiming for faster effects, pill forms, or longer-lasting injectables. Leading candidates include Eli Lilly's retatrutide (Triple-G), Viking Therapeutics' VK2735, Eli Lilly's orforglipron, Novo Nordisk's CagriSema, and Amgen's MariTide, with potential market value forecast at $100 billion.

Samsung Bioepis received positive opinions from EMA's CHMP for biosimilars 'Ovodence' and 'Xbrick' of Prolia and Xziva. Expected to receive official sales permission from EC within two to three months, expanding biosimilar lineup in Europe to 11 types.