Skye Bioscience’s nimacimab blocks CB1, the same receptor targeted by an obesity drug candidate now in the hands of Novo Nordisk. But Skye contends its Phase 2-ready antibody drug has several advantages over the small molecule that joined Novo’s pipeline in a deal valued at $1 billion.

The post Skye Bioscience Falls Short in Glaucoma Trial, But It’s Full Steam Ahead for Obesity Program appeared first on MedCity News.

Eli Lilly says its capital commitment to its new Indiana site is the largest manufacturing investment in the company’s history. The site will make tirzepatide, the active pharmaceutical ingredient in both Zepbound and Mounjaro.

The post Eli Lilly Pumps $5.3B More Into Site for Making Metabolic Meds Zepbound & Mounjaro appeared first on MedCity News.

Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.

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Amgen is confident its injectable obesity drug would have a differentiated profile compared to medications now on the market from Novo Nordisk and Eli Lilly and it’s now preparing for Phase 3 testing. But an oral obesity drug in Amgen’s pipeline will not advance beyond Phase 1.

The post Amgen Puts Its Weight Behind Obesity Drug With Potential Edge Over Lilly, Novo Nordisk Meds appeared first on MedCity News.

Blockbuster Novo Nordisk drug Ozempic now has clinical trial results showing statistically significant reductions in the risk of kidney disease progression. The company said these results support the expansion of the drug’s label to chronic kidney disease.

The post New Novo Nordisk Ozempic Data Build Case for Adding Kidney Disease to Label appeared first on MedCity News.

The weight loss achieved by Viking Therapeutics’ obesity drug tops results posted by Eli Lilly’s Zepbound in its pivotal test. But Viking still needs to show its results can hold up in a larger Phase 3 clinical trial.

The post Viking Therapeutics Obesity Drug’s Data Raise Best-in-Class Expectations appeared first on MedCity News.

Preliminary Phase 2 results show 83% of those treated with Boehringer Ingelheim and Zealand Pharma drug survodutide met the main goal of improvement in the fatty liver disease MASH. Boehringer contends this drug has best-in-class potential in a competitive field that includes an Eli Lilly drug that recently posted positive Phase 2 results.

The post Boehringer Ingelheim’s Liver Drug Data Position It for MASH Clash With Eli Lilly appeared first on MedCity News.

Eli Lilly reported 74% of patients treated with tirzepatide achieved resolution of metabolic dysfunction-associated steatohepatitis, or MASH. However, the Phase 2 results showed only “clinically meaningful” improvement in resolving liver fibrosis, a key measure of the drug’s potential competitiveness in a crowded field of contenders.

The post Eli Lilly Fatty Liver Drug Posts Promising Early Data, But Field Is Still Competitive appeared first on MedCity News.

After Novo Holdings acquires Catalent, it will sell three of the contract manufacturing giant’s sites to Novo Nordisk. Those facilities already make Novo Nordisk’s GLP-1 drugs for metabolic conditions, and they will help the company meet projected demand for these products in years to come.

The post Novo Holdings Bolsters GLP-1 Production Capacity With $16.5B Catalent Buyout appeared first on MedCity News.

Fractyl Health will use the IPO proceeds for pivotal testing of a medical device and surgical procedure intended to address root causes of diabetes and obesity. The Fractyl pipeline also includes a gene therapy for these conditions.

The post Metabolic Disorder-Focused Fractyl Health ‘GUTS’ Out a $110 Million IPO appeared first on MedCity News.

Roche’s Carmot Therapeutics acquisition brings three clinical-stage assets that the companies say could be best-in-class drugs for metabolic disorders. In addition to standalone use, Roche sees the Carmot molecules as part of potential combinations with its own drug candidates.

The post Roche Lines Up $2.7B Acquisition to Join Chase for New Diabetes, Obesity Drugs appeared first on MedCity News.

Novo Nordisk’s planned expansion will more than double the footprint of its France production site, bringing new capacity for manfacturing GLP-1 drugs for metabolic conditions. The location is already one of the company’s largest for making diabetes products.

The post Novo Nordisk Plans €2B Site Expansion as GLP-1 Drug Demand Grows appeared first on MedCity News.

Carmot Therapeutics isn’t the first company targeting both the GLP-1 and GIP receptors to treat metabolic diseases. But the company contends that biased signaling—activating certain pathways but not others—is key to setting its drugs apart from others in the same class.

The post Carmot’s IPO Filing Makes Case for Bias in Drugging Key Obesity, Diabetes Targets appeared first on MedCity News.

The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes.

The post Novo Nordisk Strikes Deal for Late-Stage Hypertension & Kidney Disease Drug appeared first on MedCity News.

A study testing Novo Nordisk’s semaglutide in chronic kidney disease is ending early after an interim analysis met efficacy goals. Detailed results are not yet available, but they could support expanding use of the GLP-1 agonist, which is far and away Novo Nordisk’s top-selling product.

The post Novo Nordisk’s Star Diabetes & Obesity Drug Shows Promise in Kidney Disease appeared first on MedCity News.

Ionis Pharmaceuticals’ olezarsen has Phase 3 results showing the therapy handily beat a placebo at reducing fat levels in the blood due to a rare, inherited metabolic disorder with no FDA-approved drugs. Ionis plans early 2024 submissions for what could become the first medicine it commercializes without a partner.

The post Ionis Posts Trial Data in Rare Disease That Position It to Finally Set Out on Its Own appeared first on MedCity News.

Sanofi is acquiring rights to a Maze Therapeutics drug candidate for Pompe disease that could give the pharmaceutical giant another option to offer patients who have the rare metabolic disorder. In February, the drug posted positive data from a Phase 1 study.

The post Sanofi Finds Way to Maze Therapeutics to Get Its Next Pompe Disease Drug appeared first on MedCity News.

A Madrigal Pharmaceuticals drug for the fatty liver disease NASH has data from a pivotal clinical trial showing improvements in the organ. Based on those results, which sent Madrigal’s stock price soaring more than 200%, the biotech is planning to seek what could become the first regulatory approval of a therapy for this metabolic disorder.

The post Madrigal Drug Meets FDA’s Twin Goals for NASH, Paving Way for FDA Filing appeared first on MedCity News.

Novo Nordisk is acquiring global rights to a Ventus Therapeutics drug candidate with potential applications in cardiometabolic disorders such as NASH and chronic kidney disease. The small molecule blocks a protein that has become an attractive target for big pharmaceutical companies, such as Roche and Novartis.

The post Novo Nordisk pays $70M for a Phase 1-ready cardiometabolic disorder drug appeared first on MedCity News.

Rivus Pharmaceuticals’ Series B round will finance ongoing clinical development of its lead drug, a pill that targets mitochondria to increase caloric expenditure. CEO Allen Cunningham said the new cash comes on the heels of results from a mid-stage obesity study showing treatment with the Rivus drug led to fat loss while also preserving skeletal muscle.

The post Fat-shedding pill’s data lead to a $132M funding round for startup Rivus Pharma appeared first on MedCity News.

Harvard University spinout GRO Biosciences has technology offering the potential for protein therapies that are safer and more effective than currently available biologic drugs. The startup’s research is now backed by $25 million, a Series A financing round whose investors include the venture arm of Bayer.

The post Synbio startup GRObio gets $25M to work with new building blocks for protein drugs appeared first on MedCity News.

ShouTi Pharmaceuticals, a startup that brings computational techniques to drug discovery, has raised $100 million in Series B financing. The clinical-stage biotech designs small molecules intended to do the work of biologic and peptide drugs.

The post ShouTi secures $100M to hit biologic and peptide targets with small molecules appeared first on MedCity News.

Takeda Pharmaceutical is partnering with startup Immusoft in a research alliance aiming to develop B cell therapies that cross the blood-brain barrier to treat rare neurometabolic disorders. Depending on the progress of the research, Takeda could pay its new partner more than $900 million.

The post Taking aim at the brain, Takeda strikes up cell therapy R&D alliance with Immusoft appeared first on MedCity News.

Cross-border biotech Anji Pharma closed $70 million in Series B funding to advance a drug pipeline that includes metabolic and cancer drugs. The biotech’s business model of finding promising drugs and forming subsidiaries to develop them is similar to approaches taken by Roivant Sciences and BridgeBio Pharma, among others.

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Atavistik Bio is one of several companies discovering and developing drugs that work by allostery, binding to less obvious sites of a target protein. Acting CEO John Josey said the startup aims to stand apart with its focus on understanding metabolic interactions, a path less trodden by others in allosteric drug discovery.

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