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Metabolic Disorders

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

Amgen Under Pressure, But Seeing Gains Ahead Of Obesity Readouts

MariTide could give Amgen a big boost if successful in obesity, but the drug just entered Phase III. Even so, Q1 revenue rose 9% to $8.15bn and more growth is expected in 2025.

Zepbound Grows, But CVS/Novo Nordisk Deal For Wegovy Casts Shadow

Lilly executives told the company’s Q1 call they were not surprised at the Wegovy deal, but some analysts said it could cut into prescription growth for Zepbound.

Semaglutide For MASH Among Raft Of New EU Filings

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

Richard DiMarchi On The GLP-1 Revolution: An Overnight Success After 40 Years

As GLP-1 agonists surge to blockbuster status transforming diabetes and obesity treatment, Richard DiMarchi, the pioneering scientist behind their development, recounts the inside story of the drug class in a fireside chat.

Biolinq’s $100M In Series C Financing Supports Efforts To Bring Diabetic Glucose Monitoring With Needle-Free Patch To Market

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

Antag Therapeutics: Developing Peptide-Based Treatments For Obesity Management

Antag CEO Joerg Moeller talked to In Vivo about the young company’s gilded roots, and how its GIP receptor antagonist asset will differentiate in the crowded obesity market.

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

Roche Means Business With Biggest Ever Obesity Pact

The Swiss giant has inked a deal potentially worth $5.30bn with Zealand to access the Danish biotech's long-acting amylin analog petrelintide.

Novo’s Low-Cost Wegovy Offers Alternative To Compounders For Self-Pay Crowd

Novo is making Wegovy available through a new direct-to-patient delivery option for individuals paying out of pocket for the obesity drug as the potential end of semaglutide compounding nears.

AbbVie Buys Into Obesity With Gubra Deal, While Novo Partners With Gensaic

AbbVie is the latest big pharma to buy into the obesity space, licensing an amylin analog from Gubra for $350m up front, while Novo will pursue cardiometabolic targets with Gensaic’s AI-based platform.

Major Public Health Interest? Scholar, Insmed & Soleno Ask EMA To Fast-Track Their Products

The European Medicines Agency is considering whether apitegromab, brensocatib and diazoxide choline, from Scholar, Insmed and Soleno respectively, are drugs that are of potential major public health interest, particularly from the point of view of therapeutic innovation.