FDA moves to nix Lilly, Novo's weight-loss drugs from compounding listAmvuttra ignites strong quarter for AlnylamLEO Pharma buys Replay and its gene therapy platformAstraZeneca picks up Pinetree's protein degraderGLP-1 boom pushes US drug spend toward $1 trillionFDA moves to nix Lilly, Novo's weight-loss drugs from compounding listThe FDA on Thursday proposed excluding Novo Nordisk's semaglutide and Eli Lilly's tirzepatide from the 503B bulks list, which features drug substances that facilities may compound. If a drug is not on the 503B bulks list or the drug shortage list, outsourcing facilities typically are not allowed to compound its active ingredient.As both GLP-1 products have been removed from the FDA's shortage list, their exclusion from the 503B bulks list could potentially stop outsourcing facilities from mass producing compounded versions of the drugs — representing a major win for Novo and Lilly, which have both attempted to crack down on compounders. The companies' shares rose 5% and 10%, respectively, on Thursday. "When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need," said FDA Commissioner Marty Makary. The agency is inviting relevant parties to submit comments until June 29. -Elizabeth EatonAmvuttra ignites strong quarter for AlnylamAlnylam Pharmaceuticals blew past analyst expectations in the first quarter due to the continued rapid ascent of its transthyretin (TTR) amyloidosis medicine Amvuttra (vutrisiran). The RNAi therapy saw sales surge 187% year-over-year to $889.9 million."This is the fourth full quarter of Amvuttra's launch in ATTR-cardiomyopathy (ATTR-CM) and this quarter's performance should give investors confidence in the full-year TTR franchise revenue guide, in our view," said William Blair analyst Myles Minter.Overall sales for the quarter were up 121% and totaled over $1 billion, easily surpassing consensus of $594.2 million. Alnylam reiterated its guidance for the year, calling for $4.9 billion to $5.3 billion in revenues, including total TTR drug sales of $4.4 billion to $4.7 billion.-Anna BratulicLEO Pharma buys Replay and its gene therapy platformLEO Pharma on Thursday moved to buy gene therapy firm Replay and its high‑payload herpes simplex virus (HSV) delivery vector technology for $50 million upfront. LEO CEO Christophe Bourdon said the company identified Replay as an acquisition target with its "unique AI‑powered scouting platform, Innoviewer."According to LEO, Replay's focus on rare genetic dermatological conditions aligns with its internal skin disease pipeline. The biotech's lead candidate is in preclinical testing for dystrophic epidermolysis bullosa; the gene therapy is formulated as a topical gel that targets the deficient gene when applied directly to the skin."Natural tropism for skin cells and the ability to redose patients make HSV uniquely suited to treating rare genetic dermatological conditions," said Replay CEO Lachlan MacKinnon. The biotech is eligible for undisclosed milestones, plus tiered single-digit royalties.-Elizabeth EatonAstraZeneca picks up Pinetree's protein degraderAstraZeneca on Thursday exercised its option to exclusively license Pinetree Therapeutics' PTX-299, a bispecific antibody degrader targeting EGFR in development for drug-resistant tumours; the decision triggers a $25-million payment to the biotech. Moving forward, the UK pharma will be responsible for the candidate's development and commercialisation. In 2024, AstraZeneca handed over $45 million in upfront and near-term payments for an exclusive option to license Pinetree's preclinical protein degrader. Under the deal, the biotech is eligible for more than $500 million in milestones, plus tiered royalties.Developed with Pinetree's AbReptor platform, PTX-299 is designed to selectively eliminate EGFR proteins and overcome key resistance mechanisms. Instead of inhibiting proteins like traditional mAbs, the candidate eliminates both membrane-bound and extracellular disease-driving targets via degradation.-Elizabeth EatonGLP-1 boom pushes US drug spend toward $1 trillionUS prescription drug spending is on track this year to cross $1 trillion for the first time, propelled by explosive demand for new weight-loss drugs, according to a report from the American Society of Health-System Pharmacists (ASHP). Total spending jumped 12.7% from 2025's spend of $915 billion, one of the sharpest increases in two decades. The surge is being driven by popular GLP-1 therapies, with Eli Lilly's tirzepatide and Novo Nordisk's semaglutide each generating roughly $60 billion in spending; that's more than twice the amount spent on the anticoagulant Eliquis (apixaban), which came in at $29 billion to claim third place. "GLP-1s have fundamentally reshaped the drug-spending landscape," said Eric Tichy, lead author of the report. "At $132 billion, this single class of drugs accounted for nearly one-third of all growth and is moving the entire market. And we are still on the steep part of the curve."According to the report, these drugs now make up around 14% of all US prescription drug spending, a figure that doesn't include direct-to-consumer sales, meaning the true market impact is likely even greater. The ASHP report attributes the growth primarily to more patients taking more medicines, rather than rising prices.-Anna Bratulic
