PharmaLive

The U.S. Food and Drug Administration has agreed to review Swiss generics ​drugmaker Sandoz’s (SDZ.S) two generic tirzepatide GLP-1s that, ‌if approved, would rival obesity drugs made by Eli Lilly (LLY.N). With Eli Lilly’s tirzepatide patent running out ​in 2036 in the U.S., makers of alternative ​drugs are fighting for a share of ⁠the weight loss market.

There’s no shortage of industry events celebrating what’s next in healthcare technology. But the ones that stay with me are the ones that never lose sight of the person at the center of it all. Omnicom Health’s NEXT: Innovation Week 2026 was one of those events.

Model N has acquired Kalderos, a technology company that provides a gross-to-net (GTN) intelligence platform with rich capabilities for driving visibility into 340B drug discount programs. The acquisition will expand Model N’s capabilities as a leading revenue management platform for life sciences manufacturers and extend its 340B offerings to better serve customers.

FDA has approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older. “The approval marks a meaningful milestone for the treatment of influenza,” said Iilun Murphy, M.D., Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research.

DeepIntent today launched Helix AI, the first agentic AI platform purpose-built for healthcare marketers. Helix AI unlocks market insights buried within the industry’s most trusted and comprehensive health datasets, enabling marketers to strategize and engage key audiences with unprecedented precision across DeepIntent’s DSP as well as other channels, such as social platforms.

Rhythm Pharmaceuticals’ weight loss injection Imcivree lowered body mass index in a Phase 2 study of Prader-Willi syndrome, helping the drug bounce back from a recent late-stage disappointment. Already approved for a handful of conditions associated with obesity, Imcivree (setmelanotide) is Rhythm’s only marketed drug, bringing in $194.8 million in 2025. Aside from Prader-Willi syndrome, the biotech is also advancing Imcivree for a host of other rare and genetic obesities.

Amgen has requested a hearing with the FDA over the agency’s insistence that Amgen pull its rare inflammatory disease drug Tavneos from the market—and this time, the company is bringing in help from the Duke Clinical Research Institute. The pharma has asked Duke researchers to conduct an “independent and fully blinded re-adjudication” of data from the ADVOCATE trial, according to a June 1 letter to the FDA, which was posted online on Thursday.

Novartis (NOVN.S) said on Thursday an experimental drug, which it acquired ​as part of its $12 billion takeover of ‌Avidity, showed promise in an early-to-mid-stage study in patients with a type ​of genetic muscle disorder characterized ​by slowly progressive muscle weakness. • The Swiss ⁠drugmaker said the drug, known as ​del-brax, lowered two blood markers linked ​to the disease and showed reduced signs of muscle damage in patients with facioscapulohumeral ​muscular dystrophy.

Today Novo Nordisk issued an alert about an IT security incident that involved unauthorized access to internal IT systems. According to the company’s incident update, certain patient personal data from trial participation was compromised. The company stated that this information is not directly linked to any patients by name or other direct identifiers. “Information about identity would therefore require access to underlying information, identifying patients by name etc.

Wegovy pill, the new daily weight management tablet, has been approved in the UK as an adjunct to a reduced-calorie diet and increased physical activity, offering a first-of-its-kind alternative to injectable treatments for adults.