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Novo Nordisk

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Novo Nordisk rolls out Wegovy subscription to lock in predictable GLP-1 prices
business11 days ago

Novo Nordisk rolls out Wegovy subscription to lock in predictable GLP-1 prices

Novo Nordisk launched a multi-month Wegovy subscription for its injectable doses and the high-dose pill, offering 3-, 6-, and 12-month plans with fixed monthly prices and potential savings up to $1,200/year for the injection and $600/year for the pill, via telehealth partners; the program aims to improve adherence and pre-empt competition from Eli Lilly’s upcoming oral GLP-1, and patients can opt out anytime (not yet on NovoCare DTC).

via CNBC|
#business#glp-1#novo-nordisk
FDA Approves Higher-Dose Wegovy to Narrow Gap with Zepbound
business23 days ago

FDA Approves Higher-Dose Wegovy to Narrow Gap with Zepbound

The FDA approved Novo Nordisk’s higher-dose Wegovy (7.2 mg) to improve weight loss outcomes, with phase 3 data showing about 20.7% average weight loss over 72 weeks; Novo plans an April launch to better compete with Eli Lilly’s Zepbound, which has demonstrated higher efficacy. A separate trial in obesity with Type 2 diabetes showed 14.1% weight loss, and the approval comes as the FDA pilots a faster review program for priority GLP-1 medications.

via CNBC|
#business#fda#novo-nordisk
FDA Warns Novo Nordisk for Underreporting Ozempic and Wegovy Adverse Events
health1 month ago

FDA Warns Novo Nordisk for Underreporting Ozempic and Wegovy Adverse Events

The FDA issued a warning letter to Novo Nordisk for serious postmarketing adverse drug event reporting violations related to the GLP-1 drugs Ozempic and Wegovy, citing three deaths (including a suicide) and a stroke report; the agency said Novo Nordisk failed to report deaths within the 15-day window and did not adequately investigate or report the suicide, though authorities have recently found no proven link between GLP-1s and suicide. Novo Nordisk has 15 days to report adverse reactions and two weeks to describe corrective actions; the company says it is addressing the concerns.

via WPXI|
#adverse-drug-events#fda#health
FDA flags Novo Nordisk for unreported side effects tied to Ozempic and Wegovy
health1 month ago

FDA flags Novo Nordisk for unreported side effects tied to Ozempic and Wegovy

The FDA sent Novo Nordisk a warning for serious lapses in reporting potential adverse events linked to semaglutide (the active ingredient in Ozempic and Wegovy), citing three deaths including a suicide and saying the company failed to investigate or report them within required timelines after an inspection of a New Jersey facility. Novo Nordisk says it will address the concerns, and the agency gave two weeks to outline corrective actions.

via NBC News|
#adverse-events-reporting#fda#health
FDA Warns Novo Nordisk Over PADE Reporting at US HQ
business1 month ago

FDA Warns Novo Nordisk Over PADE Reporting at US HQ

The FDA issued a Warning Letter to Novo Nordisk’s Plainsboro, New Jersey US headquarters after a January–February 2025 inspection found deficiencies in postmarketing adverse event surveillance and reporting under PADE, including issues with reporting timing and potential rejection of reports and insufficient root-cause analysis. Novo says it has a corrective action plan, has supplied seven progress updates, and remains confident it will address the regulator’s concerns. The letter follows a Form 483 and sits within broader U.S. regulatory scrutiny that includes other letters related to Ozempic/Wegovy and a Bloomington, Indiana facility, though the FDA states the warning does not judge drug quality or safety.

via Fierce Pharma|
#business#fda#form-483
Hims & Hers and Novo Nordisk Strike Branded GLP-1 Deal; Stock Soars
business1 month ago

Hims & Hers and Novo Nordisk Strike Branded GLP-1 Deal; Stock Soars

Barron’s reports that Hims & Hers Health and Novo Nordisk resolved their clash over GLP-1 drugs, with Novo agreeing to sell Ozempic and Wegovy on Hims’ online pharmacy. Hims stock rose about 38% on the news, while Novo lagged modestly higher; the settlement ends a patent-infringement lawsuit and requires Hims to stop advertising compounded GLP-1 products, though existing patients can transition to FDA-approved options. The deal comes amid FDA scrutiny of compounded GLP-1s and follows years of regulatory and competitive tension between the companies.

via Barron's|
#business#glp-1#hims-and-hers
business1 month ago

Hims & Hers Teams Up with Novo Nordisk to Expand FDA-Approved GLP-1 Options in US Weight Loss

Hims & Hers Health announced a strategic shift in its US weight‑loss business, partnering with Novo Nordisk to broaden access to FDA‑approved GLP‑1 therapies on its platform, while phasing out most compounded GLP‑1 offerings (with access preserved only where clinically necessary). The plan includes adding Novo Nordisk products like Ozempic and Wegovy, aligning US and global models, and educating customers to transition to FDA‑approved treatments, aiming to create a large global consumer health platform for affordable medications. The move follows a rapidly evolving GLP‑1 landscape, and Novo Nordisk’s lawsuit against Hims & Hers was dismissed without prejudice.

via HIMS Investor Relations|
#business#fda-approved#glp-1
Novo Nordisk bets $2.1B on next-gen oral biologics with Vivtex
business1 month ago

Novo Nordisk bets $2.1B on next-gen oral biologics with Vivtex

Novo Nordisk plans to invest up to $2.1 billion in Vivtex to advance next-generation oral delivery systems for biologics, leveraging Vivtex’s GI tract screening platform developed in MIT labs. Novo will fund research and later development and commercialization, aiming to expand its lead in oral obesity and diabetes therapies after Wegovy’s pill launch, while Vivtex pursues broad partnership opportunities and potential standalone programs.

via Fierce Biotech|
#biologics#business#novo-nordisk