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Pharmaceuticals, health and wellness

AbbVie’s post-Humira stalwarts Skyrizi, Rinvoq performing exactly as hoped, CEO says

AbbVie is relying on its next-gen immunology drugs Skyrizi and Rinvoq to fill what will be a massive sales gap once blockbuster Humira faces generic foes in the U.S. And as the company sees it, everything is going according to plan.  As those meds start to take off, the Chicago-based pharma expects the pair to […]

U.K. slaps Advanz Pharma with $140M fine after 1,110% price hike on ‘crucial’ thyroid drug

Drug pricing has become a hot-button issue on both sides of the pond, and late this week, the U.K. dished out another fine taking aim at “unfair” inflation.  Hoping to send the pharma industry a “clear message” on anticompetitive marketing tactics, the U.K.’s Competition and Markets Authority (CMA) on Thursday slapped Advanz Pharma with more than […]

From accelerated approval to the TV airwaves: GBT debuts first DTC campaign for sickle cell med Obryxta

Global Blood Therapeutics is taking its sickle cell messaging for Oxbryta to TV screens in its first DTC promotion launching today. Six sickle cell Oxbryta patients appear in the new commercial, ranging from 17-year-old Tully, who smiles and dances with a friend, to an older man Gerald, who cooks in the kitchen with his wife. […]

The curious case of Eohilia: Takeda drug hit with mysterious FDA delay as company leans on launches for growth

Takeda CEO Christophe Weber has been labeling 2021 as an “inflection year” for the Japanese pharma as it looks to advance its late-stage pipeline and introduce several new drugs. But at least one drug has had a difficult time reaching the market. The FDA has missed its target action date for Eohilia, an oral suspension of the […]

Ardelyx does ‘not agree’ with FDA’s view after agency rejects blockbuster prospect—and one analyst is ‘flummoxed’

Ardelyx has suffered a setback in its quest to advance chronic kidney disease (CKD) candidate tenapanor. The FDA bounced back Ardelyx’s application for tenapanor to control serum phosphorus in CKD patients on dialysis, the company said Thursday. Already approved as Ibsrela, the NHE3 inhibitor scored its first green light to treat irritable bowel syndrome (IBS) with […]

Fierce Pharma Asia—AstraZeneca’s China growth; Takeda’s $3.5B neuro pact; Biocon, Viatris’ historic biosimilar nod

AstraZeneca management tried to convince investors that its star China business will continue growing, only at a slower pace. Takeda expanded its collaboration with PeptiDream to include neurodegenerative disease targets in a deal worth up to $3.5 billion. Biocon and Viatris’ Lantus copycat has won the first FDA interchangeable tag for an insulin biosimilar. 1. Can […]

Innovation director puts new title to the test with virtual reality glasses and 3-D cities in pharma marketing

PrecisionEffect’s recently promoted innovation director Simon Wilson has worked with big-time brands like L’Oreal and Diageo and in an earlier film career, with famed director Stanley Kubrick. He’s crafted pop-up breweries and put 25 can-can dancers on an elevated bridge for marketing efforts. But now his favorite place to be is in pharma and healthcare marketing. […]

GlaxoSmithKline’s Nucala beats AZ’s Fasenra to the IL-5 punch in nasal polyps

GlaxoSmithKline’s antibody drug Nucala may not have been the first biologic approved in nasal polyps—that distinction goes to Sanofi and Regeneron’s Dupixent. But on Thursday, it did become the first IL-5 inhibitor to break into the indication, notching a win over AstraZeneca’s would-be first-in-class rival Fasenra. The FDA gave Nucala the green light to treat […]

How well will Biogen’s Alzheimer’s drug Aduhelm perform in the real world? This study is set to find out

While all eyes are on Biogen’s FDA-required Aduhelm trial that will determine whether the treatment actually aids Alzheimer’s patients, the company is involved in another real-world study in the works assessing its worth in an array of people coping with the memory-robbing disease.  That phase 4 observational study was first organized by Biogen ahead of Aduhelm’s nod in […]

Emergent wins FDA all-clear to restart J&J COVID-19 vaccine production in Baltimore

Some three months after federal officials called for a manufacturing pause, Emergent BioSolutions has righted the ship at its beleaguered Bayview facility. Emergent won the FDA’s blessing to restart production of Johnson & Johnson’s COVID-19 vaccine at its Baltimore, Maryland, plant, the company said Thursday. The move follows “extensive” FDA reviews, plus “close coordination” with […]

Can AstraZeneca sustain rapid growth in China amid price-cutting scheme and local competition? It’ll probably be slower, execs say

Over the past few years, China has been offering AstraZeneca bragging rights. But the company’s business in the country is coming to a turning point after being exposed to the government’s price-cutting scheme and local competition—and investors have caught wind. During a conference call Thursday, Wall Street analysts piled into AstraZeneca’s China performance, pressing management […]

Sanofi’s Dupixent, amid €10B sales push, posts positive data in chronic spontaneous urticaria

Amid Sanofi’s transformation under CEO Paul Hudson, the drugmaker has been counting on superstar immunology drug Dupixent to propel growth. The blockbuster medicine isn’t only doing that—it also just posted positive data in a new disease.  Alongside its second quarter results on Thursday, Sanofi touted new phase 3 data for Dupixent in moderate-to-severe chronic spontaneous urticaria. In patients with the disease, Dupixent significantly improved itch and […]