French drug maker Sanofi has come under the scanner of the nonprofit National Advertising Division (NAD) after its arch-rival Johnson & Johnson complained about the company’s misleading advertising claims.
Sanofi has been asked to abandon claims that its over-the-counter drug Zantac 360° is the “#1 Doctor Recommended” for heartburn.
Zantac, a version of which was pulled from shelves in the US by GSK in 2019 due to impurities, is an H2 blocker that stops the secretion of gastric acid and is loaded with an active ingredient called famotidine. It is recommended for mild to moderate heartburn and indigestion.
J&J, which markets a competing Pepcid product, brought the misleading claims to the notice of NAD — the overseer of self-regulation programs. NAD said the advertisements appear in “various iterations of the Google Ads appearing in search results for Zantac 360.”
Sanofi contended that its advertising claims “clearly refer” to famotidine being the number one recommended ingredient by doctors. The claims, Sanofi added, were based on a survey from IQVIA which documented physicians’ average weekly recommendations in the acid reducer category.
NAD disagreed. “These facts were not a viable substitute for an affirmative active ingredient recommendation and fell short of the evidence required to support a ‘#1 doctor recommended’ claim,” said the NAD in a press release.
NAD has recommended that Sanofi discontinue the claims such as Zantac 360 “contains the #1 doctor recommended medicine approved to both prevent and relieve heartburn,” “With the #1 doctor recommended heartburn medicine” and “#1 Doctor Recommended.”
Sanofi has decided to put up a fight and will appeal NAD’s decision. The company “disagrees with NAD’s conclusions that the underlying IQVIA survey cannot substantiate doctor recommended ingredient claims.”
The drugmaker has concerns that NAD’s decision will have downstream industry-wide ramifications. Appeals of NAD decisions are made by the National Advertising Review Board. It however added that it will “nevertheless take the NAD’s recommendations with respect to this ruling into consideration in future advertising.”
A not-so-funny thing happened to Novartis’ high-profile bid to take a PD-1 checkpoint out of China and get it approved in the US this year.
After paying BeiGene $650 million for US-plus ex-China commercialization rights for the drug — the latest in a long string of contenders to follow Keytruda and Opdivo — the FDA is deferring action on their application.
And there’s no new timeline on when the agency will make a decision.
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What a difference one really good Phase III readout and a couple of late-stage buyouts can make.
GSK CEO Emma Walmsley has been trying, hard, to build some excitement around the pipeline. And with the recent positive outcome for their RSV vaccine, she’s finally earning some market respect on that score. And with the big consumer split coming on Monday, with the birth of Haleon, you can expect plenty of buzz about the need for another M&A deal to position the company.
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With the FDA giving the thumbs up for more monkeypox vaccines to come from Bavarian Nordic’s manufacturing facility in Denmark, the US government is asking for a lot more as the CDC marks the total case count north of 1,400 people.
BARDA has asked the Danish vaccine manufacturer for 2.5 million more doses of their Jynneos vaccine, a non-replicating smallpox vaccine and the only FDA-approved vaccine against monkeypox and will be going to the strategic national stockpile, or SNS.
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Pfizer’s Hospira, plagued by quality control problems at multiple plants over the years, is once again finding itself voluntarily recalling one lot of Propofol Injectable Emulsion, USP 100 mL available for single patient use in a glass flip-top vial.
The batch is being pulled due to a visible particulate observed in a single vial during an annual examination of retained samples. The recall is being conducted with the FDA’s knowledge, with a recall letter issued by the FDA on Wednesday.
Hello. Good morning. I’m Zachary Brennan, senior editor at Endpoints News. And thank you for joining us virtually at BIO for our panel on decentralized trials. Joining me today, we have Ronan Brown, Senior Vice President of IQVIA, Craig Lipset, founder of Clinical Innovation Partners, and Bari Kowal, senior vice president of Regeneron. I’m excited for today’s discussion and I’m sure you are too, but before we get into it, we have a brief word from Vice President Matt Blume with today’s sponsor, Catalent.
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Hello, and welcome to today’s Fireside Chat. I’m Zachary Brennan, senior editor at Endpoints News and with me today is Ian Thompson, senior vice president of Amgen.
Today we’ll be discussing the evolution of the US biosimilar space, which has seen not only a slow start when we compare to our European counterparts, but also long delays between when certain biosimilars win approval and when they actually launch in the US market. So, first off I wanted to start by welcoming Ian and I also wanted to hear his take on how he’s seen the momentum building around the biosimilar industry in recent years, and maybe why he thinks that is the case that has been building more in recent years.
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Applications are now open for Merck KGaA’s newest collaboration program focused on startups located in Asia.
The German pharma announced Thursday, sparing a few details, that it was launching a new program in Asia called Uptune, which “aims to generate collaboration opportunities with early-stage innovative companies.”
The plan, according to Merck KGaA, will support and give some financing to certain companies in the healthcare and life science space, plus electronics and smart manufacturing. It did emphasize it will look for companies with a focus on digital health and “innovative technologies/materials for semiconductor and display.”
Sales of Pfizer’s Xalkori may be slipping as new drugs squeeze the oncology market, but the pharma giant hasn’t lost its appetite for new indications.
The FDA has come through with the most recent approval for the drug, giving Pfizer a green light to sell the therapy for treatment-resistant cases of inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. Regulators cite a small but positive 21-patient study in pediatric and adult patients:
After spending the last 10-plus years in court, Illumina and BGI Group have reached a $325 million settlement to resolve a number of patent and antitrust claims across the US centered around the companies’ DNA sequencing technology.
Illumina is forking over the $325 million to settle claims following two recent jury decisions in Delaware and California, as well as an antitrust case in California, according to a statement on Thursday from MGI Tech, a BGI affiliate.
Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas
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