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As expected, Novartis’ radioligand therapy Pluvicto crossed the blockbuster sales threshold with one quarter still left of 2024. The company made the decision in response to the FDA's request for "flexibility" in its review timeline, Novartis CEO Vas Narasimhan explained.
An FDA expansion of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) Elevidys has sparked a new surge in sales for the gene therapy. | An FDA expansion of Sarepta Therapeutics’ Duchenne muscular dystrophy Elevidys has sparked a new surge in sales.
AbbVie’s immunology heirs Skyrizi and Rinvoq are proving booming growth to make up for once-king Humira’s continuous sales slide. | As Humira continues its sales free fall, newer Skyrizi is proving a worthy successor with nearly matching sales ahead of an upcoming FDA decision in ulcerative colitis.
Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely.
Amneal Pharmaceuticals’ hopes for a midyear launch of its extended-release Parkinson’s disease prospect—and a shot at a potential $500 million peak sales opportunity in the U.S.—have
Less than two months after the FDA approved the combination treatment of Astellas and Pfizer’s Padcev and Merck’s Keytruda in first-line bladder cancer, the Japanese company has
Autolus will apply the capital to its CAR T-cell therapy currently under FDA review in cancer and in early clinical development in lupus. Meanwhile, BioNTech will gain access to Autolus’s cell therapy manufacturing assets as well as technologies that could support the R&D of in vivo therapies and antibody drug conjugates.
Sanofi and Regeneron’s highly anticipated approval of Dupixent to treat COPD could be delayed, as the FDA has requested additional efficacy data from two trials. The regulatory hurdle comes as Eylea showed stagnant sales, even though its new high-dose formula is seeing increased uptake.
As an FDA decision draws closer on bluebird bio’s sickle cell disease gene therapy, the company has lined up a potential sale of a priority review voucher (PRV). | The company entered an advance agreement for a priority review voucher ahead of the FDA's decision on the sickle cell disease gene therapy prospect.
The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.
Viatris just notched a win on its quest to reach $1 billion in eye care sales by 2028. | The FDA on Wednesday approved Viatris and Ocuphire’s Ryzumvi, also known as phentolamine ophthalmic solution, to treat pharmacologically-induced mydriasis, or dilation of the pupils. The partners plan to make Ryzumvi available in the U.S.
Approved by the FDA in January 2022, Vabysmo already crossed the one-billion-dollar sales mark in the first half of 2023. .” | To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.”
In a change of pace from the recent COVID-related business struggles for Pfizer, the drugmaker has picked up a valuable reward from the FDA in the form of a priority review voucher (PRV). |
It’s the third indication for the drug, which analysts project could top $4 billion in peak sales. Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers.
BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital.
Palforzia was the first FDA-approved drug for peanut allergy, but its sales were hampered by the Covid-19 pandemic. Peanut allergy therapy Palforzia, which Nestlé acquired in a multi-billion dollar deal, has been sold to allergy product company Stallergenes Greer.
sales alone, which is above consensus estimates of around $7 billion to $8 billion, the team said. One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. I, therefore, find the FDA’s decision to be puzzling. Natalie Shure, The New Republic.
the same can’t be said for the cost of an FDA priority review voucher. Since 2017, the company has sold off three PRVs—getting less in return for each successive sale. While the price of just about everything has increased over the last six years in the U.S., Just ask Sarepta Therapeutics. | Just ask Sarepta Therapeutics.
More than two years after Aduhelm's controversial and ill-fated FDA accelerated approval, Bi | Biogen is discontinuing its first Alzheimer's disease therapy, Aduhelm, after walking a rocky path. The company is taking a $60 million charge, halting sales and terminating a confirmatory trial.
Three weeks after the FDA warned that some pharmacies are making unauthorized versio | Novo Nordisk filed five lawsuits in four states on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of diabetes and weight loss drugs Ozempic and Wegovy.
Securing FDA approvals last year for three drugs that each have peak sales potential of $4 billion bodes well for the long-term future of Bristol Myers Squibb. And it's projecting overall sales decline for 2023. Bristol Myers Squibb is entering a dark stage.
As Bristol lays off staffers and works through the painful loss of exclusivity for | The first-line anemia use in MDS represents a key milestone as Bristol Myers targets $4 billion in peak sales for the new medicine.
Despite a restricted FDA label, Sarepta Therapeutics has seen early commercial success with its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. | The company is quickly moving through Elevidys' eligible patient population while awaiting the FDA's decision on a broader label.
Ipsen is paying $247 million to acquire Epizyme, a cancer drug developer with one FDA-approved product: follicular lymphoma therapy Tazverik. The drug is a modest seller now, but more cash could be paid out if the small molecule hits sales targets in coming years.
But strong demand continues to push sales of the GLP-1/GIP agonist to new highs ahead of an FDA decision on weight loss. | As strong demand continues to push Mounjaro sales to new highs, Eli Lilly CEO David Ricks said the company is "not done with" manufacturing expansions.
Ever since Novo Nordisk won FDA approval for its GLP-1 weight-loss med Wegovy more than 2 years ago, analysts and investors have been keeping a close eye on the blockbuster drug launch.
sales of $304 million during the second quarter, Regeneron’s high-dose version of Eylea came up just short of analyst projections. | sales had declined in each of the previous three quarters. The launch of Regeneron's Eylea HD has helped the Eylea franchise to a rebound after U.S.
In this episode, Samuel Adeyinka interviews John Crowder who covers how to sell effectively in medical sales. Tune in now and get medical sales-ready! — Watch the episode here Listen to the podcast here Selling Effectively In Medical Sales With John Crowder We have with us another special guest. I’m wonderful.
After an initial FDA approval came later than anticipated, UCB is looking to quickly grow Bimzelx. The company is eying four new indications and potential peak sales of 4 billion euros. After a busy 2023 marked by multiple drug approvals, UCB isn’t resting on its laurels.
Always adhere to FDA guidelines and include clear disclaimers in campaigns. Example: Use analytics to identify which regions have higher sales for branded drugs and tailor campaigns accordingly. By adopting these strategies, you’re not just boosting sales—you’re transforming lives. But how do you stand out in a crowded market?
As a sales or marketing professional in the medical device industry, you’ve probably heard the term “sales enablement”. But what exactly is medical sales enablement? Can it really help maximize your sales process and yield a higher ROI for your company? Medical Sales Enablement Defined. Let’s get started!
Diagnostic testing sales: where meticulous detail meets the human touch, changing the course of cancer care one relationship at a time. In this special episode for Breast Cancer Awareness Month, Veronica Vasek uncovers the challenges, triumphs, and the vital role that diagnostic sales reps play in the healthcare landscape.
The convenience of shorter infusion time is a big selling point for TG Therapeutics’ newly FDA-approved multiple sclerosis drug Briumvi. | The convenience of shorter infusion time is a big selling point for TG Therapeutics’ newly FDA-approved multiple sclerosis drug Briumvi.
AbbVie’s fast-growing Humira successor Skyrizi is already on a roll with skyrocketing sales. Since its original nod in 2019, AbbVie's IL-23 inhibitor has added several new uses over the years. Now, its fourth approved disease area is ulcerative colitis.
It’s no secret that being a medical sales rep is a difficult, but rewarding, profession. Sales reps are usually at the forefront of this pressure and have to work hard to make sure the product’s value is understood while adhering to the FDA regulations. Pick Your Medical Device Sales Tech Wisely. Web Conferencing Tool.
Novartis says FDA approval for frontline use of its leukaemia drug Scemblix will boost the number of eligible patients four-fold, as it hunts blockbuster sales
Roche’s surge in sales for its long-acting macular degeneration drug Vabysmo showed that patients in the market are open to switching to another treatment. After gaining FDA approval for its high-dose Eylea, Regeneron racked up $43 million in sales in the U.S.
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