Fierce Pharma

OCTOBER 30, 2023

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.

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FDA Prospecting Sales 225

Fierce Pharma

AUGUST 29, 2023

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.

Sales 190

Sales Medicine FDA 190

Fierce Pharma

SEPTEMBER 27, 2023

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.

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Pharmacology FDA Sales 244

Fierce Pharma

FEBRUARY 5, 2024

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

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Sales FDA 279

Fierce Pharma

JULY 27, 2023

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.

Sales 190

Sales FDA 190

Fierce Pharma

JULY 27, 2023

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.”

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FDA Pharma Sales 242

Fierce Pharma

JULY 5, 2023

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.

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FDA Sales 230

Fierce Pharma

NOVEMBER 6, 2023

The drug launched after an FDA approval in May 2023.

Sales 249

Sales FDA 249

Fierce Pharma

JANUARY 31, 2024

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.

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FDA Sales 308

Rep-Lite

MAY 10, 2024

The world of medical sales is bursting with change. This presents a dynamic environment for whether you are an aspiring and seasoned medical sales rep. By understanding the evolving landscape, both parties can ensure they’re equipped to navigate the exciting future of medical sales.

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Medical sales Sales Medical Medical sales reps 52

World of DTC Marketing

OCTOBER 21, 2021

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.

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FDA Insurance Prescription Medicine 234

Fierce Pharma

NOVEMBER 2, 2023

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.

Manufacturing 225

Manufacturing FDA Sales 225

Fierce Pharma

FEBRUARY 28, 2024

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.

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FDA Sales 223

Fierce Pharma

NOVEMBER 2, 2023

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.

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Manufacturing Sales FDA 244

World of DTC Marketing

JUNE 23, 2021

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.

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FDA Side effects Physicians Patients 218

Fierce Pharma

AUGUST 2, 2023

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.

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FDA Sales 200

pharmaphorum

JANUARY 4, 2023

Retail pharmacies in the US will be able to dispense mifepristone-based therapies to end pregnancies after the FDA introduced changes to its regulatory framework for the products. The American College of Obstetricians and Gynaecologists (ACOG) said the FDA’s decision was a victory for women’s health.

Retail 78

Retail FDA Sales Healthcare Provider 78

Fierce Pharma

MARCH 19, 2024

Just a few days ago, Madrigal Pharmaceuticals made history by winning FDA approval for its metabolic dysfunction-associated steatohepatitis (MASH) med Rezdiffra. Madrigal's Rezdiffra became the first drug approved to treat metabolic dysfunction-associated steatohepatitis (MASH) just a few days ago.

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Sales FDA Pharmaceutical 130

pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

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FDA Sales Marketing Medical 129

Rep-Lite

NOVEMBER 30, 2023

B2B sales consulting for medical sales is a specialized service that helps healthcare organizations navigate the unique challenges of B2B transactions within the healthcare industry. What is B2B Sales Consulting? A sales expert in this space needs to understand these intricacies and provide tailored solutions.

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B2B Sales Medical sales Consulting Sales 52

Fierce Pharma

JUNE 20, 2023

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.

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FDA Sales 294

Fierce Pharma

NOVEMBER 2, 2023

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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Sales FDA Marketing Patients 197

Contrarian Sales Techniques

DECEMBER 5, 2023

Did you know that a well-trained pharmaceutical sales rep can be the driving force behind a healthcare provider's decision-making process? Welcome to the world where sales training isn't just a formality. In this post, we’re diving deep into the realm of pharmaceutical sales training. That’s right.

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Pharmaceutical Sales Training Sales Pharmaceutical 52

Rep-Lite

MARCH 14, 2024

Medical sales representatives are the medium through which medical companies sell their healthcare products to providers like hospitals and clinics. Medical sales rep requirements include technical knowledge of medical equipment and technologies, sales skills, and interpersonal abilities. Why Pursue a Career in Medical Sales?

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Medical sales reps Medical sales Medical Sales 52

Rep-Lite

APRIL 4, 2024

Sales representatives play a crucial role in connecting healthcare facilities with innovative technologies that improve patient care. Here are some key tips for success in medical device sales: 1. Developing Effective Communication Skills Active Listening: Successful medical device sales representatives are skilled listeners.

Medical 52

Medical Sales Interpersonal Skills Ethics 52

pharmaphorum

JULY 15, 2022

Pfizer’s tyrosine kinase inhibitor Xalkori has picked up a fourth approval from the FDA, adding a new use in the treatment of a rare form of benign tumour that typically affects children and young adults. The post FDA clears Xalkori for inflammatory myofibroblastic tumours appeared first on.

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FDA Sales Patients Marketing 113

Fierce Pharma

NOVEMBER 1, 2023

Sales of Argenx’s Vyvgart increased by 151% to $329 million in the third quarter as the momentum for the treatment continues with its recent approval to be administered subcutaneously. As Argenx works to grow the reach of its up-and-coming rare disease med Vyvgart, the company is seeing significant early gains for its lone commercial product.

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FDA Sales 217

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). US sales of Stelara totalled $6.4 The post FDA approves first Stelara biosimilar, Wezlana appeared first on European Pharmaceutical Review.

Food and Drug Administration 82

Food and Drug Administration FDA Side effects Safety 82

Fierce Pharma

JUNE 28, 2023

After an FDA thumbs up on Reata's approval supplement for Skyclarys, analysts feel confident the newly commercial-stage company can meet—or potentially even exceed—a $45.9 million sales target for 2023.

FDA 207

FDA Sales Pharmaceutical Patients 207

Fierce Pharma

JULY 26, 2023

and Europe paid off with a sizable sales increase for Jardiance, the drug has added a third use to its European label. An FDA approval in chronic kidney disease could follow this year.

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FDA Sales 230

pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The company is gunning for sales in atopic dermatitis alone of $1.5

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FDA Side effects Sales Safety 93

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan.

Sales 59

Sales FDA Marketing Competition 59

MedCity News

FEBRUARY 8, 2024

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.

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Sales Manufacturing FDA Biopharma 106

Legacy MEDSearch

MARCH 7, 2024

Food and Drug Administration (FDA) announced the clearance of Dexcom’s device, marking it as the first continuous glucose monitor available over the counter. The post FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor appeared first on Legacy MEDSearch. On March 5, the U.S. increase in extended trading.

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Food and Drug Administration FDA Food Management 52

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan.

Sales 52

Sales FDA Marketing Competition 52

MedReps

JANUARY 30, 2023

Knowing what’s to come in the medical sales industry is not only interesting, but it could help you with your sales goals. Medical Sales Trends to Watch Out For in 2023 If you want to know what the future holds and create some forward-thinking sales goals, then check out these medical sales trends to watch out for in 2023.

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Medical sales Medical Sales Sales goal 74

pharmaphorum

DECEMBER 30, 2022

The FDA’s interactions with Biogen in the build-up to last year’s controversial approval of Alzheimer’s disease therapy Aduhelm have been described as “inappropriate” and “atypical” in a congressional report on the review.

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