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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World of DTC Marketing

JULY 21, 2021

SUMMARY: DTC marketing is not the reason why prescription drugs cost so much. The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. DTC ads raise awareness around health conditions.

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Marketing Prescription Side effects Doctors 285

Fierce Pharma

JUNE 10, 2024

About a month after Eisai initiated a rolling FDA application for its subcutaneous form of Leqembi, the U.S. The FDA assigned the subcutaneous Leqembi application a Prescription Drug User Fee Act decision date of January 25, 2025. agency has accepted the filing. |

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MedCity News

MARCH 19, 2023

Pear Therapeutics isn’t meeting the commercialization goals for its prescription digital therapeutics, so it’s now seeking strategic alternatives for the business. Prospective buyers can pick up Pear’s FDA-cleared products for substance use disorder, opioid use disorder, and insomnia.

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World of DTC Marketing

JUNE 24, 2021

Prescription drugs are not the same as items found in a grocery store. People don’t see an ad for a prescription drug and say, “oh, I need that!” If the FDA understood consumer behavior like marketers instead of scientists, they would understand how DTC works. This is normal, and the FDA should take note.

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MedCity News

JUNE 12, 2023

Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & Drug Administration (FDA) clearance, and provided solid clinical study evidence. Photo: Bulat Silvia, Getty Images

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Food and Drug Administration Prescription Government FDA 263

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly.

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Food and Drug Administration FDA Prescription Food 133

pharmaphorum

APRIL 1, 2024

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder

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World of DTC Marketing

FEBRUARY 25, 2021

SUMMARY: Per the Times, “what if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbohydrates and calories in an Oreo cookie?” ” Drug facts boxes are needed, but the FDA disagrees. A Drug Facts Box? A sample drug facts box.

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Side effects Prescription FDA Medical 173

World of DTC Marketing

DECEMBER 23, 2020

Among the 26% of respondents who talked to a health care provider about a specific prescription drug they saw advertised, 16% said they received a prescription for the advertised drug. Online research is used to evaluate new prescription drugs. The FDA can be myopic when researching how consumers view and react to DTC.

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World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Ad recall is essential for CPGs, but for prescription drugs, the question that’s missing is “what action did it lead to?

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Food and Drug Administration Side effects FDA Prescription 185

World of DTC Marketing

JANUARY 1, 2022

1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. People don’t want to lose weight through diet and exercise if they can lose it through a prescription drug.

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Healthcare Healthcare Side effects Prescription 244

World of DTC Marketing

APRIL 22, 2021

A website and TV commercials are not enough to get patients to ask for a prescription medication especially when fair balance lists side effects like cancer. DTC marketers need to understand the patient journey a lot better with specific recommendations to silence the “noise” around their medications.

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World of DTC Marketing

JANUARY 4, 2022

These cost estimates include cancer-attributable costs for medical services and oral prescription drugs. The FDA says it has used innovative research shortcuts to speed up the availability of medicines for desperately ill patients. National costs for cancer care were estimated to be $190.2 billion in 2015 and $208.9 population.

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Insurance Transportation Medical Medicine 273

World of DTC Marketing

APRIL 12, 2021

The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. The answer lies in both an outdated way we develop prescription drugs and the continued quest for the next big blockbuster. In other words, money over safety.

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Pharma Marketing Network

MARCH 12, 2025

Regulatory Restrictions on Keyword Use Pharmaceutical ads must comply with regulations from organizations like the FDA (U.S.) , MHRA (UK) , and EMA (EU). Many terms, particularly those related to prescription drugs, require fair balance, risk disclosures, and approved messaging. Januvia prescription cost) and non-branded (e.g.,

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World of DTC Marketing

NOVEMBER 24, 2021

The FDA on Tues­day ap­proved Aa­di Bio­science’s first drug and the first treat­ment ap­proved specif­i­cal­ly for pa­tients with an ul­tra-rare and ag­gres­sive form of sar­co­ma that oc­curs most­ly in women. One-quarter of all cancer patients chose not to fill a prescription due to cost, according to a 2013 study in The Oncologist.

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Food and Drug Administration Insurance Prescription FDA 266

World of DTC Marketing

DECEMBER 13, 2021

Among adults 65 and older with Medicare coverage, average annual out-of-pocket costs for medical services and prescription drugs were highest in the initial phase of care (first 12 months after diagnosis) — $2,200 and $243, respectively — and the end-of-life phase (12 months before death) — $3,823 and $448, respectively. ScienceNews.com.

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Pharma Marketing Network

MARCH 5, 2025

Unlike traditional businesses, pharma brands face strict advertising regulations , requiring compliance with FDA guidelines, HIPAA, and Googles healthcare ad policies. Strict ad copy guidelines , including FDA-mandated fair balance requirements. Use FDA-approved language and avoid phrases that suggest guaranteed treatment success.

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Pharmaceutical Technology

DECEMBER 23, 2024

Lillys Zepbound has become the first prescription medicine approved to treat adults with moderate to severe obstructive sleep apnoea (OSA) and obesity.

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Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. The FDA has now assigned a prescription drug user fee act action date of 23 November 2023 for the NDA.

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Food and Drug Administration FDA Prescription Food 105

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011.

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Food and Drug Administration FDA Prescription Food 98

pharmaphorum

NOVEMBER 25, 2022

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

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pharmaphorum

JANUARY 8, 2024

The FDA has approved the first request from a US state to import prescription medicines from Canada, giving the green light to Florida for a programme that aims to reduce its spending on drugs.

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Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.

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Food and Drug Administration FDA Prescription Medicine 97

World of DTC Marketing

MARCH 10, 2022

The cost of Humira, which is injected via syringe, was more than $72,000 a year on prescription drug websites this week and is not expected to come down until at least 2023. AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said”. So how do people who work for AbbVie feel?

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World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). The FDA’s stamp of approval for the Fitbit sensor is a big deal. Not if it affects their bottom line.

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Healthcare Healthcare Food and Drug Administration FDA 227

Pharma Marketing Network

FEBRUARY 27, 2025

Drive prescription intent by educating HCPs about the latest drug advancements. Using high-reach keywords like “diabetes management,” “oncology treatments,” and “prescription drug savings” , along with location-based SEO, can drive organic traffic to your content. However, compliance is key.

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Pharma Marketing Prescription Education 52

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application.

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Food and Drug Administration FDA Safety Prescription 98

pharmaphorum

JULY 7, 2022

Pfizer is still waiting for the green light to complete an acquisition of digital health company ResApp, a deal that looks even better now that its smartphone app for people with obstructive sleep apnoea (OSA) has been approved by the FDA. The post ResApp bags FDA okay for sleep apnoea app, after Pfizer takeover bid appeared first on.

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World of DTC Marketing

NOVEMBER 5, 2021

Novo Nordisk has admitted that it would not be able to keep up, adding that it would likely take until early 2022 for the supply to stabilize and that some patients “are experiencing an approximate one month or longer delay in filling prescriptions for Wegovy.” The worst thing any marketer can do is over-promise and under-deliver.

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Insurance Side effects Medical Prescription 271

Legacy MEDSearch

JUNE 20, 2023

Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. The addition of the FDA-cleared BabySat device expands on Owlet’s existing portfolio of consumer products designed to bring peace of mind to caregivers. BabySat will be available in the U.S.

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 The company expects to launch LODOCO for prescription use in the second half of 2023. mg tablet) to treat cardiovascular disease.

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Food and Drug Administration FDA Prescription Food 98

Pharmaceutical Technology

MAY 31, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH).

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Food and Drug Administration FDA Medicine Prescription 98

pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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Pharmaceutical Technology

MAY 2, 2023

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

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PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. The guidance document is short at 19 pages, and by design not prescriptive.

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