MedCity News

JUNE 14, 2023

2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study. The FDA has been notified and an investigation is underway.

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European Pharmaceutical Review

MARCH 26, 2025

The US Food and Drug Administration (FDA) has approved Blujepa ( gepotidacin ) antibiotic for uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years old and over. The post FDA approves first-in-class oral antibiotic appeared first on European Pharmaceutical Review.

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Food and Drug Administration FDA Medicine Food 86

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

World of DTC Marketing

MARCH 23, 2022

Do patients care? Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. Do patients care? Should patients be made aware that the drug they are being prescribed is an “accelerated approval drug”?

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Patients FDA Doctors Physicians 200

Pharma Marketing Network

APRIL 3, 2025

Imagine a time when pharmaceutical ads simply told patients what to ask their doctor. Today, patient marketing is no longer a one-way street. This article dives deep into how patient marketing has changed, whats driving this transformation, and what strategies are leading the way for 2025 and beyond.

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Marketing Patients Pharma Media 52

World of DTC Marketing

JULY 21, 2021

DTC ads do NOT lead to unnecessary Rxs. 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. 4our: DTC marketing should be illegal because it leads to unnecessary Rx’s.

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Marketing Prescription Side effects Doctors 285

World of DTC Marketing

JULY 9, 2021

SUMMARY: Pfizer asks for accelerated approval for a COVID booster shot even though the FDA says it’s unnecessary. From 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period.” billion. .” That is reprehensible.

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Pharma FDA Leads Competition 292

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. ” So, are we supposed to believe that better images in DTC ads lead to patients asking for an Rx? ” Uh…no.

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Food and Drug Administration Side effects FDA Prescription 185

Pharma Marketing Network

MARCH 8, 2025

It must convert visitors into leads , provide clear and accurate medical information , and ensure compliance with FDA, HIPAA, and ad platform policies. Whether targeting healthcare professionals (HCPs), patients, or caregivers , a poorly optimized page can result in high bounce rates, low conversions, and missed opportunities.

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Marketing Pharma FDA Leads 59

MedCity News

JULY 27, 2023

It is a minimally invasive treatment that has shown tremendous promise in addressing vascular calcification, which increases the risk of heart attacks, strokes, or blood clots, and can lead to limb amputations. In February of 2019, Johnson & Johnson acquired Auris Health and its FDA-cleared Monarch platform for $5.75

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Specialization Medical Medicine Leads 240

World of DTC Marketing

MARCH 6, 2022

Digital health companies aim to address the numerous health care challenges, including poor patient engagement, communication gaps between patients and providers, lack of longitudinal data, inconvenience of care delivery, and insufficient clinical decision support for providers and patients. What about patients?

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Patients Doctors Leads FDA 244

World of DTC Marketing

AUGUST 10, 2022

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. Time and time again, I’ve found, in research talking with patients, that they want a lot more information before they ask for a new drug.

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Marketing Media Side effects Pharma 252

World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Since that time, Biogen’s MS drugs have faced intense competition as MS patients continue to vent on social media that the Biogen drug has nasty side effects. Washington Post. Biogen needs a new drug revenue badly.

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FDA Side effects Patients Doctors 187

Pharma Marketing Network

MARCH 8, 2025

This guide breaks down best practices for PPC campaign optimization , helping pharma marketers reach HCPs and patients without wasting ad spend. Pay-per-click (PPC) advertising allows brands to reach healthcare professionals (HCPs) and patients when they are actively searching for treatment options, drug information, or medical education.

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Pharma Education Media Networking 59

PM360

JANUARY 7, 2025

Acquisition highlights companies shared commitment to clients, workplace culture, and attracting the industrys best people TORONTO, ON/SARATOGA SPRINGS, NY January 7, 2025 Klick Health today announced it has acquired Peregrine Market Access, a leading market access strategy and value communications specialist in life sciences.

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Marketing Leads Medical Consulting 52

World of DTC Marketing

NOVEMBER 10, 2020

Biogen shot up when an initial review of their Alzheimer’s drug was positive, but then analysts torpedoed the company when another FDA panel said there wasn’t enough data. The media knows this, and they also know COVID stories get clicks, which leads to more ad revenue. It’s a never-ending cycle.

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Media Retail FDA Safety 286

European Pharmaceutical Review

MAY 22, 2024

The US Food and Drug Administration (FDA) Now, overall, the WLA listing comprises of 36 regulatory authorities from 34 Member States. The post European authorities recognised for leading medicine regulatory oversight appeared first on European Pharmaceutical Review.

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Medicine Leads Food and Drug Administration Safety 93

Pharmaceutical Technology

FEBRUARY 10, 2023

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).

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FDA Leads Competition Marketing 105

pharmaphorum

JULY 15, 2022

Akili looks like it could bring another digital therapeutic (DTx) to market after a clinical trial backed the efficacy of its AKL-T01 in patients with the autoimmune disorder systemic lupus erythematosus (SLE). The post Akili digital therapeutic shows promise in lupus patients appeared first on.

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European Pharmaceutical Review

DECEMBER 18, 2023

After eight weeks of treatment, patients’ depression severity scores dropped by an average of 19.1 As an oncologist for many years, I experienced the frustration of not being able to provide cancer care that treats the whole person, not just the tumour,” commented Manish Agrawal, MD, of Sunstone Therapies and lead author of the study.

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Food and Drug Administration Patients Side effects Safety 116

pharmaphorum

SEPTEMBER 13, 2022

The FDA has started a priority review of Chiesi ‘s velmanase alfa, an enzyme replacement therapy for lysosomal storage disease (LSD) alpha-mannosidosis, with a decision expected in the first half of 2023. The post FDA starts review of first drug for alpha-mannosidosis, from Chiesi appeared first on.

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World of DTC Marketing

DECEMBER 29, 2020

For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. Rather than have patients fill out the paperwork online and get a specific time for their shot, Florida uses the cattle car mentality, leading to people waiting overnight.

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Pharma Food and Drug Administration Media Food 307

Pharma Marketing Network

MARCH 19, 2025

These insights help pharma marketers understand how content performs, what resonates with healthcare professionals (HCPs) and patients, and where adjustments are needed. For pharmaceutical companies, this can provide insights into public perception of drug launches, patient experiences, and industry discussions.

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Media Marketing Pharma Ethics 52

World of DTC Marketing

MARCH 14, 2022

Right now, it’s hard not to read stories about biotech companies laying off people as the FDA takes a stricter stance on new drug therapies. CEOs have to be able to lead while balancing expectations. Unfortunately, it costs a LOT of money to launch a new drug even if a company successfully gets FDA approval.

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FDA Medical Pharma Media 200

Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD patients.

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Food and Drug Administration FDA Food Safety 98

pharmaphorum

AUGUST 16, 2022

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. The post FDA grants swift review to Lynparza in first-line prostate cancer appeared first on.

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World of DTC Marketing

JANUARY 1, 2022

More and more patients demand a level of service they want with the increased costs of health insurance premiums. 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.

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Healthcare Healthcare Side effects Prescription 244

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. It dissolves rapidly releasing the active ingredient in the mouth, meaning there is no requirement for the patient to swallow a pill.

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Food and Drug Administration FDA Food Marketing 98

European Pharmaceutical Review

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 RMAT designation will provide the benefits of added intensive FDA guidance and expedited review through the programme’s development.

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Food and Drug Administration FDA Medicine Food 105

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Marketing FDA Food and Drug Administration Pharmaceutical 97

European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. Each batch of engineered T cells is manufactured individually and infused back to the original cancer patient.

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Manufacturing Food and Drug Administration FDA Engineering 105

World of DTC Marketing

MARCH 11, 2022

Most patients completely trusted their physicians “to put their needs above all other considerations” (69%). According to Accenture, “the pharma industry has ‘earned’ some modest gains in trust from patients due to vaccine development. Even patients will still line up if a prescription drug shows promise.

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Physicians Healthcare Healthcare Pharma 212

Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. at six months and 24 months, respectively, following infusion.

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Food and Drug Administration FDA Side effects Food 105

Legacy MEDSearch

APRIL 6, 2023

announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. CardioSTAT has now become the leading wearable cardiac monitoring solution in Canada.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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FDA Patients Pharmacology Pharmaceutical 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. The FDA’s review will take into account data from the Phase III MOMENTUM trial (NCT04173494).

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Food and Drug Administration FDA Prescription Food 98

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The FDA noted that the monovalent Covid-19 vaccines from Pfizer-BioNTech and Moderna are no longer authorised for use in the US.

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FDA Food and Drug Administration Food Leads 133