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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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

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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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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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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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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European Pharmaceutical Review

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel; beti-cel), the first cell-based gene therapy for the treatment of adult and paediatric patients with beta-thalassemia who require regular red blood cell transfusions. .

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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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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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Legacy MEDSearch

DECEMBER 8, 2022

took a step towards its vision of transforming chronic care management with Polso , the company’s Remote Patient Monitoring (RPM) solution, achieving 510(k) clearance from the U.S. Food and Drug Administration (FDA). “FDA clearance is an important validation of our technology. ChroniSense Medical Ltd. and globally.

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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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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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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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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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World of DTC Marketing

AUGUST 25, 2020

grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals. For the first time, I am now in fear of FDA drug approvals.

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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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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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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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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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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 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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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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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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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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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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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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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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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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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. The mutation leads to disordered thyroid hormone transport, which causes patients to experience intellectual and motor disabilities. T3 is a major hormone in the blood that regulates thyroid levels.

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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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pharmaphorum

SEPTEMBER 29, 2022

Regulators and health technology assessment (HTA) bodies are increasingly demanding the patient voice play a central role in drug development – making it riskier for developers to ignore the need for engagement than to embrace it. The patient centricity movement has been building momentum in recent years. Building relevance.

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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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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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Pharma Marketing Network

MARCH 5, 2025

With millions of healthcare professionals (HCPs) and patients turning to Google for medical information, paid search ads present a huge opportunity for pharma brands to boost engagement and conversions. Lead Generation: HCPs looking for drug samples, whitepapers, or medical education can be driven to tailored landing pages.

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Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.

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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. Google is also giving health records another whirl.

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