Fierce Pharma

AUGUST 15, 2024

So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels. | So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels.

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Side effects Safety FDA 215

European Pharmaceutical Review

JANUARY 4, 2024

Immunotherapy drugs like teclistamab can result in potentially fatal side effects, including CRS and immune cell-associated neurotoxicity syndrome (ICANS). In 2022, the drug was approved by the US Food and Drug Administration (FDA) for these patients. We are going with full steam into an era of immunotherapy.”

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Side effects Food and Drug Administration Patients Medicine 97

World of DTC Marketing

JUNE 23, 2021

One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39 I, therefore, find the FDA’s decision to be puzzling.

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FDA Side effects Physicians Patients 218

Fierce Pharma

JULY 17, 2023

Apellis Pharmaceuticals' Syfovre, after achieving the first FDA approval for advanced eye disease geographic atrophy, has been associated with rare but severe side effects, according to the America | The American Society of Retinal Specialists sent out a note to doctors on Saturday warning of eye inflammation cases in patients who took Syfovre, (..)

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Side effects Doctors FDA Pharmaceutical 215

World of DTC Marketing

JULY 21, 2021

The FDA needs to study what people do when they see a DTC ad. 3hree: DTC marketing minimizes the side effects of prescription drugs – One of the top pages within prescription drug websites continues to be “safety information.” SUMMARY: DTC marketing is not the reason why prescription drugs cost so much.

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Marketing Prescription Side effects Doctors 285

World of DTC Marketing

OCTOBER 29, 2020

It’s time to admit that the FDA is completely out of touch regarding DTC advertising. For some reason, the FDA still requires fair balance on website home pages. Fair balance needs to be scraped and the FDA needs to start by asking “what are people looking for when they come to a drug company product website?

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Side effects Safety FDA Pharma 181

World of DTC Marketing

APRIL 22, 2021

Product websites are stagnant, and online health seekers are going elsewhere to learn about your medication’s side effects and cost. 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.

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Marketing Side effects Prescription Media 265

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. What people seem to be interested in are drug side effects vs. efficacy. Since when is consumer behavior ever scientific?

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Food and Drug Administration Side effects FDA Prescription 185

World of DTC Marketing

FEBRUARY 2, 2022

While some doctors have been eager to start prescribing the newly approved drug, others had criticized the FDA for clearing the drug before studies proved it works. ” A physician on STAT News wrote, “the consequences of FDA approval are as disturbing as they are vast. Top researchers who advised the U.S. .’s

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Food and Drug Administration Physicians Side effects FDA 239

World of DTC Marketing

DECEMBER 1, 2020

Don’t just say the “most common side effects were.” ” let people know how many people what percentage of people reported certain side effects. 8ight: Challenge the FDA. 6ix: P L E A S E address misinformation by providing links to credible health sites.

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Pharma Side effects Sales Patients 186

World of DTC Marketing

JULY 15, 2021

Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. As soon as the FDA gave Aduhelm approval, investors rushed to buy Biogen’s stock, and the executive was spreading Kool-aid about the product’s efficacy. Biogen’s reputation may be damaged beyond repair.

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Food and Drug Administration FDA Side effects Ethics 202

European Pharmaceutical Review

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline Biologicals’ Boostrix vaccine for use in pregnant woman in their third trimester, to prevent against whooping cough (pertussis) in infants up to two months of age. However, babies are at highest risk for getting pertussis and having serious complications from it.”.

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FDA Food and Drug Administration Side effects Food 105

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.

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FDA Side effects Patients Doctors 187

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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FDA Side effects Pharmacology Patients 115

World of DTC Marketing

NOVEMBER 5, 2021

“Obesity is multifactorial, meaning many factors are involved and go from genetics, lifestyle, mental health issues (such as trauma) to medication side effects,” says Dr. Viana, Clinical Director Yale Medicine Metabolic Health & Weight Loss Program. Many factors contribute to obesity.

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Insurance Side effects Medical Prescription 271

World of DTC Marketing

DECEMBER 29, 2021

The demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. ” The potential for Wegovy in helping patients lose weight is exciting, but the more people who go on the drug, the higher the side effects are going to be. Unfortunately, the hype is going to exceed reality.

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Side effects Physicians Patients FDA 191

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). Like Stelara, the most serious known side effect of Wezlana is infection. The post FDA approves first Stelara biosimilar, Wezlana appeared first on European Pharmaceutical Review.

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Food and Drug Administration FDA Side effects Safety 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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FDA Side effects Prescription Recruitment 98

European Pharmaceutical Review

NOVEMBER 18, 2022

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). The FDA granted the approval of Tzield to Provention Bio.

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Food and Drug Administration FDA Side effects Food 98

World of DTC Marketing

DECEMBER 23, 2020

What are the side effects? The FDA can be myopic when researching how consumers view and react to DTC. The FDA should be engaging DTG Research to ask the question, “what are people doing when they are interested in an advertised drug?” That belief is out the window. Is it covered by my insurance?

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Prescription Doctors Side effects Marketing 249

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. Topic sponsors are not involved in the creation of editorial content.

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Food and Drug Administration FDA Side effects Food 105

European Pharmaceutical Review

JANUARY 9, 2023

The US Food and Drug Administration (FDA) has granted Leqembi (lecanemab-irmb) Accelerated Approval for Alzheimer’s. The FDA’s decision means the drug is the second of a new category of medications approved for Alzheimer’s that target the fundamental pathophysiology of the disease.

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Food and Drug Administration FDA Side effects Food 96

PM360

JANUARY 24, 2025

Advertisers want to engage audiences, but at the same time, need to adhere to updated FDA guidance released in November of 2023 for pharmaceutical ads. If an advertiser needs to utilize 60 seconds to meet FDA standards, they face spending double on their media investment versus the cost of a 30-second ad.

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Side effects Media Networking FDA 52

European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica. severe itch) in each group.

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Food and Drug Administration FDA Side effects Medicine 97

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 post FDA clears Incyte’s Opzelura as first vitiligo therapy appeared first on.

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FDA Side effects Sales Safety 98

Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolor has already obtained FDA approval for pre-operative administration. Cumberland sponsored a multi-centre trial in 21 hospitalised infants in order to validate its expanded usage.

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Food and Drug Administration FDA Side effects Safety 98

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

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Food and Drug Administration FDA Recruitment Side effects 98

pharmaphorum

OCTOBER 27, 2022

Santhera should hear from the FDA whether the speedy review has been granted within the next 60 days, and if so the review time will be cut from 10 to six months. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

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FDA Side effects Biopharma Marketing 98

World of DTC Marketing

FEBRUARY 22, 2021

Given that most obstructive sleep apnea patients are obese men, it’s dangerous that the side effects listed for Sunosi say, “tell your doctor if you have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol.”

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Pharma Doctors Side effects Prescription 181

European Pharmaceutical Review

OCTOBER 14, 2022

RemeGen has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its proprietary novel fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG). Telitacicept is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases.

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Food and Drug Administration Side effects FDA Food 124

World of DTC Marketing

FEBRUARY 9, 2021

In clinical trials, how many people experienced a listed side effect? They understand that patient content could be edited to meet FDA requirements, but they like reading others’ experiences managing their health issues. They wanted to know why pharma didn’t communicate that their websites had to meet FDA guidelines?

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Pharma Medical Side effects FDA 180

European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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Food and Drug Administration Side effects FDA Medicine 111

Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

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FDA Food and Drug Administration Side effects Safety 83

Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Vomiting and diarrhoea are the most common side effects observed in the trial.

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Food and Drug Administration Pharmaceutical FDA Side effects 72

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date.

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FDA Safety Pharmaceutical Patients 126

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. Include safety disclaimers For branded drug ads, always mention risks and side effects.

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Management Pharma Marketing Prescription 52

Pharma Marketing Network

JANUARY 11, 2025

For instance, while patients prioritize benefits and side effects, healthcare providers look for clinical evidence and efficacy. FDA Guidelines for DTC Ads: The FDA requires ads to present both benefits and risks equally. What are the FDA requirements for direct-to-consumer ads?

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Pharmaceutical Marketing Pharma Healthcare Provider 52