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 223

European Pharmaceutical Review

JANUARY 4, 2024

New research from the US indicates that a prophylactic treatment before immunotherapy can significantly reduce the rate of cytokine release syndrome (CRS) in multiple myeloma patients. Immunotherapy drugs like teclistamab can result in potentially fatal side effects, including CRS and immune cell-associated neurotoxicity syndrome (ICANS).

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Side effects Food and Drug Administration Patients Medicine 97

World of DTC Marketing

JULY 21, 2021

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. ” Patients want to understand how the drug works and the potential side effects before starting therapy.

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Marketing Prescription Side effects Doctors 285

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

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

MedCity News

MARCH 22, 2024

Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease.

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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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Food and Drug Administration Side effects FDA Prescription 185

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

World of DTC Marketing

AUGUST 10, 2022

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. While there is a segment that sees the drug as a “quick fix” to lose weight, others are skeptical and want to know more about side effects and costs.

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Marketing Media Side effects Pharma 252

World of DTC Marketing

DECEMBER 1, 2020

Walk into any corporate pharma HQ, and you’re likely to see a mission statement that’s pure b t about how patients come first. We all know that Wall Street and sales come well before patients. In the past, pharma product websites had a huge effect on whether a patient asks for an Rx. 8ight: Challenge the FDA.

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Pharma Side effects Sales Patients 186

World of DTC Marketing

DECEMBER 23, 2020

DTC marketers who believe that DTC is essentially the same as before the pandemic are failing to recognize significant shifts in patient behavior regarding prescription drugs. Any discussion around DTC should acknowledge the following: 1ne: DTC is more effective for some health categories than others. What are the side effects?

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Prescription Doctors Side effects Marketing 249

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

World of DTC Marketing

NOVEMBER 5, 2021

Patients want quick fixes, and the idea of losing some weight because of a new drug is enticing to them. In response, the company has been providing six-month waivers to some insured patients that will cap the drug’s out-of-pocket costs at $25 a month, though the long-term picture of coverage is still in flux. Click to Tweet.

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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. Wegovy can indeed help patients lose weight, but it requires that users adhere to a diet and exercise. Some were happy for any product that would help patients lose weight others were worried about the long-term use of the drug.

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Side effects Physicians Patients FDA 191

World of DTC Marketing

JULY 15, 2021

Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. This approval was NOT about patients; it was about the profits of a pharma company in quicksand and sinking fast. That meeting was reportedly followed by a formal meeting between Biogen and FDA in June 2019.

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Food and Drug Administration FDA Side effects Ethics 202

World of DTC Marketing

MAY 3, 2022

In trying to save the product, Biogen’s reputation was trashed by FDA advisors, HCPs, and the healthcare media. 2wo: The competition’s MS drugs were better – The MS market is lucrative, and competitors launched products that were better than Biogen’s with fewer side effects discussed by the MS community online.

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Side effects FDA Media Pharma 207

European Pharmaceutical Review

DECEMBER 18, 2023

After eight weeks of treatment, patients’ depression severity scores dropped by an average of 19.1 Treatment-related side effects included nausea and headache but were generally mild. “As The post Psilocybin-assisted therapy reduces depressive symptoms in cancer patients appeared first on European Pharmaceutical Review.

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Food and Drug Administration Patients Side effects Safety 116

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). A clinical trial evaluated the safety and efficacy of Tzield in 76 patients with stage 2 type 1 diabetes.

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Food and Drug Administration FDA Side effects Food 98

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. Since 2012, the CDC has recommended the vaccine series during the third trimester of each pregnancy.

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FDA Food and Drug Administration 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

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. The trial is designed to analyse the safety and efficacy of Hemgenix.

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Food and Drug Administration FDA Side effects Food 105

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. He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.”

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Food and Drug Administration FDA Side effects Safety 98

World of DTC Marketing

FEBRUARY 22, 2021

Jazz Pharmaceuticals has introduced a new prescription medication for patients with sleep apnea/narcolepsy that “helped adults get up to 9 hours of improved wakefulness in clinical studies at 12 weeks” and they’re using a flying pig on their DTC. billion in 2018, and is expected to grow at a CAGR of 7.20% to reach $86.01

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Pharma Doctors Side effects Prescription 181

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. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.

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Food and Drug Administration FDA Side effects Safety 98

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. points in patients receiving difelikefalin versus 2.4

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Food and Drug Administration FDA Side effects Medicine 97

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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World of DTC Marketing

JULY 5, 2022

Pharma websites provide the prescription that can help people overcome health problems but too often, they ignore the patient’s responsibility to lose weight and exercise. The FDA should require every pharma product website to devote part of its content to prevention and the importance of exercise.

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Insurance Doctors Pharma Side effects 200

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 92

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. A breakdown of the data showed: HbsAb levels were greater than 1000mIU/ml in 88 percent of patients.

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Patients Food and Drug Administration Side effects Food 96

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

World of DTC Marketing

FEBRUARY 9, 2021

Consistently we heard that they like images of real patients or a REAL doctor with one key message communicated. In clinical trials, how many people experienced a listed side effect? 7even: Real patient stories. 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

DECEMBER 7, 2022

The common, expected side effects were within expectations for a vaccine in this age group. In November 2021, the US Food and Drug Administration (FDA) authorised the emergency use of COVID-19 vaccine Comirnaty ® in children aged five to 11 years. Data that facilitated the line extension of Comirnaty ® for Covid-19.

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Food and Drug Administration Patients Side effects Medicine 98

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). MG is a chronic autoimmune neuromuscular disease that causes patients to be prone to fluctuating muscle weakness.

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Food and Drug Administration Side effects FDA Food 124

World of DTC Marketing

APRIL 19, 2021

You have a better chance of getting struck by lightning than developing a side effect from the J&J vaccine. The agencies should end the pause, keep sharing information and let patients decide. They have been tested per the FDA, and to die, those who have been vaccinated have less than a.008%

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Government Education Side effects Pharma 190

World of DTC Marketing

FEBRUARY 4, 2021

Food and Drug Administration (FDA) is meant to help patients and warn of potential drug side effects but a Vice report indicates something more. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S. He said it would take years to analyze all the data.

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Pharma Food and Drug Administration Side effects Safety 180

Pharmaceutical Technology

NOVEMBER 14, 2022

In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells. All five patients achieved remission after three months.

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Side effects Patients Manufacturing Safety 144

pharmaphorum

OCTOBER 24, 2022

Tremelimumab has been approved by the FDA in the US for use in tandem with AZ’s PD-L1 inhibitor Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC), the most common tumour type affecting the liver. The post AstraZeneca gets first FDA okay for CTLA4 drug tremelimumab appeared first on.

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