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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World of DTC Marketing

JUNE 6, 2021

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost?

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World of DTC Marketing

JUNE 23, 2021

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. government. Natalie Shure, The New Republic.

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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 90

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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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

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 95

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

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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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

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 75

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 80

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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Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. In 2018, the FDA had granted Pedmark a breakthrough orphan drug designation.

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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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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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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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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 Side effects Recruitment 98

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

Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. Nitisinone capsules are indicated for the treatment of adult and paediatric patients with HT-1 in combination with dietary restriction of tyrosine and phenylalanine.

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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.

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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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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). However, other studies found that the relapse in symptoms occurs in patients independent of Paxlovid use.

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Food and Drug Administration FDA Side effects Safety 59

Pharma Leaders

APRIL 19, 2023

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). Diarrhea was the most common side effect using Xphozah in clinical trials. This reduces the absorption of phosphate via the paracellular pathway, which is the main pathway of phosphate absorption.

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Food and Drug Administration FDA Side effects Food 52

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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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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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 86

Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies. During the two-year project, the companies will assess the mental health side effects of the asthma drug, montelukast.

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Safety Food and Drug Administration FDA Side effects 59

Pharma Leaders

JUNE 14, 2023

Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. It offers dual advantage of providing a longer duration of pain relief, with less systemic side effects, stated the company.

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Legacy MEDSearch

JUNE 15, 2023

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.

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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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Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment. Health technology assessment (HTA) bodies also have some appetite for this information.

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Food and Drug Administration Patients Side effects Medicine 52

pharmaphorum

SEPTEMBER 7, 2022

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug early next year. GSK said it is “committed to working closely with the US FDA to bring daprodustat to appropriate patients with anaemia of CKD.”

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pharmaphorum

JANUARY 20, 2023

Eli Lilly has been unable to secure an accelerated FDA approval for its anti-amyloid Alzheimer’s disease therapy donanemab based on mid-stage clinical results, but says it remains on track to file a traditional submission around the middle of this year. Final results from CLARITY-AD are also due in the first half of this year.

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Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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