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” Drug facts boxes are needed, but the FDA disagrees. According to the AMA one of the key reasons for non-adherence is that patients may be frightened of potential sideeffects. From seeing those sideeffects experienced by someone else, it may have led them to believe the medication caused those problems.
Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many sideeffects. FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease.
Could cautions about more common sideeffects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro? On Tuesday, the FDA revealed that it is investigating patient reports of suicidal thoughts and hair loss from the use of the blood sugar-modulating products.
BCMA-targeted therapies are transforming care for multiple myeloma patients. But these immunotherapies also come with various potentially dangerous sideeffects. |
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 sideeffects and will insurance cover the cost?
In fact, the research shows that those who were on semaglutide were less likely to have suicidal thoughts than patients on other diabetes and obesity meds.
SGAs used to treat bipolar disorder are often effective at helping young patients’ mental health improve but can have significant sideeffects including elevated blood pressure and glucose, increased appetite, as well as weight gain.
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.
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 sideeffects, including CRS and immune cell-associated neurotoxicity syndrome (ICANS).
Apellis Pharmaceuticals' Syfovre, after achieving the first FDA approval for advanced eye disease geographic atrophy, has been associated with rare but severe sideeffects, 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, (..)
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 sideeffects before starting therapy.
Product websites are stagnant, and online health seekers are going elsewhere to learn about your medication’s sideeffects and cost. A website and TV commercials are not enough to get patients to ask for a prescription medication especially when fair balance lists sideeffects like cancer.
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?
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.
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 sideeffects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections.
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.
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 sideeffects and costs.
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.
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 sideeffects?
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 sideeffects. Washington Post.
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.
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.
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.
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 sideeffects discussed by the MS community online.
After eight weeks of treatment, patients’ depression severity scores dropped by an average of 19.1 Treatment-related sideeffects 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.
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.
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.
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.
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.
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.
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 sideeffect of Wezlana is infection. He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.”
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
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.
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
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.
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.
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.
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.
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. Strict ad copy guidelines , including FDA-mandated fair balance requirements. However, the landscape isnt simple.
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. .
For instance, while patients prioritize benefits and sideeffects, healthcare providers look for clinical evidence and efficacy. A campaign that shares a real patient success story can evoke trust and engagement. FDA Guidelines for DTC Ads: The FDA requires ads to present both benefits and risks equally.
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 sideeffect? 7even: Real patient stories. They wanted to know why pharma didn’t communicate that their websites had to meet FDA guidelines?
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.
The common, expected sideeffects 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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