This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
To bring cross-agency clinical leaders together, the FDA should establish a Center of Excellence for Rare Diseases. The post To Give Rare Disease Patients Hope, the FDA Must Re-Focus its Efforts appeared first on MedCity News.
The FDA and CDC say “not so fast.” Patients are left to wonder if they need a booster shot creating anxiety as a new strain emerges. ” However, the FDA and CDC say, “Americans who have been fully vaccinated do not need a booster shot at this time,” the agencies said in a joint statement.”
SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs. The post Dear FDA: WTF?
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.
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”?
SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product. Medpage Today.
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. They research the drug online and ask their physician about it if they decide it’s a treatment option. Again this is not true.
On February 21, 2025 , the FDA officially determined that the shortage of semaglutide injection products has been resolved. When the FDA determines the drug shortage is resolved, the normal restrictions on compounding will apply once again. Those impacted must navigate critical regulatory changes now in play for compounded semaglutide.
Trust, for example, in physicians is still relatively high. Most patients completely trusted their physicians “to put their needs above all other considerations” (69%). Physician trust in the U.S. Physician trust in the U.S. Even patients will still line up if a prescription drug shows promise.
Still, consistent research has shown that they don’t provide the information patients want in a language that talks to them. Pharma companies have access to some of the best physicians in the country, and they are underutilized when helping patients understand health issues. So what’s the ROI?
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. They’re using label and FDA-friendly language, which isn’t what patients want to hear. Instead, patients are going online and spreading inaccurate information.
The demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. There are also several physicians chiming in with their concerns over the long-term use of the drug. Wegovy can indeed help patients lose weight, but it requires that users adhere to a diet and exercise.
a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. of patients positively responded to treatment at 24 months, defined as a ?30%
Here are some basics: 1ne: Physicians receive a lot of emails and don’t have time to read every one. One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.” Only send an email when you have something to say that will interest physicians.
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. In an era of a pandemic, are psoriasis patients really going to ask for a drug that may compromise their immune system? What are other patients saying about it?
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 US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. FDA’s approval is based on the Phase III VISIBLE 1 study (SC UC Trial).
Thats why referral marketing is gaining traction among pharmaceutical brands looking to increase engagement with both healthcare professionals and patients. Similarly, when patients share their experiences with others, it can drive interest more effectively than brand messaging alone. In pharma, however, the dynamic is more nuanced.
Current applications Today, there is an escalated appetite to address emerging procedures because they offer an opportunity for device makers – and physicians like me who are interested in cutting-edge technology – to influence new areas of medicine. It is akin to pioneering the untamed West in the 18th Century.
The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.
Physicians and insurers are rejecting Aduhelm because it should never have been approved in the first place. This drug was never about patients; it was about a company whose ego got too big and needed a savior in the form of a medicine that could bring in hundreds of millions of dollars. Biogen is in trouble.
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.
” An app can help patients manage their chronic conditions but there are a lot of variables. If, for existence, a pharma developed app requires patients to “check-in” everyday it could be a reminder that they are living with a chronic health issue. ” to “if it helps patient, it’s what we want to do.”
Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .
AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) combination therapy has been approved in the US for adult patients with unresectable hepatocellular carcinoma (HCC). Phase III trial results found that three years post-treatment, 31 percent of patients given the drug combination were still alive.
The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology.
Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. The SOLOIST-WHF (worsening heart failure) and SCORED trials together assessed around 12,000 patients.
Second, do people trust the FDA? ” 2wo: Physicians are still the gatekeepers of new Rx’s. For them, it’s about two things: relevant data that can be corroborated and improvements in patient outcomes. What does the data mean to the average patient, and why should they consider your product? 5ive: Please!
The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The FDA approval is based on findings from the multicentre Phase II CENTAUR clinical trial that enrolled 137 ALS patients.
announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. The FDA clearance opens the door to the world’s largest medical device market. To this day, CardioSTAT has been prescribed to more than 170,000 patients.
Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year.
These networksspanning healthcare professionals, patients, and digital platformsare the lifeblood of modern pharma marketing. In the pharmaceutical industry, these networks often include healthcare providers, patient groups, digital channels, and key opinion leaders (KOLs). Educate patients about treatments like Humira or Keytruda.
In a highly regulated industry, choosing the right keywords can determine whether your ads reach healthcare professionals, patients, or caregivers effectively. Understanding how patients and healthcare professionals search for medical information is key. Using FDA-approved terminology prevents ad disapprovals and regulatory scrutiny.
Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Healthcare systems and physicians will also be able to use the Tasso+ device with compatible collection tubes to make determinations on blood chemistries for their patients and expand care access. Tasso, Inc., About Tasso.
The promise of these and other food allergy treatments is immense and research and development, in conjunction with clinical care facilities for food allergy patients, will continue to make more treatment options available for more people in the future.
announced that over 1,200 patients have been treated with the Early Bird® Bleed Monitoring System, the first and only FDA-approved bleed detection system. The adoption of the Early Bird system is a testimony to physicians embracing the benefits of early bleed detection for their patients and practice.”. “We Saranas, Inc.
In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan. Thus, FDA funding could be what is needed on this front, says Cudkowicz.
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.
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. .
In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. million people in the UK and 2.7
Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
Pfizer is still waiting for the green light to complete an acquisition of digital health company ResApp, a deal that looks even better now that its smartphone app for people with obstructive sleep apnoea (OSA) has been approved by the FDA. The post ResApp bags FDA okay for sleep apnoea app, after Pfizer takeover bid appeared first on.
Chairman, Dave Ferrera, announced treatment of the first patients in North America with the BossStent® device designed to treat patients with symptomatic cerebral venous diseases. Both the EU and FDA clinical trials will be initiated in Q2 2023 for the purpose of obtaining European and US regulatory approvals respectively in Q1 2024.
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.
We organize all of the trending information in your field so you don't have to. Join 8,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content