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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.
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.
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?
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.
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 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.
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.
” 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. .
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.
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.
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.
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.
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.
Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics.
Food and Drug Administration (FDA) for 510(k) clearance. If FDA clearance is obtained, the ALICE device production line will be extended for Low-Rate Initial Production (LWRIP), which is an important operational stage in developing infrastructure to support serial manufacturing, quality control and shipping. Are you hiring?
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.
On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. Previously, only licensed and authorised physicians, advanced practice registered nurses, and physician assistants could prescribe the drug. .
Artificial intelligence is revolutionizing how pharma brands engage with healthcare professionals (HCPs) and patients, optimizing advertising campaigns, and improving customer experiences. Those that embrace AI-driven marketing solutions will see higher engagement, better ROI, and improved patient outcomes.
In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services.
In this article, well dive into key pharma digital marketing strategies that can help pharma brands connect with healthcare professionals (HCPs), patients, and stakeholders effectively. Improve patient engagement with valuable content and resources. Without the right strategy, you risk getting lost in a sea of content.
Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. “We are pleased to receive another FDA clearance that extends our reach into the orthopedic device market with our ever-growing suite of cleared bone-fixation devices,” said Tyber Medical CEO and President Jeff Tyber.
And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.
Social media advertising now plays a crucial role in reaching healthcare professionals (HCPs) and patients , allowing pharma brands to engage, educate, and build trust like never before. The way HCPs, patients, and caregivers seek information has changed. Animations explaining drug mechanisms attract HCPs and patients alike.
The increasing integration of platforms like LinkedIn, X (formerly Twitter), YouTube, and even TikTok has dramatically shifted how pharma brands engage with healthcare professionals (HCPs), patients, and caregivers. Brands can host live Q&As, respond to comments, and share patient stories in authentic ways that create community and trust.
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.
The Respiratory Health Test, which fits in the palm of your hand, provides accurate results in under 30 minutes at the point of care, enabling clinicians to accurately diagnose and treat patients. . Both the CDC and the Infectious Disease Society of America recommend clinicians should use rapid molecular assays (i.e., About Visby Medical.
the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc.,
In the recently released 2025 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”), the Centers for Medicare & Medicaid Services (CMS) created a new reimbursement pathway for “Digital Mental Health Treatment” (DMHT) devices and services.
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