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If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. But if you’re becoming more involved with the world of digital health, as many pharma companies are these days, you may find that your old FDA knowledge isn’t much help in knowing what will be required of you.
Proper control of type 1 and 2 diabetes can greatly reduce the personal impact and economic burden of this pervasive public health condition. To that end, stakeholders are exploring many parallel routes to help individuals and society maintain the upper hand, as the toll of diabetes continues to skyrocket.
Pharma’s evolving role in patient care. The digital revolution has already reshaped the commercial engine of biopharma companies. Pharma’s digital initiatives now routinely enable new channels that educate and market to patients, physician engagement that is more efficient and effective, and novel payment mechanisms and distribution models that improve access to therapies.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Babies born to mothers who contracted COVID-19 during seem to be at slightly higher risk of neurodevelopmental delays, say US researchers, although they caution their findings are preliminary. Their retrospective study looked at more than 7,500 infants delivered during the pandemic, including 222 born to mothers with a positive COVID-19 test during pregnancy.
There are tasks we, humans, can perform well with our eyes closed. Managing a successful multichannel customer engagement strategy is not on that list. Not seeing your output is about the second worst thing if you are a marketer, brand or product manager (after producing no output). In life sciences, that field of extra responsible decision making, detailed insights after each step are, of course, an especially prized possession.
Pharma supply chain management will be one of the earliest beneficiaries of the Fourth Industrial Revolution, and the potential of ‘networks of networks’.
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
The FDA may have safety concerns abut bluebird bio’s gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far outweigh the risks. Members of the agency’s Cellular, Tissue and Gene Therapies advisory committee voted 15 to 0 in favour of approval of elivaldogene autotemcel – also known as eli-cel and Lenti-D – ahead of the FDA’s scheduled decision on the drug in September.
GSK will start preparations for regulatory filings of its respiratory syncytial virus (RSV) vaccine straight away, after the shot hit the mark in the much-anticipated AReSVi 006 trial in adults aged 60 years and above. Top-line results from the study released this morning show that the RSVPreF3 OA vaccine showed “statistically significant and clinically meaningful” efficacy in this setting, with consistent activity across RSV A and B strains and in older age groups including the over
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Around 425,000 people in England and Wales with cardiovascular disease who are at risk of a secondary stroke or heart attack, could be eligible for treatment with Amarin’s Vazkepa, following a NICE recommendation. In draft guidance, the health technology assessment (HTA) organisation has recommended Vazkepa (icosapent ethyl) as a treatment option for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides in their blood who are already taking statins.
Takeda has reported positive new, long-term results in its pivotal trial of dengue fever vaccine TAK-003 that builds the case for the shot as regulators review marketing applications. The new data – coming after four-and-a-half years of follow-up – has revealed that TAK-003 cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic dengue illness, with no serious safety issues.
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