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Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.
By re-engineering existing approaches that have already shown clinical promise, there is potential to bring further benefit to the patient community in its fight against cancer. Since then, several next-generation antibodies have been engineered with modifications that enable them to better engage with immune cells.
The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. According to the interim efficacy data from a pre-specified patient cohort, a 5.4 In the trial, 1.9%
The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. The vaccine showed an encouraging safety and tolerability profile in both trials. The post Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults appeared first on Pharmaceutical Technology.
This is a crucial first step in our path to make the Maestro Brain Model the ‘engine’ in our navigation system supporting multiple new applications in the future. Surface meshes of segmented anatomical regions will define safety zones and optimal trajectories for patient-specific laser ablations. Press Release by: ClearPoint Neuro.
The most prominent among them include: AI misinterpretation of critical information: As an example, a team might ask ChatGPT to answer a question, and the AI engine may deliver an impressive volume of information, while misaligning with the core business, leading to conclusions that are either overvalued or flat-out wrong.
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec. Based on the safety and efficacy findings from the Phase III BENEGENE-2 study, the company made these filings.
Brand Authority: By appearing at the top of search engine results, pharmaceutical companies increase brand credibility among HCPs. Follow FDA and Regulatory Guidelines Ensure all PPC ads adhere to FDA, EMA, or MHRA regulations. Avoiding misleading claims that exaggerate efficacy or safety.
So how can pharma brands maximize their return on investment (ROI) while ensuring compliance with FDA and HIPAA regulations ? The answer is simple search engines and social platforms are where patients and HCPs find information. The key lies in data-driven strategies, precise audience segmentation, and high-performing ad placements.
The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). This marks the first-ever designation for genetically modified gamma-delta T cell therapies.
For example, a query for “rare disease drug approval” would include results for the Orphan Drug Act from the FDA. However, without integrating the company’s Adverse Event or Safety database, the search results could miss other unknown reactions such as itching, eczema, and hives. Compare this to another scenario.
With platforms like Bing, LinkedIn, and programmatic networks, pharma marketers can scale efforts across search engines and display placements. Landing pages should also adhere to FDA requirements, clearly displaying ISI (Important Safety Information) and PI (Prescribing Information) where applicable.
The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.
engine acts as a second reader to radiological technologists at point-of-care for image quality on every mammogram. Densitas ® is a global leader in artificial intelligence solutions for breast cancer screening, focused on quality, safety, efficiency, and precision breast health. The intelliMammo A.I. ” About Densitas ®.
NT-I7 is a homeostatic T cell growth factor composed of a covalently linked homodimer of an engineered Interleukin-7 (IL-7), biologically fused with the proprietary long-acting platform – hyFc®. NT-I7 exhibits reliable Pharmacokinetic (PK) and safety profiles, making it an ideal combination partner. He received his Ph.D.
Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. .” Cresilon’s mission is to save lives.
Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.
Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). Personalized medicine at FDA. What are the current trends in antibody therapeutics?
Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement. ” About Zeta Surgical Zeta Surgical is a digital surgery company focused on improving the accuracy, safety, and accessibility of image guided procedures. Are you hiring?
Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.
They must be highly targeted, compliant with FDA and HIPAA guidelines, and designed to generate meaningful interactions rather than just impressions. Ensure Regulatory Compliance with Social Media Guidelines Pharma brands must adhere to strict advertising regulations , ensuring that content: Includes fair balance and safety information.
2 Driven by the success of FMTs with clinical efficacy in several indications 3-6 and the first two FDA-approved donor-derived products on the market for recurrent Clostridioides difficile infections, 7,8 a new and promising trend is emerging that combines the ‘whole ecosystem’ of FMTs with rational consortia design. Microbiome.
The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc.
On 6 January, a milestone was achieved—lecanemab gained US Food and Drug Administration (FDA) approval via the Accelerated Approval pathway. Lecanemab is a humanised antibody generated using protofibrils engineered from Aβ harbouring genetic mutations that cause familial AD.
SPK-9001 is a novel, investigation vector containing a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity human coagulation FIX gene. This resulted in a 71% reduction in ABR after a single dose of 5e11 vg/kg of fidanacogene elaparvovec.
The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.
It’s open-source design meets FDA requirements for safety and protection. Saatchi & Saatchi Wellness and TOM (Tikkun Olam Makers) The Prescription Paper Pill Bottle An innovative alternative to plastic, the Prescription Paper Pill Bottle is 100% compostable with no artificial glue and no toxic dye.
The HYDR ogel A ugmentation F or I ntervertebral L umbar D iscs (HYDRAFIL-D) Study , is a multicenter, single-blinded, randomized, controlled trial to evaluate the safety and efficacy of the HYDRAFIL System for treatment of chronic low back pain due to degenerative disc disease. Vapotherm (NYSE:VAPO), and National Sleep Technologies.
eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform in the United States. Securing the U.S.
Our roadmap for advancing this technology entails rigorous testing, refinement, and collaboration with experts in neurology, neurosurgery, and medical engineering. The NeuroPASS device represents a significant leap forward in addressing the challenges posed by the blood-brain barrier.
The removal/separation of impurities and ensuring the purity of biologics is essential to the safety and quality of the therapeutic. Not only can impurities lead to adverse effects in patients, but they can also introduce product variability. References Kitazawa T, Shima M.
Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Joseph S Boakai (JSB): The three current trends are as follows: Increased scrutiny by regulatory bodies. How can this be mitigated?
The main trend in ADC development] has been an advancement in the engineering changes related to the drug to antibody ration (DAR)” The main change has been an advancement in the engineering changes related to the drug to antibody ration (DAR). What are two of the main trends in ADC development?
Develop an Omnichannel Strategy : Integrating multiple touchpoints, including social media, programmatic advertising, email marketing, and search engine optimization (SEO), helps maintain a consistent brand presence. Compliance and Regulatory Preparedness Adhering to compliance standards is a non-negotiable aspect of healthcare marketing.
For pharma marketers, PPC campaigns typically fall into three main categories: Search Ads: Appear on search engines when users look for specific keywords (e.g., While pharma brands should invest in search engine optimization (SEO) for sustained growth , PPC ensures immediate traffic to branded websites, drug pages, and lead-generation forms.
This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration (FDA) for UroActive. UroActive has not received marketing authorization from the FDA and is not available for sale in the United States or in the EU.
Moreover, due to the different nature of healthy and cancerous tissue, alpha radiation produced by Alpha DaRT sources diffuses about a millimeter into healthy tissue while penetrating at a diameter up to about five millimeters into tumors, providing an automatic safety mechanism. The rest of the patients had partial responses.
Upma Sharma: NeoCast has been engineered to be non-adhesive to catheters and can be delivered using standard microcatheters, without a specialized device. Designated by FDA as a Breakthrough Device, ResQFoam creates conformal contact and applies pressure to an actively bleeding site within the body.
Food and Drug Administration’s (FDA) draft guidance, “ Digital Health Technologies for Remote Data Acquisition in Clinical Investigations ”. We see how digital measures of adherence ensure that sample size calculations hold and drug developers can accurately evaluate the safety and efficacy of new molecules.
In an effort to provide a more sustainable and environmentally friendly source of meat, Good Meat is planning to build ten 250,000-liter bioreactors for meat cultivation in collaboration with biotech process engineering firm ABEC. It used to take years for a drug to progress from laboratory research to FDA approval.
Search engine marketing (SEM), display ads, social media advertising, and programmatic media buying help brands engage patients and providers during high-intent moments. Ad copy and landing pages must include ISI (Important Safety Information), follow FDA and PhRMA guidelines, and offer fair balance when promoting branded products.
One of the primary objectives of pharma marketing is to communicate the benefits and safety profiles of medications to healthcare providers and patients. Digital marketing strategies, including search engine optimization (SEO), content marketing, and online advertising, have become integral components of pharmaceutical marketing campaigns.
SEO and Content Marketing: Ranking high on search engines is crucial for visibility. Regulatory Compliance: Marketing teams must stay updated on guidelines from the FDA, EMA, and other regulatory bodies. Compliance isnt a hurdleits an opportunity to showcase your commitment to safety and quality.
A strong brand message conveys the unique value proposition of the pharmaceutical product, highlighting its benefits, efficacy, and safety. From social media and email marketing to search engine optimization and online advertising, digital channels provide cost-effective and measurable ways to promote pharmaceutical brands.
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