Pharmaceutical Technology

JUNE 5, 2023

Avadel Pharmaceuticals has introduced LUMRYZ (sodium oxybate) for commercial use in the US to treat cataplexy (excessive daytime sleepiness, or EDS) in adult patients with narcolepsy. The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023.

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European Pharmaceutical Review

SEPTEMBER 22, 2022

Rare disease drug development poses unique challenges that can be overcome by using real-world evidence (RWE). Small populations, paediatric patients, and the desire from patients and their caregivers to receive active therapy can make the conduct of randomised trials with placebo control untenable.

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OCTOBER 25, 2022

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

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Pharmaceutical Technology

MAY 1, 2023

In February this year, the US Food and Drug Administration (FDA) accepted for filing the company’s new drug application (NDA) for Avacincaptad Pegol (ACP) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

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DECEMBER 8, 2022

took a step towards its vision of transforming chronic care management with Polso , the company’s Remote Patient Monitoring (RPM) solution, achieving 510(k) clearance from the U.S. Food and Drug Administration (FDA). ChroniSense Medical Ltd. and globally. About ChroniSense Medical. About Rainbow Medical.

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European Pharmaceutical Review

FEBRUARY 27, 2024

The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen. ” Amgen Ohio is nearly 300,000 ft 2 in size and will employ 400 full-time staff.

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Pharmaceutical Technology

NOVEMBER 7, 2022

The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. We are very impressed with the Parkinson’s Foundation’s holistic approach towards improving patient care and supporting cutting-edge research. “We

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Pharmaceutical Technology

JULY 21, 2022

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Additionally, AI can improve patient wellbeing by automating health records, predicting illness, and enhancing treatment efficiency. 3D bioprinting offers an alternative to animal testing in drug development.

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NOVEMBER 9, 2022

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. Food and Drug Administration. We have not only improved our TAVR outcomes but enhanced the patient experience as well.”. Saranas, Inc.

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European Pharmaceutical Review

AUGUST 1, 2022

The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said. The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team.

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European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. Cedars-Sinai’s Institutional Review Board (IRB) will monitor the studies for Alpha network sites. Scientific and operational teams.

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SEPTEMBER 12, 2022

Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. The new RhinAer is designed to provide physicians with improved visualization, easier access and tissue apposition, especially in patients with narrow nasal airways. Aerin Medical Inc.,

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Healthcare Success

OCTOBER 17, 2024

Struggling with burnout while maintaining high-quality healthcare services that patients love? Tune in to our latest podcast as Lee Aase, founder of HELPCare, LLC, shares how he transitioned from his pioneering social media work at Mayo Clinic to lead an innovative membership-based direct-to-patient healthcare business.

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European Pharmaceutical Review

SEPTEMBER 2, 2022

An RMP is submitted as part of the dossier of all new drug applications and is evaluated by regulatory authorities before authorisation is given. Jouaville: Most RMM effectiveness studies are formatted as surveys or drug utilisation studies (DUS). How is the efficacy of RMMs assessed? These guidelines have been updated recently.

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Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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European Pharmaceutical Review

FEBRUARY 8, 2024

Regulatory plans for the cystic fibrosis medicine By mid-2024, Vertex declared that it plans to submit a New Drug Application (NDA) to the US Food and Drug Administration and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in patients with cystic fibrosis aged six years and older.

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DECEMBER 12, 2022

This most recent FDA 510(k) clearance extends the system’s previous FDA clearances and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station. ” About IRRAS. For more information, please visit www.irras.com.

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JANUARY 3, 2023

Food and Drug Administration for its Respiratory Health point of care test. 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. . About Visby Medical.

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European Pharmaceutical Review

JANUARY 19, 2023

The contribution will enable the programme to reach additional physicians and medical students, further expanding the initiative that aims to extend the reach of clinical trials in underserved patient populations in US communities. The Winn Award Program has so far trained 114 early-stage investigator physicians.

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SEPTEMBER 27, 2022

Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. About Pulse Biosciences®.

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PM360

DECEMBER 20, 2024

Clinical trials can offer life saving treatments to patients in need. Food and Drug Administration reported that 75% of clinical trial subjects were white, while only 6% were Asian, 8% were Black, and 11% were Hispanic. In some cases, this could preclude access to drugs otherwise beneficial to patient subgroups.

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European Pharmaceutical Review

DECEMBER 30, 2024

Numerous groundbreaking advances have shown these therapies hold potential to revolutionise how we treat, and potentially cure, many conditions, including for patients with underlying genetic or cellular causes of disease that have been difficult to treat with conventionalapproaches.

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European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

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Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

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AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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SEPTEMBER 16, 2022

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.

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FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. These initiatives are core to our transformative approach to MR imaging, making it a reality for a growing number of patients in the fast-evolving diversity of sites of care.” Hyperfine, Inc.,

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PM360

FEBRUARY 12, 2024

Created by The European Organization for Rare Diseases (EURORDIS) , this globally coordinated event brings together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers, and their families.

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Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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Pharma Marketing Network

JULY 26, 2023

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. appeared first on Pharma Marketing Network.

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JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc., 1 ranking in 2021.

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JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung Expansion (OLE) therapy. We are proud to introduce this innovative OLE therapy system.”

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DECEMBER 21, 2022

Food and Drug Administration (FDA) for 510(k) clearance. Inspira plans for the ALICE to be the first device to Integrate the HYLA Blood Sensor designed to be non-invasive, perform continuous measurements and alert physicians at real time of sudden changes in a patient’s specific key blood indicators.

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DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today.

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JANUARY 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the Flex-Thread Ulna Intramedullary (IM) Nail System. With multiple innovative, new products currently in development, Conventus Flower Orthopedics is focused on improving patient outcomes with novel solutions that address unmet needs in the market.

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MARCH 15, 2023

In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

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Pharmaceutical Technology

MAY 17, 2023

WuXi Biologics and InflaRx have entered a manufacturing partnership for advancing Gohibic (vilobelimab) to treat certain critically ill Covid-19 patients. Last month, the therapy received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to treat hospitalised Covid-19 adult patients.

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