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Briumvi may struggle to make headway in crowded multiple sclerosis market

Pharmaceutical Technology

Briumvi is the third approved injectable MS treatment directed against CD20 antigen expressed on B cells, with the other therapies being Kesimpta (ofatumumab, approved in 2020) and Ocrevus (ocrelizumab, approved in 2017). All three treatments are monoclonal antibodies.

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Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Pharmaceutical Technology

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59
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Pear extends digital therapeutics partnership with Spero

pharmaphorum

In 2017, reSET became the first FDA-approved DTx with both a safety and efficacy label, after the US regulator licensed it for substance use disorders involving alcohol, cocaine, marijuana, and stimulants. Pear secured approval for reSET-O in the following year.

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The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. Sunny’s healthcare marketing agency, Xavier Creative House, specializes in pharmaceutical, biotech, and medical device. Findings note that caregivers are a vital source of information.

Pharma 98
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Mainland China’s regulatory evolution brings greater access to novel drugs

Clarivate

To address this pain point, the Center for Drug Evaluation (CDE) announced in 2017 that it would accept marketing applications based on clinical evidence generated in multicenter studies conducted overseas [1]. In parallel, the CDE also established a special channel to facilitate these approvals.

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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. Edward helps clients with compliance and safety issues, including in the development, launch and marketing of new products.

Medical 117
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Alpha TAU Killing Tumors With Highly Targeted Alpha Radiation

Medgadget

Special software that takes DICOM images from CT scanners and creates a treatment plan, defines the distribution of the Alpha DaRT sources within the tumor. Using the company’s own process, radium-224 is impregnated into a steel rod to make Alpha DaRT sources, which are then packaged in a custom kit made for treating specific tumors.