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What’s in a name? Trademarking COVID-19 solutions

Clarivate

That’s why trademark analysts also assess for patient safety. It can be a tricky business, and an important one not just for commercial reasons, but also for patient safety. pharmaceuticals require some special considerations.?Ultimately, The brand name chosen for a vaccine or drug is more than a commercial matter.

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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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Competition is on the horizon for costly narcolepsy treatments

pharmaphorum

In order to bring it to market, a special program called Risk Evaluation and Mitigation Strategy (REMS) had to be put in place, where only eligible patients could access the drug through a very strict process. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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

Clarivate

In parallel, the CDE also established a special channel to facilitate these approvals. 5] Third list of overseas new drugs urgently needed in clinical practice , November 2020. [6] 6] Clinical technical requirements for overseas drugs not yet imported to China , October 2020.

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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. February 18, 2020. Reach out at swhite@xaviercreative.com.

Pharma 98
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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

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. ISPE GAMP, RDI Good Practice Guide: Data Integrity by Design, ISPE, 2020. References.

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mRNA therapeutics: a limitless revolution in medicine

European Pharmaceutical Review

An aptamer-based therapeutic defibrotide was approved in 2020 for unblocking clots in blood vessels inside the liver caused by a rare disease, veno-occlusive disease. Targeted entry of mRNA into human cells is a challenging process that requires special delivery systems to protect the therapeutic mRNA from degradation…”.

Medicine 106