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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. 2017; 55(7):1998-2008. percent for MBK-01 and 4.26 2021; 27 (2): S1-S21.

Safety 111
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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. Some 48% of patients on Briumvi also suffered with infusion reactions.

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Three-dose vaccine prevents HIV patients getting hepatitis B

European Pharmaceutical Review

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B.

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Newron says pivotal treatment-resistant schizophrenia trial is a go

pharmaphorum

Side-effect data from the open-label studies was also encouraging, helping to downplay concerns abut evenamide’s cardiovascular and central nervous system safety that emerged in 2019. ” The new data could accelerate partnering efforts of the drug this year.

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Tributes as former NICE, MHRA chair Sir Mike Rawlins dies

pharmaphorum

” Rawlins was knighted in the 1999 Queen’s New Year Honours for services to the improvement of patient protection from the side effects of medicines, and in 2017 was appointed Knight Grand Cross of the Order of the British Empire (GBE) for services to the safety of medicines, healthcare, and innovation.

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Almirall/Lilly lebrikizumab offers potential long-term management of atopic dermatitis

pharmaphorum

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. Minor side effects to long-term maintenance balance. Any clinical study seeks to achieve maximum results efficacy with minimal occurrence of side effects. However, side effects do happen.

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Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They detail the medication’s intended use, proper administration, potential side effects and precautions. percent as EU average with some Member States as high as 25 percent).