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UK agency pilots biobank to study links between genetics and drug side effects

Pharmaceutical Technology

The biobank will work in parallel with the MHRA’s Yellow Card website, which is used for reporting adverse events and side effects caused by medicines and medical devices, per the 25 May announcement. According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank.

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FDA approves first Stelara biosimilar, Wezlana

European Pharmaceutical Review

The FDA said its approval of Wezlana is based on “a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.” Like Stelara, the most serious known side effect of Wezlana is infection.

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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

Additionally, EURneffy could alleviate the risk of accidental needle-related side effects (such as injection into the blood vessel and hand) 3 and it has the attributes of being smaller in size, has better temperature sensitivity, and is less complex to use compared to needle-based injectors. Motohiro E, Kento T, Kyohei T , et al.

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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. The study included 92 adult patients with confirmed CDI.

Safety 111
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Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

Individuals who receive corticosteroids may experience limited efficacy, alongside significant side effects. The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. 3 About the interviewee Dr Marshall Fordyce is CEO of Vera Therapeutics.

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Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

Individuals who receive corticosteroids may experience limited efficacy, alongside significant side effects. The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. 3 About the interviewee Dr Marshall Fordyce is CEO of Vera Therapeutics.

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Grünenthal takes non-opioid pain drug resiniferatoxin into phase 3

pharmaphorum

Grünenthal has moved its painkiller resiniferatoxin into phase 3 trials in patients with osteoarthritis, hoping to find an option that sidesteps the side effects and addictive potential of opioid drugs. If all goes well, the aim is to bring resiniferatoxin to market in 2025.