Remove 2023 Remove Food and Drug Administration Remove Side effects
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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). Approximately 40 million people in the US experience Type I allergic reactions due to food, venom or insect stings, 4 and the numbers are similar in Europe. Derived from IQVIA Claims Data, 2023. J Allergy Clin Immunol.

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BMS strikes $14bn deal for Karuna Therapeutics

European Pharmaceutical Review

This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain.

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MHRA authorises alopecia treatment

European Pharmaceutical Review

The most common side effects of Litfulo are headache, diarrhoea, dizziness, acne, rash, inflammation of the hair follicles that may be itchy or painful and an increase in an enzyme called creatine phosphokinase, shown by blood test.

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Late-stage ulcerative colitis pipeline continues to innovate

Pharmaceutical Technology

Many of the mainstay drugs for the treatment of moderate to severely active UC, such as anti-tumour necrosis factor (anti-TNF) agents like infliximab, target inflammatory mediators that are dysregulated in this condition. To improve ease of administration, Takeda has developed a subcutaneous (SC) formulation.

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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

Additionally, in June 2023, the world’s largest radionuclide production facility of lutetium-177 opened in Germany. There have been many cases where people have tried to simply link existing drugs to radioisotopes or have attached new (recently made in scale) radioisotopes on old drugs. This is not an effective strategy.

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Blue Water Vaccines agrees to buy Veru’s Entadfi capsules business

Pharmaceutical Technology

The company will make a $20m upfront payment, which includes $6m paid at closing and an additional $4m payment in the fiscal year 2023. The US Food and Drug Administration granted approval to Entadfi for the treatment of BPH in December 2021. It will pay another $10m in instalments through to September 2024.

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FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.