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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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Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

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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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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 awards full approval to Paxlovid amidst hazy coverage plans

Pharmaceutical Technology

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). Paxlovid’s most common side effect is diarrhoea.

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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.