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FDA approves first gene therapy for high-risk early bladder cancer

European Pharmaceutical Review

The failure to achieve a complete response (CR), or the disappearance of all signs of cancer as seen on cystoscopy, biopsied tissue, and urine, is associated with an increased risk of death or a disease-worsening event. Without treatment, the cancer can invade, damage tissues and organs, and spread through the body.

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Health Canada grants expanded authorisation for Novavax’s Covid-19 vaccine

Pharmaceutical Technology

According to data from Phase III trials, the booster dose elicited greater immune responses to levels in line with or over those linked to protection against Covid-19. Additionally, data from these trials showed that local and systemic reactions following the booster dosing lasted for a median duration of nearly two days.

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Europe approves Roche’s Tecentriq liver cancer combination

pharmaphorum

Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. The most frequent serious adverse reactions for the combination, occurring in 2% or more of patients, were bleeding in the gastrointestinal tract and fever.

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FDA slaps hold on trials of Gilead’s CD47 drug magrolimab

pharmaphorum

The regulatory move applies only to trials of magrolimab given alongside Bristol-Myers Squibb’s Vidaza (azacitidine), and stems from an “imbalance” in investigator-reported serious adverse events between study arms, said the drugmaker.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

However, low doses of this medication (hence, low dose naltrexone or LDN), have been found to modulate the immune system and have shown promise in improving cases of autoimmune disease. These include Crohn’s, MS, and Hashimoto’s, as well as other immune system-related conditions such as cancer and HIV/AIDS. Doses of 1.5-4.5

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FDA Approvals: September 2022 Recap

Digital Pharmacist

Common adverse reactions include conjunctival/ocular hyperemia, photophobia, blurred vision, dry eye, pain, headache, irritation, and visual impairment. . Common adverse effects include serious or fatal respiratory failure, ischemic events, abdominal pain, nausea, and diarrhea, among others. .

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EC approves Libtayo® for metastatic cervical cancer

European Pharmaceutical Review

Immune-mediated adverse reactions (ARs) occurred in 21 percent of patients treated with Libtayo ® and led to permanent discontinuation in 4.6 The most common immune-mediated ARs were hypothyroidism (6.8 percent), hyperthyroidism (3 percent), immune-mediated pneumonitis (2.6 percent), immune-mediated hepatitis (2.4