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Roche’s Tecentriq loses bladder cancer use as FDA crackdown continues

pharmaphorum

Roche’s Tecentriq is the latest medicine to fall foul of a crackdown by the FDA on drugs that have failed to live up to their early promise. The Swiss pharma said it is voluntarily withdrawing the US indication for the immunotherapy Tecentriq (atezolizumab) in metastatic urothelial carcinoma (mUC) previously treated with chemotherapy.

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FDA looks at pulling speedy approvals for three cancer drugs

pharmaphorum

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

The FDA Law Blog

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. If FDA recommends a substance not be controlled, DEA cannot control it.

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BMS sets up Roche, Pfizer rivalry with Turning Point takeover

pharmaphorum

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

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A history of blood cancer treatment

pharmaphorum

While they may not have known it at the time, through their work Ehrlich and Metschnikow formed the cornerstone of modern immunology, including chemoreceptor and chemotherapy concepts that revolutionised blood cancer treatment over the following century. 1942 – Chemotherapy moves from trenches to treatment .

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Solving the taxing problems of taxanes?

European Pharmaceutical Review

Despite advances with targeted and immuno-oncology therapies, chemotherapies remain a cornerstone of cancer treatment for many tumour types – a reflection of their significant anti?tumour While highly effective, taxanes also exhibit several of the typical limitations associated with systemic chemotherapies. tumour effects.

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New data reinforce Keytruda’s dominance in first-line lung cancer

pharmaphorum

Furthermore, the duration of response with the PD-1 checkpoint inhibitor was nearly five times longer at 29 months versus just over six months with frontline chemotherapy. Another contender meanwhile also reported new data at ESMO.