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CHMP meeting highlights: January 2024

European Pharmaceutical Review

The European Medicine Agency’s human medicines committee (CHMP) recommended marketing authorisations for the regulatory approval of three medicines at its January 2024 meeting last week. Additionally, a positive opinion for Niapelf (paliperidone), a generic medicine for schizophrenia was adopted in the meeting.

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Inflation threatens supply of life-saving generics to Europe

Pharmaceutical Technology

These factors combined affect the commercial viability of generic medicines, with some European drugmakers already warning that they may stop making cheap generic medicines.

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Supply chain middlemen ‘pocket half of US branded medicine spending’

pharmaphorum

Over the same period, total gross expenditures on brand and generic medicines nearly doubled – from $268 billion to $517 billion, according to the report. The argument has been made that reducing or eliminating rebates could result in lower list prices, and reduce out-of-pocket expenses for patients. ” says the report.

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Only 2 per cent medicines undergo quality control checks: Former IMA President

Express Pharma

Krishna Sarma, Managing Partner, Corporate Law Group , said, “The entanglement of Registered Medical Practitioners (RMPs) in third-party activities involving pharmaceutical companies, coupled with the haze surrounding generic medicines, beckons for clarity. The establishment of a CPD-supporting entity hinges on fiscal resolutions.

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New report sets out clear steps pharma cos to curb AMR risk in antibiotic production

Express Pharma

The report analyses selected companies of varying sizes that manufacture and market antibiotics – including research-based pharma companies, generic medicine manufacturers and business-to-business providers.

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Q&A: Building a More Resilient Medicines Supply Chain

Quality Matters

USP Medicine Supply Map uses AI/Machine Learning to analyze 250M+ datapoints and insights from 40+ external data sets (including FDA and non-US regulatory agencies), as well as USP's proprietary data on usage of our quality standards in more than 22,000 locations around the world.

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Why cancer medicines are and continue to be vulnerable to drug shortages

Quality Matters

Some hospitals have reported rationing doses in response to these shortages, and the American Society of Clinical Oncologists (ASCO) has issued new clinical guidance for treating patients with gastrointestinal (GI) cancers, which are commonly treated with carboplatin and cisplatin, two chemotherapy agents currently in shortage nationwide.