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FDA approves long-acting injectable for schizophrenia and bipolar disorder

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

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AB Science announces Canadian patent for masitinib to treat ALS

Pharmaceutical Technology

This helps to prevent generic competition for eight years after initial approval. Under the notice of compliance with conditions (NOC/c) policy, AB Science received authorisation from Health Canada to file a new drug submission for masitinib to treat ALS. According to AB Science, approximately 3,000 Canadians are now living with ALS.

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Lupkynis approved for the treatment of LN in the EU and UK

Pharmaceutical Technology

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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Pharma Injecting Life into Digital Health Amidst Funding Downturn

MedCity News

digital health sector plummeted to $15 billion from more than $29 billion in 2021, according to Rock Health. billion in 2021. And in the first quarter of this year, the largest Series A ever in digital health ($203M) went into a company accelerating clinical trials and drug development. digital health at $17.7

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API nitrosamines: method sensitivity issues

European Pharmaceutical Review

1 This has led to a great deal of pre-competitive data sharing. For instance, Lhasa initiated a Nitrites in Excipients database to facilitate risk assessment of drug products, which was recently published. This data provides invaluable insight into the likelihood of nitrites in a drug product formulation. 18 November 2021.