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Healthcare Watch September 2022

PM360

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety. FDA Update. Drug Approvals.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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Delivery systems for biologics

European Pharmaceutical Review

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 The emergency use approval from the FDA of lipid nanoparticle- (LNP-) based mRNA vaccines during the COVID-19 pandemic attested the significance of LNPs.

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Comparison of Humira biosimilars in the US and Europe

Pharmaceutical Technology

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. About the author. 2019; Available from: [link].

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For rare disease patients in Mainland China, hope of greater access to treatment

Clarivate

6] [7] However, in May 2018, the National Health Commission of China (NHC), together with four other national agencies, formulated China’s First List of Rare Diseases (CRDL) to provide a foundation for policymaking around rare disease treatments. 10] [11] [12]. 10] [11] [12]. Source: Mainland China’s Center for Drug Evaluation.

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Almirall/Lilly lebrikizumab offers potential long-term management of atopic dermatitis

pharmaphorum

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. The FDA granted lebrikizumab Fast Track designation in December 2019. He explained just how promising the recent trial’s maintenance data compared to short-term data results are. About the interviewee.