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Nabriva Therapeutics plc.

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Latest From Nabriva Therapeutics plc.

2020 Sees Sharp Rise In EU New Drug Approvals

The number of new drugs containing new active substances approved in the EU rose significantly in 2020, underpinned by a strong showing for orphan-designated products and a string of novel medicines for cancer and infectious diseases. Notable among the new clutch of approvals was the first ever COVID-19 vaccine, Pfizer/BioNTech's Comirnaty.

Europe Approvals

Novartis' Inclisiran Grounded In The US By FDA Inspection Restrictions

The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.

Cardiovascular Complete Response Letters

Keeping Track: Incomplete Responses For Unusual Times; Qtrypta Is Latest CRL

Highlights from complete response letter news from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Complete Response Letters

Medicare’s Antibiotic Boost: Six Qualify For Add-On Payment

CMS final rule for hospital payment in 2021 includes enhanced payment for six novel antibiotics – including one that is not yet approved by FDA. New policies to encourage antibiotic innovation are clearly having an impact in the context of Medicare payments.

Medicare Infectious Diseases
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  • Other Names / Subsidiaries
    • Zavante Therapeutics, Inc.
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