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Latest From MYR GmbH

Japan Makes Renewed Policy Efforts To Fill 'Drug Gap'

Japan has announced several new measures to tackle the lack of rare disease and other therapeutics in the domestic market, with the country's main industry association also issuing the first common national informed consent form in a bid to lighten the “huge workload” on trial site staff.

Japan Drug Review

Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Drug Review

As Gilead’s HIV, HCV Hull Leaks In Q4, Veklury Plugs Holes

Sales of COVID-19 drug Veklury helped keep sales in the black as the pandemic and generic competition weighed on HIV and HCV products; Gilead raised full-year 2021 guidance.

Commercial BioPharmaceutical

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
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