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Latest From ViiV Healthcare

US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

Approvals Review Pathway

Six Key Infectious Disease New Drug Launches To Look Out For In 2022

In a series on articles, Scrip takes a look at some of the key novel products expected to reach the market in 2022 in a cross-section of therapy areas. Here, with input from Biomedtracker, are six new anti-infectives expected to reach the market for the first time next year, all with an above average likelihood of approval.

Companies Approvals

ViiV Aims To Extend HIV Drug Durations With Halozyme’s Technology

ViiV Healthcare’s head of R&D tells Scrip that extending the durations of its long acting HIV treatments is possible using drug delivery technology from Halozyme Therapeutics to expand the body’s capacity to absorb injected medicines.

Deals Infectious Diseases

Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla

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

US FDA Performance Tracker Approvals
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