The long-acting HIV drug’s greatest potential is for pre-exposure prophylaxis, where it would compete against ViiV’s long-acting injectable Apretude.
Gilead Sciences, Inc. is back in the game to get its long-acting subcutaneous injectable drug for treatment and prevention of HIV onto the market with a green light from the US Food and Drug Administration to resume clinical trials of lenacapavir, enabling the firm to possibly maintain its longtime hold on the pre-exposure prophylaxis (PrEP) market.
Gilead said 16 May that the FDA had lifted the hold on lenacapavir and that all clinical studies of the...
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PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.
The company will ramp up manufacturing of its Jynneos vaccine to meet demand in worst-affected African countries and stockpiling richer nations.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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