Science News
Discover the news and inspiring materials from the world of biotechnology.
Remote FDA inspections: new guidance released
The FDA has recently published a new draft guidance describing the remote oversight tools used for pre-approval evaluation of manufacturing facilities. The published regulations are expected to reduce the time to approval and facilitate the availability of innovative, generic and biosimilar drugs. The introduced oversight tools will also help agency to stay operational during the […]
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Popular obesity drug cuts the risk of heart attacks and strokes
Semaglutide (Ozempic) has been found to reduce the risk of cardiovascular events in obese people.
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FDA approves first ustekinumab biosimilar
FDA approves first ustekinumab biosimilar Ustekinumab (Stelara®), a blockbuster monoclonal antibody originally developed by Janssen Pharmaceuticals, has just got a biosimilar counterpart. The new biosimilar, Wezlana®, manufactured by Amgen, received FDA approval in all indications of the originator, which include plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The FDA also granted it an […]
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Another win for antibody-drug conjugates in breast cancer
Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2 antigen, was reported to increase survival in HR-positive, EGFR2-negative breast cancer.
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Updated Novavax’s COVID vaccine effectively neutralizes…
Novavax’s vaccine for 2023-24 season induced neutralizing responses against newly emerging subvariants EG.5.1 and XBB.1.16.6. in in vivo models.
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Market welcomes the arrival of new RSV vaccines
The FDA has approved novel vaccines preventing the grave complications of RSV infection.
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Mabion purchase of new Cytiva Xcellerex™ XDR bioreactors
Mabion signs contract to purchase new bioreactors diversifies technology and opens to new customers.
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