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Urban Retreat didn’t cooperate with Direct Selling Self-Regulatory Council’s review or “indicate any intent to comply with” recommendations to discontinue claims for its Balance Capsules. LoveBiome responded sufficiently to merit a DSSRC recommendation to pull three health claims.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
FOPO Edition: Capitalizing on positive data, eight drug developers priced follow-on public offerings that brought in $3.2bn, including $650m each for Terns and Structure plus $602m for Kymera.
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.
Decision on vitafusion and L’il Critters business planned by end of year, but Piping Rock Health provided incentive for C&D to opt for divestiture.
Data from the Phase III BRUIN CLL-313 trial presented at ASH showed clear superiority for the non-covalent BTK inhibitor as a single agent compared with bendamustine/rituximab.
Dyne’s data from a larger Phase I/II trial cohort showed much greater dystrophin production with z-rostudirsen (DYNE-251) than seen with Sarepta’s Exondys 51 and some functional gains.
The company presented positive efficacy and safety data from its registrational Phase II iMMagine-1 trial at the 2025 ASH meeting.
Public Company Edition: Uncertainty about the US FDA’s direction earlier in the year caused biotech stocks to sag, but recent leadership upheaval has not sunk the XBI. Also, Belite raised $350m, Capricor grossed $150m and Immatics brought in $125m in follow-on offerings.
Partnership aims to improve yields, cut development time, and bring data-driven control to bioprocessing.
A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.
The company will exclude data from patients at the “small number” of sites that experienced irregularities and enroll new patients in their place.