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Home » Topics » Regulatory

Regulatory
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Ivenix

Fresenius Kabi eyes repair work for Ivenix infusion pumps

Dec. 11, 2024
The FDA’s new program for communicating the hazards of devices is in play and resulted in the posting of a notice of a problem seen with the Ivenix line of large volume infusion pumps by Fresenius Kabi USA, which will require some repair work by the manufacturer.
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3D illustration of the cross-section of skin layers with atopic dermatitis
Dermatologic

Astria’s OX40 antagonist gains US IND clearance for atopic dermatitis

Dec. 11, 2024
Astria Therapeutics Inc. has gained IND clearance from the FDA for STAR-0310, a monoclonal antibody OX40 antagonist being developed for atopic dermatitis.
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Immuno-oncology

Pilatus Biosciences’ PLT-012 awarded orphan drug designation

Dec. 11, 2024
Pilatus Biosciences Inc.’s PLT-012 has been awarded orphan drug designation by the FDA for treating liver and intrahepatic bile duct cancer.
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Antibody-drug conjugate illustration
Immuno-oncology

FDA clears IND for B7-H4-targeting ADC

Dec. 11, 2024
Nextcure Inc. has reported IND clearance from the FDA enabling initiation of a phase I trial of LNCB-74, a B7-H4-targeting antibody-drug conjugate (ADC) being developed for various cancers.
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Investment advisers face fraud charges in Biovie trading

Dec. 10, 2024
The U.S. SEC filed charges against David Banister and The Market Analysts Group LLC, which Banister controls, alleging that they conducted a fraudulent scheme to promote long-term investment in Biovie Inc. without disclosing that Banister was actively selling his own shares in the biopharma company.
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Sanbexin sublingual tablets

NMPA clears drugs from Innovent/Hutchmed, Hengrui, Henlius, Luye

Dec. 10, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
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Bionomics progresses BNC-210 to phase III in PTSD

Dec. 10, 2024
By Tamra Sami
Bionomics is progressing BNC-210 to phase III trials in post-traumatic stress disorder (PTSD) following positive feedback from the U.S. FDA. Final data from the phase II Attune study showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.
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US lawmakers launch year-end push for PBM reforms

Dec. 10, 2024
By Mari Serebrov
If a bipartisan group of U.S. House members has its way, at least some of the legislation congressional committees have passed to target pharmacy benefit manager (PBM) practices could yet make it into law this year. That is if congressional leaders listen to the rank-and-file members.
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Illustration of human brain and dna

Uniqure stock doubles as FDA points to a BLA in Huntington’s

Dec. 10, 2024
By Lee Landenberger
The U.S. FDA has greenlit the first steps of Uniqure NV’s accelerated approval pathway for gene therapy AMT-130 to treat Huntington’s disease. The agency said data from the ongoing phase I/II studies compared to natural history external control are muscular enough to get the process going without having to dive into additional studies.
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Chimerix moves up US NDA for rare pediatric glioma drug; stock soars

Dec. 10, 2024
By Karen Carey
In a surprise move that drove its stock up by 292% in early trading, Chimerix Inc. revealed plans for a U.S. NDA filing by year-end, seeking accelerated approval of dordaviprone (ONC-201) to treat recurrent H3 K27M-mutant diffuse glioma, a highly aggressive tumor with limited treatment options.
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