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Home » Topics » Regulatory

Regulatory
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Immune

Imunon files IND application for COVID-19 booster

March 14, 2024
Imunon Inc. has filed an IND application with the FDA seeking clearance to begin a phase I study of IMNN-101 as a seasonal COVID-19 booster vaccine.
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Lungs
Respiratory

China NMPA approves IND for Henlius’ anti-GARP/TGF-β1 mAb for IPF

March 14, 2024
Shanghai Henlius Biotech Inc.’s IND application for HLX-6018, a novel anti-glycoprotein-A repetitions predominant (GARP)/transforming growth factor-β1 (TGF-β1) monoclonal antibody (mAb), has received approval by China’s National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF).
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Adcom to weigh CAR T benefit in myeloma against early deaths

March 13, 2024
By Mari Serebrov
There’s no denying that Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb Co.’s Abecma (idecabtagene vicleucel) show clinical benefit as they seek to move up in the line of treatment for relapsed or refractory multiple myeloma. But the question that will be put to the U.S. FDA’s Oncology Drugs Advisory Committee March 15 is whether the benefit outweighs a risk of early deaths seen with both CAR T therapies.
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U.S. flag on columned building

US circuit court case a bright spot for defendants in FCA cases

March 13, 2024
By Mark McCarty
The news about how the U.S. False Claims Act (FCA) is adjudicated in the courts is typically dismal, but the U.S. Court of Appeals for the Ninth Circuit recently provided an exception.
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Peace of Mind Angle Touch device

Research to study new AT-04 pain relief device for endometriosis

March 13, 2024
By Marian (YoonJee) Chu
Japanese researchers from Chiba University are spearheading new research into Peace of Mind Co. Ltd.’s portable Angel Touch device (AT-04), approved for neurological disorders, to treat endometriosis-related pain.
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Ribbons of digital data

European Parliament passes Artificial Intelligence Act

March 13, 2024
By Mark McCarty
The European Parliament (EP) has passed the Artificial Intelligence Act (AI Act), bringing the legislation one step closer to full passage into law, with passage by the European Council the only remaining hurdle.
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US FDA’s briefing doc sends Geron tumbling

March 12, 2024
By Mari Serebrov
Although Geron Corp.’s imetelstat met its primary and key secondary endpoints in a phase III study, the U.S. FDA is questioning the magnitude and durability of the effect of the first-in-class telomerase inhibitor as a second-line treatment of transfusion-dependent anemia in adults with low- to intermediate-1 risk myelodysplastic syndromes. The agency’s concerns resulted in more than an 12% stock tumble March 12 after the FDA released its briefing document two days ahead of an Oncology Drugs Advisory Committee meeting, in which the panel will be asked to vote on whether imetelstat’s benefits outweigh its risks.
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US DOJ sets more aggressive course for qui tam activity

March 12, 2024
By Mark McCarty
U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence. However, the more important take-away, according to Preston Pugh of Crowell & Moring LLP, is that the Department of Justice (DOJ) continues to work to make the legal environment more friendly to would-be whistleblowers, thus increasing the risk for companies inside and outside the life sciences.
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Hands holding tablet and glass of water

Shionogi’s oral COVID-19 antiviral wins full approval in Japan

March 12, 2024
By Marian (YoonJee) Chu
Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country.
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Celltrion files for US approval of Xolair biosimilar, CT-P39

March 12, 2024
By Marian (YoonJee) Chu
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
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