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BioWorld - Thursday, December 18, 2025
Home » Topics » North America » U.S.

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Globe showing Asia-Pacific region

Astrazeneca in Asia: $604M Nona deal, $1.5B Singapore ADC plant

May 24, 2024
By Marian (YoonJee) Chu
Cambridge, U.K.-based Astrazeneca plc is looking to Asia, specifically China and Singapore, to build an innovative cancer-focused pipeline filled with antibody-drug conjugates (ADC), monoclonal antibodies (MAbs) and cell therapies.
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US argues for drug, device companies in terrorism case

May 24, 2024
By Mari Serebrov
Weighing in on the side of 21 drug and device companies accused of knowingly aiding and abetting terrorist attacks against U.S. troops and civilians in Iraq from 2005 to 2011, the U.S. solicitor general is asking the Supreme Court to grant the companies’ petition for cert and then vacate a 2022 appellate court decision in Joshua Atchley v. Astrazeneca plc, remanding it for reconsideration in light of a related opinion the justices handed down a year ago.
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Lunit CEO Brandon Suh

Lunit completes $193M acquisition of Volpara

May 24, 2024
By Marian (YoonJee) Chu
“In an impressive eight-month timeline,” South Korea’s Lunit Inc. completed the $193 million (AU$292 million) acquisition of Volpara Health Technologies Ltd. to globally advance artificial intelligence (AI)-based cancer care.
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guardant bloodkit

Guardant wins over an FDA advisory panel for Shield CRC test

May 24, 2024
By Mark McCarty
The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance regarding adenoma, the advisory committee voted 6-3 that the benefits outweigh the risks in a decision the FDA is likely to affirm.
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Molecule illustration

Degron, Takeda bind $1.2B deal for molecular glue degraders

May 23, 2024
By Marian (YoonJee) Chu
Shanghai- and San Diego-based Degron Therapeutics Inc. secured a potential $1.2 billion deal with Tokyo-headquartered Takeda Pharmaceutical Co. Ltd. May 23 for a multitarget collaboration and exclusive licensing agreement for molecular glue degraders. “It is a breakthrough technology in the small-molecule drug discovery field,” Degron CEO Lily Zou told BioWorld. “People talk about cell and gene therapy, but small molecules are still the mainstream of drug discovery, [with] more reach.”
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U.S. FDA headquarters

Guardant wins over FDA advisory panel for Shield CRC test

May 23, 2024
By Mark McCarty
The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance with regard to adenoma, the advisory committee voted 7-2 that the benefits outweigh the risks in a decision the FDA is likely to affirm.
Read More
Insulin pen

FDA adcom to weigh benefit, risk of Novo’s once-weekly insulin

May 23, 2024
By Lee Landenberger
Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.
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Disgorgement but no penalty for self-reported insider trader

May 23, 2024
By Mari Serebrov
A woman who allegedly made nearly $300,000 last year on insider trading based on undisclosed information about a pending biopharma acquisition will have to disgorge her profits, along with interest, to the U.S. Treasury, but she will face no other penalties.
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Molecule illustration

Degron, Takeda bind $1.2B deal for molecular glue degraders

May 23, 2024
By Marian (YoonJee) Chu
Shanghai- and San Diego-based Degron Therapeutics Inc. secured a potential $1.2 billion deal with Tokyo-headquartered Takeda Pharmaceutical Co. Ltd. May 23 for a multitarget collaboration and exclusive licensing agreement for molecular glue degraders. “It is a breakthrough technology in the small-molecule drug discovery field,” Degron CEO Lily Zou told BioWorld. “People talk about cell and gene therapy, but small molecules are still the mainstream of drug discovery, [with] more reach.”
Read More
Roche building

Roche reports on substantive product pipeline plans

May 23, 2024
By Holland Johnson
At its investor presentation on May 22, Roche Diagnostics, a unit of Basel Switzerland-based Roche Holding AG reported on the company's pipeline plans, which include a slew of new tests, instrument upgrades, and the forthcoming launch of its fully automated mass spectrometry instrument.
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