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BioWorld - Tuesday, December 30, 2025
Home » Topics » U.S., BioWorld Asia

U.S., BioWorld Asia
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Earth threatened by virus

World Health Assembly extends deadline for pandemic agreement

June 4, 2024
By Tamra Sami
Although consensus was not reached on the World Health Organization’s pandemic agreement, the World Health Assembly recognized the progress made by member states to develop a pandemic agreement and to strengthen International Health Regulations (IHR, 2005) during the 77th World Health Assembly meeting held May 27 to June 1 in Geneva.
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Globe showing Asia-Pacific region

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

May 28, 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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Senior eye exam

Rezolute’s oral diabetic macular edema drug hits phase II goal

May 28, 2024
By Marian (YoonJee) Chu
Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME.
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Digital heart illustration

Five medical technologies set to transform care

May 28, 2024
By Annette Boyle
News out of the Heart Rhythm Society 2024 meeting May 16-19 highlighted the rapid disruption pulsed field ablation (PFA) devices have wrought in cardiac arrhythmia treatment, so it is little surprise to see that PFAs are among the top five technologies with transformative potential identified by Clarivate plc in its Medical Technologies to Watch in 2024 report. The impact of the other four – continuous glucose monitors (CGM) for diabetes, neurostimulation devices, surgical robotics and renal denervation – has been just as revolutionary, if longer in being realized.
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Global handshake silhouette

Asahi Kasei seeks global pharma growth via $1.1B Calliditas buy

May 28, 2024
By Nuala Moran
Japanese industrial conglomerate Asahi Kasei Corp. has made an offer to acquire Swedish rare diseases specialist Calliditas Therapeutics AB for SEK11.8 billion (US$1.1 billion). The offer, at an 83% premium to the closing share price of SEK113.60 on Monday, May 27, is recommended by the three biggest shareholders and the board of Calliditas, which said the company would benefit from “being part of a larger platform.”
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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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USTR seal

Usual players show up again in US trade report of bad actors

May 21, 2024
By Mari Serebrov
The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.
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Close-up of eye with digital focus

Biocon, Samsung win FDA nods for interchangeable Eylea biosimilars

May 21, 2024
By Marian (YoonJee) Chu
The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).
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Report leads to suspension of Ecohealth, NIH rebuke

May 21, 2024
By Mari Serebrov
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
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Joshua Smiley, president and chief operating officer, Zai Lab

Zai Lab exec buys stock as Augtyro, Vyvgart SC advances in China

May 21, 2024
By Marian (YoonJee) Chu
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
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