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Samsung Biologics plant

Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis

May 27, 2025
By Marian (YoonJee) Chu
No Comments
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
Read More

Longtime life sciences director hit with insider trading

May 27, 2025
By Mari Serebrov
No Comments
A former board member of Chinook Therapeutics Inc. and four others were charged May 22 in a 19-count indictment stemming from an alleged insider trading scheme that produced more than $600,000 in profits after the June 2023 announcement that Novartis AG was acquiring the Seattle-based Chinook in a $3.5 billion deal.
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Phraxis Endoforce

Phraxis Endoforce receives FDA approval for anastomosis

May 23, 2025
By Annette Boyle
The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.
Read More
U.S. Capitol building

PTO director candidate Squires appears at Senate Judiciary

May 23, 2025
By Mark McCarty
The Trump administration nominated John Squires of the firm of Dilworth Paxson to take the post of director of the Patent and Trademark Office, but the appointment faces a few hurdles.
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Antibody-drug conjugate

Yanked from the market in 2022, GSK’s Blenrep gets an EU redo

May 23, 2025
By Nuala Moran
No Comments
GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.
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In search of lower prices, FDA enhances Rx import program

May 23, 2025
By Mari Serebrov
No Comments
It’s been nearly five years since the U.S. FDA, under the first Trump administration, issued a final rule and guidance on state importation plans (SIP) for importing less expensive prescription drugs from Canada. Yet only one state, Florida, has an approved SIP. In hopes of adding to that number, the FDA is enhancing its drug importation program to ease the way for states and tribes to bring prescription medicines in from Canada, at Canadian prices.
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Lab glassware and antibodies art concept
Immuno-oncology

Avenzo obtains IND clearance for EGFR/HER3 bispecific ADC AVZO-1418

May 23, 2025
No Comments
Avenzo Therapeutics Inc. has announced IND clearance by the FDA for AVZO-1418 (DB-1418), an EGFR/HER3 bispecific antibody-drug conjugate (ADC). A first-in-human phase I/II study will begin later this year and will evaluate AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.
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GAO sees need for FDA guidance for organ-on-a-chip

May 22, 2025
By Mark McCarty
The recent emphasis on eliminating animal studies for preclinical studies of U.S. FDA-regulated products amplifies a long-standing concern, but the U.S. Government Accountability Office raised the question of whether organ-on-a-chip methods are ready to fill the gap.
Read More
U.S. White House

White House eyes 11% cut in FDA budget authority for 2026

May 22, 2025
By Mark McCarty
U.S. FDA commissioner Marty Makary appeared at the May 22 Senate Appropriations Committee with the news the White House proposed an FDA budget for fiscal 2026 of $6.8 billion including user fees. This is a cut of 11.5% that will not likely go over well on Capitol Hill as the FY 2026 budget process unwinds.
Read More
Samsung Biologics plant

Samsung Biologics to spin off biosimilar subsidiary Samsung Bioepis

May 22, 2025
By Marian (YoonJee) Chu
No Comments
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
Read More
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