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Home » Keywords » IND

Items Tagged with 'IND'

ARTICLES

Chinese flag and microscopes
Drug design, drug delivery & technologies

‘A decade of innovation, a decade to come’ for China pharma

Nov. 19, 2024
By Marian (YoonJee) Chu
As China rises to second place, next only to the U.S., for innovative new drugs, a new report by Clarivate – A Decade of Innovation, A Decade to Come – outlines key policy reforms and regulatory, R&D and investment trends driving past and future growth of Chinese biopharmaceuticals.
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Chinese flag and microscopes

‘A decade of innovation, a decade to come’ for China pharma

Nov. 18, 2024
By Marian (YoonJee) Chu
As China rises to second place, next only to the U.S., for innovative new drugs, a new report by Clarivate – A Decade of Innovation, A Decade to Come – outlines key policy reforms and regulatory, R&D and investment trends driving past and future growth of Chinese biopharmaceuticals.
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Han Taedong, CEO, Abtis

Abtis tapping ADC market with Claudin18.2-targeting AT-211

June 11, 2024
By Marian (YoonJee) Chu
Abtis Co. Ltd., Dong-A ST’s newly incorporated subsidiary since December 2023, is making headway with its leading Claudin18.2-targeting antibody-drug conjugate (ADC) candidate, AT-211, according to Abtis CEO Taedong Han. “About 80% of gastric cancers do not have HER2 overexpression, but 77% overexpressed Claudin18.2,” Han told Bio Korea 2024 audience members on May 9, stressing that AT-211 was found to be highly potent against cancer cells expressing Claudin18.2 in ADC cell viability studies.
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Han Taedong, CEO, Abtis

Abtis tapping ADC market with Claudin18.2-targeting AT-211

June 10, 2024
By Marian (YoonJee) Chu
Abtis Co. Ltd., Dong-A ST’s newly incorporated subsidiary since December 2023, is making headway with its leading Claudin18.2-targeting antibody-drug conjugate (ADC) candidate, AT-211, according to Abtis CEO Taedong Han. “About 80% of gastric cancers do not have HER2 overexpression, but 77% overexpressed Claudin18.2,” Han told Bio Korea 2024 audience members on May 9, stressing that AT-211 was found to be highly potent against cancer cells expressing Claudin18.2 in ADC cell viability studies.
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Eye illustration

Innovent thyroid eye therapy hits phase III goal, spurs China NDA

Feb. 20, 2024
By Marian (YoonJee) Chu
In a crowded thyroid eye disease (TED) space, Innovent Biologics Inc. reported positive late-stage findings for its TED therapy, IBI-311, spurring the Suzhou, China-based biopharma to file for regulatory approval in China.
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US FDA issues final guidance on charges for investigational drugs

Feb. 14, 2024
By Mari Serebrov
The U.S. FDA finalized its guidance Feb. 14 on charging for investigational drugs in clinical trials or expanded access.
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US FDA revises guidance on charging for INDs used in trials, expanded access

Aug. 22, 2022
In the six years since the U.S. FDA issued its final guidance on charging for drugs used under an investigational new drug (IND) application for clinical trials or expanded access, the agency has received several questions about how it is implementing regulations on the matters. To answer those questions, the FDA released a revised draft guidance that, when finalized, will replace the guidance issued in 2016.
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FDA checks in and Anixa plans to respond on IND for ovarian cancer

May 20, 2021
By Lee Landenberger
Anixa Biosciences Inc. and the Moffitt Cancer Center now have details the FDA said it needs regarding their CAR T therapy development program. The collaborators said the information can be provided to the FDA in about 30 days. The agency then has 30 days to respond.
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Study in a box: Pharmacyte’s IND in pancreatic cancer put on hold

Oct. 2, 2020
By Lee Landenberger
Pharmacyte Biotech Inc. is now in a series of 30-day cycles with the FDA as a planned phase IIb study of its lead candidate has been placed on hold. On Sept. 2, Pharmacyte submitted its IND for a phase IIb trial of its product, known as Cypcap, in locally advanced, inoperable pancreatic cancer and, on Oct. 2, the company said the FDA placed the application on hold.
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Yaron-Pereg-CEO-Kahr-Medical-HERO-8-13

Kahr’s anti-CD47 candidate advances to clinic in U.S.

Aug. 13, 2020
By David Ho
HONG KONG – Following FDA approval of its IND, Israel-based Kahr Medical Ltd. is set to start a phase I/II trial of lead product DSP-107, a second-generation CD47- and 41BB-targeting compound. The move puts Kahr among a number of companies working on drugs against checkpoint molecule CD47.
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