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BioWorld - Wednesday, April 8, 2026
Home » Authors » Tamra Sami

Articles by Tamra Sami

Stock market crash illustration

Immutep stock plummets 90% on efti phase III failure in NSCLC

March 17, 2026
By Tamra Sami
No Comments
Immutep Ltd.’s stock on Australia’s Securities Exchange plummeted nearly 90% on March 13 on the news that its phase III TACTI-004 trial evaluating eftilagimod alfa (IMP-321, efti) in first-line non-small-cell lung cancer was discontinued due to futility.
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Illustration of inflamed spine

China’s Qyuns moves IL-17 biologic toward first approval

March 17, 2026
By Tamra Sami
No Comments
Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and sacroiliac joints.
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doctor, checklist, apple, prescription bottle and blood glucose meter illustration

Hightide wins China NDA acceptance for oral metabolic therapy

March 17, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutics Inc.’s NDA for HTD-1801 for type 2 diabetes, marking the Shenzhen-based company’s first NDA submission and a major step toward commercialization.
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Stock market crash illustration

Immutep stock plummets 90% on efti phase III failure in NSCLC

March 13, 2026
By Tamra Sami
No Comments
Immutep Ltd.’s stock on Australia’s Securities Exchange plummeted nearly 90% on March 13 on the news that its phase III TACTI-004 trial evaluating eftilagimod alfa (IMP-321, efti) in first-line non-small-cell lung cancer was discontinued due to futility.
Read More
Illustration of inflamed spine

China’s Qyuns moves IL-17 biologic toward first approval

March 11, 2026
By Tamra Sami
No Comments
Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and sacroiliac joints.
Read More
doctor, checklist, apple, prescription bottle and blood glucose meter illustration

Hightide wins China NDA acceptance for oral metabolic therapy

March 11, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutics Inc.’s NDA for HTD-1801 for type 2 diabetes, marking the Shenzhen-based company’s first NDA submission and a major step toward commercialization.
Read More
Induced pluripotent stem cells

Japan approves first iPSC therapy for Parkinson’s disease

March 10, 2026
By Tamra Sami
No Comments
Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.
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Fallopian tubes, ovaries and uterus

China approves first noninvasive therapy for cervical precancer

March 10, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2.
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Gold dollar sign inside gold cog

Sanofi licenses Sino Biopharm’s JAK/ROCK drug for $1.4B

March 10, 2026
By Tamra Sami
No Comments
On the heels of China’s approval of Sino Biopharmaceutical Ltd.’s rovadicitinib, Sanofi SA is now inlicensing the first-in-class dual JAK/ROCK inhibitor in a deal worth more than $1.4 billion.
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Lab vials and dropper

Kyowa Kirin discontinues rocatinlimab trials due to safety issues

March 10, 2026
By Tamra Sami
No Comments
Shortly after Amgen Inc. walked away from its partnership with Kyowa Kirin Co. Ltd., the Tokyo-based company said it is discontinuing all ongoing clinical trials for rocatinlimab due to safety concerns.
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