Clinical

ESMO Asia 2019

Panelists urge better designs, more global focus for phase I trials

November 26, 2019

SINGAPORE – While a lot of focus is placed on phase III trials and the subsequent approvals, panelists during the ESMO Asia Congress pointed to the importance of designing the right kind of phase I trials, from reaching global populations to using appropriate endpoints.

ESMO Asia 2019

Quality of life and quality of studies take stage as Takeda reports solid NSCLC findings

November 26, 2019

By David Ho

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SINGAPORE – Takeda Pharmaceutical Co. Ltd. presented new findings from its phase III ALTA-1L trial evaluating its Alunbrig (brigatinib) vs. crizotinib in adults with advanced anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) who had not received a prior ALK inhibitor, showing Alunbrig reduced the risk of disease progression or death by 76% after more than two years of follow-up.

Hua Medicine achieves primary efficacy endpoint in phase III trial for type 2 diabetes candidate

November 26, 2019

By David Ho

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HONG KONG – China-based Hua Medicine (Shanghai) Ltd.’s phase III trial of a potentially first-in-class dual-acting glucokinase activator, dorzagliatin, met its primary efficacy endpoint.

Aslan's varlitinib clinical study for BTC patients failed to meet primary endpoints

November 19, 2019

By Jihyun Kim

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HONG KONG – Singaporean drugmaker Aslan Pharmaceuticals Ltd. announced top-line data from its pivotal phase III TreeTopp (treatment opportunity with varlitinib (ASLAN-001) in biliary tract cancer) study in second-line biliary tract cancer patients, which failed to meet co-primary endpoints of progression-free survival (PFS) and overall response rate (ORR).

Chinatrials12 Summit

With the help of trial experts, Chinese biotechs set sail for global market

November 13, 2019

By Elise Mak

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SHANGHAI – Innovation-driven biotech companies are sprouting up in China and they now aim to gain a bigger global presence through conducting clinical trials not just in their home country but also abroad.

Visen to start phase III for China's first long-acting growth hormone for children

October 30, 2019

By Elise Mak

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BEIJING – Shanghai-based Visen Pharmaceuticals is pushing its long-acting growth hormone therapy, which is also the first of its kind in China, one step closer to the NDA-stage after receiving clearance from Chinese regulators this week to start a phase III trial.

Helixmith points to success in VM-202 phase III-Ib trial, though investors skeptical

October 23, 2019

By Jihyun Kim

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HONG KONG – South Korea's Helixmith Co. Ltd. has announced the results of a phase III trial extension testing VM-202 (donaperminogene seltoplasmid), a regenerative plasmid DNA gene therapy candidate, in diabetic peripheral neuropathy (DPN).

Chi-Med gears up for China NDA after surufatinib hits phase III endpoint in NET

October 9, 2019

By David Ho

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HONG KONG – Hutchison China Meditech Ltd.'s (Chi-Med) is preparing for the next step after surufatinib achieved its primary endpoint in a phase III SANET-ep study in extra-pancreatic advanced neuroendocrine tumors (NETs) in China.

Merck's Recarbrio, Shionogi's cefiderocol tackle bacterial pneumonia in phase III studies

October 9, 2019

By Michael Fitzhugh

No Comments

WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).

Tocagen shares trounced after phase III brain cancer trial results in 'clear miss'

September 18, 2019

By Michael Fitzhugh

No Comments

Shares of San Diego-based Tocagen Inc. (NASDAQ:TOCA) fell 77.7% to 93 cents on Sept. 12, and further since, after its two-part immunotherapy for people with recurrent brain cancer failed to surpass standard of care on overall survival (OS), the primary endpoint of the company's phase III Toca 5 trial. Secondary endpoints in the registrational study were also missed, showing no meaningful difference between study arms.

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Panelists urge better designs, more global focus for phase I trials

Quality of life and quality of studies take stage as Takeda reports solid NSCLC findings

Hua Medicine achieves primary efficacy endpoint in phase III trial for type 2 diabetes candidate

Aslan's varlitinib clinical study for BTC patients failed to meet primary endpoints

With the help of trial experts, Chinese biotechs set sail for global market

Visen to start phase III for China's first long-acting growth hormone for children

Helixmith points to success in VM-202 phase III-Ib trial, though investors skeptical

Chi-Med gears up for China NDA after surufatinib hits phase III endpoint in NET

Merck's Recarbrio, Shionogi's cefiderocol tackle bacterial pneumonia in phase III studies

Tocagen shares trounced after phase III brain cancer trial results in 'clear miss'

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