Beigene Ltd. unveiled positive interim results from its Alpine phase III trial comparing its small-molecule BTK inhibitor, Brukinsa (zanubrutinib), to Abbvie Inc.’s Imbruvica (ibrutinib), lending validity to one of the company’s most important development programs.
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies.
With Pharmabcine Inc.’s anti-angiogenic antibody TTAC-0001 (olinvacimab) already in testing against recurrent glioblastoma multiforme (GBM) and metastatic triple negative breast cancer, CEO Jin-San Yoo is now giving serious thought to starting trials to test it in children with brain tumors. Plans to begin four additional trials between the end of 2021 and the beginning of 2022 are also underway.
In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy. The data built on positive data released in August from another phase III study showing sugemalimab (CS-1001) prolonged PFS when used as a first-line treatment for stage IV squamous and nonsquamous NSCLC plus standard-of-care chemotherapy, hitting the study’s primary endpoint.
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
HONG KONG – Following a wave of concern about the efficacy of two COVID-19 vaccine candidates developed by China National Pharmaceutical Group (Sinopharm), interim analysis of an ongoing phase III trial, published May 26 in the Journal of the American Medical Association, has shown that adults receiving at least one dose of either of the company’s two inactivated SARS-CoV-2 vaccines had significantly reduced the risk of symptomatic COVID-19.
New three-year safety and efficacy data on Takeda Pharmaceutical Co. Ltd.'s dengue vaccine candidate, TAK-003, showed it to be 62% more effective than placebo in preventing virologically confirmed infections with the virus and 83.6% more effective than placebo in preventing hospitalizations caused by the mosquito-borne viral disease and due to any of the four dengue virus serotypes in patients ages 4 to 16.
VANCOUVER, British Columbia – Yiviva Inc., a pharmaceutical company focused on developing botanical drugs, has moved its lead candidate further into an international phase IIb trial for liver cancer and closer to an application through the FDA’s little-used botanicals pathway and a similar pathway in China.
HONG KONG – Mitoimmune Therapeutics Inc., a company that earlier this year completed a ?27.5 billion (US$24.41 million) series B financing led by Korea Development Bank, has received investigational new drug approval in the U.S. for MIT-001, its anti-inflammatory and anti-necrotic agent, moving the company a step closer to entering the clinic.
Beigene Ltd.’s selective inhibitor, Brukinsa (zanubrutinib), made up for a 2019 miss in a head-to-head study against Johnson & Johnson and Abbvie Inc.’s Imbruvica (ibrutinib) with positive new data from a phase III trial.
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