Aslan Pharmaceuticals Pte. Ltd. announced variegated results from its phase IIb TREK-AD trial testing eblasakimab, its biologic tested for moderate to severe atopic dermatitis (AD), that drew an equally mixed reaction from the market.
Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma.
Aslan Pharmaceuticals Pte. Ltd. announced variegated results from its phase IIb TREK-AD trial testing eblasakimab, its biologic tested for moderate to severe atopic dermatitis (AD), that drew an equally mixed reaction from the market.
Edding Group Co. Ltd. announced June 23 it filed for an IPO on the Hong Kong Exchange – news that comes amid a steep drop in China’s biopharma IPO market forecasting sluggish activity in a near-frozen “capital winter.”
Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older.
South Korean pharmaceutical giant Yuhan Corp. gained Korea’s MFDS approval to expand indications for its potent oral third-generation tyrosine kinase inhibitor Leclaza (lazertinib) as a first-line treatment for EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC).
Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma.
SK Bioscience Ltd. and Sanofi Pasteur SA announced June 30 positive results from a phase II study for its 21-valent pneumococcal conjugate vaccine (PCV) candidate called GBP-410, or SP-0202 under Sanofi.
Although the highest dose of Bioxcel Therapeutics Inc.’s BXCL-501 hit the primary endpoint in the phase III Tranquility II trial for acute agitation in Alzheimer’s disease patients, shares fell dramatically on June 29 by 64% when investors learned the company received an FDA warning letter over infractions at a trial site.
South Korea’s JW Pharmaceutical Corp. announced a redo of its IND application to the Taiwan FDA on June 27 for its phase III trial on gout treatment URC-102 (epaminurad). The second filing comes in response to a regulatory rejection in March citing a problem with the proposed reference drug.
