EBR Systems (ASX:EBR) said the US Food and Drug Administration (FDA) started its pre-approval inspection of the company's new manufacturing facility in Santa Clara, California, marking a key step in the regulatory process, according to a Tuesday filing with the Australian bourse.
The company still anticipates receiving US FDA approval for the facility by the end of the year, the filing added.
Orora (ASX:ORA) said Ann Stubbings plans to step down as chief safety, sustainability, and governance officer, effective Dec. 31, after more than 13 years with the packaging products firm, according to a Monday filing with the Australian bourse.In addition, Susannah Jobling Hodgens will be appointed as chief legal officer, the company said. Hodgens has worked with Orora for 13 years in senior legal and governance roles, most recently as general counsel and alternate company secretary.Orora shares gained nearly 1% in recent Monday trade.
Sichuan Biokin Pharmaceutical (SHA:688506) enrolled the first subject for the third-phase clinical trial of biologic drug T-Bren for injection, according to a weekend filing with the Shanghai bourse.The trial evaluates T-Bren combined with pertuzumab versus standard chemotherapy in neoadjuvant treatment of HER2-positive breast cancer, according to a weekend filing with the Shanghai bourse.Shares of the pharmaceutical company rose 4% in recent trade.
South Korea's main stock market, the Korea Exchange, will enable trading till 8 pm following the regular close at 3:30 pm from Monday, in its move toward 24-hour trading, Bloomberg News reported Sunday.This decision opens 2,400 Korea Composite Stock Price Index, or Kospi, and Kosdaq stocks for evening trades, which include short-selling. The move excludes exchange-traded funds, the report said.The Korea Exchange plans to introduce pre-market trading by the end of next year, it said.(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)