Coherus, Junshi Biosciences Say FDA Accepts Resubmission Of Toripalimab BLA

RTTNews | 1226 dagar sedan
Coherus, Junshi Biosciences Say FDA Accepts Resubmission Of Toripalimab BLA

(RTTNews) - Coherus BioSciences, Inc. (CHRS) and Shanghai Junshi Biosciences Co., Ltd. announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for December 23, 2022. The Agency earlier communicated that the review timeline for the BLA resubmission would be six months, as onsite inspections in China would be required.

The travel restrictions related to the COVID-19 pandemic previously hindered the FDA's ability to complete required inspections. Coherus plans to launch toripalimab in the U.S. in the first quarter of 2023, if approved.

For More Such Health News, visit rttnews.com.

read more
Coherus Rolls Out YUSIMRY At $995 Per Carton In US

Coherus Rolls Out YUSIMRY At $995 Per Carton In US

Coherus BioSciences, Inc. (CHRS) announced Monday that YUSIMRY (adalimumab-aqvh) is now available for commercial sale in the United States at a list price of $995 per carton for two 40 mg/0.8 mL autoinjectors.
RTTNews | 864 dagar sedan
Bay Street Likely To Open On Mixed Note

Bay Street Likely To Open On Mixed Note

Canadian shares are likely to open on a mixed note on Thursday, tracking earnings updates, and commodity prices. The end to the U.S. government shutdown following President Donald Trump signing a short term bill is likely to aid sentiment.
RTTNews | 3h 26minuter sedan
European Stocks Pare Early Gains As Markets Digest Earnings, Economic News

European Stocks Pare Early Gains As Markets Digest Earnings, Economic News

European stocks gave up early gains and are broadly lower Thursday afternoon as investors look ahead to some crucial economic data following the longest federal government shutdown in U.S. history coming to an end after President Donald Trump signed a funding package.
RTTNews | 3h 52minuter sedan
Disney Q4 Profit Beats Street, Revenues Miss; Sees Adj. EPS Growth, Plans $7 Bln Buyback; Stock Down

Disney Q4 Profit Beats Street, Revenues Miss; Sees Adj. EPS Growth, Plans $7 Bln Buyback; Stock Down

Shares of Walt Disney Co. were losing around 4 percent in the pre-market activity on Thursday after the media and entertainment major reported nearly flat revenues in its fourth quarter below market estimates, even though profit beat the Street. Further, the firm said it expects double digit year-over-year growth in adjusted earnings per share for fiscal 2026 and 2027, and targets doubling share
RTTNews | 4h 5minuter sedan
UK Economy Logs Marginal Growth

UK Economy Logs Marginal Growth

The UK economy logged only a marginal growth in third quarter as the cyber attack on Jaguar Land Rover hit production, official data revealed on Thursday. Gross domestic product grew 0.1 percent sequentially, following the prior quarter's 0.3 percent expansion, the Office for National Statistics reported Thursday. Output was expected to advance 0.2 percent.
RTTNews | 4h 49minuter sedan
CAC 40 Rises 0.5%; Bank, Luxury Stocks Shine

CAC 40 Rises 0.5%; Bank, Luxury Stocks Shine

France's CAC 40 rose to a record high Thursday morning as stocks climbed higher, reacting to U.S. President Donald Trump signing a bill to end the longest government shutdown in history. Expectations of an interest rate cut by the Federal Reserve next month contribute as well to market's positive move.
RTTNews | 5h 32minuter sedan
DAX Retreats After Positive Start, Down Nearly 0.5%

DAX Retreats After Positive Start, Down Nearly 0.5%

German stocks are swinging between gains and losses in cautious trade on Thursday with investors digesting the news about U.S. President Donald Trump signing the short-term funding bill that brings an end to the government shutdown, and looking ahead to some key U.S. economic data.
RTTNews | 5h 52minuter sedan