Coherus, Junshi Biosciences Say FDA Accepts Resubmission Of Toripalimab BLA

RTTNews | 1216 days ago
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 | 854 days ago
Swiss Market Pares Early Gains, Settles Flat

Swiss Market Pares Early Gains, Settles Flat

Save for a brief while during the closing minutes, Switzerland's SMI index stayed positive on Monday, but still ended the session with just a slender gain as several stocks pared early gains due to a lack of support at higher levels.
RTTNews | 4h 12min ago
European Stocks Close Higher As Investors Asses Economic Data, Recent Earnings

European Stocks Close Higher As Investors Asses Economic Data, Recent Earnings

European markets closed mostly higher on Monday, led by gains in the banking and automobile sectors. Investors assessed U.S.-China trade discussions, recent earnings updates, and digested the latest batch of regional economic data, in addition to awaiting the Bank of England's monetary policy announcement due this week.
RTTNews | 4h 43min ago
U.S. Manufacturing Index Unexpectedly Edges Lower In October

U.S. Manufacturing Index Unexpectedly Edges Lower In October

Manufacturing activity in the U.S. unexpectedly contracted at a slightly faster rate in the month of October, according to a report released by the Institute for Supply Management on Monday. The ISM said its manufacturing PMI slipped to 48.7 in October after edging up to 49.1 in September, with a reading below 50 indicating contraction. Economists had expected the index to inch up to 49.5.
RTTNews | 6h 58min ago
Bay Street Likely To Open On Positive Note

Bay Street Likely To Open On Positive Note

Canadian shares are likely to open higher Monday morning, with firm metal prices expected to trigger buying in the materials sector. The focus will be on the developments on the trade front and corporate earnings announcements.
RTTNews | 8h 59min ago
UK Manufacturing PMI At 1-Year High

UK Manufacturing PMI At 1-Year High

The UK manufacturing activity shrank in October but the pace of contraction was the slowest in a year, the final purchasing managers' survey from S&P Global revealed on Monday. The factory Purchasing Managers' Index rose to a 12-month high of 49.7 in October from 46.2 in September. The flash reading was 49.6.
RTTNews | 9h 32min ago