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Regulatory

SCYX

SCYNEXIS has announced a recall of BREXAFEMME and a temporary halt to clinical studies of ibrexafungerp due to the risk of cross contamination with a non-antibacterial beta-lactam drug substance during manufacturing, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 1:08 pm

SHPH

Shuttle Pharma has announced the results of its pre-IND meeting with the FDA for the Phase II clinical trial of Ropidoxuridine for patients with Glioblastoma. The company is on track to initiate the clinical trial in Q4 of 2023.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 1:04 pm

SCLX

Scilex Holding Company announced that the State of Indiana Medicaid will add Elyxyb, a drug developed by the company, to its Preferred Drug List effective from October 1, 2023.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 1:03 pm

TAK

Takeda Pharmaceutical Company Limited (TAK) has received approval for its subcutaneous immunoglobulin plasma therapy, CUVITRU, in Japan. The approval is based on clinical studies conducted in Japan, Europe, and North America, confirming the efficacy and safety of CUVITRU for patients with agammaglobulinemia or hypogammaglobulinemia.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:45 pm

SPY

Chicago Fed's Goolsbee has expressed that concerns over an inverted yield curve may not take into account possible differences in the post-pandemic economy. This statement was reported by CNBC.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:43 pm

SPY

Chicago Fed's Goolsbee suggests that the Federal Reserve will have to 'play by year' regarding whether interest rates need to increase. He also indicates that rates may have to stay higher for longer than markets had anticipated.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:41 pm

SPY

Chicago Fed's Goolsbee suggests that monetary policy takes a long time to impact the economy. The focus may shift from how high to raise rates to how long they will stay there.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:40 pm

SPY

Chicago Fed's Goolsbee stated that the Federal Reserve should have a '100% commitment' to returning inflation to 2%, emphasizing that the target will not change. He warned that undermining the target and 'giving up' would defeat the purpose of having a target.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:39 pm

SPY

Chicago Fed's Goolsbee has stated that the risk of inflation staying higher is still the bigger risk. He also mentioned that the current path is unusual for inflation to fall like it is without unemployment rising.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:38 pm

CHRS

Coherus BioSciences announced that the FDA issued a complete response letter for UDENYCA ONBODY Biologics License Application due to an ongoing review of inspection findings at a third-party filler. No issues with clinical efficacy, safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing were identified. No additional clinical data or trials have been requested by the FDA. The company also announced the completion of Toripalimab FDA inspections.

Portfolio Pulse from Benzinga Newsdesk

September 25, 2023 | 12:33 pm