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Regulatory

CRDL

Cardiol Therapeutics has announced that all collaborating clinical research centers are now initiated and eligible to enroll patients in ARCHER, a Phase II trial of CardiolRx for the treatment of acute myocarditis.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 11:29 am

PYPD

PolyPid Ltd. (NASDAQ:PYPD) has successfully completed the production of three process validation batches of D-PLEX100, a significant step towards the submission of D-PLEX100 New Drug Application (NDA) and Marketing Authorization Application (MAA) regulatory filings.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 11:12 am

BHG

Bright Health Group's insurance subsidiaries have entered into repayment agreements with the Centers for Medicare & Medicaid Services (CMS) for an aggregate amount of $380 million. The amount is due 18 months from September 15, 2023, and bears an interest rate of 11.5% per annum. Failure to make payments or entering into liquidation will result in a default.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 11:12 am

BLRX

BioLineRx has announced that pilot phase data from a Phase 2 trial with Motixafortide in first-line pancreatic ductal adenocarcinoma will be presented at the American Association for Cancer Research Special Conference on Pancreatic Cancer.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 11:12 am

GSK

PFE

The European Commission has approved ViiV Healthcare's Apretude for HIV prevention in high-risk adults and adolescents. ViiV Healthcare is owned by GSK, Pfizer, and Shionogi.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 10:49 am

MRK

Merck's (NYSE:MRK) new drug WELIREG has been granted priority review by the FDA for the treatment of advanced renal cell carcinoma. The drug has shown significant improvement in progression-free survival compared to everolimus in the LITESPARK-005 trial. The FDA has set a target action date of January 17, 2024.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 10:47 am

CCL

CUK

FXI

NCLH

RCL

China's Transport Ministry has announced the full resumption of international cruise ship transport to and from ports in the country starting Tuesday.

Portfolio Pulse from Charles Gross

September 19, 2023 | 10:40 am

SXTP

60 Degrees Pharma has withdrawn its Covid Phase 2B Investigational New Drug, with plans to resubmit after assessing its ability to meet FDA requirements. This has led to a decrease in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 10:30 am

BGNE

The FDA has accepted for review Beigene's application for Tislelizumab as a first line treatment for unresectable, locally advanced or metastatic esophageal squamous cell carcinoma. The target action date is set for the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 10:21 am

BGNE

The European Commission has approved Beigene's Tevimbra (Tislelizumab) for unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 10:19 am