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Regulatory

COLL

The Appeals Court has upheld the Patent Trial and Appeal Board's (PTAB) decision that Purdue Pharma's patent, number 961, is invalid. This ruling is a significant blow to Purdue Pharma, which has been embroiled in legal challenges over its patents.

Portfolio Pulse from Bill Haddad

November 27, 2023 | 1:06 pm

SEEL

Seelos Therapeutics has chosen its SLS-002 (Intranasal Racemic Ketamine) for inclusion in the U.S. Department of Defense's Adaptive Platform Trial, which aims to evaluate potential treatments for Post-traumatic Stress Disorder (PTSD).

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:01 pm

SPY

USA Building Permits for the month showed an increase of 1.8%, surpassing the estimated 1.1%. This is a significant improvement from the previous month's decline of 4.5%.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:01 pm

GSK

GSK plc announced positive Phase 3 trial results for belantamab mafodotin, showing significant improvement in progression-free survival for multiple myeloma compared to the standard of care. Despite previous setbacks with FDA and EMA regulatory issues, the encouraging data could signal a potential comeback for the drug, marketed as Blenrep. GSK shares saw minimal change in premarket trading.

Portfolio Pulse from Vandana Singh

November 27, 2023 | 12:57 pm

ABEO

Abeona Therapeutics Inc. announced that the FDA has accepted and granted Priority Review for their BLA for pz-cel, a treatment for RDEB. The FDA set a PDUFA target action date of May 25, 2024, and indicated no Advisory Committee meeting is planned for the application.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:32 pm

AUTL

Autolus Therapeutics has submitted a Biologics License Application (BLA) to the FDA for obecabtagene autoleucel, a treatment for relapsed/refractory adult B-cell acute lymphoblastic leukemia. The company is also planning to submit an application to the European Medicines Agency in the first half of 2024.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:11 pm

FXI

China's Central Bank has announced plans to replenish its monetary policy toolkit and is determined to fend off overshooting risks. Additionally, the bank aims to maintain a basically stable Yuan exchange rate, according to Reuters.

Portfolio Pulse from Charles Gross

November 27, 2023 | 12:10 pm

GMAB

Genmab has been granted FDA Breakthrough Therapy Designation for Epcoritamab, aimed at treating relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Additionally, the European Medicines Agency has validated an application for Epcoritamab for the same indication.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:03 pm

RDHL

RedHill Biopharma has been granted a 5-year US market exclusivity for Talicia by the FDA, with intellectual property protection extending to 2034. This exclusivity enhances the company's competitive position in the market for Talicia, a treatment for Helicobacter pylori infection.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:02 pm

KRYS

Krystal Biotech has announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application for VYJUVEK, a treatment for Dystrophic Epidermolysis Bullosa. This validation is a significant step in the regulatory process, indicating that the application is complete and the EMA will now begin its formal review.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 12:02 pm