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Regulatory

CRON

Cronos Group Inc. has announced its first shipment of bulk cannabis under the PEACE NATURALS® brand in Germany, following a distribution agreement with Cansativa Group, a leading distributor of medical cannabis in Germany. This move marks Cronos' re-entry into the German market, which is expected to see significant growth due to recent regulatory changes. A bill introduced in August 2023 to legalize adult-use cannabis could further fuel this growth.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2023 | 11:33 am

ZLAB

Zai Lab Limited (NASDAQ:ZLAB) has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its efgartigimod alfa injection for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The designation was supported by data from the ADHERE study, which demonstrated significant efficacy and a favorable safety profile. Zai Lab and argenx reported positive topline results from the ADHERE study in July 2023.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2023 | 11:32 am

CFRX

ContraFect has submitted an IND application to the FDA for its development candidate CF-370, an intravenous antibacterial agent for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2023 | 11:31 am

DB

HSBC

MS

TSLA

China's central bank and forex regulator held a meeting with several foreign financial institutions, including Morgan Stanley, HSBC, Deutsche Bank, and other foreign firms such as Tesla. The details of the meeting were not disclosed.

Portfolio Pulse from Charles Gross

September 18, 2023 | 11:23 am

GRTX

Galera Therapeutics has scheduled a Type A meeting with the FDA to discuss the next steps for its radiotherapy Avasopasem. The company is seeking guidance on the regulatory path forward for the drug.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2023 | 11:22 am

AIMD

Ainos' VELDONA has received Orphan Drug Designation from the US FDA for its promising oral warts treatment in HIV-seropositive patients. AIMD may be mentioned in the article.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2023 | 11:07 am

KYMR

The FDA has granted Fast Track designation to Kymera Therapeutics' KT-333 for the treatment of relapsed/refractory cutaneous T-cell lymphoma and peripheral T-cell lymphoma.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2023 | 11:05 am

ACRS

Aclaris Therapeutics has announced the results from its Phase 1 Multiple Ascending Dose Trial of ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor. The results of the trial are not specified in the news.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2023 | 11:05 am

RDHL

The FDA has approved a supplemental new drug application (sNDA) for Talicia, changing its dosing to a simplified three times daily regimen. This change may support increased patient adherence and treatment outcomes.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2023 | 11:04 am

BCRX

The Institut National D'excellence En Santé Et Services Sociaux has issued a positive recommendation for BioCryst Pharmaceuticals' Orladeyo (Berotralstat) to be reimbursed for the prevention of hereditary angioedema attacks in adults and pediatric patients.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2023 | 11:02 am