Sanofi's Blood-Disorder Drug Enjaymo Given Green Light by FDA

 Sanofi SA said late Friday that enjaymo, a drug it developed to treat a rare blood disorder, was approved by the U.S. Food and Drug Administration.

The French pharma major said the drug, which works to prevent the destruction of red blood cells due to cold agglutinin disease, is the first and only approved treatment against it.

The drug has a list price of $1,800 a vial and is expected to be available in the U.S. in the coming weeks, Sanofi said. It is being evaluated for regulatory approval in Europe and Japan.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-s-Blood-Disorder-Drug-Enjaymo-Given-Green-Light-by-FDA-37799038/

Synaffix, MacroGenics In Pact For Next Gen Antibody-Drug Conjugates

Synaffix BV has entered into a technology agreement with MacroGenics Inc 

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.

• Under the licensing agreement, MacroGenics will access Synaffix's clinical-stage GlycoConnect antibody conjugation technology, HydraSpace polar spacer technology, and select toxSYN linker-payloads.
• These will be combined with MacroGenics' proprietary antibody and bispecific DART antibody platform technologies to generate next-generation antibody-drug conjugates (ADCs).
• Under the terms of the agreement, Synaffix will be eligible to receive up to $586 million in payments spanning upfront and milestone payments across three programs plus royalties on commercial sales. 
• The license rights of MacroGenics for each program will be designated as exclusive or non-exclusive to each program's antibody target (or to the combination of two targets, if bispecific). 
• The first program will commence at the signature, with the option to expand the collaboration to a further two programs by March 2023.

https://www.benzinga.com/general/biotech/22/02/25400873/synaffix-macrogenics-ink-pact-for-next-generation-antibody-drug-conjugates

Delcath's Chemosat Hepatic Delivery System Shows Overall Response Rate Of 60.5%

 Delcath Systems Inc's 

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 single-institution retrospective study data on CHEMOSAT Hepatic Delivery System for liver dominant metastatic uveal melanoma (mUM) were published in the journal Melanoma Research.

• 41 of 81 (50.6%) patients had received other treatments, either systemic or liver-directed, before percutaneous hepatic perfusion (PHP) treatment. 250 PHP procedures were performed in 81 patients. 
• The Company's PHP system is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.
• The PHP system is being developed under the tradename, Hepzato Kit.
• Related: Delcath Systems Reveals Initial Survival Data From Ocular Melanoma Trial.
• The analysis demonstrated a hepatic disease control rate of 88.9% (72/81), a hepatic response rate of 66.7%, and an overall response rate of 60.5%.
• After a median follow-up of 12.9 months, median overall progression-free survival (PFS) and median overall survival (OS) were 8.4 and 14.9 months, respectively.
• Treatment-emergent adverse events of Grade 3 or 4 occurred in 23 patients, anemia observed in 11 patients (13.3%), and thrombocytopenia in 10 patients (12%). 
• There were no fatal treatment-related adverse events.

https://www.benzinga.com/general/biotech/22/02/25419639/delcaths-chemosat-hepatic-delivery-system-shows-overall-response-rate-of-60-5-in-eye-cancer-that-