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NEWS & INSIGHTS

Dive into the Biopharma Space

Stay up-to-date on major biopharma news, deeper dives into specific companies and biopharma themes, and how it all relates to biopharma partners.

Biopharma approvals, new data, M&A activity, and more - March 22nd 2024

FDA approved gene tx for children w/ early-onset MLD + 13 updates...👇


Optinose

🎯 FDA approved XHANCE, the first and only medication treating adults with chronic rhinosinusitis w/o nasal polyps.


Orchard Therapeutics 

🎯 Received FDA approval for Lenmeldy™ (atidarsagene autotemcel) treating children w/ early-onset metachromatic leukodystrophy.


Bristol Myers Squibb 

🎯 EU approved Abecma (idecabtagene vicleucel), the first CAR-T cell therapy for triple-class exposed r/r multiple myeloma.


Journey Medical Corporation 

🎯 FDA accepted the NDA for treating rosacea w/ PDUFA goal date of Nov. 4, 2024.


Citius Pharmaceuticals 

🎯 FDA accepted the BLA resubmission of LYMPHIR™ (Denileukin Diftitox) for treating r/r CTCL. 


Seelos Therapeutics 

🔬 Reported top-line data for SLS-005 (IV Trehalose) treating ALS.


AstraZeneca

🔬 Lynparza and Imfinzi showed more than doubled median duration of response vs. chemotherapy in endometrial cancer. 


Kiromic BioPharma

🔬 Reported tumor stabilization and complete disappearance of brain metastases in the early efficacy datasets from the Deltacel-01 trial of Deltacel™ (KB-GDT-01). 


Crinetics

🔬 Oral Paltusotine achieved both primary and secondary endpoints in the Ph3 PATHFNDR-2 study in acromegaly patients. 

  

Gilead Sciences & CymaBay

🤝 Gilead completed the acquisition of CymaBay. 


Fusion Pharmaceuticals

🤝 AZN To acquire Fusion Pharmaceuticals expanding its radioconjugates pipeline treating cancer. 


Novartis & MorphoSys 

🤝 U.S. Antitrust cleared the proposed acquisition of MorphoSys. 





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Data:

March 18-22, 2024


Article History:

RF, DV (03/22/24)


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