🧬 Biopharma Bite Sized News 🍪 April 29th - May 3rd

INGREZZA FDA approval & 9 more major updates...

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🎯 → Approvals

🔬 → New data

🤝 → M&A activity

Neurocrine Biosciences 

🎯 Received FDA approval of INGREZZA® SPRINKLE (valbenazine) capsules for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.

Pfizer 

🎯 FDA approved TIVDAK® treating recurrent or metastatic cervical cancer.

Aquestive Therapeutics 

🎯 Received FDA approval for Libervant™ (diazepam) buccal film treating seizure clusters in children aged two to five years. 

X4 Pharmaceuticals 

🎯 FDA approved of XOLREMDI™ (mavorixafor) treating patients with WHIM syndrome.

Vertex Pharmaceuticals 

🎯 Received EC approval for KALYDECO® to treating infants with cystic fibrosis for ages 1 month and older. 

Merck 

🔬 Reported results from the Ph3 KEYNOTE-811 trial evaluating KEYTRUDA® + trastuzumab + fluoropyrimidine- and platinum-containing chemotherapy meeting its dual primary endpoint of overall survival (OS) in patients with HER2-positive advanced gastric or GEJ adenocarcinoma 

🔬 Data reported from the STRIDE-10 Ph3 trial evaluating V116, an Investigational, 21-valent Pneumococcal conjugate vaccine for adults eliciting significant immune response and good safety profile.  

Sellas Life Sciences 

🔬 Reported Ph2 preliminary data of SLS009 in r/r AML achieving a 100% response rate in patients with ASXL1 mutation at the optimal dose level.

Senti Bio 

🔬 Published SENTI-202preclinical data showing the potential of logic-gated CAR-NK Cell therapy for treating AML. 

Astellas & Poseida Therapeutics 

🤝 Initiated research collaboration and license agreement to develop novel allogeneic cell therapies in oncology.

Deciphera Pharmaceuticals & ONO Pharmaceutical

🤝 Ono Pharmaceutical to acquire Deciphera Pharmaceutical for $2.4B.

Akari Therapeutics & Peak Bio 

🤝 Completed the portfolio prioritization plan as part of the imminent merger focusing on Peak’s antibody-drug conjugate (ADC) technology. 

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Data:

April 29-May 3, 2024

Article History:

RF, DV, DG (05/6/24)