Repair Biotechnologies Receives FDA Feedback on REP-0003 for HoFH
Key TakeawaysRepair Biotechnologies completes a positive Pre-IND meeting with the FDA for REP-0003 mRNA therapy.
REP-0003 targets homozygous familial hypercholesterolemia (HoFH), a rare...
MedMira’s Reveal® G4 HIV Test Approved for Point-of-Care Use
Key TakeawaysMedMira receives Health Canada approval for its Reveal® G4 Rapid HIV-1/2 Test.
The test offers 99.64% sensitivity and 99.71% specificity, providing accurate...
UnisLink Approved as Qualified Clinical Data Registry for MIPS 2025
Key TakeawaysUnisLink earns CMS approval as a Qualified Clinical Data Registry (QCDR) for 2025 MIPS reporting.
The designation empowers healthcare providers with streamlined...
MedMira Gains Approval to Trial Rapid Syphilis Test
Key TakeawaysMedMira secures Health Canada authorization for clinical trials of its Multiplo® Complete Syphilis Antibody Test.
The test detects both active and past...
Catalent Partners with Galapagos for Decentralized CAR-T Manufacturing
Key TakeawaysCatalent collaborates with Galapagos to expand decentralized CAR-T therapy manufacturing in the U.S.
The initiative focuses on improving patient outcomes by reducing...
Launch of Electronic Patient Record (ePA) in Germany’s Model Regions
Key TakeawayThe electronic patient record (ePA) marks a significant milestone in digitizing Germany's healthcare system.
Beginning with pilot testing in model regions, the...
Arvinas Announces Phase 3 Trials for Vepdegestrant
Key TakeawaysArvinas plans to initiate two Phase 3 trials for vepdegestrant in 2025, targeting ER+/HER2- metastatic breast cancer.
Topline data from the VERITAC-2...
FDA Places Clinical Hold on Atara’s EBVALLO™ and ATA3219 Trials
Key TakeawaysThe FDA has placed a clinical hold on Atara Biotherapeutics’ trials for EBVALLO™ (tabelecleucel) and ATA3219 due to unresolved GMP compliance issues...
Atara Receives CRL for EBVALLO™, Manufacturing Issues Identified
Key TakeawaysThe FDA has issued a Complete Response Letter (CRL) to Atara Biotherapeutics concerning EBVALLO™ (tabelecleucel), citing issues at a third-party manufacturing facility.
...
Germany Shakes Up Drug Pricing with Confidential Rebates and IRP Ban
Key TakeawaysGermany’s Medical Research Act eliminates international reference pricing (IRP) from its drug pricing framework.
New confidential rebate options aim to protect German...
HUTCHMED Gains Full Approval for ORPATHYS® in NSCLC
Key Takeaways:ORPATHYS® receives full NMPA approval in China for treatment-naïve and previously treated NSCLC patients with MET exon 14 alterations.
Confirmatory Phase IIIb...
PulseSight Begins Phase I Trial for Dry AMD Therapy
Key Takeaways:PulseSight initiates the Phase I trial for PST-611, targeting dry AMD/geographic atrophy.
PST-611 uses non-viral vectorized therapy to regulate iron homeostasis and...
Boehringer Shares Phase III Schizophrenia Trial Results
Key TakeawaysBoehringer Ingelheim reports Phase III iclepertin trial did not meet primary endpoints.
No significant cognitive improvements observed in schizophrenia patients over six...
Eckert & Ziegler Strengthens Global Ac-225 Supply with Key Chinese Partnership
Key TakeawaysEckert & Ziegler secures a €10 million license agreement with Qi Kang Medical (QKM).
Partnership enhances Actinium-225 supply for expanding radiopharmaceutical applications.
...
Terumo and Fujifilm Collaborate to Advance T Cell Expansion for Cell Therapy
Key TakeawaysTerumo Blood and Cell Technologies partners with Fujifilm Irvine Scientific to accelerate T cell expansion.
Fujifilm's PRIME-XV® media integrates with Terumo's Quantum...
