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THE GOOD
Approvals & Labels

PharmaMar's Zepzelca (lurbinectedin) plus atezolizumab wins Swiss approval for extensive-stage small cell lung cancer maintenance
Small molecule, cancer, combination therapy, small cell lung cancer, maintenance therapy - Read more

Novartis receives FDA approval for Itvisma (onasemnogene abeparvovec-brve) gene therapy targeting spinal muscular atrophy in patients two years and older
Gene therapy, neurological, gene replacement therapy, spinal muscular atrophy, SMN1 gene - Read more

Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) wins European Commission approval for relapsed or refractory mantle cell lymphoma
Cell therapy, cancer, CAR-T, mantle cell lymphoma, CD19 target, relapsed refractory - Read more

THE GOOD
Business Development & Partnerships

Academy of Medical Sciences, Wellcome strengthen UK health research partnership with £27.3M ($35.4M) five-year agreement
Research collaboration, workforce development, biomedical research, funding agreement - Read more

Biogen, Dayra Therapeutics partner on oral macrocyclic peptides for immunology, $50M upfront plus milestones
Research collaboration, immunological, macrocyclic peptides, milestone payments - Read more

Gilead, Sprint Bioscience partner on TREX1 cancer program, $14M upfront, $400M milestones
Acquisition, oncology, small molecule, milestone payments - Read more

BioCorteX, CD Biopharma partner on precision immunotherapy development using Carbon Mirror technology
Strategic collaboration, oncology, precision immunotherapy, bispecific fusion protein, in silico drug development - Read more

Inventage Lab, Boehringer Ingelheim expand collaboration on long-acting injectable formulations using microfluidic technology
Research collaboration, drug delivery, peptide therapeutics, microfluidic technology - Read more

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THE GOOD
Clinical Trials

NervGen's NVG-291 peptide shows significant improvement in Ph2 chronic spinal cord injury study
Protein therapy, neurological, peptide therapeutic, spinal cord injury, neural regeneration - Read more

Sarepta Therapeutics' SRP-1003 siRNA targeting type 1 myotonic dystrophy receives positive safety review in Ph1/2 trial
Small interfering RNA, neurological, siRNA, myotonic dystrophy, TRiM platform, muscle targeting - Read more

Kelun-Biotech's sacituzumab tirumotecan (sac-TMT) plus Merck & Co.’s Keytruda combo hits Ph3 endpoint in first-line non-small cell lung cancer
Antibody-drug conjugate, cancer, non-small cell lung cancer, TROP2 target, combination therapy, checkpoint inhibitor - Read more

Eli Lilly's Jaypirca (pirtobrutinib) shows superior progression-free survival in Ph3 chronic lymphocytic leukemia trial
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, treatment-naive patients - Read more

Johnson & Johnson's Tecvayli (teclistamab) combination shows 83.4% three-year survival rate in Ph3 multiple myeloma trial
Antibody, cancer, bispecific antibody, multiple myeloma, BCMA target, combination therapy - Read more

Kelonia Therapeutics reports promising Ph1 data for KLN-1010 in vivo anti-BCMA CAR-T therapy in relapsed refractory multiple myeloma
Cell therapy, cancer, CAR-T, multiple myeloma, BCMA target, in vivo delivery - Read more

Junshi Biosciences' toripalimab (JS001sc) subcutaneous formulation meets Ph3 endpoints for non-squamous non-small-cell lung cancer
Antibody, cancer, monoclonal antibody, non-small cell lung cancer, PD-1 inhibitor, subcutaneous formulation - Read more

Biokin Pharmaceutical's Iza-bren meets Ph3 endpoints for advanced esophageal squamous cell carcinoma treatment
Antibody-drug conjugate, cancer, bispecific antibody, esophageal squamous cell carcinoma, EGFR, HER3 - Read more

Enlivex reports positive Ph1/2 data for Allocetra cell therapy showing durable pain reduction in knee osteoarthritis
Cell therapy, musculoskeletal, Allocetra, knee osteoarthritis, pain management - Read more

THE GOOD
Fundraises

Phrontline Biopharma raises $60M Pre-A+, bispecific and dual-payload ADC development
Oncology, antibody-drug conjugate, bispecific ADC, clinical-stage, platform technology - Read more

MindImmune raises $30M Series A, inflammation-focused Alzheimer's therapy development
Neurological, Alzheimer disease, antibody, inflammation-focused - Read more

Quarry Thera raises $32M for novel protein degrader therapeutics
Antibody drug conjugate, oncology, strategic, major transaction - Read more [Paywall]

THE GOOD
Politics & Policy

UK negotiates drug pricing deal with US, raising NHS cost-effectiveness thresholds for lower tariffs
Pharmaceutical pricing, strategic, financial, major transaction - Read more

THE GOOD
Product Launches

Sandoz launches Afqlir aflibercept biosimilar in Europe, offering affordable alternative to Eylea for retinal diseases
Monoclonal antibody, ophthalmology, biosimilar, competitive, affordable access - Read more

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THE BAD
Clinical Trials

Novo Nordisk's semaglutide fails Ph3 trials for Alzheimer's disease targeting GLP-1 receptor pathway
Small molecule, neurological, GLP-1 agonist, Alzheimer's disease, semaglutide - Read more

THE BAD
Regulatory

FDA issues untitled letter to SK Life Science over misleading Xcopri antiseizure medication advertisement
Small molecule, neurological, regulatory, operational - Read more

THE BAD
Strategic Plans

Clearside Biomedical files Chapter 11 bankruptcy, seeks strategic sale of eye therapy delivery assets
Injectable suspension, ophthalmology, strategic, bankruptcy, asset sale - Read more

THE UGLY
Regulatory

White House blocks FDA aide Jain-Nagpal's promotion amid ongoing tensions with Commissioner Makary
Regulatory, operational, strategic, organizational - Read more

You’re all caught up on the latest Pharma & Biotech News!

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