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THE GOOD
Approvals & Labels

Astellas’ Vyloy lands FDA approval for gastric cancer, first-line in certain adults
Monoclonal antibody, gastric cancer - Read more

Novo Nordisk’s Alhemo nabs EMA approval recommendation
Monoclonal antibody, haemophilia A, haemophilia B - Read more

Novartis lands positive EMA approval recommendation
Small molecule, breast cancer - Read more

THE GOOD
Business Development

Poseida Therapeutics nominates new CAR-T developmental candidate, triggering $15M milestone payment from partner Roche 
Cell therapy, cancer, multiple myeloma, CAR-T, allogeneic - Read more

THE GOOD
Clinical Trials

Merck & Co.’s clesrovimab passes Ph2b/3 trial with flying colors, “significantly reduce[s]“ RSV disease incident rate
Monoclonal antibody, respiratory syncytial virus - Read more

Marinus Pharmaceuticals touts positive ganaxolone Ph3 data in seizure disorder
Small molecule, refractory status epilepticus, seizure disorder - Read more

AgeneBio showcases positive AGB101 Ph2b data in slowing brain atrophy in certain Alzheimer’s patients
Small molecule, Alzheimer’s Disease - Read more

SpyGlass Pharma touts “promising” 18-month following data for first in-human SpyGlass Intraocular Lens recipients
Small molecule, glaucoma, ocular hypertension, drug delivery - Read more

Supernus Pharmaceuticals’ showcases fast-acting potential of SPN-820 in depression, reports Ph2a trial data
Small molecule, depression - Read more 

Verastem Oncology presents updated Ph2 data for ovarian cancer small molecule due (avutometinib + defactinib)
Small molecule, ovarian cancer - Read more

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⬇️ More Good News ⬇️

THE GOOD
Fundraises

LaNova Medicines CN¥300M ($42.2M) Series C1
Antibody-drug conjugate, cancer, monoclonal antibody, drug discovery platform - Read more

Bright Minds Biosciences $35M private placement
Small molecule, refractory epilepsy, depression - Read more 

THE GOOD
IPOs

Telix Pharmaceuticals aims to list ordinary shares, trade on Nasdaq
Radiopharma, cancer, radiodiagnostics - Read more

THE GOOD
Mergers & Acquisitions

REGiMMUNE, Kiji Therapeutics merger, aspiring to master regulatory T cells (Tregs)
Small molecule, graft-versus-host disease, monoclonal antibody, cell therapy, gene therapy - Read more

THE GOOD
Partnerships

ClearB Therapeutics, Adjuvance Technologies, Inc. partner on hepatitis B vaccine development
Therapeutics vaccine, hepatitis B, vaccine adjuvant - Read more

Xenetic Biosciences, Tokyo Medical University partner to develop latter’s systemic DNase program
Recombinant protein, Ewing sarcoma, cancer - Read more

FibroBiologics, Charles River Laboratories partner on cell banking, manufacturing collaboration for CYWC628
Cell therapy, diabetic foot ulcer, fibroblast-based spheroids - Read more

THE GOOD
Patient Access

Baxter pledges 18,000 tons of IV solutions imported by EOY as Florida facility remains out of commission
IV solution - Read more

THE GOOD
Regulatory

European Commission officially adopts guidance on how it will work more closely with the European Medicines Agency
Regulatory cooperation - Read more [Paywall]

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THE BAD
Approvals & Labels

PTC Therapeutics’ Translarna handed another thumbs-down from European Medicines Agency
Small molecule, Duchenne’s muscular dystrophy - Read more

AB Science’s gets negative approval opinion for masitinib from European Medicines Agency
Small molecule, amyotrophic lateral sclerosis - Read more

THE BAD
Clinical Trials

Roche discontinues RO7617991 development before any patient enrolment, citing “strategic review“
Bispecific T-cell engager, solid tumor, cancer- Read more

BioNTech, OncoC4’s gotistobart Ph3 trial put under partial hold by FDA
Monoclonal antibody, lung cancer - Read more

Pfizer looks around at competitors and decides to also discontinue an SHP2 inhibitor
Small molecule, cancer - Read more [Paywall]

THE BAD
Layoffs

Apertura, Atalanta Therapeutics both confirm layoffs
Gene therapy, RNAi - Read more [Paywall]

THE BAD
Mergers & Acquisitions

Volume rises on calls to FTC to intervene in impending Novo Holdings, Catalent takeover
Antitrust, manufacturing - Read more 

THE BAD
Public Health

Congo’s mpox vaccine rollout “slower than expected”
Vaccine, monkepox (mpox) - Read more

THE UGLY
Patient Access

UnitedHealthcare, CVS, Humana allegedly used technology to obstruct senior’s access to post-acute care
Medicare advantage, post-acute care - Read more

THE UGLY
Withdrawals & Recalls

Gilead withdraws accelerated-approved Trodelvy in bladder cancer after it flunks a confirmatory trial
Antibody-drug conjugate, bladder cancer - Read more

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

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