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THE GOOD
Approvals & Labels

Vertex Pharmaceuticals non-opioid pain med NDA accepted by FDA
Small molecule, moderate to severe pain - Read more

Novartis myeloid leukemia med lands FDA priority review
Small molecule, myeloid leukemia, cancer - Read more

Roche’s Vabysmo snags third indication via EC (Europe) go-ahead
Small molecule, retinal vein occlusion - Read more

Stallergenes Greer’s peanut allergy immunotherapy naps indication extension from FDA
Allergen powder, immunotherapy, peanut allergy - Read more

Amneal Pharmaceuticals ready-to-use saline bag NDA approved by FDA
Small molecule, compounding - Read more

THE GOOD
Clinical Trials

BioNTech, Regeneron mRNA cancer med combo does well in Ph2
mRNA, melanoma, cancer - Read more

Roche kicks off on Ph2 obesity injectable trial, stemming from $2.7B Carmot Therapeutics takeover earlier this year
GLP-1/GIP, obesity, weight loss - Read more

Celldex Therapeutics chronic hives antibody notches Ph2 win
Monoclonal antibody, hives, inducible urticaria - Read more

Novo Nordisk’s older GLP-1 drug (liraglutide) looks to slow Alzheimer’s-induced cognitive decline in Ph2b study
GLP-1, Alzheimer’s disease - Read more

Incyte plots PD-1 comeback with Ph2 trial win in anal cancer
Monoclonal antibody, anal cancer - Read more

Imunon stock skyrockets (but settles down again) after reporting positive Ph2 ovarian cancer data
DNA plasmid vector, nanoparticle delivery, ovarian cancer - Read more

Verastem Oncology pancreatic cancer small molecule combo lands FDA orphan drug designation
Small molecule, combo therapy, pancreatic cancer - Read more

Clearside Biomedical positive topline results in China macular edema Ph2
Small molecule, uveitic macular edema - Read more

Yamo Pharmaceuticals reports positive Ph2 data for autism disorder med
Small molecule, autism spectrum disorder - Read more

THE GOOD
Company Launches

Montara Therapeutics launches with $8M and goal of more targeted delivery of neurological therapeutics
Small molecule, neurological disorder, drug combo - Read more

THE GOOD
Earnings & Finances

Pfizer earnings offer hope for the rest of 2024, raises guidance - Read more

THE GOOD
Fundraises

Day One Biopharmaceuticals oversubscribed $175M private placement
Small molecule, pediatric cancer - Read more

Pinetree Therapeutics $17M Series A
Antibody, protein degrader, oncology, cancer - Read more

LTZ Therapeutics $20M Series A
Bispecific antibody, cancer, autoimmune - Read more

Shenzhen Synthetica Pioneering Series A (amount undisclosed)
Living bacterial therapeutics, solid tumor, cancer - Read more

THE GOOD
Product Launches

LineaBio launches off-the-shelf GMP iPSC lines
Induced pluripotent stem cells - Read more

THE GOOD
Research

GLP-1s may help address tobacco use disorder; study
GLP-1, diabetes, obesity, tobacco use disorder - Read more 

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THE BAD
Company Shutdown

VBI Vaccines is restructuring and considering those dreaded “strategic alternatives”
Vaccine, COVID-19, zika virus, glioblastoma, cancer - Read more

THE BAD
Earnings & Finances

Merck & Co.’s stock takes significant hit after reporting surprise Gardasil sales slowdown in China
HPV vaccine, human papillomavirus infection - Read more

THE BAD
Regulatory

FDA raises drug filing application costs to $4.3M come October
New drug application - Read more

FDA rejects (again) Novartis’ Entresto generics petition
Small molecule, heart failure, generic - Read more [Paywall]

THE BAD
Strategic Plans

Incyte slims down pipeline, cutting multiple cancer assets in discovery and early clinical phases
Immunotherapy, monoclonal antibody, bispecific antibody - Read more

Pfizer fully cuts DMD program to the tune of a $230M loss, and cuts RSV combo vaccine program
Gene therapy, Duchenne muscular dystrophy (DMD), vaccine, respiratory syncytial virus (RSV), combo therapy - Read more

THE UGLY
Regulatory

South Korea’s MFDS hands out penalties to GSK on failing to report API changes to asthma med and confusing label on acne drug
Small molecule, drug labelling, API, asthma, acne - Read more

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

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