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THE GOOD
Approvals & Labels

Novartis’ scores first-line accelerated approval from FDA for Scemblix in myeloid leukemia
Small molecule, myeloid leukemia, cancer - Read more

Protega Pharmaceuticals’ Roxybond scores first ever FDA approval for abuse-deterrent opioid
Small molecule, pain, opioid abuse, opioid abuse deterrent - Read more

AstraZeneca’s Wainzua lands UK NICE recommendation
Antisense oligonucleotide, hereditary transthyretin-related amyloidosis, polyneuropathy - Read more

Pfizer also gets into UK NICE’s good graces with recommendation for Elrixfio
Bispecific T-cell engager, multiple myeloma, cancer - Read more

Shorla Oncology lands FDA expanded label for Jylamvo into pediatric patients for an autoimmune and an oncology indication
Small molecule, acute lymphoblastic leukemia, polyarticular juvenile idiopathic arthritis, cancer, autoimmune - Read more

Abeona Therapeutics resubmits BLA to FDA for prademagene zamikeracel to treat recessive dystrophic epidermolysis bullosa
Gene therapy, recessive dystrophic epidermolysis bullosa - Read more

THE GOOD
Business Development

GSK pays Chimagen Biosciences $300M for CMG1A46, Ph1 asset with lupus potential
Bispecific antibody, lupus, autoimmune - Read more

Genmab licenses Revitope’s T-cell engager tech platform, $9M upfront + $600M biobucks
T-cell engager, solid tumor, drug development - Read more

Vaxxas gains license to US NIH next-gen RSV vaccine antigen
Vaccine, respiratory syncytial virus - Read more

THE GOOD
Clinical Trials

Eli Lilly’s revised Kisunla dosing regimen leads to lower brain swelling according to new Ph3 data
Monoclonal antibody, Alzheimer’s disease - Read more

Invivyd COVID-19 prophylactic pemivibart provides “substantial protection” over 6 months as touted in new Ph3 data
Monoclonal antibody, COVID-19, pre-exposure prophylaxis - Read more

Shionogi Therapeutics touts Ph3 data on the opposite side of COVID-19, Xocova as a post-exposure prophylaxis
Small molecule, COVID-19, post-exposure propylaxis - Read more 

Zai Lab’s posts positive Ph3 data for KarXT in Schizophrenia
Small molecule, schizophrenia - Read more

Innovent Biologics positive Ph2 win for psoriasis hopeful picankibart
Monoclonal antibody, psoriasis - Read more

Eledon Pharmaceuticals touts first evidence of insulin independence in two type 1 diabetes patients after iselt transplant but without standard immunosuppressant tacrolimus, instead using Eledon’s antibody tegoprubart
Monoclonal antibody, transplant rejection prevention, type 1 diabetes, islet transplant - Read more

Coya Therapeutics’ COYA 301 linked to biomarker, cognition improvements in small Alzheimer’s disease trial
Biologic combination therapy, Alzheimer’s disease - Read more

Clover posts positive Ph1 data for SCB-1019, RSV vaccine, in head-to-head with GSK’s Arexvy
Vaccine, respiratory syncytial virus - Read more

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⬇️ More Good News ⬇️

THE GOOD
Earnings & Finances

Pfizer reports Q3 earnings with a vengeance, blasts past earnings estimates and raises full year guidance - Read more

Novartis Pluvicto sales beat’s analyst expectations, hits blockbuster status
Radiopharm, prostrate cancer, radioligand therapy - Read more

THE GOOD
Fundraises

415 Capital €150M ($165M) Second Fund
Venture capital, medical technology investment - Read more

EyePoint Pharmaceuticals upsized public offering, expected gross proceeds of $140M
Small molecule, diabetic macular edema, drug-device combo, sustained release - Read more

Pathos AI $62M Series C, AI-driven cancer asset search & patient selection
AI, oncology asset, clinical trial recruitment, cancer - Read more

Paterna BioSciences $6M Seed raise, in vitro spermatogenesis tech
Reproductive health, in vitro spermatogenesis, in vitro fertilization - Read more

Vensica Medical $11M raise
Small molecule, overactive bladder, medical device - Read more

INBRAIN Neuroelectronics $50M Series B
Brain-computer interface, neurology, Parkinson’s, stroke - Read more

Vera Therapeutics public offering, $300M expected raise
Fusion protein, IgAN, Berger’s disease, lupus nephritis - Read more

Monopar Therapeutics public offering, $19.2M expected raise
Small molecule, Wilson disease, radiopharm, cancer imaging - Read more

THE GOOD
Investments

Merck KGaA’s MilliporeSigma puts $76M into St. Louis ADC facility expansion
Antibody-drug conjugate, manufacturing, facility expansion - Read more

THE GOOD
Mergers & Acquisitions

Crescent Biopharma reverse merger with GlycoMimetics, $200M in additional financing
Bispecific antibody, cancer, antibody-drug conjugate - Read more

Quris-AI acquires Nortis
Kidney-on-Chip, drug development, AI, personalized medicine - Read more

Dr. Falk Pharma acquires Kynos Therapeutics
Small molecule, acute pancreatitis, inflammatory disease - Read more

THE GOOD
Partnerships

Ryvu Therapeutics, nCage Therapeutics research collab to develop “next-generation” ADC platform
Antibody-drug conjugate, research & development, platform development - Read more

JW Pharmaceuticals, Tempus AI anti-cancer drug development pact, utilizing real-world data and organoids
Small molecule, cancer, drug development - Read more

THE GOOD
Product Launches

Iambic Therapeutics launches an “Enchant”ing clinical outcome prediction AI
Drug development, AI, clinical outcome prediction - Read more

PacBio launches new sequencing tech, purported to enable sequencing cost drops to $500M per human genome
Sequencing, human genome, long-read sequencing - Read more

THE GOOD
Politics & Policy

White House launches private sector pilot program to combat pediatric cancer drug shortages
Drug shortages, pediatric cancer - Read more

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THE BAD
Approvals & Labels

Lexicon Pharmaceuticals’ sotagliflozin may face tough adcom, as FDA briefing docs hint at continued diabetic ketoacidosis risk
Small molecule, type 1 diabetes, chronic kidney disease, diabetic ketoacidosis - Read more

THE BAD
Clinical Trials

GemVax & KAEL’s GV1001 falters in Ph2
Peptide, progressive supranuclear palsy - Read more

GlycoMimetics Uproleselan misses Ph2/3 primary endpoint
Small molecule, myeloid leukemia, cancer - Read more

THE BAD
Earnings & Finances

Novartis takes a big $800M oof (write-down) of $2.9B MorphoSys acquisition due to pelabresib safety signal, longer required follow-up time pushes back potential approval by “years”
Small molecule, myelofibrosis, cancer - Read more

THE BAD
Layoffs

ElevateBio cuts 4% of their total staff, stopping preclinical cellular engineering R&D
CDMO, therapeutic development, advanced therapies - Read more [Paywall]

THE BAD
Partnerships

Neurocrine Biosciences, Idorsia part ways two years after NBI-827104 Ph2 failures
Small molecule, epilepsy - Read more

THE BAD
Strategic Plans

Sage, Biogen discontinue zuranolone devepment in the US for major depressive disorder
Small molecule, major depressive disorder - Read more

THE UGLY
Politics & Policy

Brain worms, bear carcasses, antivax rhetoric, “Make America Health Again”; biopharma industry braces for a potential Trump, RFK Jr.-influenced FDA
Drug policy, regulatory policy - Read more [Paywall]

THE UGLY
Warnings Letters, Form 483s

Novo Nordisk’s Ozempic manufacturing site cited by FDA earlier this year for “quality related issues”
Drug manufacturing, quality - Read more [Paywall]

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

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