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THE GOOD
Approvals & Labels

FDA approves Bavarian Nordic's freeze-dried Jynneos vaccine for smallpox and mpox
Vaccine, Mpox (monkeypox), smallpox, drug formulation - Read more

Moderna's RSV vaccine mRESVIA approved by Australian TGA in adults 60+
Vaccine, respiratory syncytial virus (RSV) - Read more

Pfizer's RSV vaccine Abrysvo lands EC approval for high-risk adults 18-59
Vaccine, respiratory syncytial virus (RSV) - Read more

Genmab's Tivdak (targeting CD142) lands EC approval for for recurrent or metastatic cervical cancer after prior therapy
Antibody-drug conjugate (ADC), cervical cancer - Read more

THE GOOD
Business Development

Eagle Pharmaceuticals sells Bendeka royalty rights to “an entity that was provided capital by funds managed by“ Blue Owl Capital for $69 million to repay debt and fund corporate purposes
Royalty, small molecule, leukemia, lymphoma, cancer - Read more

Organon acquires US rights to Tofidence (targeting IL-6; Actemra biosimilar, Biogen)
Monoclonal antibody, biosimilar, rheuma­toid arthri­tis, giant cell arteritis, arthritis, COVID-19 - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Gubra's GUBamy (targeting amylin receptor) delivers positive Ph1 weight loss results and safety profile in obesity
Peptide, obesity - Read more

Compass Therapeutics' tovecimig (targeting DDL4xVEGF-A) plus paclitaxel hits Ph2/3 primary endpoint in biliary tract cancer
Bispecific Antibody, biliary tract cancer - Read more

Eli Lilly's solbinsiran (targeting ANGPTL3) delivers positive Ph2 data in mixed dyslipidemia (with potential for quarterly dosing)
siRNA, dyslipidemia - Read more

Palatin's Ph2 trial shows bremelanotide (MC4R agonist) combined with Eli Lilly's Zepbound (targeting GLP-1/GIP) enhances weight loss in obesity treatment
Peptide, GLP-1, Combo therapy, obesity - Read more

LB Pharmaceuticals' LB-102 (targeting D2/3, 5-HT7) delivers positive Ph2 trial results in schizophrenia
Small molecule, schizophrenia - Read more

FDA lifts clinical hold on Oncopeptides' OPD5 (targeting aminopeptidases), continuing Ph1 prep in multiple myeloma
Peptide drug conjugate, cancer, multiple myeloma - Read more

THE GOOD
Fundraises

AIRNA $155M Series B, RNA editing startup advancing clinical trials for rare genetic disease treatment and pipeline development
RNA editing, alpha-1 antitrypsin deficiency, cardiometabolic disease - Read more

Prazer Therapeutics $21.3M Series B, developing targeted protein degrader across oncology and neurodegenerative conditions
Small molecule, Protein degrader - Read more

Ensysce Biosciences $1.1M registered direct offering, small molecules for severe pain while reducing opioid abuse potential
Small molecule, drug delivery, pain - Read more

Polyrizon $17M Private Placement, develops intranasal hydrogel barriers against infectious disease + drug delivery tech
Drug delivery, medical device, hydrogel, nasal spray - Read more

THE GOOD
Investments

SHL Medical opens $220M automated plant in South Carolina, creating 300 jobs for autoinjector production
New facility, autoinjector manufacturing, sterile manufacturing - Read more

THE GOOD
IPOs

Picard Medical seeks $12M IPO to expand SynCardia, its FDA-approved implantable artificial heart for pre-transplant patients
Medical device, artificial Heart - Read more

THE GOOD
Lawsuits

Lawsuit challenges HHS's decision to revoke $11B in public health grants, with 23 state AGs claiming it harms pandemic preparedness efforts
Federal funding, federal research funding, COVID-19, pandemic preparedness - Read more

THE GOOD
Mergers & Acquisitions

Science Exchange acquires HappiLabs, expanding its procurement solutions for life sciences companies
Equipment/Instrumentation, procurement, software - Read more

THE GOOD
Partnerships

Pfizer, Flagship Pioneering, Valo Health, Charles River Laboratories partner to develop AI-powered autoimmune disease candidates using Logica platform
Small molecule, drug discovery, drug development, autoimmune disease, AI - Read more

THE GOOD
Product Launches

Causaly launches scientific AI agents, providing life science teams with the “industry's most comprehensive biomedical knowledge for drug discovery“
AI, drug discovery, Research & Development - Read more

THE GOOD
Regulatory

EMA proposes eliminating extensive clinical trials for biosimilars if structural similarity and pharmacokinetic data confirm equivalence to reference drugs
Drug approval process, biosimilar - Read more

THE GOOD
Strategic Plans

Lonza implements streamlined operating model, splitting CDMO services into three platforms
CDMO (Contract Development & Manufacturing Organization) - Read more

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THE BAD
Clinical Trials

Axsome Therapeutics, despite missing Ph2 primary endpoint, advances solriamfetol (targeting DAT, NET) to Ph3 for major depressive disorder
Small molecule, major depressive disorder - Read more

Cerevance's solengepras (GPR6 inhibitor) flops in Ph2 Parkinson’s disease trial
Small molecule, Parkinson's disease - Read more

Lundbeck stops developing subcutaneous version Lu AG09222 (anti-PACAP) migraine prevention after Ph2b futility analysis, pivoting to intravenous
Monoclonal antibody, migraine - Read more

THE BAD
Company Shutdown

Carisma Therapeutics lays off 42 staff, leaving 6 employees to manage asset sale and potential company dissolution
Cell therapy, CAR-macrophage, mRNA, lipid nanoparticle (LNP), liver disease, cancer, solid tumor - Read more

THE BAD
Lawsuits

Eli Lilly sues Strive Pharmacy and Empower Pharmacy for making unauthorized copycats of weight-loss drugs Zepbound and Mounjaro
GLP-1, obesity, compounding, compounding suit - Read more

Johnson & Johnson abandons bankruptcy settlement strategy for 90,000 talc lawsuits, will fight them in court after third attempt rejected
Talc - Read more

THE BAD
Layoffs

Organon to lay off 93 Jersey City employees by May 31, part of ongoing 5% workforce reduction
Women's health, big pharma layoffs - Read more

THE BAD
Politics & Policy

Trump cuts to global AIDS relief threaten rollout of Gilead's promising six-month HIV prevention drug lenacapavir
Drug access, human immunodeficiency virus (HIV), low- and middle-income countries - Read more [Paywall]

THE UGLY
Politics & Policy

FDA hit with mass firings; employees locked out, reassigned, or forced to resign amid Trump administration's health agency cuts
Public agency layoffs, Food & Drug Administration (FDA) - Read more [Paywall]

HHS begins layoffs, employees getting termination notices as part of Trump administration's downsizing efforts to "reshape the workforce."
US Department of Health & Human Services (HHS), public agency layoffs - Read more

THE UGLY
Regulatory

FDA layoffs under Trump administration's HHS job cuts spark concerns about future of drug regulation in US
Food & Drug Administration (FDA), drug approval process - Read more

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

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