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THE GOOD
Approvals & Labels

Novo Nordisk's Ozempic lands FDA approval for adults with kidney disease and type 2 diabetes
GLP-1, kidney disease, type 2 diabetes - Read more

AstraZeneca, Daiichi Sankyo's Enhertu (targeting HER2) scores FDA approval for HER2-ultralow metastatic breast cancer after
Antibody-drug conjugate, breast cancer - Read more

THE GOOD
Business Development

Philips sells its emergency care and AED business to Bridgefield Capital, maintaining brand licensing for up to 15 years
Medical device, emergency care, defibrillator - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

ITM's Ph3 trial shows ITM-11 (β-emitting radioisotope + somatostatin receptor agonist) outperforms everolimus (rapamycin kinase inhibitor) in treating gastroenteropancreatic neuroendocrine tumors
Radiopharm, gastroenteropancreatic neuroendocrine tumor, cancer - Read more

Roche's Itovebi plus palbociclib (PI3K inhibitor) and fulvestrant (estrogen receptor antagonist) delivers positive Ph3 data in “a certain type of” PIK3CA-mutated hormone receptor-positive breast cancer
Small molecule, breast cancer - Read more

SAB BIO touts positive Ph1 safety data for SAB-142 (anti-thymocyte) in type 1 diabetes
Polyclonal antibody, type 1 diabetes - Read more

Beckley Psytech's BPL-003 (intranasal 5-MeO-DMT) delivers positive Ph2a data in reducing alcohol consumption in alcohol use disorder patients
Small molecule, alcohol use disorder, addition, psychedelic - Read more

Tris Pharma's cebranopadol (opioid peptide receptor agonist) shows lower abuse potential than oxycodone in Ph1 trial, supporting its development as pain treatment alternative
Small molecule, pain, opioid alternative - Read more

THE GOOD
Company Launches

Helicore Biopharma, Versant Ventures newest obesity upstart, launches with $65M Series A to develop HCR-188 (targeting GIP) for “higher-quality” weight loss
Monoclonal antibody, obesity - Read more

THE GOOD
Fundraises

Atalanta Therapeutics $97M Series B, developing CNS-penetrating RNAi drugs for epilepsy and Huntington's disease
RNAi, epilepsy, Huntington’s disease - Read more

Quibim $50M Series A, AI-powered medical imaging biomarker company expanding precision medicine capabilities
Medical imaging, biomarker, precision medicine, AI - Read more

ONCOMATRYX €25M ($27.2M) raise, developing ADCs “against the tumor microenvironment”
Antibody-drug conjugate, solid tumor, cancer - Read more

Lutris Pharma $30M funding, developing topical gel to reduce skin rashes from cancer treatments
Small molecule, EGFR inhibitor side effect reduction, radiation side effect reduction, acneiform lesions, radiation-induced dermatitis - Read more

Commit Biologics €5.5M ($5.7M) Seed extension, developing complement system platform for cancer/autoimmune treatments
Bispecific complement engaging, cancer, autoimmune - Read more

Akero Therapeutics $300M public offering after showcasing successful Ph2b MASH trial
Fusion protein, metabolic dysfunction-associated steatohepatitis (MASH), liver cirrhosis - Read more

89bio $250M public offering, developing therapies for liver and cardiometabolic diseases
Growth factor, metabolic dysfunction-associated steatohepatitis (MASH), hypertriglyceridemia - Read more

THE GOOD
IPOs

Chinese biopharma Vigonvita Life Sciences seeks public listing on Hong Kong Stock Exchange
Small molecule, COVID-19, infectious disease, generic - Read more

SPAC Drugs Made In America Acquisition raises $200M IPO to target US pharmaceutical businesses, led by Bright Green founder
SPAC, domestic manufacturing, on-shoring manufacturing - Read more

THE GOOD
Lawsuits

Amgen settles with Celltrion, allowing biosimilar launches of Prolia (targeting RANKL) and Xgeva (targeting RANKL)
Monoclonal antibody, osteoporosis, solid tumor, cancer, multiple myeloma - Read more

Judge rules Alcon can't block Aurion Biotech's IPO plans, rejecting claim that investor consent was required.
Cell therapy, corneal edema, corneal endothelial dysfunction, allogeneic corneal endothelial cells - Read more

THE GOOD
Mergers & Acquisition

Lantheus acquires Evergreen Theragnostics for $250M upfront, expanding radiopharmaceutical pipeline with cancer diagnostic agent
Radiopharm, cancer, theranostics, PET diagnostic agent - Read more

THE GOOD
Partnerships

BioAge Labs, Eli Lilly partner to discover antibodies targeting metabolic aging using BioAge's discovery platform
Antibody, metabolic aging, drug discovery - Read more

THE GOOD
Politics & Policy

Biden-started CMS Innovation Center’s Medicaid pilot program to test payment methods for CGTs therapies continues under Trump
CMS, Medicaid, advanced therapy finances - Read more [Paywall

THE GOOD
Public Health

USAID resumes delivery of (certain) essential medical supplies and humanitarian aid after US Secretary of State Marco Rubio grants waiver amid Trump administration's foreign aid freeze
United States Agency for International Development, foreign aid - Read more

THE GOOD
Research

OHSU researchers working towards a potential universal flu vaccine targeting multiple strains, including bird flu, which could eliminate need for annual shots
Vaccine, universal flu vaccine, bird flu, influenza - Read more

University of Missouri researchers create AshPhos, new ligand for that could help reduce drug production costs related to carbon-nitrogen bond formation
Small molecule, catalysis, manufacturing - Read more

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THE BAD
Clinical Trials

Leap Therapeutics’ sirexatamab (anti-DKK1) deliver disappointing midstage Ph2b data in gastric cancer, though continues clinical development colorectal cancer
Monoclonal antibody, gastric cancer - Read more

BioAge Labs discontinues azelaprag (apelin receptor agonist) development in Ph2 obesity trial due to potential liver damage concerns
Small molecule, obesity, liver damage concerns - Read more

Eli Lilly discontinues volenrelaxin (targeting relaxin receptor) for heart failure and chronic kidney disease, with the latter in Ph2 before discontinuation
Recombinant protein, heart failure, chronic kidney disease - Read more

THE BAD
Layoffs

Atara Biotherapeutics to lay off 50% of workforce by June following FDA double tap of Ebvallo rejection and clinical asset holds
Cell therapy, lymphoma, cancer, systemic lupus erythematosus, post-transplant lymphoproliferative - Read more

Zentalis Pharmaceuticals makes a WEE1 40% cut of their workforce to ensure solvency until a key Ph2 readout
Small molecule, ovarian cancer - Read more

THE BAD
Politics & Policy

Novo Nordisk seeks fast court decision on IRA drug pricing challenge, as Medicare negotiation deadline approaches for Ozempic and Wegovy
Drug pricing, inflation reduction act - Read more

THE UGLY
Approvals & Labels

FDA postpones opioids advisory meeting and cancels review of Novartis' Fabhalta label expansion due to HHS communications freeze under Trump
Advisory committee, opioid, small molecule, IgA nephropathy - Read more

THE UGLY
Politics & Policy

Independent pharmacists may stop stocking Medicare-negotiated drugs due to financial concerns, NCPA survey of 8,000 pharmacy owners reveals
Medicare, pharmacy benefit manager, drug pricing - Read more

RFK Jr.'s (physician) niece releases private emails revealing his anti-vaccine stance and false claims about Covid-19, autism, and flu shots
Anti-vaccine, COVID-19, autism, misinformation- Read more [Paywall[

THE UGLY
Public Health

Trump administration's freeze on PEPFAR funding disrupts global HIV treatments, endangering millions who depend on the program for medication
Foreign aid, human immunodeficiency virus, acquired immune deficiency syndrome (AIDS) - Read more

THE UGLY
Warning Letters, Form 483

FDA warns ProRx Pharmacy over quality issues in semaglutide and tirzepatide compounding at Pennsylvania facility
GLP-1, obesity, compounding - Read more

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

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