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THE GOOD
Approvals & Labels

AstraZeneca's Imfinzi (PD-L1 inhibitor) lands FDA approval for muscle-invasive bladder cancer before and after surgery
Monoclonal antibody, bladder cancer - Read more

Alnylam's Qfitlia (targeting antithrombin) approved by FDA for hemophilia A or B in patients 12 and older
siRNA, hemophilia - Read more

THE GOOD
Business Development

Apollomics sells Asia rights (excluding Greater China) for vebreltinib (c-MET inhibitor) to LaunXP Biomedical for $10M upfront plus $50M milestones.
Small molecule, lung cancer - Read more

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THE GOOD
Clinical Trials

Eli Lilly touts positive Ph2 data for lepodisiran (targeting Lp(a)) in heart disease
RNA, heart disease - Read more

Novo Nordisk's Rybelsus 14mg dosing reduced cardiovascular events by 14% in Ph3 trial for those with type 2 diabetes & cardiovascular disease
GLP-1, type 2 diabetes, atherosclerotic cardiovascular disease, chronic kidney disease - Read more

Novo Nordisk's Ozempic 1 mg showed improved walking distance and quality of life in Ph3b trial for those with type 2 diabetes & peripheral artery disease
GLP-1, type 2 diabetes, peripheral artery disease - Read more

BiomX's BX211 (targeting Staphylococcus aureus) shows Ph2 promise in treating diabetic foot osteomyelitis
Bacteriophage, diabetic foot osteomyelitis - Read more

Transcend Therapeutics' neuroplastigen TSND-201 delivers positive Ph2 data in PTSD
Small molecule, psychedelics, post-traumatic stress disorder (PTSD) - Read more

AstraZeneca's touts positive Ph2b results for AZD0780 (PCSK9 inhibitor) in dyslipidemia
Small molecule, dyslipidemia - Read more

Merck & Co. showcases positive Winrevair (activin signalling inhibitor) Ph3 data in PAH
Fusion protein, pulmonary arterial hypertension (PAH) - Read more

Corcept Therapeutics' relacorilant (targeting GR) delivers positive Ph3 data in ovarian cancer
Small molecule, ovarian cancer - Read more

Vaxcyte's VAX-24 delivers positive safety and immunogenicity in Ph2 infant trial for invasive pneumococcal disease, advancing to Ph3
Vaccine, pneumococcal disease, bacterial infection - Read more

Brii Biosciences touts positive Ph2 data for BRII-179 therapeutic vaccine in hepatitis B
siRNA, hepatitis B - Read more

Virion Therapeutics reports positive Ph1b data for VRON-0200 (CD8+ T cell exhaustion checkpoint modifer) in hepatitis B
Immunotherapy, hepatitis B - Read more

THE GOOD
Company Launches

SV Health launches Endlyz Therapeutics with $16M from AbbVie and others to develop Parkinson's treatments focusing on cellular recycling
Small molecule, Parkinson's disease - Read more [Paywall]

THE GOOD
Earnings & Finances

British investor Richard Magides explores rescue plan for bankrupt 23andMe, believing the company remains viable despite financial troubles
Genetic screening, fire sale - Read more

THE GOOD
Fundraises

Isomorphic Labs $600M funding round, AI-driven drug discovery engine for oncology and immunology
Drug discovery, AI, drug design - Read more

Novotech receives investment (undisclosed) from GIC, Temasek, and TPG to accelerate global growth as biotech clinical research organization
CRO (Contract Research Organization) - Read more

Spectrum Vascular, undisclosed investment from SK Capital Partners, to expand vascular access product operations
Medical device, vascular access - Read more

THE GOOD
Mergers & Acquisitions

HAS acquires Cerbios, API manufacturing CDMO expertise
CDMO, antibody-drug conjugate (ADC), API manufacturing, manufacturing - Read more

Kardigan acquires Prolaio, gaining its cardiovascular data platform to enhance clinical trial design and patient care
Undisclosed modality, clinical data, cardiovascular disease, AI - Read more

THE GOOD
Product Launches

Exact Sciences launches upgraded Cologuard Plus home test for colorectal cancer screening
Commercialization, cancer detection/screening, colorectal cancer, biomarker - Read more

GE HealthCare unveils Revolution Vibe CT scanner with one-beat cardiac imaging for improved diagnosis of cardiovascular disease
CT imaging, cardiovascular disease, coronary artery disease - Read more

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THE BAD
Approvals & Labels

European Commission denies renewed market authorization for PTC Therapeutics' DMD drug Translarna after negative regulatory opinions
Small molecule, Duchenne muscular dystrophy (DMD) - Read more

THE BAD
Clinical Trials

Vertex Pharmaceuticals discontinues VX-264 (islet cell therapy drug-device combo for type 1 diabetes) after not meeting efficacy in Ph1/2 trial
Cell therapy, diabetes, drug-device combo, islet transplant, allogeneic cell therapy - Read more

After second flopped Ph3 trial, Opthea discontinues sozinibercept (VEGF-C/D inhibitor) development
Fusion protein, wet age-related macular degeneration (wet AMD) - Read more

THE BAD
Company Shutdown

Inspirna shuts down after Phase 2 trial failure of ompenadclid (targeting SLC6A8) in KRAS colorectal cancer, ending 10-year run
Small molecule, colorectal cancer - Read more

THE BAD
Lawsuits

Court upholds HHS decision against Vertex Pharmaceuticals' $70,000 fertility support program for gene therapy patients, citing kickback concerns
Gene therapy, gene-editing, sickle cell disease, beta thalassemia, infertility, kick-backs - Read more

THE BAD
Layoffs

LifeMine Therapeutics reduces staff to focus resources on advancing lead program LIFE-001
Small molecule, transplant rejection, fungal infection - Read more

Tenaya Therapeutics announces 30-40% staff cuts, primarily affecting research and manufacturing teams, while decommissioning its Union City facility
Gene therapy, heart disease, site closure - Read more [Paywall]

THE BAD
Regulatory

Texas judge overturns FDA's plan to regulate lab-developed tests, ruling the agency overstepped its authority
Lab-developed tests, regulatory jurisdiction - Read more [Paywall]

THE BAD
Research

Antidepressant use significantly increases sudden cardiac death risk across most age groups, Danish study finds
Antidepressant-associated adverse events, sudden cardiac death - Read more

THE UGLY
Lawsuits

Judge increases Johnson & Johnson's penalty from $150M to $1.64B for false claims in HIV drug marketing lawsuit
Small molecule, human immunodeficiency virus (HIV), drug marketing, drug marketing violations - Read more

THE UGLY
Politics & Policy

FDA regulator Peter Marks' unexpected exit alarms biotech industry, jeopardizing progress in advanced therapies and vaccines
Food & Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), drug approval process, regulatory guidance - Read more [Paywall]

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

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