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THE GOOD
Approvals & Labels

FDA approves Merck & Co.'s Keytruda Qlex, subcutaneous PD-1 inhibitor for solid tumors, matching IV formulation's efficacy
Antibody, cancer, monoclonal antibody, solid tumors, subcutaneous formulation, PD-1 inhibitor - Read more

FDA approves Stealth Bio's Forzinity (elamipretide) as first treatment for Barth syndrome via accelerated pathway
Protein therapy, metabolic, peptide, Barth syndrome, ultrarare disease, X-linked genetic disorder - Read more

Novo Nordisk's Kyinsu (icodec/semaglutide) GLP-1/insulin combo for Type 2 diabetes receives CHMP endorsement in Europe
Small molecule, metabolic, combination therapy, Type 2 diabetes, GLP-1 receptor agonist, insulin - Read more

Chugai's Tecentriq receives Japanese approval for extranodal natural killer/T-cell lymphoma as first PD-L1 inhibitor treatment
Antibody, cancer, monoclonal antibody, lymphoma, extranodal natural killer/T-cell lymphoma, PD-L1 inhibitor - Read more

Astellas's IZERVAY receives conditional approval in Japan for geographic atrophy in age-related macular degeneration
Small molecule, ophthalmologic, complement C5 inhibitor, age-related macular degeneration, geographic atrophy - Read more

EU approves Sobi's Tryngolza, an apoC-III RNA therapy for familial chylomicronaemia syndrome following Ph3 success
RNA therapy, metabolic, antisense oligonucleotide, familial chylomicronaemia syndrome, triglyceride reduction, rare disease - Read more

Johnson & Johnson's TREMFYA receives FDA approval for subcutaneous induction in adults with ulcerative colitis as first IL-23 inhibitor option
Antibody, autoimmune, monoclonal antibody, ulcerative colitis, IL-23 inhibitor, subcutaneous administration - Read more

THE GOOD
Business Development & Partnerships

xFOREST, Axcelead DDP partner on RNA-targeted small molecule drugs; milestone payments included
Research collaboration, small molecule, RNA therapeutics, drug discovery, milestone payments - Read more

JCR Pharmaceuticals, Alexion achieve neurodegenerative disease tech milestone, triggering payment to JCR
Research collaboration, neurological, rare disease, milestone payments, therapeutic protein, technology platform - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Affibody's izokibep delivers positive Ph3 results for hidradenitis suppurativa, with 37% achieving HiSCR75 at week 16
Protein therapy, autoimmune, IL-17 inhibitor, hidradenitis suppurativa, dermatological - Read more

Ascletis Ph1 results: ASC47/semaglutide combo shows 56.2% greater weight loss in obesity than semaglutide alon
Small molecule, metabolic, obesity, combination therapy, GLP-1, thyroid hormone receptor beta - Read more

THE GOOD
Fundraises

AusperBio raises $63M Series B2 for hepatitis B functional cure therapies development
Hepatitis B, clinical-stage, oligonucleotide therapy, infectious disease, therapeutic platform - Read more

THE GOOD
Investments

Merck KGaA opens €150M ($170.6M) climate-neutral manufacturing plant in Cork, creating 200 jobs by 2028
Manufacturing technology, operational, strategic, investment, sustainability - Read more

THE GOOD
Lawsuits

Moderna and Alnylam settle patent litigation over COVID-19 vaccine delivery technology, dismissing all claims permanently
mRNA vaccine, infectious disease, legal resolution, intellectual property, strategic - Read more

THE GOOD
Regulatory

CDC strongly endorses Gilead's twice-yearly HIV prevention drug Yeztugo despite access barriers from insurers
Long-acting antiretroviral, infectious disease, HIV prevention, regulatory approval, access barriers - Read more

THE GOOD
Strategic Plans

Eli Lilly plans India launch of orforglipron GLP-1 oral weight loss pill following Ph3 success
Small molecule, metabolic, oral GLP-1 RA, obesity, diabetes, weight loss - Read more

THE BAD
Approvals & Labels

FDA rejects Otsuka/Lundbeck's Rexulti for post-traumatic stress disorder in Ph3 efficacy dispute
Small molecule, neurological, PTSD, combination therapy, FDA rejection, psychiatric disorder - Read more

THE BAD
Clinical Trials

GENFIT discontinues VS-01 Ph3 UNVEIL-IT trial for acute-on-chronic liver failure following serious peritonitis event
Protein therapy, metabolic, liver disease, urea cycle disorder, ACLF, treatment discontinuation - Read more

THE BAD
Regulatory

Eli Lilly censured by UK watchdog for sponsored Facebook spam targeting healthcare professionals
Oncology, breast cancer, regulatory, digital marketing, compliance - Read more

CDC panel postpones vote on delaying hepatitis B vaccination for some newborns amid safety debates
Vaccine, infectious disease, regulatory, policy change - Read more

CDC's ACIP narrowly rejects prescription requirement for COVID-19 vaccines, preserving wider access
mRNA vaccine, infectious disease, regulatory, operational, access policy - Read more

THE UGLY
No Ugly News Today!

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