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THE GOOD
Approvals & Labels

FDA approves Celltrion's Avtozma (tocilizumab-anoh) for cytokine release syndrome, expanding biosimilar's label alignment with Actemra
Antibody, autoimmune, biosimilar, cytokine release syndrome, inflammatory diseases, tocilizumab - Read more

FDA lifts age restriction on Valneva's Ixchiq chikungunya vaccine for seniors with updated safety warnings
Vaccine, infectious disease, live attenuated vaccine, chikungunya virus, elderly population, adverse events - Read more

FDA grants accelerated approval to Boehringer Ingelheim's Hernexeos for HER2-mutated non-small-cell lung cancer after Ph1b trial success
Small molecule, cancer, tyrosine kinase inhibitor, non-small cell lung cancer, HER2 mutation, accelerated approval - Read more

THE GOOD
Business Development & Partnerships

Almirall, Absci expand AI drug discovery collaboration with second dermatology target following successful antibody development
Research collaboration, dermatology, AI/ML, antibody, drug discovery, global - Read more

Cosmo, Takeda renew manufacturing agreement for ulcerative colitis treatment Lialda/Mezavant
Manufacturing agreement, gastrointestinal, CDMO, global, autoimmune - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

AbbVie, Genmab's Epkinly (epcoritamab) Ph3 trial shows 79% reduced disease progression in follicular lymphoma
Antibody, cancer, bispecific antibody, follicular lymphoma, T-cell engager, combination therapy - Read more

Eli Lilly's oral GLP-1 orforglipron achieves 27.3 lbs weight loss in Ph3 obesity trial
Small molecule, metabolic, GLP-1 receptor agonist, obesity, oral therapy, weight loss - Read more

Assembly Bio's ABI-5366 shows 94% reduction in viral shedding in Ph1b trial for recurrent genital herpes
Small molecule, infectious disease, helicase-primase inhibitor, genital herpes, HSV-2, long-acting therapy - Read more

THE GOOD
Fundraises

SNIPR Biome raises €35M ($41M) Series B for CRISPR therapies targeting antimicrobial resistance
CRISPR, infectious disease, antimicrobial resistance, cystic fibrosis, platform technology, clinical-stage - Read more

Luxna Biotech raises 150M ($1M) yen in Series C, accelerating nucleic acid drug discovery
Nucleic acid, drug discovery, platform technology, pharmaceutical collaboration - Read more

Strand Therapeutics raises $153M Series B to advance programmable mRNA cancer therapies
mRNA therapeutics, oncology, immunotherapy, platform technology, clinical-stage - Read more

Minghui Pharmaceutical raises $131M Pre-IPO funding, advancing late-stage biopharmaceutical pipeline and commercial launch
Oncology, antibody, clinical-stage, bispecific antibody, ADC - Read more

Maxwell Biosciences raises $20M funding for Claromer-based antimicrobial solutions
Small molecule, infectious disease, platform technology, AI-driven, antimicrobial - Read more

BioVie raises $12M public offering for liver disease and neurological disorder therapies
Neurological, liver disease, clinical-stage, drug therapies, chronic conditions - Read more

THE GOOD
Lawsuits

BioNTech pays $870 million to settle patent dispute with CureVac and GSK while acquisition proceeds
mRNA vaccine, infectious disease, legal settlement, major transaction, strategic - Read more

THE GOOD
Mergers & Acquisitions

CorMedix to acquire Melinta Therapeutics for $300 million, expanding infectious disease portfolio in acute care settings
Small molecule, infectious disease, strategic, major transaction, portfolio expansion - Read more

THE GOOD
Product Launches

Gilead confident in Yeztugo HIV PrEP launch despite Preventive Task Force uncertainties
HIV prevention, infectious disease, regulatory, financial, strategic - Read more

THE GOOD
Regulatory

FDA launches PreCheck program to streamline regulatory process for domestic pharma manufacturing amid tariff concerns
Regulatory policy, manufacturing infrastructure, strategic, operational, national security - Read more

FDA's Vinay Prasad returns to lead biologics office after brief, politically charged departure
Gene therapy, rare disease, regulatory, operational - Read more

THE BAD
Approvals & Labels

FDA rejects Stealth BioTherapeutics' reconsideration request for rare disease drug elamipretide, threatening company viability
Peptide therapy, rare disease, regulatory, operational - Read more

FDA restricts bluebird bio's Skysona gene therapy after increased blood cancer cases in CALD patients
Gene therapy, rare disease, neurological, regulatory, safety concern - Read more

THE BAD
Clinical Trials

Gilead discontinues Ph2 cilofexor-firsocostat-semaglutide MASH therapy, partnered with Novo Nordisk, after trial completion.
Small molecule, metabolic, MASH/NASH, liver disease, combination therapy, pipeline discontinuation - Read more

THE BAD
Earnings & Finances

Gilead reports 7% drop in CAR-T sales while HIV drug Yeztugo gains momentum
CAR-T therapy, oncology, competitive landscape, financial impact, market share - Read more

THE BAD
Layoffs

Bicycle Therapeutics cuts 25% of workforce after Genentech terminates oncology R&D collaboration
Bicycle toxin conjugate, oncology, cost reduction, financial, operational, partnership termination - Read more

Dewpoint Therapeutics cuts 70% of workforce amid cash shortage, seeks private financing round
Small molecule, neurological, financial, operational, strategic - Read more

Iovance Therapeutics cuts 19% of staff amid disappointing Amtagvi launch, seeks $100M annual savings
TIL therapy, oncology, operational, cost reduction, revenue impact - Read more

THE BAD
Strategic Plans

Gilead cuts six programs from pipeline including MASH treatment and cancer immunotherapies
Pipeline prioritization, oncology, infectious disease, metabolic disease, co-development, milestone payments - Read more

THE UGLY
No Ugly News Today!

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