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THE GOOD
Approvals & Labels

ALK's EURneffy (adrenaline) receives positive CHMP opinion for emergency anaphylaxis treatment in children
Protein therapy, autoimmune, adrenaline, anaphylaxis, pediatric population, needle-free delivery - Read more

THE GOOD
Business Development & Partnerships

Roche, SanegeneBio partner on RNAi programme, $200M upfront, $1.5B milestones
Licensing deal, RNAi, milestone payments, metabolic disease - Read more

Optellum, NHS partner on AI-powered lung cancer diagnostic pilot using Virtual Nodule Clinic platform
Government partnership, oncology, AI/ML, diagnostics - Read more

Newsoara, vTv Therapeutics expand partnership for global HPP737 inflammation drug rights, $135M total deal value
Licensing deal, autoimmune, small molecule, milestone payments - Read more

WuXi Biologics, Vertex license trispecific T-cell engager for B-cell autoimmune diseases with milestones
Licensing deal, autoimmune, antibody, milestone payments, research collaboration - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Novo Nordisk's CagriSema (semaglutide/cagrilintide) tops semaglutide in Ph3 type 2 diabetes trial targeting GLP-1/amylin pathways
Small molecule, metabolic, GLP-1 receptor agonist, type 2 diabetes, combination therapy, weight loss - Read more

Skye Bioscience reports positive Ph2a results for nimacimab plus semaglutide combination in obesity treatment
Antibody, metabolic, monoclonal antibody, obesity, CB1 inhibitor, combination therapy - Read more

Arcutis Biotherapeutics' ZORYVE (roflumilast) cream shows positive Ph2 results for atopic dermatitis in infants
Small molecule, autoimmune, PDE4 inhibitor, atopic dermatitis, pediatric population, topical therapy - Read more

Skye Bioscience's nimacimab-Wegovy combo achieves 22.3% weight loss at 52 weeks in Ph2 extension study
Small molecule, metabolic, CB1 inhibitor, obesity, combination therapy, semaglutide - Read more

Sanofi's venglustat (glucosylceramide synthase inhibitor) hits Ph3 goal in Gaucher disease, misses in Fabry disease
Small molecule, rare disease, glucosylceramide synthase inhibitor, Gaucher disease, Fabry disease - Read more

THE GOOD
Fundraises

Vaxcyte raises $632.5M public offering, clinical-stage vaccine innovation company
Vaccine innovation, clinical-stage - Read more

Biorce raises $52M Series A, AI-driven clinical trials acceleration and expansion
Clinical trial platform, AI-driven, software platform, services - Read more

PranaX raises $17M Series A, stem cell-derived exosomes for regenerative medicine
Regenerative medicine, stem cell technology, exosome therapeutics, biotechnology - Read more

Santé Ventures closes $330M Fund V, early-stage healthcare and life sciences investing
Venture capital, biotechnology, medical technology, digitally enabled healthcare - Read more

THE GOOD
Regulatory

FDA launches PreCheck pilot program to help manufacturers build domestic drug production facilities with early regulatory guidance
Manufacturing, regulatory, strategic, operational - Read more

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THE BAD
Approvals & Labels

FDA issues complete response letter for Pharming Group's Joenja (leniolisib) pediatric label expansion in activated phosphoinositide 3-kinase delta syndrome
Small molecule, primary immunodeficiency, PI3K delta inhibitor, APDS, pediatric population - Read more

Aquestive Therapeutics receives FDA complete response letter for Anaphylm (dibutepinephrine) sublingual film targeting type I allergic reactions
Small molecule, allergic reactions, epinephrine, anaphylaxis, sublingual film - Read more

EMA CHMP delivers negative trend vote on Acadia Pharmaceuticals' Daybue (trofinetide) for Rett syndrome treatment
Small molecule, neurological, IGF-1 analogue, Rett syndrome, rare disease - Read more

THE BAD
Business Development & Partnerships

GSK returns Wave Life Sciences' RNA editor WVE-006 after disappointing AATD trial data
Licensing deal, rare disease, RNA editing, milestone payments - Read more

THE BAD
Layoffs

GSK trimming up to 350 R&D jobs across US and UK despite rising development spending
Monoclonal antibody, autoimmune, operational, cost reduction - Read more

Thermo Fisher Scientific closes Franklin Massachusetts site, cuts 80 jobs by 2027 amid restructuring
Manufacturing equipment, operational, cost reduction, strategic - Read more

THE BAD
Regulatory

European regulators introduce new pharma package requiring stricter criteria for drugmakers to maximize market exclusivity periods
Rare disease, regulatory, competitive, strategic - Read more [Paywall]

THE BAD
Strategic Plans

Daiichi Sankyo stops internal DS-9606 ADC development, delays AstraZeneca-partnered Datroway phase 3 readout again
Antibody-drug conjugate, oncology, strategic, operational - Read more

THE UGLY
No Ugly News Today!

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

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