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THE GOOD
Approvals & Labels

UK approves Servier's Voranigo (vorasidenib), IDH-targeting oral therapy for brain tumours, following Ph3 progression-free survival data
Small molecule, cancer, targeted therapy, brain tumors, IDH inhibitor, glioma - Read more

NHS approves AstraZeneca's Imfinzi for limited-stage small cell lung cancer following Ph3 trial success
Antibody, cancer, monoclonal antibody, small cell lung cancer, immunotherapy, combination therapy - Read more

THE GOOD
Business Development & Partnerships

CSL, VarmX sign $117M upfront option deal for blood-clotting drug VMX-C001, potential $2.1B total value
Acquisition, option agreement, hematology, milestone payments, drug development, clinical trial funding - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Areteia's oral drug dexpramipexole hits Ph3 endpoint for eosinophilic asthma, challenging injectable biologics
Small molecule, respiratory disease, eosinophilic asthma, oral therapy, anti-eosinophil, biologic alternative - Read more

Apollo's anti-IL-18 antibody camoteskimab achieves Ph2 success in atopic dermatitis, outperforming placebo with meaningful efficacy
Antibody, autoimmune, monoclonal antibody, atopic dermatitis, IL-18 target, eczema - Read more

Novo Nordisk's cagrilintide shows 11.8% weight reduction versus placebo in Phase III obesity trial
Protein therapy, metabolic, amylin analog, obesity, weight loss, GLP-1 competitor - Read more

SK Biopharmaceuticals' Cenobamate (XCOPRI) shows 71.9% seizure reduction in Ph3 trial for generalized tonic-clonic seizures
Small molecule, neurological, anti-epileptic, seizure disorder, primary generalized tonic-clonic seizures - Read more

Eli Lilly's oral GLP-1 orforglipron achieves 12.4% weight loss in Ph3 obesity trial results
Small molecule, metabolic, GLP-1 receptor agonist, obesity, weight loss, oral therapy - Read more

HighTide's HTD1801 meets Ph3 primary endpoint for type 2 diabetes, showing significant HbA1c reduction versus placebo
Small molecule, metabolic, anti-inflammatory, type 2 diabetes, AMPK activation, cardiometabolic - Read more

Aptevo's mipletamig achieves 100% remission rate in Ph1b/2 trial for acute myeloid leukemia patients
Antibody, cancer, bispecific antibody, leukemia, acute myeloid leukemia, combination therapy - Read more

THE GOOD
Company Launches

AllRock Bio launches with $50M, licenses Sanofi’s pan-ROCK inhibitor for pulmonary hypertension, led by former CinCor Pharma executives
Cardiovascular, pulmonary disease, small molecule, clinical-stage - Read more

Dualitas Therapeutics emerges with $65M Series A, Lilly-backed support to advance DualScreen platform for differentiated bispecific drug discovery
Antibody, bispecific technology, platform technology, autoimmune, allergic disease, preclinical - Read more

THE GOOD
Earnings & Finances

Ark, Atom file for Hong Kong IPOs, advancing respiratory and renal disease treatments
Infectious disease, small molecule, respiratory, ADHD, clinical-stage, rare disease - Read more [Paywall]

THE GOOD
Fundraises

Genoskin raises $8.7M Series A to advance human skin testing platforms for drug development
CRO, ex vivo skin models, platform technology, animal testing alternative, multiomics, AI-driven - Read more

Tezcat Biosciences receives CTF grant to study TZT-102 in NF1-associated nerve tumors
Rare disease, oncology, small molecule, preclinical, neurological - Read more

Mamedica raises £4.5M ($6.12M) funding, cannabis-based prescription medicines for chronic conditions
Cannabis-based medicines, neurological, chronic pain, digital health, telehealth - Read more

Reunion Neuroscience raises $133M Series A for psychedelic-inspired mental health therapeutics
Neurological, psychedelics, mental health, clinical-stage, anxiety disorder - Read more

Basilea receives $25M BARDA funding to advance novel antifungal drug candidates
Infectious disease, antifungal, small molecule, clinical-stage, biopharmaceutical - Read more

Tafalgie Therapeutics raises €12M ($14M) Series A, developing non-opioid pain treatments
Pain treatment, small molecule, clinical-stage, non-opioid, neurology, platform technology - Read more

Synthesize Bio raises $10M seed, building AI models to predict gene expression results
AI/ML platform, genomics, platform technology, gene expression, data analytics - Read more [Paywall]

THE GOOD
Investments

GSK announces $30B five-year investment in US manufacturing, R&D, and clinical development facilities
Biologics manufacturing, strategic investment, R&D expansion, financial, operational - Read more

Eli Lilly breaks ground on $5B Virginia API plant as part of $27B domestic manufacturing expansion
Antibody-drug conjugate, bioconjugate, monoclonal antibody, manufacturing, strategic, operational - Read more

THE GOOD
Mergers & Acquisitions

GHO Capital acquires Scientist.com, expanding healthcare portfolio with AI-powered R&D orchestration platform
AI platform, research services, major transaction, strategic, operational - Read more

THE GOOD
Product Launches

Causaly launches specialized agentic AI platform for life sciences R&D, automating research workflows
AI platform, research & development, strategic, operational - Read more

THE GOOD
Strategic Plans

Novo Nordisk plans high-dose Wegovy submission in US to compete with Eli Lilly's Zepbound
GLP-1 agonist, obesity, regulatory, competitive, strategic - Read more

THE BAD
Layoffs

AGC Biologics to sell Colorado plants, lay off 278 workers amid strategic refocus
CDMO, biologics manufacturing, operational, strategic, facility closure - Read more

THE BAD
Market Reports

Despite safety concerns, 90% of doctors still prescribe Sarepta's Elevidys DMD gene therapy for ambulatory patients
Gene therapy, duchenne muscular dystrophy, rare disease, safety concerns, regulatory impact - Read more

THE BAD
Regulatory

FDA issues Form 483 to Dr. Reddy's India biologics plant, citing five manufacturing deficiencies
Biologics manufacturing, regulatory, operational, quality control - Read more

FDA cites AstraZeneca's FluMist TV ad for misleading viewers about self-administration, targeting FDA's DTC ad crackdown
Nasal spray vaccine, infectious disease, regulatory, direct-to-consumer advertising - Read more

THE UGLY
Regulatory

FDA sends over 100 warning letters to pharma companies for misleading drug ads
Regulatory, marketing compliance, financial impact, operational, competitive - Read more

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

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