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THE GOOD
Approvals & Labels

FDA approves Kedrion's Qivigy, an intravenous immunoglobulin therapy for primary humoral immunodeficiency in adults
Protein therapy, immunological, intravenous immunoglobulin, primary humoral immunodeficiency, plasma-derived product, rare disease - Read more

FDA approves Johnson & Johnson's TREMFYA (guselkumab), first IL-23 inhibitor for pediatric plaque psoriasis and psoriatic arthritis
Antibody, autoimmune, monoclonal antibody, plaque psoriasis, psoriatic arthritis, IL-23 inhibitor - Read more

THE GOOD
Business Development & Partnerships

Gilead Sciences, Health Hope Pharma partner on P-gp inhibitor encequidar; $10M upfront, $72.5M in milestones
Licensing deal, virology, drug transporter, infectious disease, milestone payments - Read more

BioLineRx and Hemispherian form joint venture to develop glioblastoma candidate GLIX1, with BioLineRx's stake growing from 40% to 70%
Joint venture, oncology, small molecule, R&D, glioblastoma, pipeline expansion - Read more

Cell X Technologies, BioLamina partner to integrate laminin reagents with Celligent platform for standardized iPSC manufacturing workflows
Research collaboration, cell therapy, manufacturing, drug discovery, standardization - Read more

Hanmi, HHP, Gilead partner on oral P-gp inhibitor Encequidar for virology applications with milestone payments
Licensing deal, virology, oral drug delivery, milestone payments, global, infectious disease - Read more

Dogwood Therapeutics, Serpin Pharma partner on SP16 cancer pain treatment via all-stock, royalty-free licensing deal
Licensing deal, oncology, small molecule, R&D, milestone payments - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

AstraZeneca's Enhertu outperforms Roche's Kadcyla in Ph3 trial for HER2-positive early breast cancer
Antibody-drug conjugate, cancer, monoclonal antibody, breast cancer, HER2-positive, adjuvant therapy - Read more

Boehringer Ingelheim's nerandomilast shows reduced mortality risk for pulmonary fibrosis in Ph3 FIBRONEER trial data
Small molecule, respiratory disease, PDE4B inhibitor, pulmonary fibrosis, IPF, mortality reduction - Read more

Artelo's ART27.13 shows positive Ph2 data: 6% weight gain in cancer anorexia-cachexia syndrome patients
Small molecule, cancer, cannabinoid receptor agonist, cancer anorexia-cachexia syndrome, quality of life - Read more

MindRank AI's oral GLP-1 receptor agonist MDR-001 achieves 8.9% weight reduction in Ph2 obesity trial
Small molecule, metabolic, GLP-1 receptor agonist, obesity, weight loss - Read more

Metsera's GLP-1 agonist MET-097i shows 14.1% weight loss in Ph2 obesity trials; Pfizer acquisition advances
Small molecule, metabolic, GLP-1 receptor agonist, obesity, type 2 diabetes, ultra-long-acting - Read more

FDA greenlights Larimar's Ph3 trial of nomlabofusp, showing increased frataxin levels in Friedreich's ataxia patients
Protein therapy, neurological, rare disease, Friedreich's ataxia, frataxin replacement, subcutaneous administration - Read more

Enanta's zelicapavir shows promise in Ph2b trial despite missing primary endpoint for respiratory syncytial virus
Small molecule, infectious disease, antiviral, respiratory syncytial virus (RSV), high-risk patient population, oral therapy - Read more

THE GOOD
Company Launches

Rezon Bio launches in Poland with two manufacturing sites to provide biologics CDMO services across development, production, and commercial supply
CDMO launch, biologics manufacturing, Europe, single-use technology, AI/ML, R&D - Read more

THE GOOD
Fundraises

Star Therapeutics raises $125M Series D, advancing therapies for bleeding disorders
Bleeding disorder, antibody, hematology, immunology, clinical-stage, rare disease - Read more

Crystalys Therapeutics raises $205M Series A, developing safer URAT1 inhibitor for gout treatment
Gout, small molecule, clinical-stage, URAT1 inhibitor, inflammatory disease - Read more

ReCode Therapeutics raises $29M additional funding, developing targeted mRNA and gene therapeutics
mRNA therapeutics, genetic medicine, lipid nanoparticle platform, rare disease, clinical-stage, respiratory disease - Read more

uniQure raises $345M in public offering for commercialization and pipeline development
Gene therapy, rare disease, clinical-stage, platform technology - Read more

MAIA Biotechnology raises $2.25M private placement for Phase II cancer immunotherapy trial
Oncology, immunotherapy, clinical-stage, cancer, targeted therapy - Read more

Aarvik Therapeutics raises Series Seed 2 funding to advance ADC cancer therapy platform
Cancer, antibody drug conjugate (ADC), oncology, platform technology, preclinical - Read more

Full-Life Technologies raises $77M Series C, advancing radiopharmaceutical pipeline and manufacturing
Radiopharmaceutical, oncology, manufacturing, clinical-stage, platform technology - Read more

THE GOOD
Mergers & Acquisitions

Genmab to acquire Merus for $8 billion, gaining promising head and neck cancer drug petosemtamab
Bispecific antibody, oncology, major transaction, strategic acquisition - Read more

Lupin acquires ophthalmology company VISUfarma from GHO Capital to expand European specialty business
Ophthalmology, strategic acquisition, specialty therapy, market expansion, international growth - Read more

THE GOOD
Product Launches

Boehringer Ingelheim and Novartis launch direct-to-consumer platforms offering discounted medications, bypassing traditional intermediaries
Small molecule, respiratory disease, autoimmune, strategic, operational, direct-to-consumer - Read more

THE GOOD
Regulatory

FDA alignment signals Applied Therapeutics' aldose reductase inhibitor govorestat may advance for Sorbitol Dehydrogenase Deficiency despite Ph2/3 failure
Small molecule, neurological, aldose reductase inhibitor, rare disease, hereditary neuropathy, accelerated approval - Read more

THE GOOD
Strategic Plans

AstraZeneca plans direct NYSE listing while maintaining UK, Sweden presence to access global capital markets
Financial, strategic, operational, investment - Read more

THE BAD
Clinical Trials

Applied Therapeutics awaits FDA guidance on govorestat for Charcot-Marie-Tooth sorbitol dehydrogenase deficiency after Ph2/3 miss
Small molecule, neurological, aldose reductase inhibitor, Charcot-Marie-Tooth disease, rare disease, muscle weakness - Read more

KALA halts KPI-012 development after Ph2b trial fails for persistent corneal epithelial defect treatment
Protein therapy, ophthalmology, mesenchymal stem cell secretome, persistent corneal epithelial defect, clinical trial failure - Read more

THE BAD
Layoffs

IO Biotech cuts 50% of workforce after FDA rejects cancer vaccine approval plans
Cancer vaccine, melanoma, regulatory setback, layoffs, financial restructuring - Read more

THE BAD
Politics & Policy

PhRMA plans new website highlighting direct-to-patient discount programs amid Trump's pricing pressure
Drug pricing, healthcare policy, operational, regulatory, strategic - Read more

AbbVie prices UK ovarian cancer drug Elahere at US levels amid negotiations with NHS cost watchdog
Antibody-drug conjugate, oncology, pricing strategy, regulatory approval, market access - Read more

THE UGLY
Politics & Policy

HHS refers Harvard for potential debarment amid allegations of discrimination against Jewish students
Civil rights, policy, regulatory, government funding - Read more

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

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