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The Good News

THE GOOD
Approvals & Labels

Lupin's Ranluspec (ranibizumab) receives FDA approval as interchangeable biosimilar targeting VEGF-A for multiple retinal conditions
Antibody, ophthalmology, monoclonal antibody fragment, biosimilar, VEGF-A inhibitor, macular degeneration - Read more

MHRA grants marketing authorisation for Aujemflu (adjuvanted trivalent influenza vaccine) protecting adults aged 50 and over against influenza
Vaccine, infectious disease, influenza, adjuvanted vaccine, older adults - Read more

THE GOOD
Business Development & Partnerships

Pfizer partners with Chai Discovery on AI-driven drug discovery using custom and Chai-3 models
Research collaboration, AI/ML, drug discovery, biologics, antibody - Read more

Made Scientific, Pluristyx launch integrated iPSC development and manufacturing partnership for next-generation cell therapies
Manufacturing agreement, cell therapy, iPSC, drug discovery, R&D - Read more

MIRA Pharmaceuticals secures worldwide exclusive rights to MIRA-55 and SKNY-1 from MIRALOGX
Licensing deal, neurological, small molecule, commercialization, global rights - Read more

Stipple Bio, Lonza enter multi-target ADC licensing deal to advance precision oncology therapies
Licensing deal, oncology, antibody-drug conjugate, milestone payments, royalties - Read more

Everest Medicines, Beijing Mabworks Biotech sign Asia-Pacific license for Bejescin, RMB 23M ($3.39M) upfront, RMB 186M ($27.4M) milestones
Licensing deal, autoimmune, antibody, commercialization, milestone payments - Read more

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More Good News

THE GOOD
Clinical Trials

Otsuka Pharmaceuticals' Voyxact (sibeprenlimab) Ph3 data show kidney function stabilization in immunoglobulin A nephropathy
Protein therapy, autoimmune, monoclonal antibody, IgA nephropathy, APRIL inhibitor, BAFF inhibitor - Read more

Autobahn Therapeutics advances (elunetirom) to pivotal trial after Ph2 success in bipolar depression
Small molecule, neurological, thyroid hormone receptor agonist, bipolar disorder, depression, combination therapy - Read more

HighTide Therapeutics' (HTD1801) targets AMPK-NLRP3 axis, shows renoprotective Ph3 results in type 2 diabetes mellitus patients
Small molecule, metabolic, AMPK-NLRP3 axis, diabetic nephropathy, renoprotective, type 2 diabetes - Read more

Finerenone Ph3 trial shows slowed kidney function decline, reduced cardiovascular-kidney risk in non-diabetic chronic kidney disease
Small molecule, cardiovascular, chronic kidney disease, mineralocorticoid receptor antagonist, finerenone, non-diabetic CKD - Read more

InnoCare Pharma's (orelabrutinib) Ph2 meets endpoints in systemic lupus erythematosus, first BTK inhibitor to show significant efficacy
Small molecule, autoimmune, BTK inhibitor, systemic lupus erythematosus, glucocorticoid reduction - Read more

THE GOOD
Fundraises

OliX Pharmaceuticals raises $71M, advancing siRNA pipeline across multiple therapeutic areas
siRNA, OASIS platform, metabolic disease, ophthalmology, skin and hair - Read more

NRx Pharmaceuticals closes $22.3M public offering, supporting working capital and corporate growth
Clinical-stage, biopharmaceutical, neurological, small molecule, suicide prevention - Read more

Montara Therapeutics receives undisclosed Michael J. Fox Foundation grant for CNS disease R&D
Neurological, small molecule, CNS, preclinical, platform technology - Read more

ARTAN Bio raises $200K seed funding to advance longevity suppressor tRNA platform development
Longevity, RNA therapeutics, preclinical, platform technology, rare disease - Read more

THE GOOD
Lawsuits

Hikma Pharmaceuticals wins unanimous Supreme Court ruling in landmark skinny labels patent case against Amarin
Small molecule, cardiovascular, competitive, intellectual property - Read more

THE GOOD
Mergers & Acquisitions

Gilead Sciences, Lakefront Biotherapeutics complete $1.675B acquisition of Ouro Medicines, expanding autoimmune inflammation pipeline
T cell engager, autoimmune, rare disease, major transaction, strategic - Read more

THE GOOD
Regulatory

NICE recommends NHS funding for AbbVie's Elahere, first new resistant ovarian cancer treatment in 20 years
Antibody-drug conjugate, ovarian cancer, reimbursement, competitive - Read more

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The Bad News

THE BAD
Lawsuits

Takeda records $2.5B legal provision over Amitiza antitrust case, swinging to $951M loss
Small molecule, gastrointestinal, antitrust litigation, financial, major provision - Read more

THE BAD
Regulatory

FDA stakeholders urge pause on Makary's National Priority Voucher program over transparency, political interference concerns
FDA independence, rare disease, regulatory, operational - Read more

FDA's CNPV pilot program faces mixed reception at first public hearing, drawing industry support and expert concern
Regulatory policy, oncology, small molecule, monoclonal antibody, strategic - Read more

👹 The Ugly News 👹

THE UGLY
Layoffs

Fulcrum Therapeutics lays off 85% of staff, leaving nine employees after discontinuing sickle cell disease candidate
Small molecule, sickle cell disease, cost reduction, strategic - Read more

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

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