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THE GOOD
Approvals & Labels

Johnson & Johnson's Imaavy, targeting neonatal Fc receptor, receives FDA approval for treating generalized myasthenia gravis in adults and children 12+
Monoclonal antibody, myasthenia gravis - Read more

BridgeBio's Beyonttra (acoramidis), a TTR stabilizer, gets UK MHRA approval for treating adult wild-type or variant transthyretin amyloidosis with cardiomyopathy based on Ph3 results.
Small molecule, transthyretin amyloidosis/transthyretin amyloid cardiomyopathy (ATTR-CM) - Read more

Regeneron's Lynozyfic (linvoseltamab), a BCMA-targeting bispecific antibody, receives European Commission approval for relapsed/refractory multiple myeloma based on Ph1/2 trial results
Bispecific antibody, multiple myeloma, cancer - Read more

Roche's Phesgo (pertuzumab/trastuzumab combination) receives CHMP recommendation for at-home administration in HER2-positive breast cancer treatment
Monoclonal antibody, combo therapy, breast cancer - Read more

Roche's VENTANA TROP2 RxDx Device, an AI-powered companion diagnostic for TROP2 protein, received FDA breakthrough designation for non-small-cell lung cancer patients receiving Datroway
Medical device, companion diagnostic, lung cancer - Read more

THE GOOD
Business Development

Dimerix licenses DMX-200, a Phase 3 kidney disease drug, to Amicus for US commercialization in FSGS, receiving $30M upfront
Small molecule, kidney disease, Focal Segmental Glomerulosclerosis, commercialization - Read more

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THE GOOD
Clinical Trials

GSK's Zejula (niraparib) reduces risk of progression and death by 27% in Ph2 trial for patients with relapsed mesothelioma after platinum therapy
Small molecule, mesothelioma - Read more

Bayer's Nubeqa (darolutamide) plus ADT shows ultra-low PSA response in metastatic hormone-sensitive prostate cancer patients in Ph3 ARANOTE trial, correlating with improved outcomes
Small molecule, prostate cancer - Read more

GSK's Nucala (mepolizumab), an IL-5 targeting monoclonal antibody, reduces chronic obstructive pulmonary disease exacerbations in Ph3 MATINEE trial with type 2 inflammation
Monoclonal antibody, Chronic obstructive pulmonary disease (COPD) - Read more

THE GOOD
Company Launches

Zeon Systems launches from Y Combinator, building AI-driven robotics for laboratory automation, turning natural language into experimental design
Laboratory automation, AI research assistant, AI - Read more

THE GOOD
Earnings & Finances

BridgeBio's Attruby exceeds expectations with $36.7M in first quarter, gaining traction in ATTR-CM market despite competition
Small molecule, Transthyretin amyloidosis/Transthyretin amyloid cardiomyopathy (ATTR-CM) - Read more

THE GOOD
Fundraises

Voom Medical Devices raises $30M in debt and Series B, accelerating commercialization of minimally invasive orthopedic solutions
Small molecule, transthyretin amyloidosis/transthyretin amyloid cardiomyopathy (ATTR-CM) - Read more

deepull raises €50M ($54M) in Series C funding to advance UllCORE diagnostic system for sepsis and acute infections
Medical device, diagnostics, blood test, sepsis, infectious disease, disease screening - Read more

Chipiron $17M fundraise, developing miniaturized MRI scanners for wider patient accessibility and hospital deployment
Medical device, magnetic resonance imaging (MRI), imaging - Read more

Verily $14.7M grant from MJFF, creating molecular dataset to accelerate Parkinson's disease research
Molecular data, health data, AI, parkinson's disease, research & development - Read more

Digi.Bio raised undisclosed funding to advance single-cell analysis for immunotherapy development
Single cell analysis, immunotherapy, drug discovery, drug development, AI -Read more

THE GOOD
Lawsuits

USPTO invalidates Pharmacyclics patent claims against BeiGene's BRUKINSA, strengthening BeiGene's market position for B-cell malignancy treatments
Small molecule, patent suit, drug patents, cancer - Read more

Gilead pays $202 million to settle claims it bribed doctors to prescribe HIV drugs
Small molecule, human immunodeficiency virus (HIV), kickbacks, kickbacks suit - Read more

THE GOOD
Mergers & Acquisitions

Novartis acquires Regulus Therapeutics for $800M upfront, potentially $1.7B total, gaining miRNA-targeting drugs for rare kidney disease
miRNA, oligonucleotide, polycystic kidney disease (PKD) - Read more

Sanofi sold 50% of consumer health unit Opella to CD&R for €10B($11.3B), plans small acquisitions rather than major mergers
Consumer health - Read more

THE GOOD
Partnerships

Addex Therapeutics, Sinntaxis partnering on mGlu5 inhibitors for brain injury recovery with option for exclusive license
Small molecule, traumatic brain injury, research & development - Read more

THE GOOD
Politics & Policy

Collins and GOP senators reject Trump's biomedical research cuts, criticizing staff firings and funding reductions that harm US leadership.
Federal research funding - Read more [Paywall]

NIH establishes office to reduce animal testing in federally funded research, focusing on human-based alternatives and expanded funding.
Research & development, animal models, National Institute of Health (NIH) - Read more [Paywall]

THE GOOD
Strategic Plans

GSK prepares for potential US drug tariffs with regional supply chains and productivity improvements amid declining vaccine sales
Tariffs, big pharma strategy - Read more

Altamira Therapeutics plans to partially spin off its RNA delivery business to private equity investors in the coming months
M&A strategy, RNA, drug delivery, nanoparticle - Read more

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THE BAD
Clinical Trials

Immunic's vidofludimus calcium (Nurr1 activator) falls short on primary endpoint in Ph2 MS trial, showing modest brain volume benefit but better disability results
Small molecule, multiple sclerosis (MS) - Read more

THE BAD
Lawsuits

Regeneron faces lawsuit for allegedly inflating Medicare reimbursements for Eylea by concealing distributor credit card subsidies
Fusion protein, eye disease, reimbursement suit - Read more

THE BAD
Layoffs

Entrada Therapeutics cuts 20% of staff to focus on Duchenne muscular dystrophy, following FDA clearance of lead DMD asset
Oligonucleotide, duchenne muscular dystrophy (DMD) - Read more

NGM Biopharmaceuticals lays off staff amid strategic shift, ends discovery research and appoints new CEO
Monoclonal antibody, hyperemesis gravidarum, cancer cachexia - Read more

THE BAD
Market Reports

Biopharma venture financing dropped 20.2% to $6.5 billion in Q1 2025, with investors preferring late-stage companies
Biotech ecosystem, venture capital, life science investment, Biotech Investing - Read more

THE BAD
Strategic Plans

Cellectar Biosciences seeks strategic alternatives after failing to partner its only clinical asset, causing 15% stock drop
Small molecule, radiopharm, phospholipid drug conjugate, cancer - Read more

Acelyrin investor Trium Capital opposes Alumis merger, advocates liquidation to return cash to shareholders instead.
M&A strategy, liquidation - Read more

THE UGLY
Regulatory

FDA drug office faces loss of institutional knowledge as senior managers retire amid 20% agency-wide staff cuts.
Food & Drug Administration (FDA), public agency layoffs - Read more [Paywall]

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

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