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THE GOOD
Approvals & Labels

Roche's Evrysdi tablets (SMN2 splicing modifier) lands FDA approval in spinal muscular atrophy
Small molecule, spinal muscular atrophy - Read more

Pfizer's Adcetris (targeting CD30) approved by FDA in combination with lenalidomide and rituximab for pretreated large B-cell lymphoma patients
Antibody-drug conjugate, B-cell lymphoma, cancer - Read more

Specialised Therapeutics' Nerlynx (targeting HER2) approved in Thailand for early-stage hormone receptor positive breast cancer recurrence prevention
Small molecule, breast cancer - Read more

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⬇️ More Good News ⬇️

THE GOOD
Business Development

Biogen signs $250M royalty agreement with Royalty Pharma to fund litifilimab (targeting BCDA2) development and commercialization
Monoclonal antibody, lupus erythematosus, royalty - Read more

Neuphoria Therapeutics receives $15M milestone payment as Merck & Co. begins Phase 2 trial of MK-1167 (α7 nicotinic acetylcholine receptor positive allosteric modulator) for Alzheimer's disease dementia
Small molecule, Alzheimer's disease, dementia - Read more

J&J explores sale of its Cerenovus stroke product line for over $1B
Medical device, stroke - Read more

THE GOOD
Clinical Trials

AnaptysBio showcases Ph2b win for rosnilimab (targeting PD-1) in treating moderate-to-severe rheumatoid arthritis
Monoclonal antibody, rheumatoid arthritis - Read more

Children's Minnesota and University of Minnesota test combination cancer vaccine + synthetic peptide in diffuse midline glioma Ph1 trial - out-licensed to OX2 Therapeutics
Cancer vaccine, synthetic peptide, brain cancer, glioma, pediatric cancer - Read more

Study suggests GLP-1 drugs like Ozempic may help reduce alcohol cravings, with new clinical trial data supporting earlier animal research
GLP-1, obesity, alcohol-use disorder - Read more

THE GOOD
Company Launches

Terrain Biosciences debuts AI-powered RNA design platform to accelerate development of mRNA therapies and personalized medicines
RNA, CRO, drug design, vaccine development, drug development, AI - Read more

THE GOOD
Fundraises

Abcuro $200M Series C, money in-part will be used to advance ulviprubart (targeting KLRG1) into Phase II/III trial
Monoclonal antibody, inclusion body myositis - Read more

Junevity $10M Seed, developing siRNA therapies targeting transcription factors linked to aging and disease
siRNA, longevity, aging, transcription factors - Read more [Paywall]

Aligos Therapeutics $105M private placement, advancing development of a hepatitis B infection therapy
Small molecule, hepatitis B - Read more

Bioxodes $2.9M Series A extension, developing therapies for thrombotic diseases and brain hemorrhage treatment
Small molecule, intracerebral hemorrhage, thrombotic diseases - Read more

Resolute Science Seed/early investment (Amount not disclosed), “synthetic-drug conjugate” based cancer therapies
Synthetic-drug conjugate, cancer - Read more

THE GOOD
Investments

GSK relocates vaccine R&D teams from Maryland to Cambridge, MA, consolidating operations at four Boston-area facilities
Vaccine, research & development, facility move - Read more

THE GOOD
Mergers & Acquisition

MMS acquires Exploristics and its KerusCloud platform, expanding global biostatistics capabilities and strengthening its data-focused clinical research services
CRO, biostatistics, data science - Read more

THE GOOD
Partnerships

AbbVie, Xilio Therapeutics partner on tumor-activated immunotherapies in $2.1B deal focused on T cell engagers
T-cell engager, cancer, drug discovery - Read more

Alloy Therapeutics, Pfizer partner to develop advanced antibody discovery platform targeting challenging disease targets
Antibody, platform technology, drug discovery - Read more

Simcere, Fermion parter to develop pain drug FZ002-037 in Greater China, targeting diabetic peripheral neuropathic pain (SSTR4 agonist)
Small molecule, diabetic peripheral neuropathic pain, drug development - Read more

Gates Foundation, Novo Nordisk Foundation, Wellcome partner on $50M program to discover new antibiotics for gram-negative bacteria
Small molecule, antibiotics, antibiotic-resistance infection, drug discovery - Read more

Moffitt Cancer Center, 1ST Biotherapeutics enter into 5-year alliance to develop a HPK1 inhibitor and advance cancer immunotherapy research
Small molecule, cancer, solid tumor, research & development, drug development - Read more

MaxCyte, TG Therapeutics partner on cell therapy platform licensing deal for B-cell disease treatments
Cell therapy, cell-engineering, platform technology, electroporation, instrumentation - Read more

Boehringer Ingelheim, ExpressionEdits partner to develop gene therapies using AI-powered Genetic Syntax Engine technology
Gene therapy, drug development, AI - Read more

Firefly Neuroscience, NVIDIA partner to develop AI-powered brain foundation model using BNA technology
Human brain modelling, AI, neurology, mental health disorders - Read more

THE GOOD
Research

Reducing CUL5 gene activity enhances CAR-T cell therapy's effectiveness against aggressive cancers like leukemia, improving treatment outcomes
Cell therapy, cancer, CAR-T, CAR-T efficacy - Read more

Scientists develop antisense oligonucleotide that halts Huntington's disease-causing gene expansion in lab tests with neurons and mice
Antisense oligonucleotide, Huntington's disease - Read more

THE GOOD
Strategic Plans

Gilead prepares for mid-2025 launch of lenacapavir HIV prevention drug, with high demand expected following anticipated FDA approval
Small molecule, HIV infection, antiretroviral, pre-exposure prophylactic - Read more

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THE BAD
Earnings & Finances

Biogen forecasts lower 2025 earnings and sales, citing declining MS drug revenue; shares drop 4% despite CEO's optimistic restructuring plans
Big pharma earnings, multiple sclerosis - Read more

THE BAD
Lawsuits

UK court rejects Abbott's trademark lawsuit against Sinocare, ruling their diabetes CGM device design doesn't infringe on FreeStyle Libre
Medical device, diabetes, continuous glucose monitor, trademark infringement - Read more

THE BAD
Layoffs

Odyssey Therapeutics laid off undisclosed number of San Diego staff and discontinued cancer drug discovery programs in late 2024 according to Endpoints sources
Small molecule, ulcerative colitis, Crohn's disease, atopic dermatitis, hidradenitis suppurativa, osteoarthritis - Read more [Paywall]

THE BAD
Politics & Policy

Despite a Federal judge temporarily blocking NIH's 15% funding cap for research costs, universities remain uncertain about future grant applications
Public research funding, National Institute of Health - Read more [Paywall]

THE BAD
Regulatory

Kaiser Permanente urges stronger FDA regulations and Congressional action on follow-up trial requirements as part of the accelerate approval process
Drug approval process, accelerated approvals - Read more [Paywall]

THE BAD
Strategic Plans

Biogen discontinues four drug programs, including acquired Reata Pharmaceuticals asset and early neurodegenerative disease treatments, during Q4 results announcement
Small molecule, Parkinson's disease, Alzheimer's disease, diabetic peripheral neuropathic pain, neurodegenerative disease - Read more

Astellas shifts investment strategy away from early-stage novel technologies and towards later-stage opportunities, “not happy about the pace” about earlier regenerative/advanced med ambitions
Gene therapy, Pompe disease, AAV, cell therapy, geographic atrophy, cancer - Read more

THE BAD
Criminal Acts

DOJ investigates Inspire Medical over potential Medicare/Medicaid false claims and anti-kickback violations following January civil probe
Medical device, sleep apnea, kickbacks, insurance fraud - Read more

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

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