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THE GOOD
Approvals & Labels

Eisai and Biogen's subcutaneous Leqembi formulation slades for FDA decision by August
Monoclonal antibody, Alzheimer’s disease - Read more

THE GOOD
Business Development

Daiichi Sankyo acquires gatipotuzumab (anti-TA-MUC1) antibody rights from Glycotope for $132.5M; antibody component of ADC DS-3939
Monoclonal antibody, solid tumor, cancer, antibody-drug conjugate - Read more

SpringWorks Therapeutics in-licenses global rights to Rappta Therapeutics’ cancer drug RPT04402 (PP2A molecular glue) for $13M upfront + milestone payments and royalties
Small molecule, cancer, molecular glue - Read more

KYORIN Pharmaceuticals secures option for BIODOL Therapeutics’ pain treatment hopeful BDT272 (FLT3 inhibitor) in Japan and other Asian countries (excluding China)
Small molecule, pain - Read more

Verastem Oncology in-licenses ex-China rights to VS-7375 (KRAS G12D inhibitor) from GenFleet Therapeutics
Small molecule, pancreatic cancer, lung cancer - Read more

Hikma Pharmaceuticals out-licenses Kloxxado (naloxone nasal spary) US and Canada commercial rights to Emergent BioSolutions
Small molecule, opioid overdose - Read more

THE GOOD
Clinical Trials

Biohaven's BHV-1400 (targeting Gd-IgA1) delivers promising Ph1 results for IgA nephropathy, enough to jump directly to Ph3 trials
Small molecule, IgA nephropathy, protein degrader - Read more [Paywall]

Anavex Life Sciences’'s blarcamesine (targeting SIGMAR1, muscarinic receptors) demonstrates reduced clinical decline in Ph2b/3 trial for early Alzheimer's disease over three years
Small molecule, Alzheimer’s disease - Read more

Sling Therapeutics' linsitinib (IGF-1R inhibitor) meets Ph2b/3 trial endpoints for thyroid eye disease, setting up competition with Amgen's Tepezza
Small molecule, thyroid eye disease - Read more

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⬇️ More Good News ⬇️

THE GOOD
Earnings & Finances

Harmony Biosciences reports $714M revenue in 2024, expecting strong growth into 2025
Small molecule, neurological disorder, idiopathic hypersomnia, fragile x syndrome, narcolepsy - Read more

Sarepta Therapeutics' DMD gene therapy Elevidys exceeds Q4 revenue expectations with $384.2M, showing strong market performance since launch.
Gene therapy, Duchenne muscular dystrophy - Read more

THE GOOD
Fundraises

VisiRose $3M Seed raise, developing Rose Bengal-based eye infection treatments as Provectus Biopharmaceuticals spinoff company
Small molecule, infectious keratitis, photodynamic antimicrobial therapy - Read more

Immunis $25M Series A-1, iPSC-derived therapies targeting age-related muscle atrophy
iPSC, age-related muscle atrophy, stem cells - Read more

Optieum Biotechnologies ¥1.33B ($8.5M) Series A, developing CAR-T cell therapy for glioblastoma treatment
Cell therapy, glioblastoma, CAR-T, cancer - Read more

Umoja Biopharma $100M Series C, fueling CAR-T cell therapy clinical ambitions
Cell therapy, osteosarcoma, cancer, CAR-T - Read more

Clear Labs $30M Series D, genomics platform maker expanding automated DNA sequencing solutions globally
Diagnostics, next generation sequencing - Read more

iBio $650K private placement, AI-driven biotech developing antibody treatments for obesity and cardiometabolic diseases
Antibody, obesity, cardiometabolic disease, cancer, AI - Read more

Grifols $21M grant from The Micheal J. Fox Foundation, research to identify plasma biomarkers for early Parkinson's disease detection
Research grant, Parkinson’s disease, biomarkers - Read more

Inhibrx Biosciences up to $150M loan facility from Oxford Finance
Fusion protein, tetravalent antibody, cancer, solid tumor - Read more

Arctic Bioscience NOK 30M ($2.6M USD) loan/convertible debt, marine biomolecule-derived therapies and neutraceuticals
Small molecule, psoriasis - Read more

Tethis €15M ($15.5M) fundraise, blood-based cancer diagnostic platform and liquid biopsy technology
Diagnostics, cancer detection, blood test, liquid biopsy - Read more

THE GOOD
Investments

Moffitt Cancer Center and Cryoport partner to to build 30,000-square-foot biorepository at new Florida research campus
Cryopreservation, biorepository, facility build - Read more

BioDuro opens new Shanghai-based peptide manufacturing facility
CDMO, peptide, manufacturing, facility build - Read more

THE GOOD
Mergers & Acquisitions

Cycle Pharmaceuticals completes Banner Life Sciences acquisition
Small molecule, multiple sclerosis - Read more

THE GOOD
Opinions

Pfizer CEO defends company's performance despite stock decline, citing COVID-19 successes and strong execution capabilities
Big pharma, COVID-19 - Read more

THE GOOD
Partnerships

REGENXBIO, Nippon Shinyaku partner on developing and commercializing two gene therapies for rare metabolic disorders, in up to $800M deal
Gene therapy, mucopolysaccharidosis type II, mucopolysaccharidosis type I, drug development - Read more

MediLink Therapeutics, AstraZeneca partnering to test combination therapy of YL201 (targeting B7-H3) and Imfinzi (anti-PD-L1) in solid tumors
Antibody-drug conjugate, solid tumor, cancer, monoclonal antibody, combo therapy - Read more

Veneno Technologies, Aska Pharmaceutical partner to develop ion channel therapies using peptide discovery platform PERISS
Peptide, ion channel therapies, drug discovery - Read more

TheraVac Biologics, Perceiv AI partner to enhance clinical trials using AI-driven patient selection and prognostic biomarkers
Clinical trial recruitment, biomarker, AI, precision medicine - Read more

THE GOOD
Research

HighField Biopharmaceuticals studies reveal how lipid nanoparticle structure impacts RNA delivery effectiveness in gene therapies and vaccines.
RNA, lipid nanoparticle, gene therapy, vaccine, drug delivery - Read more

THE GOOD
Strategic Plans

BridgeBio reports 430 prescriptions for newly-approved Attruby and completes enrollment in three Phase 3 trials for genetic diseases
Small molecule, cardiomyopathy, transthyretin-mediated amyloidosis - Read more

Pfizer CEO expresses confidence in obesity drug danuglipron, planning late-stage trials for once-daily oral weight loss treatment
Small molecule, obesity - Read more

Roche has $10B yearly for acquisitions, focusing on five therapeutic areas, but will only spend on transformative assets
Big pharma, M&A strategy - Read more

CEOs of Bristol Myers Squibb, Pfizer, and Merck & Co. outline strategies to address revenue losses from upcoming patent expirations.
Drug patent, patent cliff, patent expiry - Read more

Merck & Co. accelerates plans for subcutaneous Keytruda launch to 2025, targeting 30-40% conversion from IV version with potential $6.5B sales
Monoclonal antibody, solid tumor, cancer - Read more

Novartis CEO predicts breast cancer drug Kisqali will become company's top-selling drug, despite initial market struggles after 2017 launch.
Small molecule, breast cancer - Read more

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THE BAD
Earnings & Finances

Eli Lilly stock falls 8% after lowering Q4 guidance due to weaker-than-expected sales of weight-loss and diabetes meds Zepbound and Mounjaro
GLP-1, obesity, diabetes - Read more

Charles River Labs stock drops 12% after forecasting continued revenue decline through 2025, citing multiple business unit challenges.
CDMO, CRO, contract research, contract manufacturing - Read more

Regeneron's Eylea HD sales dropped to $305M in Q4, falling short of expectations
Recombinant fusion protein, macular degeneration - Read more

THE UGLY
Politics & Policy

FTC report accuses major pharmacy benefit managers of inflating drug prices and favoring affiliated pharmacies over independent ones
Pharmacy benefit manager, drug pricing - Read more

THE UGLY
Regulatory

Federal watchdog finds FDA deviated from protocol three times during accelerated drug approvals, including with controversial Alzheimer's drug Aduhelm (Biogen)
Accelerated approval, approval pathway - Read more [Paywall]

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

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