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THE GOOD
Approvals & Labels

CSL and Arcturus Therapeutics' Kostaive self-amplifying mRNA vaccine for COVID-19 in adults receives EC approval
mRNA, vaccine, COVID-19 - Read more

Galderma's Nemluvio (targeting IL-31) lands EC approval for atopic dermatitis and prurigo nodularis treatment
Monoclonal antibody, atopic dermatitis, prurigo nodularis - Read more

Egetis Therapeutics’ Emcitate (thyroid hormone analogue) scores EC approvals in MCT8 deficiency
Small molecule, monocarboxylate transporter 8 deficiency - Read more

Astellas' Izervay (targeting C5) receives FDA label update removing 12-month use limit for geographic atrophy in age-related macular degeneration patients
RNA aptamer, geographic atrophy secondary to age-related macular degeneration - Read more

Ono Pharmaceutical's Romvimza (CSF1R inhibitor) scores FDA approval for treating inoperable tenosynovial giant cell tumor in adults
Small molecule, tenosynovial giant cell tumor, cancer - Read more

GSK's Penmenvy vaccine scores FDA approval for meningococcal disease caused by Neisseria meningitidis
Vaccine, meningococcal disease - Read more

Samsung Bioepis lands pair of FDA approvals for Ospomyv (RANKL inhibitor; Prolia biosimilar, Amgen) and Xbryk (RANKL inhibitor; Xgeva biosimilar, Amgen)
Monoclonal antibody, osteoporosis, bone metastases, cancer, biosimilar - Read more

Sanofi's Merilog (insulin analog; NovoLog biosimilar, Novo Nordisk) lands FDA approval as rapid-acting insulin for blood sugar control in diabetes
Insulin analog, diabetes, biosimilar - Read more

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THE GOOD
Business Development

SmartCella acquires rights to develop Karolinska Institutet-originating cell therapy hopeful in Parkinson's disease
Cell therapy, Parkinson's disease, cell replacement, stem cells - Read more

THE GOOD
Clinical Trials

Corbus and CSPC Pharmaceutical's CRB-701 (targeting Nectin-4) shows promise in Ph1 trial for solid tumors, competing with Pfizer's Padcev
Antibody-drug conjugate, cancer, solid tumor - Read more

Bayer's NUBEQA (androgen receptor antagonist), coupled with androgen deprivation therapy, delivers improved survival in Ph3 trial for metastatic hormone-sensitive prostate cancer patients
Small molecule, prostate cancer - Read more

Allogene Therapeutics’ touts “durable response data” from cemacabtagene ansegedleucel Ph1 trial in large B-cell lymphoma
Cell therapy, lymphoma, cancer, CAR-T, allogeneic cell therapy - Read more

Arcus Biosciences showcases “Best-in-Class Potential” Ph1/1b data for casdatifan (HIF-2a inhibitor) in metastatic kidney cancer
Small molecule, renal cell carcinoma, kidney cancer, cancer - Read more

Bristol Myers Squibb showcases positive five-year data from Sotyktu (TYK2 inhibitor) Ph3 trial in moderate-to-severe plaque psoriasis
Small molecule, plaque psoriasis - Read more

AstraZeneca's Imfinzi (targeting PD-L1) with chemotherapy improved survival in muscle-invasive bladder cancer patients in Ph3 trial
Monoclonal antibody, bladder cancer - Read more

Formycon wraps up Ph3 trial early for FYB206 (PD-1 inhibitor; Keytruda biosimilar, Merck & Co.) as collected data sufficient for FDA approval
Monoclonal antibody, cancer, melanoma, biosimilar - Read more

Pliant Therapeutics assembles external expert panel to assess unblinded bexotegrast (integrin inhibitor) Ph2b data, to understand rationale for last week’s clinical hold recommendation from an independent data safety monitoring board
Small molecule, idiopathic pulmonary fibrosis, independent panel review - Read more

THE GOOD
Company Launches

Coeptis launches COEP Venture Group to invest in AI startups focusing on “Robotic Process Automation” and AI Agents
Venture capital, AI - Read more

FLEX MARKETING launches as a new healthcare marketing agency agency
Pharma marketing - Read more

THE GOOD
Fundraises

StemSight €2.3M ($2.4M) seed round, developing stem cell treatments for corneal blindness
Cell therapy, limbal stem cell deficiency (LSCD), corneal blindness, stem cells - Read more

Bambusa Therapeutics raises $90M Series A to develop bispecific antibodies for immune disorders
Bispecific antibody, immunology, inflammatory disease - Read more

Oculis $100M public offering, developing therapeutics for eye diseases
Synthetic peptide, antibody fragment, diabetic macular edema, acute optic neuritis, dry eye disease - Read more

Mair Therapeutics Pre-Seed (undisclosed amount), Dutch biotech developing treatments for neurodegenerative disorders
Small molecule, Parkinson's disease, neurodegenerative disease - Read more

InflaRx $30M public offering, developing complement-targeting anti-inflammatory therapeutics to fund pipeline development including vilobelimab
Monoclonal antibody, small molecule, inflammatory disease - Read more

THE GOOD
Lawsuits

Johnson & Johnson seeks court approval for $8 billion bankruptcy plan to settle thousands of talc-related cancer lawsuits
Talc, ovarian cancer, settlement - Read more [Paywall]

THE GOOD
Mergers & Acquisition

Private equity firm Olympus Partners acquires PAI Pharma, manufacturer of generic liquid medicines in cups and bottles
Generic, pharmacy - Read more

Strive Medical acquires Bronx-based Charles Pharmacy & Surgical, expanding its diabetes supplies and medical equipment services nationwide
Medical device, diabetes, pharmacy - Read more

THE GOOD
Partnerships

Eisai, Oita University partner to develop AI model predicting Alzheimer's brain amyloid buildup using clinical markers
Alzheimer's disease, research & development, disease prediction, machine learning, biomarker, AI - Read more

THE GOOD
Politics & Policy

Trump establishes health commission led by HHS Secretary RFK Jr. to investigate causes of chronic disease and health system reforms
Public policy, preventative medicine, chronic disease, HHS - Read more

Major pharmaceutical CEOs (and maybe PhRMA) allegedly planning White House meeting with Trump, details TBD
Public policy, pharma industry policy - Read more [Paywall]

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THE BAD
Clinical Trials

Bristol Myers Squibb's Opdualag (relatlimab, targeting LAG-3, and nivolumab, targeting PD-1) fails Ph3 trial in post-surgery melanoma, missing survival goal versus nivolumab alone
Monoclonal antibody, melanoma, combo therapy - Read more

Moderna's mRNA-1403 norovirus vaccine Ph3 trial halted by FDA after single case of Guillain-Barré syndrome reported during testing
Vaccine, mRNA, norovirus, adverse event, Guillain-Barré syndrome - Read more

THE BAD
Company Shutdown

Kojin Therapeutics cell death ambitions die as biotech shutters operations, citing funding challenges
Small molecule, cancer, autoimmune - Read more

THE BAD
Earnings & Finances

Moderna's Q4 revenue falls 66% to $966M, reports $1.12B loss as COVID vaccine sales decline amid focus on pipeline development
Big pharma earnings, vaccine, COVID-19, research & development - Read more

Moderna incurs $238M cancellation charge amid post-pandemic production cuts, with total Q4 costs reaching $739M
Contract manufacturing, big pharma earnings, COVID-19 - Read more

Formycon shares drop 35% after forecasting 2024 earnings decline due to U.S. biosimilar price reductions and product impairments
Biosimilar, drug pricing - Read more

West Pharma stock drops 38% after losing glucose monitor clients, but GLP-1 packaging deals help offset some losses
Drug packaging, glucose monitoring device, GLP-1, drug delivery - Read more [Paywall]

THE BAD
Strategic Plans

Otsuka discontinues multiple cancer drug programs, including OPB-111077 (STAT inhibitor), citing strategic reasons
Small molecule, cancer, lymphoma - Read more

THE UGLY
Layoffs

Trump administration begins mass layoffs at the CDC, terminating 1,300 probationary employees as part of larger HHS workforce reduction plans
Federal health agency, CDC - Read more

FDA initiates layoffs across multiple divisions, following CDC's 1,300 staff cuts, with terminations effective March 14
Federal health agency, FDA - Read more

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

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