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  • Biotech & Pharma Updates | April 23 - 24, 2025

Biotech & Pharma Updates | April 23 - 24, 2025

Granite Bio's $100M launch going after I&I, Sanofi reports strong Q1 earnings, Thermo Fisher joins the US manufacturing rush with $2B commitment, Merck & Co.'s $200M tariff warning, FDA's drug safety databases neglected after sweeping agency layoffs + 29 more stories

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✅ The Good News ✅ 

THE GOOD
Business Development

Qyuns Therapeutics, Caldera Therapeutics $555M licensing deal for development of QX030N autoimmune antibody
Bispecific antibody, autoimmune disease - Read more

Mosaic Therapeutics, Astex Pharmaceuticals in-licensing two clinical oncology assets (ASTX029, an ERK1/2 inhibitor, and ASTX295, an MDM2 antagonist) for developing combination therapies targeting cancer with synergistic activity
Small molecule, cancer - Read more

THE GOOD
Clinical Trials

Bioxodes Ph2a trial for BIOX-101 (Ir-CPI) in intracerebral hemorrhagic stroke hits safety and efficacy endpoints, trial ended early
Recombinant protein, intracerebral hemorrhagic stroke - Read more

HK inno.N's K-CAB (tegoprazan), a P-CAB drug, outperformed lansoprazole in Ph3 trials for erosive esophagitis and non-erosive reflux disease
Small molecule, erosive esophagitis, non-erosive reflux disease - Read more

VivaVision Biotech's VVN461, a dual JAK1/TYK2 inhibitor, showed positive Ph2 results for Non-Infectious Anterior Uveitis, comparable to prednisolone acetate.
Small molecule, anterior uveitis - Read more

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 More Good News 

THE GOOD
Company Launches

Novartis-backed Granite Bio launches with $100M to develop two antibody therapies targeting autoimmune conditions and inflammation
Monoclonal antibody, inflammatory disease, autoimmune disease, fibrosis-driven disease - Read more

Dutch biotech Avidicure launches with $50M to develop AVC-Boosters, a new antibody engineering platform for cancer therapies
Antibody, antibody-drug conjugate (ADC), T cell engager, platform technology, cancer - Read more

Flagship unveils Etiome, a $50M biotech using AI to map disease progression and develop preventive medicines
Disease progression tracking, AI, -omics, parkinson's disease, rheuma­toid arthri­tis, metabolic dysfunction-associated steatohepatitis (MASH) - Read more

THE GOOD
Earnings & Finances

Sanofi reports strong Q1 growth with Dupixent sales up 22.8% to €3.5 billion, while Altuviiio is poised to become their next blockbuster
Monoclonal antibody, recombinant protein, fusion protein, hemophilia A, asthma, atopic dermatitis, eczema, big pharma earnings - Read more

BMS reports $27 million in first quarter sales for new schizophrenia drug Cobenfy, with strong prescription numbers.
Small molecule, schizophrenia, big pharma earnings - Read more

THE GOOD
Fundraises

Novo Holdings and EIFO commits €48M in HealthCap IX venture fund to strengthen Nordic life sciences ecosystem, establishing Copenhagen presence
Biotech ecosystem, Venture capital, Biotech Investing, Life science investment - Read more

Ovo Labs £4M ($5M) Seed, fertility startup developing therapeutics to improve egg quality for women over 35.
Fertility, In vitro fertilization (IVF) - Read more

Ensysce Biosciences $2.2M warrant exercise, developing novel opioids for severe pain with reduced abuse potential via TAAP and MPAR platforms
Small molecule, pain, opioid, drug delivery - Read more

Cultivarium $10M nonprofit grant, developing open-source tools for fungi and archaea research for drug development
Drug development, fungi & archaea research - Read more

Coologics $3M Seed, developing Vlisse, a drug-free intravaginal cooling device to treat vaginal infections.
Medical device, vaginal infections - Read more

THE GOOD
Investments

Thermo Fisher invests $2B in US manufacturing and R&D over four years amid tariff concerns affecting global trade
Domestic manufacturing, CDMO (Contract Development & Manufacturing Organization), reagents, equipment/Instrumentation, tariffs - Read more

THE GOOD
Market Reports

Report shows only 66% of FDA-approved biosimilars have launched, despite 10 new approvals and 5 launches this quarter
Biosimilar, market access, commercialization - Read more [Paywall]

THE GOOD
Mergers & Acquisitions

PCI Pharma Services to acquire Ajinomoto Althea, expanding North American sterile fill-finish capabilities for injectable drug products
CDMO (Contract Development & Manufacturing Organization), fill-finish, aseptic filling, injectables manufacturing - Read more

Merck KGaA nears $3.5 billion acquisition of SpringWorks Therapeutics, gaining rare disease and cancer treatments including recently approved Ogsiveo (gamma secretase inhibitor) and Gomekli (MEK1/MEK2 inhibitor)
Small molecule, neurofibromatosis type 1-associated plexiform neurofibromas, desmoid tumor, cancer - Read more

THE GOOD
Partnerships

Debiopharm, Oncodesign Services collaborate on AbYlink technology for radiopharmaceutical preclinical research in cancer treatment
CRO (Contract Research Organization), platform technology, radiopharm, cancer - Read more

Silexion Therapeutics, Catalent, partner on formulation development and clinical manufacturing of SIL204 siRNA for KRAS-driven cancers
siRNA, CDMO (Contract Development & Manufacturing Organization), drug development, drug formulation, cancer - Read more

THE GOOD
Politics & Policy

Senator Cassidy's report demands transparency reforms to 340B discount program amid rapid growth and disputes between providers and drugmakers.
340B Drug Pricing Program, drug pricing - Read more

THE GOOD
Research

UVA researchers discover prostate cancer has distinct genetic properties across different ethnic groups, opening door for more targeted treatments
Prostate cancer, dancer detection/screening - Read more

THE GOOD
Strategic Plans

BMS CEO prioritizes dealmaking in 2025 to drive growth after layoffs, pipeline cuts, and stock slump
Big pharma earnings, M&A strategy - Read more

Roche shifts pharma production to US to mitigate tariff impacts while engaging global governments for exemptions
Domestic manufacturing, tariffs, big pharma strategy - Read more

❌ The Bad News

THE BAD
Clinical Trials

Sanofi halts balinatunfib, a TNF inhibitor, monotherapy development after Ph2 trial missed PASI-75 endpoint in psoriasis
Small molecule, psoriasis - Read more

THE BAD
Earnings & Finances

Merck & Co. warns of $200 million tariff costs amid US-China trade tensions, while continuing to strengthen US operations
Big pharma earnings, tariffs - Read more

Merck & Co. reports 41% drop in HPV vaccine sales due to lower Chinese demand, despite growth in other markets.
Vaccine, human papillomavirus (HPV) infection - Read more

THE BAD
Lawsuits

Halozyme sues Merck & Co. for allegedly copying patented delivery technology for Keytruda's injectable form, which awaits FDA approval
Monoclonal antibody, drug formulation, drug delivery, patent suit - Read more

THE BAD
Opinions

Roche CEO warns potential pharmaceutical tariffs could hinder industry-wide M&A efforts and financial viability of deals.
M&A strategy, tariffs - Read more [Paywall]

👹 The Ugly News 👹

THE UGLY
Politics & Policy

FDA drug safety databases neglected due to layoffs, leaving physicians without crucial prescribing information
Public agency layoffs, patient safety, drug safety - Read more

NIH grant funding fell 28% under Trump, with infectious disease, heart, and lung research suffering most amid political tensions.
National Institute of Health (NIH), federal funding - Read more [Paywall]

THE UGLY
Warning Letters, Form 483

FDA issues warning letter to Empower Pharmacy over production violations amid Eli Lilly's GLP-1 knockoff lawsuit
GLP-1, obesity, compounding, quality concerns - Read more

THE UGLY
Withdrawals & Recalls

Lupin recalls nearly 3,000 bottles of clomiPRAMINE hydrochloride OCD medication in US due to failed stability testing
Small molecule, depression, obsessive-compulsive disorder (OCD), stability concerns - Read more

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

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