All the top Biotech & Pharma news in one daily newsletter.*

*Big Bold Editor’s Note:

This is NOT your usual TLDR Biotech - I was OOO last week (out camping 🏕️) and thought I’d have enough cell service to still publish this daily newsletter…

…turns out I’m not good at planning.

So instead you’re getting all the news we covered last week in one, giant newsletter.

If you’re getting this by email, I highly highly recommend you click “Read Online” at the very top right corner of this email to read the web version.

And tomorrow (Monday), we’re back to your regularly rescheduled daily newsletters - huzzah!

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THE GOOD
Approvals & Labels

China approves Sinovac's Bilive vaccine re-registration for hepatitis A and B prevention in children and adults
Vaccine, infectious disease, hepatitis A and B, combination vaccine, pediatric and adult formulations - Read more

Zenara receives first FDA approval for generic sertraline, treating major depressive disorder, with exclusivity
Small molecule, neurological, SSRI, depression, OCD, generic drug - Read more

FDA approves Jazz's Modeyso (dordaviprone), first H3 K27M inhibitor for diffuse midline glioma patients after treatment failure
Small molecule, cancer, neurological, epigenetic modulator, diffuse midline glioma, H3 K27M mutation - Read more

NICE approves MSD's Keytruda-chemotherapy combination for advanced endometrial cancer as first-line immunotherapy treatment
Monoclonal antibody, cancer, immunotherapy, endometrial cancer, combination therapy, PD-1 inhibitor - Read more

THE GOOD
Business Development & Partnerships

Charles River and BioTech Social partner to offer crowdfunding portal access to incubator biotechs, enabling $5M annual fundraising opportunities.
Business development, cell therapy, gene therapy, crowdfunding, early-stage biotechs, R&D - Read more

Everest Medicines, I-Mab partner on oncology platforms with $30.9M strategic equity investment
Equity investment, oncology, bispecific antibody, cancer immunotherapy, global, R&D - Read more

Alveolus Bio, Shilpa Medicare partner on respiratory drug development
Equity investment, respiratory disease, live biotherapeutics, manufacturing agreement, small molecule, clinical development - Read more

Metavia, Syntekabio partner to use AI for identifying new indications for MASH drug DA-1241
Research collaboration, AI/ML, small molecule, metabolic disease, drug discovery - Read more

MaxCyte, Adicet Bio partner on cell therapy platform license; MaxCyte receives licensing fees for Flow Electroporation technology
Licensing deal, cell therapy, oncology, autoimmune disease, manufacturing - Read more

Surv Biopharma, Nippon Zoki partner on oncolytic virus therapy in Japan; deal worth up to ¥10.5B plus royalties
Licensing deal, oncology, rare disease, milestone payments, royalties, Japan - Read more

Polpharma Biologics, Fresenius Kabi partner on vedolizumab biosimilar; Fresenius gains global commercialization rights except MENA
Licensing deal, biosimilar, autoimmune, manufacturing, commercialization, global - Read more

US WorldMeds acquires Adaptimmune's cell-therapy portfolio for $55M upfront, potential $30M in milestones
Acquisition, cell therapy, oncology, milestone payments, US - Read more

AstraZeneca partners with SOPHiA GENETICS to use multimodal AI for breast cancer treatment optimization
Research collaboration, oncology, AI/ML, breast cancer, multimodal data, real-world evidence - Read more

Kaken Pharmaceutical, Astria Therapeutics’ partner on HAE drug navenibart in Japan; $32M deal includes $16M upfront payment
Licensing deal, rare disease, antibody, milestone payments, commercialization - Read more

XtalPi, DoveTree Medicines form $6 billion AI drug discovery collaboration for novel therapeutics across multiple disease areas
AI/ML, drug discovery, research collaboration, oncology, milestone payments, royalties - Read more

Medicus Pharma, HelixNano partner to develop thermostable mRNA vaccines using microneedle array technology
Joint venture, infectious disease, vaccine, mRNA, manufacturing, co-development - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Hansa Biopharma reports imlifidase enables Elevidys gene therapy delivery in Ph1 Duchenne muscular dystrophy trial
Enzyme therapy, gene therapy, rare disease, Duchenne muscular dystrophy, AAV vector, immune desensitization - Read more

Praxis reports 56% seizure reduction with vormatrigine sodium-channel modulator in Ph2 focal epilepsy trial
Small molecule, neurological, sodium channel modulator, epilepsy, focal onset seizures, combination therapy - Read more

BioMarin's Ph1 trial shows BMN 333 CNP may outperform Voxzogo for achondroplasia treatment
Protein therapy, genetic disorder, peptide therapy, achondroplasia, long-acting formulation, growth disorder - Read more

Eli Lilly's Kisunla shows growing three-year benefit for early Alzheimer's disease in Ph3 extension study
Monoclonal antibody, neurological, Alzheimer disease, amyloid beta target, early intervention - Read more

Elevar's rylapugratinib shows superior response rates in Ph2 trial for FGFR2-positive cholangiocarcinoma
Small molecule, cancer, kinase inhibitor, cholangiocarcinoma, FGFR2 target - Read more

UroGen Pharma's ZUSDURI shows 72.2% durability at 24 months in Ph3 trial for non-muscle invasive bladder cancer
Small molecule, cancer, mitomycin, bladder cancer, non-muscle invasive bladder cancer, intravesical therapy - Read more

Faron Pharmaceuticals' bexmarilimab achieves 43% complete remission rate in Ph1/2 trial for high-risk myelodysplastic syndrome
Antibody, cancer, myelodysplastic syndrome, combination therapy, immunotherapy, hematological malignancy - Read more

Precision BioSciences reports Ph1 data showing PBGENE-HBV gene editor reduces hepatitis B viral markers
Gene therapy, infectious disease, ARCUS gene editing, hepatitis B virus, cccDNA targeting, chronic infection - Read more

Cardiol's CardiolRx shows promising Phase II results for acute myocarditis, reducing myocardial inflammation markers
Small molecule, cardiovascular, cannabinoid therapy, myocarditis, inflammation, heart failure - Read more

THE GOOD
Earnings & Finances

BioNTech doubles Q2 revenue to €260.8M ($302.2M) despite loss, maintains guidance on COVID-19 vaccine sales
mRNA vaccine, infectious disease, financial, revenue impact - Read more

Pfizer raises 2025 profit forecast as cost cuts and strong Q2 sales boost financials
Small molecule, cardiovascular, financial, operational, cost reduction - Read more

Madrigal's MASH drug Rezdiffra reports $212.8M quarterly revenue, surpassing analyst expectations despite looming GLP-1 competition
Small molecule, liver disease, financial, revenue impact, competitive - Read more

BeOne's Brukinsa extends lead over AstraZeneca's Calquence with $950M quarterly sales, widening revenue gap
BTK inhibitor, oncology, competitive, financial, revenue growth - Read more

Recursion reports Q2 2025 financial results with $19.2M revenue, $171.9M net loss, extends cash runway to 2027
AI drug discovery, financial update, operational, cash runway, restructuring - Read more

THE GOOD
Fundraises

OrbiMed raises $1.86B for fifth fund, providing non-dilutive financing to healthcare companies
Investment firm, healthcare financing, credit and royalty funding, venture capital, biotech investor - Read more

AB Science raises €2.55M ($2.95M) private placement, financing AB8939 clinical development
Oncology, clinical-stage, drug development, therapeutics - Read more

Gates Foundation pledges $2.5 billion to accelerate women's health research in neglected areas over five years
Women's health, reproductive health, strategic investment, global health, funding - Read more

METiS Technologies raises RMB 400M ($55.7M) Series D, advancing AI-driven nanodelivery platform
AI/ML platform, nanodelivery, platform technology, biopharmaceutical - Read more

PhnyX Lab raises $4M seed funding for GenAI solutions in life sciences
AI/ML platform, services, life science, software platform, data analytics - Read more

Lysoway Therapeutics receives $2.93M MJFF grant for Parkinson's disease treatment development
Neurological, small molecule, Parkinson's disease, preclinical, lysosomal targets - Read more

Orchestra BioMed raises $111M in public/private equity for AVIM therapy and Virtue SAB programs
Cardiovascular, platform technology, clinical-stage, medical devices - Read more

ForCast Orthopedics raises Series A, developing targeted antibiotic therapies for joint infections
Orthopedics, infectious disease, periprosthetic joint infection, antibiotic therapy, development-stage - Read more

Slipstream raises undisclosed funding from GreyLion and Denali, expanding life sciences technology solutions
Services, technology platform, software platform, life sciences, data analytics, pharmaceutical services - Read more

Mission Bio raises undisclosed funding, advancing single-cell multi-omics platform for precision medicine
Oncology, precision medicine, single-cell platform, biomarker discovery, platform technology - Read more

Chai Discovery raises $70M Series A, AI company predicts biochemical interactions for therapeutics
AI/ML platform, drug discovery, molecular design, platform-enabled, platform technology, therapeutics - Read more

THE GOOD
Investments

Eli Lilly selling New Jersey plant amid $27 billion US manufacturing expansion
GLP-1 agonist, metabolic disease, operational, strategic, manufacturing - Read more

THE GOOD
Mergers & Acquisitions

Nucleus Network acquires UK's Hammersmith Medicines Research, expanding global early phase clinical trial capabilities
Clinical research, strategic, major transaction, global expansion, operational - Read more

Xoma Royalty acquires struggling biotechs HilleVax and Lava in cash deals with contingent value rights
Vaccine, infectious disease, strategic, acquisition, distressed assets - Read more

Y-mAbs sells to SERB Pharmaceuticals for $412M, doubling share price amid post-approval challenges
Monoclonal antibody, oncology, major transaction, strategic acquisition - Read more

ESTEVE CDMO acquires Regis Technologies, expanding US API development and manufacturing capabilities
Small molecule API, CDMO, strategic acquisition, manufacturing expansion - Read more

Sanofi completes $470 million acquisition of Vigil Neuroscience, adding Alzheimer's drug candidate VG-3927 to pipeline
Small molecule, neurological, strategic acquisition, major transaction, Alzheimer's disease - Read more

Novartis explores Avidity acquisition as Entresto faces generics; biotech shares soar 20%
Antisense oligonucleotide, genetic muscular dystrophy, M&A, major transaction - Read more

THE GOOD
Politics & Policy

Senate Committee rejects Trump's NIH cuts, proposes $400M budget increase instead
Government funding, research support, strategic, financial, policy - Read more

Trump administration to pilot 340B drug program rebate model, favoring pharmaceutical industry's policy preferences
Drug pricing policy, healthcare policy, strategic, financial, regulatory - Read more

CMS considers GLP-1 obesity drug coverage with 5-year pilot for Medicare/Medicaid plans
GLP-1 receptor agonist, obesity, regulatory, coverage policy, healthcare reimbursement - Read more

Pfizer’s CEO Bourla: Pharmaceutical industry ready to collaborate with Trump on direct-to-consumer drug sales
Blood thinner, cardiovascular, financial policy, regulatory, strategic - Read more

Pfizer’s CEO Bourla negotiating with Trump administration on Most Favored Nation drug pricing policy
Drug pricing, strategic, regulatory, financial, competitive - Read more

THE GOOD
Product Launches

Creative Biogene launches advanced CRISPR/Cas9 platform for stable knockout cell lines, enhancing gene function research
CRISPR/Cas9, gene editing platform, research tool, strategic, operational - Read more

Noom launches low-dose GLP-1 program with minimal side effects at $119 monthly starting price
GLP-1 agonist, obesity, commercial strategy, cost reduction, market competition - Read more

Gedeon Richter UK launches Nalvee, first dydrogesterone-only HRT option for menopause in 17 years
Hormone replacement therapy, women's health, reproductive health, strategic, regulatory - Read more

THE GOOD
Strategic Plans

Incyte's new CEO Bill Meury outlines strategic priorities to accelerate growth beyond Jakafi revenue gap
JAK inhibitor, oncology, dermatology, immunology, strategic, operational - Read more

BioNTech reaffirms infectious disease investment despite pivoting to oncology amid declining COVID vaccine demand
mRNA vaccine, infectious disease, oncology, strategic, financial - Read more

Contineum halts MS and CTX-343 programs to prioritize PIPE-791's phase 2 IPF trial, challenging BMS
Small molecule, pulmonary fibrosis, pipeline prioritization, strategic, competitive positioning - Read more

Nxera Pharma unveils oral GLP-1 agonist and six metabolic programs for obesity market expected to exceed $100B
Small molecule, obesity, metabolic disorders, strategic, cardiovascular - Read more

Novo Nordisk fights back against obesity drug competition with CVS deal and expanded lawsuits against compounders
GLP-1 agonist, obesity, competitive, strategic, financial - Read more

Novo Nordisk's new CEO Doustdar prioritizes obesity and diabetes focus, discontinues several pipeline assets
GLP-1 receptor agonists, obesity, diabetes, strategic, pipeline optimization, competitive - Read more

Terns Pharmaceuticals seeks partners for metabolic assets, shifts focus to cancer as obesity market saturates
Small molecule, obesity, strategic, pipeline refocus, oncology, partnering - Read more

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THE BAD
Business Development & Partnerships

Sirona Biochem, AbbVie/Allergan: Skin treatment partnership ends amid collapsed financing plans
Licensing deal, skin care, ingredient development, commercialization, deal termination, financial challenges - Read more

THE BAD
Clinical Trials

Vertex abandons VX-993 sodium channel inhibitor for acute pain after Ph2 failure in bunion surgery
Small molecule, neurological, pain management, sodium channel inhibitor, acute pain, NaV1.8 - Read more

HMNC's BH-200 vasopressin receptor antagonist misses Ph2b primary endpoint in major depressive disorder
Small molecule, neurological, depression, major depressive disorder, vasopressin receptor antagonist, precision medicine - Read more

Pfizer discontinues PF-06954522 GLP-1 agonist for obesity after Ph1 trial shows underwhelming data amid fierce competition
Small molecule, metabolic, GLP-1 agonist, obesity, competitive landscape, drug discontinuation - Read more

BioMarin discontinues pre-clinical PKU drug BMN 390 due to immunogenicity concerns amid competition from PTC's Sephience
Enzyme replacement therapy, phenylketonuria, rare disease, pipeline setback, competitive pressure, financial performance - Read more

THE BAD
Lawsuits

Novo Nordisk faces investor lawsuit over misleading semaglutide sales projections amid compounding competition concerns
GLP-1 agonist, diabetes/obesity, financial, regulatory, competitive, legal - Read more

THE BAD
Layoffs

BioNTech cuts 90 more US jobs amid strategic pipeline realignment following disappointing CAR-T data
Cell therapy, oncology, strategic, operational, cost reduction - Read more

Thermo Fisher cuts 85 California jobs amid ongoing cost reductions following pandemic growth
CDMO, operational, cost reduction, financial - Read more

Flagship's Alltrna cuts 12% of staff while advancing engineered tRNA therapeutics toward clinical trials
tRNA therapy, genetic disorders, preclinical, operational, financial - Read more

Bayer announces more layoffs following 11,000 cuts since 2023 amid litigation costs and sales decline
Operational, financial, cost reduction, strategic restructuring - Read more

THE BAD
Politics & Policy

Pfizer’s CEO warns US biotech losing ground to China, urges government support amid rising cross-border deals
Policy, strategic, competitive, investment - Read more

THE BAD
Strategic Plans

Imunon deprioritizes COVID-19 vaccine program, seeks partners amid $4.7M cash reserves, focuses on phase 3 ovarian cancer candidate
Partnership seeking, vaccine, DNA plasmid, COVID-19, deprioritization, cash constraints - Read more

Keros halts cibotercept development, prioritizes KER-065 for DMD following workforce reduction
TGF-β modulator, muscular dystrophy, strategic, operational - Read more

THE UGLY
Adverse Events

Agios shares tumble after four patient deaths reported with anemia drug Pyrukynd
Small molecule, rare blood disorder, safety concern, regulatory risk, financial impact - Read more

THE UGLY
Earnings & Finances

Sarepta evaluates efficiency measures as $1B debt looms amid Elevidys safety concerns and declining sales
Gene therapy, rare disease, financial, cost reduction, operational efficiency - Read more

THE UGLY
Regulatory

FDA cancer chief Pazdur stepped in to reject Replimmune's melanoma drug, crashing stock 75%
Viral immunotherapy, oncology, regulatory rejection, clinical trial design, competitive impact - Read more

FDA rejects Replimmune's cancer therapy; trial researchers protest decision in open letter
Oncolytic virus therapy, oncology, regulatory, clinical trial - Read more

THE UGLY
Politics & Policy

HHS cancels $500 million in BARDA-funded mRNA vaccine projects, impacting Moderna and others
mRNA vaccine, infectious disease, regulatory, financial, strategic - Read more

Trump plans up to 250% tariffs on pharmaceutical imports, with gradual implementation over 18 months
Pharma manufacturing, regulatory policy, financial impact, operational risk - Read more

GAO rules Trump administration violated law by withholding $1.8 billion in Congress-approved NIH funding
Federal funding, research policy, legal violation, regulatory, financial scope - Read more

THE UGLY
Regulatory

CDC bars AMA and other medical groups from vaccine work groups, citing concerns about bias
Vaccine policy, infectious disease, regulatory, operational - Read more

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

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