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Extra big edition covering the equivalent of two regular sized TLDR Biotech updates. Back to the regular sized updates tomorrow!

THE GOOD
Approvals & Labels

Scotland approves GSK's Blenrep targeting BCMA for relapsed/refractory multiple myeloma based on Ph3 data
Antibody, cancer, antibody-drug conjugate, multiple myeloma, combination therapy, relapsed refractory - Read more

Theramex's linzagolix receives Scottish Medicines Consortium approval for endometriosis in adult women of reproductive age
Small molecule, reproductive health, GnRH antagonist, endometriosis, hormonal therapy - Read more

China approves Amoytop's Pegbing targeting hepatitis B surface antigen for chronic hepatitis B functional cure
Protein therapy, infectious disease, hepatitis B, combination therapy, functional cure - Read more

FDA approves Teva + Medincell's Uzedy (risperidone) monthly injectable for bipolar I disorder maintenance treatment
Small molecule, neurological, extended-release injectable, bipolar I disorder, risperidone - Read more

Roche, Eli Lilly win FDA approval for Elecsys pTau181 blood test for primary care Alzheimer's assessment
Diagnostic test, neurological, blood biomarker, Alzheimer's disease, pTau181 protein - Read more

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THE GOOD
Business Development & Partnerships

Takeda, Nabla Bio expand AI partnership for antibody design, $1B+ potential value
Research collaboration, AI/ML, antibody, milestone payments - Read more

GC Biopharma, Curevo Vaccine sign CMO agreement for recombinant shingles vaccine amezosvatein
Manufacturing agreement, vaccine, infectious disease, global - Read more

Actithera licenses Weizmann covalent chemistry technologies for targeted radiopharmaceutical development
Licensing deal, oncology, radiopharmaceuticals, drug discovery, covalent chemistry - Read more

Sumitomo Pharma, Novo Nordisk co-promote Wegovy obesity treatment in Japan starting November 2025
Co-promotion agreement, obesity, commercialization - Read more

SystImmune, Bristol Myers Squibb reach $250M milestone for iza-bren cancer therapy development collaboration
Licensing deal, oncology, antibody-drug conjugate, milestone payments, global - Read more

Biophytis, RONGHUI RENHE form $20M joint venture for sarcopenia drug Phase 3 trial
Joint venture, rare disease, small molecule, equity investment - Read more

Bristol Myers Squibb, insitro extend ALS drug discovery alliance into design phase
Research collaboration, neurological, AI/ML, small molecule, milestone payments - Read more

QUANTRO Therapeutics, Boehringer Ingelheim extend cancer transcription factor collaboration, €500M ($578.3M) milestone potential
Research collaboration, oncology, drug discovery, small molecule, milestone payments - Read more

THE GOOD
Clinical Trials

AbbVie presents encouraging Ph1/Ph2 data for telisotuzumab adizutecan, ABBV-706 ADCs in pancreatic, colorectal solid tumours
Antibody-drug conjugate, cancer, solid tumors, pancreatic cancer, colorectal cancer, targeted therapy - Read more

Moderna reports 67% response rate for mRNA-4359 PD-L1/IDO1 cancer vaccine in Ph2 checkpoint-resistant melanoma
Vaccine, cancer, mRNA vaccine, melanoma, PD-L1 target, combination therapy - Read more

Alligator Bioscience reports Ph1 data: mitazalimab CD40 agonist shows immune activation in metastatic pancreatic cancer
Antibody, cancer, monoclonal antibody, pancreatic cancer, CD40 agonist, combination therapy - Read more

iOnctura Ph1b cambritaxestat meets primary endpoint targeting autotaxin for metastatic pancreatic ductal adenocarcinoma
Small molecule, cancer, autotaxin inhibitor, pancreatic cancer, combination therapy - Read more

Clarity Pharmaceuticals' 64Cu-SAR-bisPSMA hits Ph2 primary endpoint detecting prostate-specific membrane antigen-positive prostate cancer lesions.
Radiopharmaceutical, cancer, diagnostic imaging, prostate cancer, PSMA target, PET imaging - Read more

RemeGen's telitacicept Ph3 trial in Sjögren's syndrome meets primary endpoint, targeting B-cell activating factor
Protein therapy, autoimmune, fusion protein, Sjögren's syndrome, BAFF/APRIL inhibitor, phase III - Read more

iRegene reports promising Ph1 clinical data for NouvNeu001 iPSC therapy in Parkinson's disease patients
Cell therapy, neurological, iPSC therapy, Parkinson's disease, allogeneic transplantation - Read more

Nouscom's NOUS-209 shows 15% response rate in Ph2 trial for microsatellite instability-high metastatic colorectal cancer
Vaccine, cancer, therapeutic vaccine, colorectal cancer, combination therapy, MSI-H - Read more

Pfizer's Tukysa hits Ph3 primary endpoint in HER2-positive metastatic breast cancer first-line maintenance
Small molecule, cancer, tyrosine kinase inhibitor, HER2-positive breast cancer, HER2 target, maintenance therapy - Read more

Mabwell's 7MW3711 B7-H3-targeting ADC shows promising Ph1/2 results in advanced solid tumors at ESMO 2025
Antibody-drug conjugate, cancer, ADC, solid tumors, B7-H3 target, lung cancer - Read more

THE GOOD
Company Launches

Excellergy launches with $70M Series A led by Samsara BioCapital to develop first-in-class ECRI drugs redefining allergy treatment
Autoimmune, antibody, preclinical, platform technology - Read more

THE GOOD
Fundraises

EVerZom raises €10M ($11.6M) Series A, exosome-based biotherapies for inflammatory diseases
Exosome-based therapy, inflammatory diseases, regenerative medicine, preclinical - Read more

ADC Therapeutics raises $60M PIPE, commercial expansion of ZYNLONTA cancer therapy
Antibody drug conjugates, oncology, commercial-stage - Read more

Novo Nordisk Foundation pledges $31M grant, AI-powered pandemic preparedness platform
AI/ML platform, infectious disease, pandemic preparedness, data analytics - Read more

Lila Sciences raises $115M Series A extension for scientific superintelligence platform
AI/ML platform, platform technology, drug discovery, materials discovery - Read more

Kailera raises $600M Series B, advancing Zepbound-like obesity drug across global clinical trials
Obesity, small molecule, clinical-stage, injectable therapy - Read more

Candel raises $130M loan, viral immunotherapy development for cancer indications
Oncology, immunotherapy, viral-based therapy, clinical-stage - Read more

Spyre Therapeutics raises $275M public offering, IBD antibody therapeutics development
Autoimmune, antibody, clinical-stage, inflammatory bowel disease - Read more

BioNTech receives €95M ($110M) EU funding boost for African mRNA vaccine manufacturing facility in Rwanda
mRNA vaccine, infectious disease, strategic, investment - Read more

MAIA Biotechnology raises $700K private placement, targeted cancer immunotherapies development
Cancer, targeted immunotherapies, clinical-stage, oncology - Read more

Kardigan raises $254M Series B, developing late-stage cardiovascular drugs including danicamtiv
Cardiovascular, small molecule, clinical-stage, cardiac myosin activator - Read more

THE GOOD
Investments

Takeda completes $170 million Thousand Oaks campus expansion for rare disease manufacturing
Enzyme replacement therapy, rare disease, strategic, major transaction, operational - Read more

Almac invests $48M in new trial coordinator platform to address clinical site system fragmentation challenges
Clinical technology platform, multi-therapeutic, strategic, major transaction, operational - Read more

THE GOOD
Mergers & Acquisitions

LTS Lohmann acquires Renaissance Lakewood CDMO to expand US drug delivery manufacturing footprint
Drug delivery systems, strategic, major transaction, operational - Read more

BioCryst acquires Astria Therapeutics for $700M to gain hereditary angioedema drug navenibart
Monoclonal antibody, rare disease, strategic, major transaction - Read more

THE GOOD
Politics & Policy

Johson & Johnson CEO Duato expects pricing deal with Trump administration following Pfizer, AstraZeneca MFN agreements
Drug pricing policy, strategic, regulatory, financial, operational - Read more

THE GOOD
Strategic Plans

J&J spins out orthopedics business into standalone DePuy Synthes company
Spinout, orthopedics, medical devices, strategic restructuring - Read more

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THE BAD
Clinical Trials

Tvardi's TTI-101 STAT3 inhibitor fails Ph2 idiopathic pulmonary fibrosis trial with high dropout rates
Small molecule, fibrotic disease, STAT3 inhibitor, idiopathic pulmonary fibrosis, combination therapy - Read more

Astellas' Vyloy targeting CLDN18.2 fails Ph2 overall survival endpoint in metastatic pancreatic adenocarcinoma study
Antibody, cancer, monoclonal antibody, pancreatic cancer, CLDN18.2 target - Read more

THE BAD
Earnings & Finances

Shah Capital urges Novavax sale citing strategic missteps, poor execution after 95% stock decline
Protein vaccine, infectious disease, strategic, major transaction - Read more

THE BAD
Regulatory

FDA adds boxed warning to Johnson & Johnson's Carvykti for potentially fatal intestinal disorder affecting 1% patients
CAR-T cell therapy, oncology, regulatory, safety warning - Read more

FDA delays Denali's Hunter syndrome therapy decision by three months to April 5.
Enzyme replacement therapy, rare disease, regulatory, strategic - Read more

THE UGLY
Regulatory

FDA hits Novo Nordisk's Indiana plant with serious OAI classification, threatening delays for Scholar Rock, Regeneron drug approvals
Monoclonal antibody, neurological, regulatory, operational, manufacturing - Read more

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

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