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THE GOOD
Approvals & Labels

Abeona Therapeutics' Zevaskyn, a skin cell therapy, received FDA approval for epidermolysis bullosa at $3.1 million list price
Cell therapy, dystrophic epidermolysis bullosa, cell transplant - Read more

AbbVie's Rinvoq (upadacitinib), a JAK inhibitor, approved by FDA for giant cell arteritis, showing 46.4% remission in Ph3 trial with reduced steroid use
Small molecule, giant cell arteritis - Read more

Telix Pharmaceuticals' Illuccix, a gallium-68 gozetotide PSMA-targeted imaging agent, approved in France for prostate cancer detection and localization
Radiopharm, prostate cancer - Read more

AstraZeneca's Calquence (acalabrutinib) with venetoclax recommended by CHMP for EU approval, showing reduced disease progression in previously untreated chronic lymphocytic leukaemia in Ph3 trial.
Small molecule, leukemia, cancer - Read more

THE GOOD
Business Development

Henlius grants Sandoz exclusive commercialization rights for ipilimumab biosimilar HLX13 in major markets for up to $301 million.
Monoclonal antibody, biosimilar, commercialization, cancer - Read more

Genprex in-licenses NYU Langone Health patent for Reqorsa gene therapy as potential mesothelioma treatment
Gene therapy, mesothelioma, Lipid nanoparticle (LNP) - Read more

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THE GOOD
Clinical Trials

Relmada Therapeutics' NDV-01 showed 90% disease-free status in Ph2 trial for non-muscle invasive bladder cancer
Small molecule, combo therapy, bladder cancer - Read more

Artios Pharma's ART0380, an ATR enzyme inhibitor, showed tumor shrinkage in 37% of ATM-deficient advanced cancer patients in Ph1/2 study with irinotecan
Small molecule, cancer - Read more

GENFIT and Ipsen's elafibranor, a PPAR agonist, shows significant ALP reduction and improved liver parameters in Ph2 trial for Primary Sclerosing Cholangitis
Small molecule, primary sclerosing cholangitis (PSC) - Read more

Purple Biotech's NT219, a dual inhibitor of IRS1/2 and STAT3, in Ph2 trials for head and neck cancer with pembrolizumab and cetuximab
Small molecule, head & neck cancer - Read more

THE GOOD
Company Launches

Y Combinator-backed Synthio Labs emerges from stealth with AI teammates to revolutionize pharma-physician engagement
AI, physician engagement, patient engagement - Read more

THE GOOD
Earnings & Finances

Novartis raises 2025 revenue guidance after strong Q1 sales of $13.2 billion, led by growth in Kisqali, Kesimpta, and Leqvio
Big pharma earnings, small molecule, cancer, monoclonal antibody, multiple sclerosis (MS), hepatitis, siRNA - Read more

THE GOOD
Fundraises

Novo Nordisk Foundation DKK 600M ($91M) Challenge Programme grants, supporting research collaborations on global challenges across European countries.
Research funding, foundation - Read more

Lexaria Bioscience $2M registered direct offering, drug delivery platform innovator raising funds for working capital and corporate purposes.
Drug delivery, drug formulation - Read more

Gestalt Diagnostics raises $7.5M Series A to expand customer base, enhance AI capabilities, and pursue FDA clearance for digital pathology solutions.
Pathology, AI, disease screening - Read more

Basil Systems raises $11.5M to expand AI-powered intelligence platform for life sciences product lifecycle management.
AI, intelligence - Read more

THE GOOD
Investments

Merck & Co. breaks ground on $1B Delaware facility for cancer drug Keytruda amid push for US manufacturing
Biologics manufacturing, new facility, domestic manufacturing - Read more

THE GOOD
Mergers & Acquisitions

AlphaRose Therapeutics acquires Alpha Anomeric, gaining novel oligonucleotide chemistry platform to enhance their neurogenetic disease treatments
Platform technology, antisense oligonucleotide, drug development - Read more

THE GOOD
Opinions

Pfizer CEO Bourla expects Trump's pharmaceutical tariffs will target adversaries, not allies, based on White House conversations
Tariffs, geopolitics, supply chain - Read more

THE GOOD
Partnerships

Eli Lilly, Creyon Bio, partnering on AI-powered oligonucleotide therapeutics with $13M upfront and potential $1B in milestones
Oligonucleotide, drug development, platform technology, machine learning, AI - Read more

Novo Nordisk, Hims & Hers, partner to offer discounted Wegovy through telehealth platform after settling compounding dispute
GLP-1, obesity, compounding, distributon partnership - Read more

Senseonics, Sequel Med Tech, collaborating to develop automated insulin delivery system combining 365-day CGM with twiist pump.
Medical device, diabetes, Insulin delivery, continuous glucose monitoring, medical device development - Read more

Araris Biotech, Johnson & Johnson partner to develop antibody-drug conjugates in undisclosed therapeutic areas
Antibody-drug conjugate (ADC), drug development - Read more

RoosterBio, Thermo Fisher, partnering to accelerate development and manufacturing of hMSC and exosome therapies for degenerative diseases
Cell therapy, cell therapy manufacturing, exosome, mesenchymal stem cell - Read more

Kytopen, Aldevron, partnering to enhance CRISPR-mediated T-cell engineering workflow for cell therapy manufacturing
CDMO (Contract Development & Manufacturing Organization), CRISPR, cell therapy, cell therapy manufacturing - Read more

THE GOOD
Product Launches

Tempus AI launched Loop platform using patient data, organoids and AI to accelerate cancer drug target discovery.
Target discovery, cancer, drug discovery, drug development, AI - Read more

THE GOOD
Regulatory

FDA won't reorganize, only plans to consolidate offices handling travel, technology, and other departments, Commissioner Makary confirms.
Food & Drug Administration (FDA) - Read more

Bayer successfully appeals ruling, proving advisory board meeting for Eylea was legitimate, not pre-license promotion
Fusion protein, drug marketing, drug marketing violations - Read more

THE GOOD
Research

Tonix Pharmaceuticals presented data showing TFF2-MSA with anti-PD1 reduces immunosuppression in gastric cancer models, advancing TNX-1700 development.
Recombinant protein, gastric cancer - Read more

SK Life Science Labs presents research on p300-selective degraders showing potent inhibition of tumor growth in prostate cancer and solid tumors.
Small molecule, cancer - Read more

SELLAS' SLS009, a CDK9 inhibitor, shows strong preclinical efficacy against TP53 mutated acute myeloid leukemia
Small molecule, myeloid leukemia, cancer - Read more

THE GOOD
Strategic Plans

Pfizer boosts cost cuts to $7.7B with R&D shakeup, admin trims, and AI-driven digital enablement
Big pharma strategy - Read more

AstraZeneca and Novartis plan to produce drugs locally in the US to avoid potential pharmaceutical tariffs
Domestic manufacturing, tariffs, big pharma strategy - Read more [Paywall]

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THE BAD
Clinical Trials

AstraZeneca halted Ph3 trial of AKT inhibitor Truqap (capivasertib) in metastatic castration-resistant prostate cancer due to unlikely efficacy, impacting sales potential
Small molecule, prostate cancer - Read more

Novartis discontinues LRX712, a chondrogenic drug for knee osteoarthritis, after Ph2 trial showed good safety but insufficient effect on cartilage.
Radiopharm, small molecule, osteoarthritis, ovarian cancer, lung cancer - Read more

THE BAD
Company Shutdown

Octagon Therapeutics shuts down after deprioritizing lead program and facing unresolved biology questions in autoimmune disease research
Biologic, autoimmune disease - Read more

THE BAD
Earnings & Finances

Regeneron shares drop 7% after Q1 earnings miss, FDA rejection, and 26% decline in Eylea sales
Fusion protein, injectables, age-Related Macular Degeneration (AMD), wet age-related macular degeneration (wet AMD) - Read more

THE BAD
Politics & Policy

AstraZeneca may face $8 million fine in China for unpaid import taxes on cancer drug Enhertu.
Tax Investigation, antibody-drug conjugate (ADC), breast cancer - Read more

THE BAD
Regulatory

FDA misses deadline for Stealth BioTherapeutics' elamipretide review, no new decision date set amid staffing concerns.
Peptide, barth syndrome, drug approval process - Read more

THE BAD
Strategic Plans

AstraZeneca exits neuroscience field, discontinuing Alzheimer's and migraine programs to focus on other priorities.
Pipeline strategy, big pharma strategy, neuroscience, immunology, obesity - Read more

THE UGLY
No Ugly News today!

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