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THE GOOD
Approvals & Labels

Genmab's Epkinly (targeting CD3xCD20) nabs MHLW (Japan) approval for relapsed/refractory follicular lymphoma after two prior therapies
Bispecific antibody, follicular lymphoma, cancer - Read more

Chugai's Tecentriq (anti-PD-L1) scores MHLW (Japan) approval for unresectable alveolar soft part sarcoma, based on Ph2 trial results
Monclonal antibody, alveolar soft part sarcoma - Read more

Daiichi Sankyo's Lixiana (FXa inhibitor) lands MHLW (Japan) approval to prevent blood clots in chronic thromboembolic pulmonary hypertension
Small molecule, pulmonary arterial hypertension (PAH) - Read more [Press release in Japanese]

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⬇️ More Good News ⬇️

THE GOOD
Business Development

Psilera out-licenses DMT patent portfolio to atai Life Sciences
Small molecule, neurology, mental health disorders, psychedelics, frontotemporal dementia, neuroplastogen - Read more

UroGen acquires IconOVir's oncolytic virus therapy ICVB-1042 (targeting CD46), bladder cancer hopeful
Oncolytic immunotherapy, bladder cancer - Read more

Brexogen out-licenses certain rights and tech transfers BxC-I17e (exosome based injectable therapeutic) manufacturing process to BMI Korea
Exosomes, injectables - Read more

Canada secures 500k doses of GSK's bird flu vaccine through existing agreement with Public Health Agency of Canada
Vaccine, bird flu - Read more

THE GOOD
Clinical Trials

Hengrui Pharmaceuticals' touts promising Ph1 data for SHR-A2102 (targeting Nectin4) in urothelial carcinoma treatment
Antibody-drug conjugate, urothelial cancer - Read more [Press release in Chinese]

Imunon's IMNN-001 delivers promising Ph1/2 trial results in advanced ovarian cancer, combined with chemotherapy
DNA, interleukin, ovarian cancer - Read more

Immunic's IMU-856 (targeting SIRT6) shows dose-dependent GLP-1 increase in Ph1b celiac disease trial, suggesting potential for weight management
Small molecule, celiac disease - Read more

Novadip's NVDX3, derived from human osteogenic adipose tissue-derived mesenchymal stem cells, delivers shows positive Ph1b/2a results in treating distal radius fractures
Allogeneic bone graft, distal radius fracture, mesenchymal stem cells - Read more

THE GOOD
Earnings & Finances

BridgeBio reports strong initial demand for Attruby (TTR stabilizer), outpacing investor expectations
Small molecule, transthyretin amyloidosis with cardiomyopathy (ATTR-CM) - Read more

THE GOOD
Fundraises

2048 Ventures files with SEC for their third fund, aiming for $75M
Venture capital, biotech investing - Read more

Spore.Bio $23M Series A, French AI-powered bacteria detection startup expanding team and commercializing tech
Bacterial quantification, AI - Read more

EG 427 €27M ($28.4M) Series B, developing herpes virus-based gene therapy for bladder control in spinal injury patients
Gene therapy, neurogenic detrusor overactivity (NDO), spinal cord injury, HSV-based vector - Read more

Stablepharma €2.5M ($2.6M) EIC grant, developing fridge-free vaccines for tetanus and diphtheria
Vaccine, tetanus, diphtheria, fridge-free - Read more

EnPlusOne Biosciences $10M financing, RNA biotech expanding operations and enzyme-based RNA production research
RNA, manufacturing, enzyme optimization - Read more

Kane Biotech Private Placement closing with gross total CAD1.7M ($1.2M), developing anti-bacterial biofilm technologies and products
Biofilm, antibiotic - Read more

Variational AI $5.5M Seed extension, AI-powered small molecule drug discovery platform
Small molecule, drug discovery, AI - Read more

ABIONYX Pharma receives €8.7M French government grant to develop CER-001, a recombinant protein treatment for sepsis
Recombinant high-density lipoprotein (HDL) mimetic, sepsis - Read more

VitalConnect $100M funding round, develops wearable cardiac monitoring patches for hospital patient tracking
Medical device, cardiac monitor - Read more

THE GOOD
Lawsuits

Federal judge allows FTC lawsuit to proceed against major PBMs over alleged insulin price manipulation through rebate practices
Pharmacy benefit manager, insulin - Read more

THE GOOD
Mergers & Acquisition

AstraZeneca acquires FibroGen's China operations for $160M
Small molecule, chemotherapy-induced anemia, antibody-drug conjugate, monoclonal antibody, prostate cancer, solid tumor - Read more

THE GOOD
Partnerships

Incyte, Genesis Therapeutics partner to accelerate AI-driven small-molecule drug discovery in $900M deal
Small molecule, drug discovery, AI - Read more

Harbour BioMed, Insilico Medicine collaborate to develop AI-powered antibody discovery platform for immunology and oncology therapeutics
Antibody, drug discovery, drug development, AI - Read more

BioMed X, Barbados Government partner to AI model to help develop better cardiometabolic treatment regimens for those of African descent
Research, healthcare equity, cardiometabolic disease, AI - Read more

Ginkgo Bioworks, European Health Agency partner to develop rapid virus detection system
Next generation sequencing (NGS), diagnostics, respiratory illness - Read more

THE GOOD
Politics & Policy

PhRMA leaders and pharma CEOs to meet Trump, seeking changes to drug pricing policies in Inflation Reduction Act
Lobbying, pharma industry policy, Inflation Reduction Act - Read more

THE GOOD
Product Launches

Illumina reveals plans to enter spatial transcriptomics market
Sequencing, spatial transcriptomics - Read more

Roche introduces new faster DNA sequencing tech
Next generation sequencing (NGS) - Read more

THE GOOD
Research

First prenatal treatment of spinal muscular atrophy using risdiplam shows promise, with patient showing no disease symptoms after two years
Small molecule, spinal muscular atrophy - Read more

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THE BAD
Earnings & Finances

Deep Track Capital nominates four directors to Dynavax's board, opposing acquisitions and pushing focus on Heplisav hepatitis B vaccine
Proxy fight, vaccine, hepatitis B - Read more

THE BAD
Lawsuits

Major pharmaceutical companies oppose hospital group's intervention in lawsuits over 340B drug rebate program changes
340B Drug Pricing Program - Read more

HHS defends Medicare drug price negotiations against Novartis lawsuit, citing need to address unsustainable price increases
Inflation Reduction Act, Drug pricing, HHS - Read more

THE BAD
Layoffs

Illumina to cut 96 San Diego jobs by April following Chinese blacklisting
Sequencing, next generation sequencing (NGS) - Read more [Paywall]

THE BAD
Mergers & Acquisition

Hookipa Pharma cancels planned all-stock acquisition of Poolbeg Pharma, reversing merger agreement made in early 2024
Arenaviral immunotherapy, cancer, small molecule, immunotherapy-induced cytokine release syndrome prevention - Read more

THE BAD
Politics & Policy

CDC delays vaccine advisory committee meeting, which impacting vaccine policies and coverage recommendations
Vaccine, CDC, advisory committee - Read more

Under RFK Jr.'s direction, HHS halts CDC's vaccine ads, including flu campaign, to focus messaging on "informed consent" instead
Vaccine, drug marketing, drug advertising - Read more [Paywall]

AdvaMed CEO warns HHS that recent FDA staff cuts could harm patient care and US medical technology leadership position
Food & Drug Administration (FDA), federal health agency, HHS - Read more

THE BAD
Regulatory

EU's proposed ban on “forever chemicals” (PFAS) in drug packaging raises concerns among manufacturers and investors about costly manufacturing changes
PFAS, injectables, drug packaging - Read more [Paywall]

THE BAD
Strategic Plans

Zealand Pharma still on the hunt for a “strategic partner” for obesity drug hopeful petrelintide
Synthetic peptide, obesity - Read more

THE UGLY
Politics & Policy

Trump threatens 25% tariffs on imported drugs, offering exemptions to pharmaceutical companies that manufacture domestically
Tariffs - Read more

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

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