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THE GOOD
Approvals & Labels

Satsuma's Atzumi, a nasal powder formulation of dihydroergotamine, approved by FDA for adult migraine treatment following Ph3 ASCEND trial
Small molecule, drug delivery, migraine - Read more

Edwards Lifesciences' Sapien 3 TAVR implants received FDA approval for treating severe aortic stenosis before symptoms appear
Heart surgery, implant, medical device - Read more

THE GOOD
Business Development

Repare Therapeutics licenses discovery platforms to newly-launched DCx Biotherapeutics, focusing on clinical portfolio while reducing costs
Antibody-drug conjugate (ADC), cancer - Read more

Cytotheryx licenses OHSU's in vivo hepatocyte selection technology for liver disease treatments, with financial benefits to OHSU
Platform technology, cell therapy, liver disease - Read more

Samsung Biologics signs $518M contract with US pharma through 2031, following recent $1.2B Asia deal
CDMO (Contract Development & Manufacturing Organization) - Read more

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THE GOOD
Clinical Trials

Amgen's obesity drug AMG 513 resumes Ph1 trial enrollment after FDA lifts clinical hold.
Undisclosed modality, obesity, clinical hold - Read more

Alphamab Oncology and CSPC Pharmaceutical's anti-HER2 bispecific antibody KN026 with chemotherapy met primary endpoint in Ph2/3 trial for HER2-positive gastric cancer
Bispecific antibody, gastric cancer, gastroesophageal junction adenocarcinoma - Read more

THE GOOD
Earnings & Finances

Biogen's Q1 revenue exceeds expectations, driven by rare disease assets like Skyclarys despite multiple sclerosis sales decline.
Big pharma earnings, small molecule, friedreich ataxia - Read more

Madrigal's MASH drug Rezdiffra exceeds sales projections with $137.3 million in Q1, reaching over 17,000 patients
Small molecule, metabolic dysfunction-associated steatohepatitis (MASH) - Read more

Biogen reports continued growth of Alzheimer's drug Leqembi, reaching $96 million in Q1 sales, with EU approval and subcutaneous formulation pending.
Monoclonal antibody, Alzheimer's disease - Read more

THE GOOD
Fundraises

Stately Bio $12M Seed, developing ML live-cell imaging platform for regenerative medicine therapies
Computational platform, machine learning, imaging, single cell analysis - Read more

Zucara Therapeutics $5M Series B, developing ZT-01 to prevent hypoglycemia in diabetes patients
Small molecule, diabetes, hypoglycemia - Read more

Spark Biomedical $15M Series A, develops wearable neurostimulation technology for neurological health, hemostasis, and women's health.
Medical device, women's health, neurology - Read more

SafeHeal €35M ($38.5M) Series C, colorectal surgery company developing Colovac device as ostomy alternative.
Surgery, colorectal cancer, medical device - Read more

EnChannel Medical raises $82.2M Series B (600M RMB) to develop cardiac electrophysiology platform for atrial fibrillation treatment.
Medical device, atrial fibrillation - Read more

Siren Biotechnology goes after $5M raise by an unconventional (for biotech) funding route - crowdfunding
Gene therapy, glioma, cancer, Adeno-associated virus (AAV) - Read more

THE GOOD
Mergers & Acquisitions

Kronos Bio agrees to acquisition by Kevin Tang's Concentra Biosciences for $0.57 per share plus contingent value rights, despite 36% discount
Small molecule, cancer, Sjögren's disease, autoimmune disease, multiple myeloma - Read more

Sun Nuclear acquires Oncospace, adding AI and machine learning technology to improve radiation oncology treatment outcomes.
AI, radiation, cancer, machine learning - Read more

PCI Pharma Services acquires Ajinomoto Althea, expanding US sterile fill-finish capabilities for prefilled syringes and cartridges as part of $1B investment strategy
CDMO (Contract Development & Manufacturing Organization), drug product, injectables manufacturing, aseptic filling, fill-finish - Read more

Summit Clinical Research acquires Houston Research Institute
CRO (Contract Research Organization) - Read more

Roquette acquires IFF Pharma Solutions, strengthening its pharmaceutical presence following Qualicaps acquisition in 2023.
Pharmaceutical excipient, drug delivery - Read more

Eurazeo acquires remaining shares of Kurma Partners, a biotech investment firm with €600M assets under management.
Biotech Investing, life science investment, private equity - Read more

THE GOOD
Partnerships

Illumina, Ovation.io, creating large dataset to improve GLP-1 treatment effectiveness using genomic and protein analysis
Clinical data, -omics, GLP-1, obesity, Liver disease, chronic kidney disease, type 2 diabetes - Read more

THE GOOD
Patient Access

CVS Caremark adds Novo Nordisk's weight loss drug Wegovy to preferred formulary, dropping Eli Lilly's Zepbound, effective July 1
Pharmacy benefit managers, GLP-1, obesity - Read more

THE GOOD
Politics & Policy

Eli Lilly CEO opposes Trump's pharmaceutical tariffs, arguing the threat alone has already prompted supply chain changes
Tariffs, supply chain - Read more [Paywall]

Democrats urge RFK Jr. to reverse suspension of public comments on health agency business, backed by advocacy groups.
US Department of Health & Human Services (HHS) - Read more [Paywall]

THE GOOD
Product Launches

FutureHouse launches AI tools Crow, Falcon, Owl, and Phoenix to accelerate scientific research and discovery
AI research assistant, AI - Read more

THE GOOD
Public Health

HHS launches initiative to develop universal vaccines against various respiratory viruses, with initial focus on two candidates entering studies in 2024.
US Department of Health & Human Services (HHS), infectious disease, vaccine - Read more

THE GOOD
Regulatory

FDA advisors to review decade-old studies on long-term opioid use risks, including addiction and overdose
Food & Drug Administration (FDA), advisory committee, opioid, opioid epidemic - Read more [Paywall]

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THE BAD
Approvals & Labels

Moderna's combination flu and COVID-19 vaccine faces FDA delay until 2026, requiring additional Ph3 efficacy data for approval
Vaccine, COVID-19, influenza, drug approval process - Read more

THE BAD
Clinical Trials

Arvinas and Pfizer discontinue two Ph3 trials of vepdegestrant, an estrogen receptor degrader PROTAC, for breast cancer following mixed results
Protein degrader, small molecule, breast cancer - Read more

AN2 Therapeutics' epetraborole failed to meet Ph3 primary endpoint for quality of life in treatment-resistant Mycobacterium avium complex lung disease.
Small molecule, antibiotic, nontuberculous mycobacterial pulmonary disease - Read more

THE BAD
Company Shutdown

Bloomsbury Genetic Therapies shutting down due to funding challenges despite scientific advances in ultra-orphan disease treatments
Gene therapy, ornithine transcarbamylase deficiency, adeno-associated virus (AAV), dopamine transporter deficiency syndrome, infantile neuroaxonal dystrophy, Parkinson's disease - Read more

THE BAD
Earnings & Finances

Icon and Medpace report high cancellations and delays in R&D projects due to Trump funding cuts and tariff concerns.
CRO (Contract Research Organization), tariffs - Read more [Paywall]

Moderna missed Q1 revenue targets but plans $1.5 billion in additional cuts while maintaining ambitious 2025 financial guidance and product approval goals
mRNA, vaccine, big pharma earnings - Read more

Eli Lilly shares drop after CVS removes Zepbound from coverage lists, despite CEO downplaying impact on sales
GLP-1, obesity - Read more

THE BAD
Layoffs

Arvinas cuts 33% of workforce and halts two late-stage breast cancer trials with Pfizer, extending financial runway
Protein degrader, small molecule, breast cancer - Read more

Phathom cuts 6% of staff and shifts marketing strategy to reduce costs after $90 million Q1 loss
Small molecule, erosive esophagitis, heartburn - Read more

BMS closing Illinois viral vector facility, consolidating cell therapy manufacturing to Devens site as part of cost-saving restructuring.
Site closure, viral vector manufacturing, cell therapy, cell therapy manufacturing - Read more

THE BAD
Strategic Plans

Moderna deprioritizes flu/COVID combo vaccine for younger adults as FDA demands efficacy data, delaying potential approval to 2026.
Vaccine, COVID-19, influenza - Read more

THE UGLY
Regulatory

RFK Jr.'s administration to mandate placebo-controlled trials for new vaccines, raising concerns about delays and vaccine confidence
Vaccine, infectious disease, vaccine hesitancy, drug approval process - Read more

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

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