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THE GOOD
Approvals & Labels

Eisai and Biogen's Leqembi, targeting amyloid beta, receives conditional EC approval for early-stage Alzheimer's disease, ahead of Eli Lilly's Kisunla
Monoclonal antibody, Alzheimer's disease - Read more

Edwards Lifesciences received CE mark for Sapien M3, a transcatheter mitral valve replacement system for mitral regurgitation using transfemoral approach
Medical device, mitral valve, mitral regurgitation - Read more

THE GOOD
Business Development

Oak Hill Bio licenses Roche's abandoned Angelman syndrome drug rugonersen (targeting UBE3A-ATS), plans Phase III trial after seeing promising results
Antisense oligonucleotide, Angelman Syndrome - Read more

Spruce Biosciences acquires BioMarin's tralesinidase alfa clinical asset for Sanfilippo syndrome type B
Enzyme, Sanfilippo syndrome type B - Read more

Rege Nephro acquires Tamibarotene-related assets from Syros Pharmaceuticals, to conduct US clinical trials after confirming efficacy + safety in ongoing Japan trials
Small molecule, polycystic kidney disease (PKD) - Read more

Nikon CeLL Innovation, RoosterBio strategic licensing agreement to enable GMP manufacturing of MSC and EV therapeutics in Japan
Manufacturing, mesenchymal stem cell, microvesicles - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

eGenesis and OrganOx receive FDA IND clearance for EGEN-5784, a genetically engineered porcine liver with OrganOx ELC system, to treat acute-on-chronic liver failure
Gene-edited organs, liver failure - Read more

MetaVia's DA-1726 (GLP-1/glucagon dual receptor agonist) shows promising weight loss in Ph1 trial for obesity treatment with good safety profile
Hormone, obesity, cardiometabolic disease - Read more

Faron Pharmaceuticals' bexmarilimab, targeting Clever-1, shows high response rates (63% in relapsed/refractory, 76% in frontline) for high-risk myelodysplastic syndrome in Ph2 trial
Monoclonal antibody, myelodysplastic syndrome - Read more

HighTide Therapeutics' berberine ursodeoxycholate (HTD1801) hits primary endpoints in two Ph3 trials for type 2 diabetes mellitus
Small molecule, type 2 diabetes - Read more

GSK's experimental antibiotic gepotidacin (targeting DNA gyrase, topoisomerase IV) was non-inferior to current standard in gonorrhea treatment
Small molecule, gonorrhea, sexually transmitted diseases - Read more

THE GOOD
Company Launches

Meribel Pharma Solutions launches as new mid-size CDMO with 13 European sites
CDMO (Contract Development & Manufacturing Organization), oral solids manufacturing, sterile manufacturing - Read more

THE GOOD
Earnings & Finances

Johnson & Johnson beats Q1 estimates, maintains 2025 earnings guidance despite looming pharmaceutical tariffs
Big pharma earnings - Read more

THE GOOD
Fundraises

Northern Gritstone £50M ($66.2M) fund, UK deeptech and life sciences investment firm supporting early-stage companies
Life science investment, deeptech - Read more

Attovia Therapeutics $90M Series C, developing ATTOBODIES for I&I diseases with Sanofi backing
Biologic, immunology, inflammatory disease, chronic pruritus - Read more

HepaRegeniX €21.5M (~$24.4M) funding, developing liver regeneration therapies for clinical trials of HRX-215 candidate
Small molecule, liver disease, liver regeneration - Read more

ThirtyFiveBio (undisclosed amount) bridge financing, developing small molecule inhibitors for gastrointestinal disease treatment
Small molecule, digestive tract colitis, cancer - Read more

Potato raises $4.5M to develop AI research assistants (and eventually robotics) for automating scientific experiments and science in general
AI, laboratory automation, AI research assistant, autonomous research lab - Read more

THE GOOD
Investments

Tailored Genes building viral vector facility in Ontario, expanding fivefold to enhance gene therapy services by 2025
New facility, adeno-associated virus (AAV), lentiviral vector (LVV), reagents, viral vector manufacturing - Read more

THE GOOD
Mergers & Acquisitions

Norgine acquires French rare disease drugmaker Theravia, adding established treatments to its expanding rare disease portfolio
Small molecule, sickle cell disease, bile acid synthesis disorder - Read more

Haleon acquires Tianjin Pharmaceutical's 12% stake in their Chinese joint venture for €190 million, gaining full control
Consumer health, over-the-counter - Read more

THE GOOD
Opinions

Johnson & Johnson CEO urges tax policy changes over tariffs to boost US pharmaceutical manufacturing, highlighting $55B investment plan
Tariffs, domestic manufacturing - Read more

THE GOOD
Partnerships

Merck & Co., Cyprumed collaborate on oral formulations of macrocyclic peptides using Cyprumed's delivery technology
Peptide, drug delivery, drug development - Read more

Illumina, Tempus AI partnering to expand DNA sequencing tests beyond cancer through AI algorithm training
DNA sequencing, AI, disease screening - Read more

Biostate AI, Accelerated Cure Project partnering to develop AI models for predicting MS progression using transcriptomic data
-omics, AI, multiple sclerosis (MS), disease progression tracking, clinical outcome prediction - Read more

Sartorius, Mabion partner to streamline biologics development with integrated CDMO services
CDMO (Contract Development & Manufacturing Organization), manufacturing partnership - Read more

THE GOOD
Politics & Policy

Trump orders Congress to remove IRA's "pill penalty" in effort to lower drug prices
Inflation Reduction Act, drug patents - Read more

THE GOOD
Strategic Plans

NAYA Biosciences spins off cancer drug business to NAYA Therapeutics, returning to fertility focus as INVO Fertility
Bispecific antibody, cancer, hepatocellular carcinoma, infertility - Read more

THE BAD
Clinical Trials

Sanofi's amlitelimab (anti-OX40) misses primary endpoint in Ph2 asthma trial
Monoclonal antibody, asthma - Read more

Mural Oncology discontinues nemvaleukin alfa (targeting IL-2Rβγc, composed of CD122 and CD132) after unsuccessful Ph2 ARTISTRY-6 trial in melanoma and Ph3 ARTISTRY-7 in platinum-resistant ovarian cancer
Fusion protein, ovarian cancer, melanoma - Read more

THE BAD
Layoffs

Mural Oncology cuts 90% of staff after nemvaleukin alfa comes up short in two cancers, seeks strategic alternatives
Fusion protein, ovarian cancer - Read more

Myeloid Therapeutics restructures to focus on clinical-stage programs, cutting staff by about one-third
Cell therapy, gene-editing, In-vivo cell therapy, cancer, solid tumor - Read more

THE BAD
Politics & Policy

Trump administration investigates pharmaceutical imports to assess national security risks, likely prelude to tariffs
Tariffs, generic, medical countermeasures - Read more [Paywall]

THE UGLY
Politics & Policy

Harvard faces $2.2 billion funding freeze from Trump administration over refusal to limit campus activism
Federal research funding - Read more

Harvard scientist ordered to halt TB research due to federal funding freeze amid antisemitism allegations against university
Tuberculosis, federal research funding - Read more [Paywall]

THE UGLY
Warning Letters, Form 483

FDA issues 11 observations to Aurobindo's North Carolina inhaler plant following March-April inspection
Inhaler, inhaler manufacturing, undisclosed regulatory infraction - Read more

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

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