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THE GOOD
Approvals & Labels

ARS Pharmaceuticals' Neffy (epinephrine nasal spray) lands FDA approval for treating anaphylaxis in children 4+ years weighing 15-30kg
Small molecule, anaphylaxis, allergic reaction, nasal spray, drug delivery - Read more

Biocon Pharma receives two FDA approvals, one each for for lenalidomide (targeting CRBN) and dasatinib (tyrosine kinase inhibitor)
Small molecule, lymphoma, anemia, myelodysplastic syndrome, cancer, leukemia, generic - Read more

Neurotech nabs FDA approval for Encelto (ciliary neurotrophic factor delivery) encapsulated cell therapy for macular telangiectasia type 2 (MacTel)
Cell therapy, macular telangiectasia type 2 (MacTel), encapsulated delivery, drug delivery - Read more

THE GOOD
Business Development

Nhwa Pharmaceutical invests $3.5M for 10.448% stake in Neuro3 Therapeutics
Small molecule, Parkinson's disease, epilepsy, pain - Read more [Press release in Chinese]

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THE GOOD
Clinical Trials

Luxa Biotechnology's RPESC-RPE-4W cell therapy shows vision improvement in Ph1/2a trial for dry age-related macular degeneration patients.
Cell therapy, age-related macular Degeneration (AMD), stem cell-derived therapy -Read more

ITM's ¹⁷⁷Lu-edotreotide delivers positive topline Ph3 data in treating neuroendocrine tumors
Radiopharm, neuroendocrine tumor, cancer - Read more

Tris Pharma's showcases positive Ph2 data for cebranopadol (mu-type opioid receptor) for moderate-to-severe acute pain following bunionectomy surgery; FDA submission planned
Small molecule, pain following bunionectomy surgery - Read more

Laminar Pharma touts positive Ph2 data for LAM561 (SGMS1 stimulant) for newly diagnosed glioblastoma with MGMT-methylation, when combined with chemoradiotherapy
Small molecule, glioblastoma, cancer - Read more

THE GOOD
Fundraises

Frazier Life Sciences raising new venture fund (XII) following $987M FLS XI
Venture capital - Read more [Paywall]

Ataraxis AI $20.4M Series A, AI precision medicine company developing next-gen cancer prognosis and treatment selection tools
Precision medicine, AI, clinical outcome prediction, breast cancer, cancer detection/screening - Read more

hema.to €3.6M ($3.9M) funding, digital medtech company advancing blood cancer diagnostics and immune disorders.
Cancer, diagnostics - Read more

Innovate UK £14M+ ($18M+) investment in 29 projects to transform sustainable UK medicines manufacturing
Company creation/building, sustainability - Read more

THE GOOD
IPOs

Kestra Medical Technologies prices upsized IPO at $17 per share, hoping to raise $202M before expenses
Virtual healthcare, medical device, wearable device - Read more

THE GOOD
Lawsuits

Court approves $700M settlement from drug companies to 1,000+ hospitals over opioid misconduct allegations
Opioid epidemic - Read more

THE GOOD
Mergers & Acquisition

Momentum Biotechnologies acquires OmicScouts, expanding its mass spectrometry-based drug discovery services into Europe
Drug discovery, mass spectrometry, proteomics, high-throughput screening - Read more

Cold Chain Technologies acquires Global Cold Chain Solutions, expanding its thermal packaging capabilities in Australia and India
Supply chain, cold chain - Read more

Supreme Group acquires Kadiko, its seventh acquisition, expanding AI-enhanced digital marketing capabilities for healthcare and life sciences brands
Drug marketing, life science marketing, AI - Read more

Walgreens to be acquired by Sycamore Partners for $10B, going private at $11.45 per share
Pharmacy, take-private deal - Read more

CVS Health sells Medicare Shared Savings Program to Wellvana, making Wellvana a major value-based care support company
Centers for Medicare and Medicaid Services (CMS) - Read more

THE GOOD
Partnerships

Astellas Pharma, YASKAWA, establishing joint venture for cell therapy manufacturing platform using Maholo robot
Cell therapy, cell therapy manufacturing, automated manufacturing, manufacturing platform - Read more

Alfresa Holdings, Minaris Regenerative Medicine, collaborate on cell therapy development and manufacturing in Japan
CDMO (Contract Development & Manufacturing Organization), cell therapy, cell therapy manufacturing - Read more

THE GOOD
Strategic Plans

Novo Nordisk's rare disease unit awaits late-stage trial data on etavopivat for sickle cell disease next year after $1.1B Forma acquisition
Small molecule, sickle cell disease - Read more [Paywall]

Novo Nordisk to investigate potential of GLP-1 drugs like Ozempic and Wegovy in treating addiction
GLP-1, addiction - Read more

Merck KGaA expects minimal impact from Trump's China tariffs, thanks to earlier supply chain regionalization efforts
Supply chain, domestic manufacturing, tariffs - Read more [Paywall]

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THE BAD
Approvals & Labels

UK's NICE rejected Biogen and Eisai's Leqembi (targeting amyloid beta) and Eli Lilly's Kisunla (targeting amyloid beta) for Alzheimer's disease, deeming them not cost-effective despite regulatory approvals
Monoclonal antibody, Alzheimer's disease - Read more

THE BAD
Clinical Trials

Denali Therapeutics' DNL343 (target eIF2B) failed to slow amyotrophic lateral sclerosis progression in Ph2/3 trial
Small molecule, amyotrophic lateral sclerosis (ALS/Lou Gehrig's disease) - Read more

Merck KGaA's enpatoran (TLR7/8 antagonist) misses Ph2 primary endpoint in systemic lupus erythematosus, but may advance due to subgroup responses
Small molecule, lupus erythematosus - Read more

THE BAD
Lawsuits

German court rules Pfizer and BioNTech violated Moderna's COVID-19 vaccine patent, orders compensation
Patent suit, vaccine, COVID-19, vaccine suit - Read more

On the other side of the pond, US Patent Office invalidates two Moderna COVID-19 vaccine patents amid infringement lawsuit against Pfizer and BioNTech
Patent suit, vaccine, COVID-19, vaccine suit - Read more

THE BAD
Mergers & Acquisitions

Merck KGaA may be stalling on SpringWorks acquisition, though says talks are ongoing
M&A strategy, big pharma strategy - Read more

Relief Therapeutics ends merger talks with Renexxion after key conditions weren't met within required timeframe
Rare disease, dermatological disorders, metabolic disease, respiratory disease - Read more

THE BAD
Politics & Policy

Bhattacharya, Trump's NIH nominee, faced Senate questions on vaccine skepticism and research funding during confirmation hearing
Vaccine, political appointee, public trust, public health policy, NIH - Read more

THE BAD
Strategic Plans

Zymeworks changes course, suspending development of ZW220 (targeting NaPi2b) to focus on ZW251 (targeting GPC3) for hepatocellular carcinoma
Antibody-drug conjugate (ADC), cancer, hepatocellular carcinoma - Read more

THE UGLY
Politics & Policy

RFK Jr.'s decision to limit public comment on HHS rules faces opposition from patient groups pushing for transparency
Public health policy - Read more [Paywall]

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

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