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THE GOOD
Approvals & Labels

Merck & Co.’s Keytruda nabs 29th and 30th approvals in Europe
Monoclonal antibody, endometrial carcinoma, cervical cancer - Read more

Medtronic lands European approval for transcatheter aortic valve replacement implant
Medical device, transcatheter aortic valve replacement implant - Read more

THE GOOD
Business Development

Monopar Therapeutics buys rights to discontinues Wilson’s disease asset ALXN-1840 from AstraZeneca, terms undisclosed
Small molecule, Wilson’s disease - Read more

Chinoin buys Mexico, Latam commercial rights to NTC’s NTC015 colonoscopy prep solutions
Small molecule, colonoscopy preparation - Read more

THE GOOD
Clinical Trials

Intellia Therapeutics posts promising Ph2 data for gene-editing therapy NTLA-2002 in hereditary angioedema
Gene-editing, hereditary angioedema - Read more

GSK touts positive Arexvy (RSV vaccine) Ph3b data in younger adults
Vaccine, respiratory syncytial virus - Read more

Regeneron showcases positive Ph3 Dupixent data in treating uncontrolled chronic spontaneous urticaria
Monoclonal antibody, chronic spontaneous urticaria - Read more

BridgeBio CANaspires confidence with positive preliminary Ph1/2 data for gene therapy BBP-812 in Canavan disease
Gene therapy, Canavan disease - Read more

Hope Medicine inspires hope with positive interim Ph2 data for mAb HMI-115 in treating endometriosis-associated pain
Monoclonal antibody, endometriosis-associated pain - Read more

Zai Lab’s shares jump after reporting positive Ph1a/b data in for ADC ZL-1310 in extensive-stage small-cell lung cancer
Antibody-drug conjugate, lung cancer - Read more

Precision BioSciences makes history with “the first in vivo gene editing program for chronic hepatitis B virus to move into global clinical trials“, PBGENE-HBV
Gene-editing, chronic hepatitis B infection - Read more

Interius BioTherapeutics doses first patient Ph1 trial for in vivo CAR gene therapy
In vivo cell therapy, B-cell malignancies, CAR-T, CAR-NK - Read more

UK Dementia Research Institute launches “Dementia Trial Accelerator” to increase dementia clinical trial recruitment
Dementia, clinical trial recruitment - Read more

Arcus Biosciences casdatifan posts promising Ph1/1b data, could be a strong competitor to Merck & Co.’s Welireg
Small molecule, renal cell carcinoma - Read more 

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⬇️ More Good News ⬇️

THE GOOD
Company Launches

Alyssum Therapeutics launches with $26M Series A, small molecule asset AT-1965 to heat up “immunologically cold tumors“
Small molecule, solid tumor, cancer - Read more

THE GOOD
Fundraises

Fable Therapeutics raises $53.5M with aims to develop new obesity meds by leveraging AI
Antibody, obesity, peptides, AI - Read more [Paywall]

Epitopea $31M Pre-Series A, off-the-shelf RNA-based immunotherapies hard-to-treat cancers
RNA, cancer - Read more

THE GOOD
Investments

Rentschler plans manufacturing site upgrade at their German HQ
CDMO, manufacturing, facility expansion - Read more

Thermo Fisher signs MOU to build 10k sqft “Bioprocess Design Centre” in India’s “Genome Valley”
Greenfield facility, bioprocess - Read more

THE GOOD
Mergers & Acquisitions

Lyell Immunopharma acquires ImmPACT Bio, strengthening CAR-T pipeline
Cell therapy, liquid tumor, cancer, CAR-T - Read more

THE GOOD
Partnerships

Roche, Dyno Therapeutics sign second AAV delivery tech development partnership, $50M upfront, $1B biobucks + royalties
Gene therapy, drug delivery, AAV - Read more

Bayer exercises license option as part of Dewpoint Therapeutics biomolecular condensates collaboration, $424M combined upfront + biobucks
Biomlecular condensates, dilated cardiomyopathy - Read more

QUANTRO Therapeutics, Research Institute of Molecular Pathology partner on transcriptomic drug discovery
Drug discovery, cancer, transcription factor complexes - Read more

PMV Pharmaceuticals partners with MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center for new Ph1b studies using rezatapopt
Small molecule, myelodysplastic syndromes, acute myeloid leukemia, cancer - Read more

THE GOOD
Politics & Policy

19 Massachusetts area companies, including Moderna and Vertex Pharmaceuticals, receive $21.4M in tax breaks to fuel creation of 1,155 jobs
Job creation, tax incentives - Read more

THE GOOD
Public Health

CDC recommends lowering routine pneumococcal vaccine age from 65 to 50
Vaccine, pneumococcal disease - Read more 

THE GOOD
Research

GLP-1s continue their wonderdrug rampage, as Novo Nordisk’s semaglutide linked to reduced risk of Alzheimer’s disease
GLP-1, obesity, Alzheimer’s disease - Read more

Poseida Therapeutics to present encouraging mouse (reduced kallikrein protein activity), primate (edited a gene in the liver) data for hereditary angioedema gene therapy P-KLKB1-101
Gene therapy, hereditary angioedema - Read more

THE GOOD
Strategic Plans

Viking Therapeutics announces accelerated development plans for obesity hopeful VK2735
GLP-1, obesity - Read more

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THE BAD
Clinical Trials

Marinus Pharmaceuticals stock craters after ganaxolone fails in Ph3, company begins exploring dreaded “strategic alternatives”
Small molecule, tuberous sclerosis complex, seizures - Read more

PMV Pharmaceuticals’ rezatapopt + Keytruda (Merck & Co.) exhibits dose-limiting toxicity in Ph1b, combination arm recruitment stopped
Small molecule, solid tumor, cancer - Read more 

THE BAD
Earnings & Finances

CRO Icon’s earnings hit by wider biotech, pharma industry slowdown
Contract research organization - Read more [Paywall]

Lundbeck stomaches $79M write-down on Abide Therapeutics acquisition ($250M in 2019) after pain molecule Lu AG06474 setback
Small molecule, pain - Read more

THE BAD
Layoffs

As part of strategic alternatives search, Marinus Pharmaceuticals plans workforce reduction
Small molecule, tuberous sclerosis complex, seizures - Read more

THE BAD
Market Reports

Europe’s share of global clinical trials shrinks (though total number increases) as trials increase elsewhere; IQVIA report
Global clinical trials - Read more

THE BAD
Patient Access

MGM Resorts to stop covering GLP-1 weight loss meds to its 83,000 employees
GLP-1, obesity, insurance - Read more [Read more]

THE BAD
Public Health

CDC stands firm on RSV vaccine guidance, declines to endorse for younger adults, dealing financial blows to GSK, Moderna, Pfizer
Vaccine, respiratory syncytial virus - Read more 

THE UGLY
Clinical Trials

Eli Lilly, Eisai allegedly failed to disclose Alzheimer’s genetic test results, despite increased brain injury risk if taking Leqembi, Kisunla
Monoclonal antibody, Alzheimer’s disease, brain injury - Read more

THE UGLY
Criminal Acts

UnitedHealth allegedly collected billions from Medicare based on questionable diagnoses, and of which patients received no follow-up care
Health insurance, Medicare - Read more [Paywall]

THE UGLY
Lawsuits

Biocon accused by biotech Y-Trap of stealing their confidential info, using it to start Bicara Therapeutics
Bifunctional antibody-ligand tranps, patent suit, confidential information - Read more  

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

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