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THE GOOD
Approvals & Labels

Biocon Biologics’ Yesintek (targeting IL-12 and IL-23; Stelara biosimilar, Johnson & Johnson) nabs FDA approval
Monoclonal antibody, Crohn's disease, ulcerative colitis, plaque psoriasis, psoriatic arthritis - Read more

Johnson & Johnson submits sBLA to FDA for pediatric Tremfya (targeting IL-23) approval
Monoclonal antibody, plaque psoriasis, juvenile psoriatic arthritis - Read more

Stallergenes Greer lands positive CHMP opinion to extend Palforzia label to toddlers age 1 to 3 with confirmed peanut allergy
Defatted peanut powder, peanut allergy - Read more

THE GOOD
Business Development

Novartis lands exclusive licensing rights to PTC Therapeutics’ PTC518 (huntingtin pre-mRNA splicing modifier)
Small molecule, Huntington’s disease - Read more

Helix Biopharma acquires rights to Laevoroc Immunology’s LR 09 (metabolic immune checkpoint inhibitor) in relapsing leukemia
Small molecule, leukemia, cancer - Read more

China Medical System buys commercial rights to Atom Therapeutics’ lingdolinurad (URAT1 inhibitor) in gout and hyperuricemia
Small molecule, chronic gout, hyperuricemia - Read more

THE GOOD
Clinical Trials

Merus touts expanded Ph2 data for petosemtamab (targeting EGFR) bispecific in head-and-neck cancer
Bispecific antibody, head-and-neck squamous cell carcinoma, cancer - Read more

Purple Biotech’s mAb CM24 (blocking CEACAM1) delivers positive Ph2 results in pancreatic cancer
Monoclonal antibody, pancreatic ductal adenocarcinoma, cancer - Read more

Senti Biosciences’ stock skyrockets 400%+ on positive early Ph1 data for their allogeneic CAR-NK therapy in acute myeloid leukemia
Cell therapy, acute myeloid leukemia, cancer, CAR-NK - Read more

Novocure’s tumor treating electric fields hit Ph3 goals in pancreatic cancer
Medical device, pancreatic adenocarcinoma, cancer, electric fields - Read more

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⬇️ More Good News ⬇️

THE GOOD
Earnings & Finances

AstraZeneca, Daiichi Sankyo’s Enhertu (targeting HER2) added to Chinese drug reimbursement list
Antibody-drug conjugate, lung cancer - Read more

THE GOOD
Finances

KisoJi Biotechnology $41M equity raise, to push KJ-103 (targeting TROP2) into clinic for solid tumors
Monoclonal antibody, solid tumor, cancer - Read more

Allink Biotherapeutics $42M Series A, advancing bispecific and ADC pipeline
Bispecific antibody, antibody-drug conjugate, cancer - Read more

Senti Biosciences $37.6M private placement, advancing pipeline of off-the-shelf CAR-NK therapies
Cell therapy, acute myeloid leukemia, cancer, CAR-NK - Read more

Autoimmunity BioSolutions $2M Seed raise, developing mAbs targeting sIL7R to treat autoimmune disorders
Monoclonal antibody, autoimmune disorders - Read more

SRTD Biotech undisclosed Seed raise, RNA-based therapeutics for liver cancer
RNA, liver cancer - Read more

Theratechnologies up to $75M credit facility
Monoclonal antibody, small molecule, human immunodeficiency virus, cancer, hepatology - Read more

THE GOOD
Investments

Sanofi earmarks €1B ($1.1B) for Beijing, China-based insulin manufacturing site
Insulin, diabetes, manufacturing - Read more

THE GOOD
Mergers & Acquisitions

XOMA Royalty acquires Pulmokine, primarily for hypertension Ph3 hopeful seralutinib (selective kinase inhibitor targeting PDGFRα/β, CSF1R, and c-KIT)
Small molecule, pulmonary arterial hypertension - Read more

THE GOOD
Partnerships

Novartis, Olema Oncology clinical trial and supply collab for palazestrant (complete estrogen receptor antagonist, selective estrogen receptor degrader) + ribociclib (CDK4/6 inhibitor) combo for Ph3 trial in breast cancer
Small molecule, breast cancer - Read more

Samjin Pharmaceutical, APITBIO ADC research & development partnership targeting solid tumors
Antibody-drug conjugate, solid tumor, cancer, research & development - Read more [Press release in Korean]

THE GOOD
Regulatory

FDA defends use of guidance documents in new report
Regulatory guidance - Read more

THE GOOD
Research

University of Illinois develop DNA-based “nanorobot” that could prevent viral infections
DNA-based nanorobot, biosensor, infectious disease, viral infection - Read more 

THE GOOD
Strategic Plans

Agenus launches CDMO business
CDMO, biologics manufacturing - Read more [Paywall]

Apogee Therapeutics has ambitions plans for their mAb APG777 (targeting IL-13), head-to-head with Dupixent (Sanofi, Regeneron)
Monoclonal antibody, atopic dermatitis, inflammation - Read more [Paywall]

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THE BAD
Layoffs

Alligator Bioscience to cut 70% of workforce
Monoclonal antibody, pancreatic cancer - Read more

THE BAD
Politics & Policy

Former Trump-era FDA commissioner has grave concerns over incoming HHS head RFK Jr.’s vaccine policy, will “cost lives in this country”
Political appointee, vaccine policy, public health - Read more

THE UGLY
Public Health

When it comes to preventing antibiotic resistant superbugs, most major US restaurant chains aren’t taking it seriously
Antibiotic resistance, superbugs - Read more

THE UGLY
Shortages

Radiopharma industry growth (and patient access) threatened by “significant talent shortage”
Radiopharm, qualified personnel - Read more [Paywall]

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

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