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THE GOOD
Approvals & Labels

Eli Lilly nabs FDA approval for lebrikizumab in atopic dermatitis
Monoclonal antibody, atopic dermatitis, eczema - Read more

Nuvation Bio hopes for FDA ok with pooled data NDA for taletrectinib in lung cancer
Small molecule, lung cancer - Read more

THE GOOD
Clinical Trials (big section today due to ESMO 2024)

Monoclonal antibody

Pfizer posts positive Ph2 results with ponsegromab in patients with cachexia
Monoclonal antibody, cachexia, cancer - Read more

GSK, iTeos Therapeutics Ph2 monoclonal antibody combo win (Jemperli + belrestotug) in lung cancer
Monoclonal antibody, lung cancer - Read more

Bristol Myers Squibb touts impressive 10+ year survival results in extended Ph3 for Opdivo-Yervoy combo in melanoma
Monoclonal antibody, melanoma, skin cancer - Read more

Merck & Co., Eisai hope new Ph3 Keytruda-Lenvima combo data LEAPs past previous liver cancer failings
Monoclonal antibody, small molecule, liver cancer - Read more

AstraZeneca posts positive Ph3 Imfinzi perioperative study data
Monoclonal antibody, bladder cancer - Read more

Incyte touts positive Ph3 Zynyz data in advanced anal cancer
Monoclonal antibody, squamous cell carcinoma, anal cancer - Read more [Paywall]

Small molecule

Scorpion Therapeutics posts positive Ph1/2 STX-478 solid tumor, breast cancer data
Small molecule, solid tumor, breast cancer - Read more

Novartis’ Kisqali Ph3 shows reduced breast cancer reoccurrence risk
Small molecule, breast cancer - Read more

Bayer’s darolutamide (+ androgen deprivation therapy) Ph3 data points to reduced prostrate cancer radiological progression
Small molecule, prostrate cancer - Read more

Boehringer Ingelheim’s nerandomilast hits Ph3 endpoint
Small molecule, idiopathic pulmonary fibrosis - Read more

FDA lifts Zentalis Pharmaceutical’s partial clinical hold on azenosertib
Small molecule, ovarian cancer, uterine serous carcinoma - Read more

Exelixis, Ipsen shut the CABINET with “final results” from Ph3 Cabometyx data in neuroendrocrine tumors
Small molecule, neuroendocrine tumor, cancer - Read more

All other modalities

BioAtla presents “meaningful” ozuriftamab vedotin Ph2 carcinoma data
Antibody-drug conjugate, cancer - Read more

BioNTech showcases bispecific antibody Ph2 lung cancer data
Bispecific antibody, lung cancer - Read more [Paywall]

Jazz Pharmaceuticals’ positive Ph2 zanidatamab data in gastroesophageal cancer
Bispecific antibody, gastroesophagel cancer - Read more

IO Biotech’s off-the-shelf cancer vaccine (IO102-IO103) + Keytruda combo Ph2 hits primary endpoint in squamous cell carcinoma
Cancer vaccine, carcinoma, head & neck cancer - Read more

Ascendis Pharma’s TransCon CNP’s stellar Ph3 data, once-weekly regimen directly challenges BioMarin’s daily Voxzogo
Recombinant polypeptide, dwarfism, achondroplasia - Read more

Evaxion Biotech posts “convincing” Ph2 cancer vaccine data
Personalized cancer vaccine, melanoma, skin cancer - Read more

Exact Sciences touts blood-based colorectal cancer detection data
Cancer screening, blood test, colorectal cancer - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Company Incubation

SCbioDrive inaugural oncology/neuroscience startup cohort
Company building, incubation - Read more

THE GOOD
Fundraises

Nuvalent upsized public offering of common stock, up to $500M in gross proceeds
Small molecule, cancer - Read more

THE GOOD
Investments

Sanofi’s new beyfortus manufacturing line christened by FDA
Vaccine, respiratory syncytial virus (RSV), manufacturing - Read more 

THE GOOD
IPOs

Biotech IPOs get late year boost, with Bicara Therapeutics, Zenas BioPharma, MBX Bioscience all debuting last friday - Read more [Paywall]

THE GOOD
Partnerships

Novo Nordisk, Korro Bio’s $530M biobucks deal using Korro’s “Oligonucleotide Promoted Editing of RNA (OPERA) platform“ for cardiometabolic-related targets
RNA editing, platform technology, cardiometabolic disease - Read more

Vivtex, Equillium partner on oral formulation for EQ302 anti-inflammatory peptide
Peptide, autoimmune, inflammation - Read more

Tharimmune, Intract Pharma partner on infliximab oral formulation
Monoclonal antibody, autoimmune, inflammation - Read more

THE GOOD
Regulatory

FDA posts draft guidance for multiregional (global) oncology trials
Clinical trial design, oncology, cancer - Read more

EMA provides further single-arm trial advice but prefers placebo-controlled trials; working paper
Clinical trial design - Read more [Paywall]

THE GOOD
Research

mRNA COVID-19 vaccines may increase cancer immunotherapy effectiveness; study
mRNA, COVID-19, immunotherapy - Read more

THE GOOD
Strategic Plans

As Roche plows ahead with obesity ambitions, manufacturing plans aim to avoid supply bottlenecks faced by Novo Nordisk, Eli Lilly
Small molecule, GLP-1 agonist, type 2 diabetes, obesity - Read more

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THE BAD
Approvals & Labels

Intercept Pharmaceutical’s Ocaliva handed fat thumbs down from FDA adcomm regarding full approval
Small molecule, primary biliary cholangitis - Read more

Medexus’ treosulfan FDA PDUFA date pushed by back 3 months
Small molecule, allogeneic hematopoietic stem cell transplantation, leukemia, myelodysplastic syndrome, cancer - Read more

THE BAD
Clinical Trials

Lantheus’ “statistically significant” Lu-PNT2002 Ph3 data makes little SPLASH as compared to Novartis’ already approved Pluvicto
Radiopharma, prostrate cancer - Read more

THE BAD
Partnerships

Bristol Myers Squibb walks on $150M Immatics bispecific wager as part of ongoing “portfolio prioritization”
Bispecific fusion protein, solid tumor, cancer - Read more

THE BAD
Strategic Plans

Biotech veteran Genentech faces mounting concerns, citing recent closures and layoffs - Read more [Paywall]

THE UGLY
No Ugly News today!

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

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