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  • Biotech & Pharma Updates | January 23 - 26, 2025

Biotech & Pharma Updates | January 23 - 26, 2025

Chaos amongst US public health and research agencies, Novo Nordisk gets a boost on next-gen obesity hopeful's amycretin Ph1b/2a data, Aardvark Therapeutics files IPO to fund development of obesity drug candidates, Merck & Co. and Eisai's Keytruda + Lenvima combo (partially) flops in gastroesophageal cancer treatment Ph3 + 28 more stories

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⬇️ The Good News ⬇️

THE GOOD
Clinical Trials

Novo Nordisk's amycretin (targeting GLP-1 and amylin receptors) demonstrates 22% weight loss in Ph1b/2a obesity trial, potentially besting competitor Eli Lilly
Small molecule, obesity - Read more

ALX Oncology touts positive Ph2 results for evorpacept (targeting CD47) in HER2-positive gastric cancer when combined with trastuzumab, ramucirumab and paclitaxel
Fusion protein, gastric cancer - Read more

SELLAS Life Science showcases positive Ph3 interim analysis data for galinpepimut-S (targeting WT1) Ph3 trial continues after positive interim analysis for treating acute myeloid leukemia, with final analysis expected this year.
Peptide, myeloid leukemia, cancer, cancer vaccine - Read more

EXUMA Biotech's touts promising Ph1 results for CCT303-406 (targeting HER2) CAR-T therapy in advanced solid tumors, including gastrointestinal and breast cancers
Cell therapy, gastrointestinal cancer, breast cancer, CAR-T - Read more

CG Pharmaceuticals showcases Ph1b/2 trial results of ivaltinostat (HDAC inhibitor) plus capecitabine (nucleoside metabolic inhibitor) for metastatic pancreatic cancer
Small molecule, pancreatic cancer - Read more

Bristol Myers Squibb's Opdivo (targeting PD1) and Yervoy (targeting CTLA-4) combo delivers better survival than Opdivo alone in Ph3 trial for metastatic colorectal cancer
Monclonal antibody, colorectal cancer - Read more

Exelixis touts Ph1b/2 data for zanzalintinib (tyrosine kinase inhibitor) alone or with atezolizumab (targeting PD-L1) in metastatic colorectal cancer
Small molecule, colorectal cancer - Read more

Outlook Therapeutics' posts further details of ONS-5010 (target VEGF) Ph3 trial in wet age-related macular degeneration
Monoclonal antibody, wet age-related macular degeneration (wet AMD) - Read more

THE GOOD
Company Launches

Swarm Oncology emerges from stealth, appoints CEO Martin Olin, and reveals platform for T cell cancer therapy targeting solid tumors
Cell therapy, solid tumor, cancer, T cell - Read more

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⬇️ More Good News ⬇️

THE GOOD
Fundraises

Evotec, Yonsei University, Zymedi collectively receive $4.5M grant from Korea Institute of Advanced Technology to develop antibody treatments for lung diseases
Antibody, asthma, idiopathic pulmonary fibrosis - Read more

Allurion $7.4M registered direct offering, medical device company developing weight loss solutions uses funds for working capital
Medical device, obesity, gastric balloon - Read more

THE GOOD
IPOs

Aardvark Therapeutics files IPO to fund development of obesity drug candidates, following competitor Metsera's similar move
Small molecule, obesity - Read more

Chinese biotech Ascentage Pharma raises $126M in 2024's first US IPO to advance cancer drugs, including China-approved leukemia treatment
Small molecule, leukemia, cancer - Read more

THE GOOD
Marketing

EMA leaves X (formerly Twitter) platform for Bluesky, citing communication needs, but keeps X account to prevent impersonation and monitor health discussions
Social media, outreach - Read more

THE GOOD
Market Reports

Merck & Co.'s PAH drug Winrevair expected to grow strongly in 2025, as real-world bleeding risks appear lower than clinical trials suggested
Fusion protein, pulmonary arterial hypertension - Read more

THE GOOD
Partnerships

China Medical System, Hunan Mabgeek Biotechnology partner to develop and commercialize inflammatory disease drug MG-K10 (IL-4Rα) in China
Monoclonal antibody, inflammatory disease, drug development, commercialization - Read more [Press release in Chinese]

Zerion Pharma, Aché partner to enhance bioavailability and patient-friendliness of two marketed oncology and neuroscience drugs
Drug delivery, drug formulation, oncology, cancer, neuroscience - Read more

Flagship Pioneering, Cambridge University Health Partners, Milner Therapeutics Institute partner for biotech resource sharing and research development
Research collaboration, biotech resource sharing, company incubation - Read more

Tevogen Bio, Microsoft expand AI partnership to develop PredicTcell T-cell targeting technology on Azure cloud platform
Cell therapy, drug development, T-cell, AI - Read more

Biosero, BD partner to integrate robotic automation with flow cytometry systems for drug discovery acceleration
Drug discovery, robotics, automation, flow cytometry, drug development - Read more

THE GOOD
Research

Scientists develop peptides that may help boost drug effectiveness via novel formulations, showing promise in leukemia models
Peptide, cancer, leukemia, drug formulation - Read more

Scientists identify type of immune cells that appear crucial for successful treatment of relapsed acute myeloid leukemia
Leukemia, cancer - Read more

THE GOOD
Strategic Plans

Fujifilm Diosynth CEO expects half of $8B manufacturing investments to be operational by late 2025, including Denmark plant expansion
CDMO, contract manufacturing, facility investments, facility expansion - Read more

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⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Merck & Co. and Eisai's combo Keytruda (targeting PD-1) + Lenvima (multi-kinase inhibitor) delivers a Ph3 overall survival flop in first-line gastroesophageal cancer treatment (though hits progression-free survival endpoint)
Monoclonal antibody, gastroesophageal cancer, small molecule - Read more

THE BAD
Company Shutdown

Westlake-backed Dantari Pharmaceuticals probably defunct, sells assets and technology to fellow Westlake portfolio company Adanate
Polymer nanoparticle-drug conjugate, breast cancer - Read more [Paywall]

THE BAD
Earnings & Finances

Astellas faces $1.1B impairment charges, mostly from eye drug Izervay (targeting C5), after European market withdrawal and reduced profit forecasts
RNA aptamer, geographic atrophy secondary to age-related macular degeneration, market withdrawal - Read more

THE BAD
Patient Access

Takeda discontinues gout medication Uloric in US after 14 years due to increased generic competition
Small molecule, gout, generic - Read more

THE BAD
Warning Letters, Form 483

Novo Nordisk faces UK criticism for failing to disclose seven years of payments to health organizations, violating industry codes
Disclosure, payments to organizations - Read more [Paywall]

⬇️ The Ugly News ⬇️

THE UGLY
Politics & Policy

NIH grant review cancellations cause panic among scientists, threatening research funding and future medical innovations in the United States
National Institute of Health, grant reviews, research funding - Read more [Paywall]

THE UGLY
Regulatory

HHS, FDA, and other public health agency pause could delay upcoming drug approval decisions (but won't affect final outcomes)
Department of Health and Human Services, drug approval process - Read more

FDA compelled to remove clinical trial diversity guidelines from website following Trump administration's DEI opposition, flying in the face of everything we know about diversity in clinical trials
Clinical trial diversity, diversity equity and inclusion - Read more [Paywall]

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

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