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  • Biotech & Pharma Updates | December 11 - 12, 2024

Biotech & Pharma Updates | December 11 - 12, 2024

Investors sue BMS on alleged reneging on milestone payments, Novo Nordisk's Ozempic lands kidney disease-related label expansion in the EU, Expression Therapeutics has “promising” Ph1 hemophilia A gene therapy data, Keros Therapeutics stock plummets on PAH clinical trial holds due to pericardial effusion cases + 32 more stories

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Novo Nordisk’s Ozempic lands kidney disease-related label expansion from EMA
GLP-1, chronic kidney disease - Read more

Johnson & Johnson’s miniaturized heart pumps get FDA nod in pediatric patients
Medical device, heart pump, acute heart failure, cardiogenic shock - Read more

THE GOOD
Business Development

Elevation Oncology licenses ADC drug development platform from Synaffix
Antibody-drug conjugate, cancer, drug development - Read more

Meitheal Pharmaceuticals buys US commercial rights to Xenleta (lefamulin acetate) from Hong Kong King-Friend Industrial (which it had acquired from now defunct Nabriva Therapeutics)
Small molecule, community-acquired bacterial pneumonia, infection - Read more

Neopharm Israel buys Israel commercial rights to Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) from Esperion Therapeutics
Small molecule, cardiovascular disease, cholesterol, myocardial infarction, coronary revascularization - Read more

BeiGene buys global license to CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) SYH2039 (MAT2A inhibitor)
Small molecule, glioblastoma, pancreatic cancer, lung cancer - Read more

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⬇️ More Good News ⬇️

THE GOOD
Clinical Trials

Pfizer touts Ph3 win for palbociclib (CDK4/6 inhibitor) in "double-positive" metastatic breast cancer
Small molecule, breast cancer - Read more

Blue Lake Biotechnology’s additional “promising” data from pediatric Ph1/2a trial of BLB201 intranasal RSV vaccine
Vaccine, respiratory syncytial virus, intranasal - Read more

Caliway Biopharmaceutical touts “successful” Ph2b trial of CBL-514 (inducing adipocyte cell death by apoptotic mechanism) in reducing abdominal subcutaneous fat
Small molecule, abdominal subcutaneous fat - Read more

Expression Therapeutics touts “promising” Ph1 data for lentiviral vector-based gene therapy ET3 in hemophilia A
Gene therapy, hemophilia A, LVV - Read more

ADC Therapeutics showcases positive initial Ph1b data for ADC Zynlonta (targeting CD19) in combo with bispecific Columvi (targeting CD20, CD3) in B-cell lymphoma
Antibody-drug conjugate, B-cell lymphoma, cancer, bispecific antibody - Read more

Aptevo Therapeutics touts positive acute myeloid leukemia remission results from specific cohort in Ph1b mipletamig (CD3, CD123) trial
Bispecific antibody, leukemia, cancer - Read more 

THE GOOD
Company Incubation

Evotec and Novo Nordisk’s drug discovery accelerator LAB eN2 debuts first three projects and five new academic partners
Drug discovery, company creation - Read more

THE GOOD
Fundraises

Redesign Health’s closes $175M towards new fund focused on healthcare, health tech companies
Venture capital, healthcare investing, health tech - Read more

KHP Ventures aims for a new, $25M focused mental health-startup fund
Venture capital, company creation, depression, anxiety, psychosis - Read more 

NewAmsterdam Pharma $300M public offer
Small molecule, cholesterol, cardiovascular disease - Read more

Essential Pharma €900M ($945M) recapitalization
Small molecule, chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis, biologic, neuroblastoma, cancer - Read more

Okogen $3.3M financing to drive Ph2b trial of pink eye treatment
Enzyme, acute infectious conjunctivitis, pink eye - Read more

Pleno $25M Series B, multiomic diagnostics
Diagnostics, omics, multiplexing, sequencing - Read more

Aptevo Therapeutics exercises of warrants for $6.2M gross proceeds
Bispecific antibody, leukemia, cancer - Read more

THE GOOD
Mergers & Acquisitions

General Inception acquires Enable Medicine, AI-powered biological data platform for drug R&D
Biological data, AI, drug development, drug discovery - Read more

Tenpoint Therapeutics, Visus Therapeutics merger, focusing on next-gen ophthalmic medicines
Small molecule, presbyopia, eye drop - Read more

Bausch + Lomb confirms rumors that they’re exploring a sale
Contact lenses, eye care - Read more

THE GOOD
Partnerships

Dewpoint Therapeutics, ConcertAI “transitional oncology” partnership focused on solid tumor hopeful DPTX3186 (beta catenin oncogenic function inhibitor)
Small molecule, solid tumor, cancer - Read more

Neurimmune, AICURA Medical AI-powered Alzheimer’s disease drug development collab
Monoclonal antibody, Alzheimer’s disease, AI - Read more

Neuraxpharm, Pharmathen long-acting injectable development collab
Long-acting injectables, central nervous system disorder, psychiatric disorder - Read more

Daewoong Pharmaceutical, Tiolab Therapeutics, Daehan Nupharm, Dalim Biotech collab on once-monthly obesity injection development based on semaglutide and novel slow-release tech
GLP-1, obesity, drug delivery - Read more [Press release in Korean]

THE GOOD
Research

Evaxion bullish on cancer vaccine resurgence, touts preclinical data on their cancer vaccine attempt powered by their AI-immunology platform; mouse studies
Cancer vaccine, solid tumor, AI - Read more

Topical vaccines might be a thing, as common skin bacteria engineered to express a tetanus toxin, with exposed mice developing tetanus resistance (similar results in diphtheria)
Vaccine, diphtheria, tetanus, topical - Read more

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⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Keros Therapeutics stock plummets as two Ph2 treatment arms of KER-012 (anti-MSTN/INHBA/GDF11) in pulmonary arterial hypertension put on hold after unexpected cases of pericardial effusion
Monoclonal antibody, pulmonary arterial hypertension - Read more

Corcept Therapeutics’ dazucorilant (selective cortisol modulator) Ph2 flop in ALS
Small molecule, amyotrophic lateral sclerosis - Read more

THE BAD
Lawsuits

Bristol Myers Squibb allegedly reneged on milestone payments to investors of acquisition Padlock Therapeutics, according to new lawsuit
Antibody, rheumatoid arthritis, autoimmune - Read more [Paywall]

THE BAD
Layoffs

Bavarian Nordic closes San Diego site, cuts 48 employees
Vaccine, manufacturing site - Read more

Editas Medicine will layoff 180 employees after unsuccessful attempts to out-license sickle cell disease CRISPR med
Gene-editing, sickle cell disease, CRISPR - Read more

THE BAD
Strategic Plans

iTeos Therapeutics drops Ph2-asset inupadenant (adenosine A2A receptor antagonist) in lung cancer after failing internal review
Small molecule, lung cancer - Read more

Lonza preps capsule and health ingredient business exit, despite “industry-leading profit margins” in pivot towards the “pure-play CDMO business”
CDMO, manufacturing, capsules, health ingredients - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Adverse Events

Intercept Pharmaceuticals, Alfasigma’s primary biliary cholangitis med Ocaliva (farnesoid X receptor agonist) faces additional setbacks as FDA flags 20 new “serious liver damage” cases
Small molecule, primary biliary cholangitis, liver damage - Read more

THE UGLY
Earnings & Finances

ICER flags another flagrant cash grab by the pharma industry - $815M in price increases “unsupported” by new clinical data and “far above the rate of inflation”
Drug pricing - Read more

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

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