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  • Biotech & Pharma Updates | August 19 - 20, 2024

Biotech & Pharma Updates | August 19 - 20, 2024

Eli Lilly's GIP/GLP-1 golden-goose reduces type 2 diabetes occurrence, J&J nabs FDA approval for first-line mAb+small molecule combo in lung cancer, Pathalys Pharma $105M Series B, Organon buys migraine med Emgality rights from Eli Lilly for multiple countries, Emergent to donate 50k smallpox vaccines, Ozempic/Wegovy use may be linked to suicidal thoughts, Teva & Biogen (separately) sued for alleged pharmacy/PBM kickbacks related to MS meds

All the top Biotech & Pharma news in one daily newsletter.

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⬇️ The Good News ⬇️

THE GOOD
Approvals & Labels

Johnson & Johnson nabs first-line treatment approval from FDA for lung cancer bispecific mAb + small molecule combo (Rybrevant + Lazcluze)
Bispecific antibody, small molecule, lung cancer - Read more 

AstraZeneca’s Fasenra for severe asthma approved by China’s NMPA
Monoclonal antibody, severe eosinophilic asthma - Read more

Astellas’ Padcev ADC approved for urothelial cancer by China’s NMPA
Antibody-drug conjugate, urothelial cancer - Read more

AbbVie, Genmab’s Tepkinly label expansion ok’d by European Commission 
Bispecific antibody, lymphoma, cancer - Read more

THE GOOD
Business Development

Organon buys marketing and distribution rights in multiple countries for Eli Lilly’s Emgality migraine med
Monoclonal antibody, migraine, cluster headaches - Read more

Shanghai Henlius Biotech lands commercialization rights to Convalife Pharmaceuticals’ Neratinib in China and select ex-China territories
Small molecule, breast cancer, adjuvant treatment - Read more

Genovis divests antibody business unit to Leinco Technologies
Biologics R&D, drug development, diagnostics - Read more 

Adcendo buys ex-China development and commercialization rights to Multitude Therapeutics ADC ADCE-T02; deal worth up to $1B
Antibody-drug conjugate, solid tumor, cancer - Read more

THE GOOD
Clinical Trials

Eli Lilly tirzepatide follow-on study shows users have significantly lowered risk of developing diabetes
GLP-1, obesity, diabetes - Read more

THE GOOD
Earnings & Finances

WuXi XDC sees revenue jump despite looming Biosecure threats
Antibody-drug conjugate, CDMO, manufacturing - Read more [Paywall]

Lundbeck ups 2024 guidance
Small molecule, monoclonal antibody - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

Pathalys Pharma $105M Series B
Small molecule, secondary hyperparathyroidism - Read more

Kymera Therapeutics $225M public offering
Small molecule protein degrader - Read more

Moleculin Biotech $16.5M public offering
Small molecule, antibiotic, multidrug resistance - Read more

Talus Bioscience $11.2M Seed+ raise
AI-driven drug discovery, brachyury-driven cancers, prostate cancer - Read more

THE GOOD
Mergers & Acquisitions

Johnson & Johnson to buy V-Wave for up to $1.7B
Medical device, heart failure, transplant, cardiovascular disease - Read more

THE GOOD
Partnerships

Merck & Co. refines ADC collab with Sichuan Kelun-Biotech Pharmaceutical
Antibody-drug conjugate, solid tumor, cancer - Read more

BerGenBio, Tempus clinical development collab for first-line lung cancer small molecule bemcentinib
Small molecule, lung cancer - Read more

THE GOOD
Patient Access

Life Molecular Imaging, PharmaLogic announce Neuraceq biomarker access
Radiopharm, biomarker, Alzheimer’s disease, CDMO - Read more

THE GOOD
Public Health

Emergent BioSolutions to donate 50k smallpox vaccine doses to mpox-afflicted African nations
Vaccine, public health emergency, smallpox, monkeypox (mpox) - Read more

THE GOOD
Regulatory

US FTC onboard with FDA’s proposed biosimilar interchangeability changes
Biosimilar, interchangeability - Read more

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⬇️ The Bad News ⬇️

THE BAD
Opinions

IRA price cuts might actually be a problem according to one analyst firm
Inflation reduction act, drug pricing - Read more

⬇️ The Ugly News ⬇️

THE UGLY
Lawsuits

Teva gets kicked with new kickback lawsuit from seven private Medicare coverage providers
Polypeptide, multiple sclerosis (MS), kickbacks, illegal co-pay scheme - Read more

Double coincidence; Biogen is also under fire for alleged kickback scheme with PBMs to fight back generic competition, also for MS drug
Small molecule, multiple sclerosis (MS), kickbacks, generics - Read more

THE UGLY
Politics & Policy

House lawmakers push FDA to investigate alleged Chinese PLA (People’s Liberation Army) involvement in clinical trials
Clinical trials, military - Read more [Paywall]

THE UGLY
Research

Novo Nordisk Ozempic & Wegovy use may be linked to suicidal thoughts; study
GLP-1, diabetes, obesity, suicidal thoughts - Read more [Paywall]

THE UGLY
Warnings Letters, Form 483

Aurobindo’s Eugia manufacturing unit slapped with another FDA warning letter
Manufacturing, terminal sterilization - Read more

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

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