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THE GOOD
Approvals & Labels

AstraZeneca-acquired MedImmune scores first FDA approval for at-home nasal spray influenza vaccine
Vaccine, influenza, nasal spray - Read more 

Johnson & Johnson three-peat for Rybrevant lung cancer indications approved by FDA 
Bispecific antibody, lung cancer - Read more

Zevra Therapeutics’ Miplyffa approved by FDA for Niemann-Pick disease
Small molecule, Niemann-Pick disease - Read more

Ipsen’s Iqirvo gets EU approval for primary biliary cholangitis
Small molecule, primary biliary cholangitis, liver disease - Read more

Samsung Bioepis, Biogen’s SB15 biosimilar (Regeneron’s Eylea) scores positive CHMP opinion
Fusion protein, wet AMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema, myopic choroidal neovascularisation - Read more

THE GOOD
Business Development

Gilead pays Yuhan Corporation $81M for HIV drug ingredient manufacturing
Small molecule, HIV, antiretroviral - Read more

THE GOOD
Clinical Trials

Sanofi uncovers “mixed” Ph3 tolebrutinib, forecasts 2024 approval filing
Small molecule, multiple sclerosis - Read more

Oncolytics Biotech attempts to charm with “favorable” BRACELET-1 Ph2 data, pelareorep-based combination therapy
Oncolytic virus, breast cancer - Read more

THE GOOD
Fundraises

YK Bioventures outlines $100M fund plans
Biotech venture capital - Read more [Paywall]

THE GOOD
Mergers & Acquisitions

Stryker makes big-brain move, acquires brain surgery-focused Nico
Surgical technology, brain surgery - Read more

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⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Regulatory

FDA attempts to quell inspection shortfall consternation, says “[site inspector] hiring rates outpace our attrition“
Site inspections - Read more

THE GOOD
Research

Duo of new studies points towards new potential neurodegenerative disease approaches; mouse models
Neurodegenerative disease, Alzheimer’s disease - Read more

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THE BAD
Approvals & Labels

Apellis Pharmaceuticals’ pegcetacoplan again rejected by EMA
Peptide, geographic atrophy - Read more

THE BAD
Clinical Trials

Lose weight & your mind? Novo Nordisk stock takes hit after obesity-hopeful monlunabant’s Ph2 reports cases of “mild to moderate neuropsychiatric side effects”
Small molecule, obesity - Read more

Genfit faces slower-than-expected enrolment for VS-01 Ph2 trial
Small molecule, acute on-chronic liver failure - Read more

Novo Nordisk axes an etavopi­vat Ph2 trial originating from $1.1B Forma Therapeutics acquisition
Small molecule, myelodys­plas­tic syn­dromes, anemia - Read more [Paywall]

THE BAD
Lawsuits

FTC goes lawsuit mode on big three PBMs over insulin prices
Pharmacy benefit manager, drug pricing, insulin - Read more

THE BAD
Layoffs

Bristol Myers Squibb to cut 79 more New Jersey-based staffers - Read more

THE BAD
Partnerships

Yuhan Corporation ends 4th-gen EGFR-targeted anticancer R&D collab with Johnson & Johnson, keeps 3rd gen collab
Small molecule, cancer - Read more

Gilead’s Kite Pharma ditches China CAR-T collab with Fosun Pharmaceuticals, latter to buy out former’s China-stake for $27M
Cell therapy, CAR-T, cancer - Read more

THE BAD
Politics & Policy

PhRMA’s Medicare drug pricing offensive revived in US appeals court
Inflation reduction act, drug pricing - Read more [Paywall]

THE UGLY
Patient Access

Eli Lilly makes unusual request for compounded GLP-1 users’ medical histories
GIP/GLP-1, obesity - Read more

THE UGLY
Public Health

Africa’s Monkeypox outbreak is still out of control
Infectious disease, monkeypox (mpox) - Read more

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

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