Recon: FDA advisors back Entasis pneumonia antibiotic; GSK to buy Bellus Health for $2B

• Single Dose of Omicron-Targeting Vaccines to Become Main Covid-19 Shot in U.S. (WSJ)
• FDA authorizes second bivalent COVID booster for older adults (Reuters) (Washington Post) (Fierce) (FDA)
• Adcomm unanimously recommends Entasis' bacterial pneumonia candidate for resistant infections (Endpoints) (MedPage Today) (BioSpace) (Pink Sheet)
• FDA OKs Cell Therapy to Lower Infection Risk After Stem Cell Transplant (MedPage Today)
• FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain (MedPage Today) (Pink Sheet)
• Otsuka subsidiary gets date with FDA for Lonsurf combo; Vaxcyte sells stock to bankroll PhIII vaccine trial (Endpoints)
• CDER Laments Lack Of Shortage Funding, But FDA Didn’t Request New Money For 2024 (Pink Sheet)
• Ban On US FDA User Fee Spending For Certain Facility Costs Forced Budget Shift (Pink Sheet)
• FDA inspection at Lupin manufacturing site uncovers breakdowns left uninvestigated and data questions (Endpoints)
• Most large U.S. funders of clinical research have poor transparency policies, analysis finds (STAT)
• A bellwether moment: Once a distant dream, gene therapy for Duchenne nears historic decision (STAT)
• PhRMA calls document destruction part of new guidance on drug price negotiations 'unconstitutional' (Endpoints)

• EU Widens Use Of Multinational Assessment Teams As Demand Rises (Pink Sheet)
• New EU Filings Include Serplulimab For Lung Cancer & Zynyz For MCC (Pink Sheet)
• Global CEO Grouping Lays Out Japan, Global Priorities Ahead Of G7 Meeting (Pink Sheet)
• WHO warns Sudan's hospitals running out of supplies, staff (Reuters)
• India Exempts Rare Disease Drugs, Keytruda From Customs Duty - Is It Enough? (Pink Sheet)

• GSK to buy Bellus Health for $2 billion, gaining chronic cough drug (STAT) (Endpoints) (Fierce) (Reuters)
• Eli Lilly invests another $1.6B into Indiana manufacturing sites (Endpoints)
• J&J records $130M restructuring expense in Q1 overhaul of infectious disease unit (Fierce)
• AstraZeneca confident new COVID antibody protects against known variants (Reuters)
• AACR: Lilly challenges Amgen, Mirati with early KRAS data, heading for a field ‘much less crowded than it seems’ (Fierce)
• AACR: Kinnate ends cancer data wait but fails to captivate investors (Fierce)
• Cancers caused by HPV are still on the rise, even as awareness of the connection is dropping: #AACR23 (Endpoints)

• How Authorities Should Communicate Globally About Device Threats (MedTech Insight)
• New test detects Parkinson’s biomarker before movement symptoms start (Fierce)
• Illumina taps Henry Ford Health System to explore whole-genome testing for heart disease (Fierce)
• J&J raises forecast as medtech procedures recover (MedTech Dive)
• Define Ventures raises $460 million to fuel early-stage health tech startups (STAT)

• J&J talc unit again seeks to halt 38,000 cancer lawsuits (Reuters)
• Ravgen settles patent fight with Illumina over genetic testing (Reuters)