Recon: Pfizer North Carolina plant damaged by tornado; WHO issues alert over contaminated cough syrup in Africa

• Pfizer Plant Is Damaged by Tornado Amid US Drug Shortage (Bloomberg) (Endpoints) (Reuters)
• House committee probes FDA inspections of pharma plants in China and India (STAT) (BioSpace)
• Cancer Drug Endpoints: More Standardization Needed In ctDNA Assessments, US FDA Says (Pink Sheet)
• BARDA's Next-Pandemic Response Plan Relies On Warp Speed-Like Partnership (Pink Sheet)
• FTC, Department of Justice Release New Draft Merger Guidelines (BioSpace) (STAT) (Fierce)
• Despite Dem opposition, House committee advances pandemic preparedness bill sans drug shortage provisions (Endpoints)
• SEC fines former Merck exec over insider trading allegations (Endpoints)
• Congress considers easing regulations on air transport of donated organs (Fierce)
• Key lawmaker blasts Congress’ efforts on addiction: ‘Shame on us’ (STAT)
• Stanford president’s departure begs the question: Who takes the credit — or blame — in team science? (STAT) (Endpoints) (Bloomberg)
• Specialty Drug ‘Doom Loop:’ Manufacturers Fight Against Becoming Primary Payers For Own Drugs (Pink Sheet)
• These proteins could predict dementia risk decades before symptoms, new study suggests (STAT)
• A new explanation for why some stubborn cancer cells resist treatment (STAT)
• Genetic cheat code might explain why some people catch Covid but never get sick (STAT)

• WHO seeks help from India in latest toxic syrup case (Reuters) (Endpoints)
• European Commission rejects Ipsen's ultra-rare disease drug after two negative opinions from EMA (Endpoints) (Fierce) (Reuters)
• EMA Picks Antibiotic Combo & RSV Vaccine For New International Parallel Review Framework (Pink Sheet)
• UK Industry Lambasts Government For High Rebates In Proposed New Statutory Pricing Scheme (Pink Sheet)
• Regulator flags concerns on Australian Clinical's buyout offer for Healius (Reuters)
• A Q&A with Gavi’s Seth Berkley on vaccines, Covid, and challenges ahead (STAT)

• Janssen’s newly-merged infectious disease and vaccine unit sees significant pipeline cuts (Fierce)
• Hikma, Fresenius shares rally after tornado hits rival Pfizer's U.S. plant (Reuters)
• Eisai Says Alzheimer’s Drug Shows Benefit on Amyloid-Beta, Tau (Bloomberg) (Fierce)
• J&J Exceeds Q2 Expectations, Oncology and Immunology Top Pharma Drivers (BioSpace) (Reuters)
• Ramsay, Sime Darby tap Bank of America, Deutsche Bank to sell $1.3 billion Asia healthcare venture (Reuters)
• Sanofi pays $125M to go after undruggable inflammatory target with Recludix’s preclinical program (Fierce) (Endpoints)
• Activist investor Elliott takes stake in drug manufacturer Catalent (Reuters)
• Idorsia sells off Asian operations, top drug licenses to Sosei Heptares in $465M deal (Endpoints)
• Vir’s shares crater as influenza vaccine flames out in ‘disappointing’ phase 2 result (Fierce) (STAT)
• Pfizer, Gilead and GSK to seize majority of the growing $150B infectious diseases market by 2029: report (Fierce)
• Amarin lays off US salesforce, names new CEO in shakeup (Endpoints)
• FibroGen’s cost-cutting search spurs 104 layoffs while ImmuneID also restructures (Fierce)
• Pfizer hails phase 2 data as proof that GBS maternal vaccine offers ‘meaningful protection’ (Fierce)
• Biotech’s optimism is returning amid signs of a better second half and a brighter 2024 (Endpoints)
• Special report 2023: Meet 20 women reshaping biopharma (Endpoints)
• Doctors without Borders asks J&J not to enforce secondary patents for TB drug after generic deal with nonprofit (Endpoints)

• Risk Of Cardiac Arrest Leads To Recall Of Medtronic ICDs (MedTech Insight) (MedTech Dive)
• New Pointers For Industry On How To Comply With EU Requirements For Legacy Devices (MedTech Insight)
• MHRA Includes UKCA Marking Updates In New IVD Guidance For Great Britain (MedTech Insight)
• Boston Scientific lays off 52 workers as it closes another Silicon Valley facility (Fierce)
• FDA clearance opens up MeMed’s bacteria-versus-virus blood test to the point of care (Fierce)
• Abbott beats profit estimates on recovery in demand for medical devices (Reuters)
• Regulator says found no animal welfare breaches at Musk firm beyond 2019 incident (Reuters)
• CDS Final Guidance Infringes On Free Speech, Professor Says (MedTech Insight)

• J&J Must Pay $18.8 Million in California Talc-Cancer Trial (Bloomberg)
• Endo’s $6 Billion Sale Opposed by IRS, DOJ Over Payout Concerns (Bloomberg)
• FTC Says Amgen-Horizon Deal Block Settlement Talks Have Ended (Bloomberg) (MedWatch)