Recon: FDA approves Appili’s oral antibiotic; Pfizer plant in North Carolina resumes production after tornado damage

• Appili Gets FDA Approval for Liquid, Oral Reformulation of Antibiotic Metronidazole (BioSpace) (Reuters)
• Rollout of Covid vaccines is bumpy, but not unexpected, experts say (STAT)
• Uncle Sam Wants You—to Fight High Drug Prices (The Wall Street Journal)
• Theradaptive Receives $7.4M From DoD, Advances Human Trials With ‘Paint-Like’ Regenerative Therapeutic (MedTech Insight)
• Tornado-damaged Pfizer plant in North Carolina restarts production (Associated Press)
• Medicare Advantage plans for dual-eligible enrollees set to get Senate scrutiny (STAT)

• EU Bodies Agree On Ways To Future-Proof EMA Funding System (Pink Sheet)
• EU in talks with Moderna over new deal for COVID vaccines – FT (Reuters)
• New study suggests anti-COVID drug may be causing virus to mutate (The Times of Israel)
• UK Regulators Withhold Support for Astra Breast-Cancer Drug (Bloomberg)
• UK Phases In New Standards On Information Materials For Potential Study Participants (Pink Sheet)
• Report calls for 'grand bargain' to fix antibiotic development market (CIDRAP)
• Pakistan recalls altered dose of Avastin; FDA rejects Botanix gel (Endpoints)
• Cough syrup deaths overseas prompt US crackdown on toxic testing (Reuters)
• Exclusive: Edwards Lifesciences targeted in EU antitrust raid last week – sources (Reuters)
• UK puts CSL Seqirus on standby for flu pandemic preparedness, with vaccines to be produced in Liverpool (Fierce Pharma)

• Intercept, once a biotech trailblazer, sells itself for less than $1 billion (STAT)
• Early data are promising for autoimmune disease drug from Roivant Sciences’ Immunovant (STAT)
• Ionis inches toward first solo drug launch with late-stage trial success for rare genetic disease therapy (STAT) (BioSpace)
• Pliant shares spike on exploratory study results of lead drug in chronic liver disease (Endpoints)
• Novo Nordisk forms cardiometabolic drug discovery accelerator to get to research faster (Endpoints)
• Despite a summer of blockbuster rounds, biotech funding is on track to level off at pre-pandemic norms (Endpoints)
• Poxel takes writedown on NASH drug as it continues layoffs, search for cash (Endpoints)
• Ionis plans NDA filing for first independent drug after positive data readout in rare genetic disorder (Endpoints)
• Omega Therapeutics' epigenomic medicines reduce MYC expression by 55% in early study of cancer patients (Endpoints)
• Updated: Roivant’s FcRn antibody for autoimmune disease shows early potential in study with healthy subjects (Endpoints)
• Schott Pharma IPO expected to price at 27 euros per share – bookrunner (Reuters)

• Generating And Assessing Evidence To Optimize MDR And IVDR Governance and Innovation (MedTech Insight)
• Exclusive: DeepMind’s Demis Hassabis unveils his vision for Isomorphic and AI’s future in biotech (Endpoints)
• Enovis inks $847M acquisition to boost orthopedic reconstruction business (MedTech Dive)
• Clinical data from Boston Scientific and rivals could reshape pulmonary embolism market: analysts (MedTech Dive)
• Surgical robot maker Vicarious faces possible NYSE delisting (MedTech Dive)
• Minute Insight: Virtual Incision Draws In Another $30m With Its Table-Top Surgical Robot (MedTech Insight)

• The problem with potential changes to the biosimilar regulatory framework (STAT)
• Vanda Sues FDA Over Approval of Generic Rival Sleep Medicine (Bloomberg)
• IBM, Johnson & Johnson Hit With Class Action Over Data Breach (Bloomberg) (Fierce Pharma)
• Gilead Sciences, after trial win, moves ahead with $247M settlement in HIV antitrust case (Fierce Pharma)