Recon: FDA adcomm approves AstraZeneca’s asthma inhaler for adults; Biogen names former Sanofi head Christopher Viehbacher as CEO

• FDA Panel Backs Novel Combination Inhaler for Asthma in Adults Only (MedPage Today) (Fierce)
• In a squeaker, Veru’s COVID-19 drug loses split decision at FDA advisory committee (Fierce) (Pink Sheet)
• FDA Authorizes IL-1 Drug for Hospitalized COVID Patients (MedPage Today)
• U.S. authorizes Sobi's drug to treat COVID-19 in high-risk patients (Reuters)
• AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments (Fierce) (Reuters) (Biospace)
• Amylyx’s Relyvrio: US FDA Review Shows Regulatory Flexibility Can Come In Many Forms (Pink Sheet)

• European regulator recommends Pfizer's Omicron booster for children (Reuters)
• EU regulator approves Sanofi, GSK's COVID shot for Beta variant as booster
• (Reuters)
• EU Fast Track Sought For Epidermolysis Bulbosa Gene Therapy & Bispecific RRMM Drug (Pink Sheet)

• UK signs off on Sanofi, AstraZeneca's RSV antibody four days after Europe
  (Endpoints)
• Negotiators Prioritize Generic And Biosimilar Oncology Medicines Over Newer Drugs (Pink Sheet)
• The Perils Of Ignoring Patients In Drug Development (Pink Sheet)
• Indonesia suspends licences of two more drug firms amid probe into child deaths (Reuters)

• Biogen picks Christopher Viehbacher, former leader of Sanofi, as new CEO (STAT)
• In transition and tumult, Seagen names former Novartis oncology chief Epstein as new CEO (STAT)
• Novartis cuts 275 jobs at Illinois site to consolidate Zolgensma manufacturing in North Carolina (Endpoints)
• Pfizer faces labor action in Australia as workers protest wage increase at manufacturing facility (Endpoints)
• ‘The decision is clear’: Curis cuts workforce as pending data hint at near-term FDA application (Fierce)
• AstraZeneca discards Moderna-partnered solid tumor prospect, kidney disease asset in pipeline clear-out (Fierce)
• Alimentiv, Summit Clinical partner to improve research on NASH treatments (Fierce)
• Novavax tempers its revenue expectations as it unveils PhIII data for bivalent booster (Endpoints)
• A cancer drug under clinical hold, an mRNA therapy, a kidney med: AstraZeneca punts three early-stage programs (Endpoints)
• Shares of Merrimack, a dormant drugmaker, soar after cancer drug succeeds in trial (STAT)
• Much of biopharma industry yet to set any climate impact targets – report (Reuters)
• The tipping point is coming’: Unprecedented exodus of young life scientists is shaking up academia (STAT)

• Whole EU Medtech Industry Behind Latest Push To Have MDR Problems Tackled At Highest Levels (MedTech Insight)
• EU Regulating AI ‘Like A Microwave’ When Focus Should Be Its Ability To Cook (MedTech Insight)
• Just Four Items Remain On European Commission’s High Priority IVDR List (MedTech Insight)
• Siemens Healthineers to reduce diagnostics staff, portfolio footprint in  €300M restructuring (Fierce)
• Getting Back On The EU Agenda Is Uppermost For Swiss Medtech Industry (MedTech Insight)
• New Data Supports GlucoModicum's Needle-Free Glucose Monitor (MedTech Insight)
• Surgalign aims to slash $30M from 2023 spending with planned layoffs (Fierce)
• J&J names Tezel global head of medtech R&D as Shen retires (MedTech Dive) (Fierce)

• Supreme Court tosses Bristol Myers' bid to revive $1.2B CAR-T case against Gilead (Endpoints)
• AstraZeneca’s Symbicort Patent Claims Tossed by Federal Court (Bloomberg)
• U.S. Supreme Court's Sotomayor rejects challenge to N.Y. COVID vaccine mandate (Reuters)
• Eli Lilly ordered to pay $176.5 mln to Teva in U.S. migraine drug patent trial (Reuters)
• Amgen Whistleblower’s Attorney Wins Fee Priority Dispute With US (Bloomberg)