Recon: FDA authorizes Novavax vaccine; EMA re-elected ICMRA chair

Updated 13 July 2022 to note FDA's issuance of an emergency use authorization (EUA) for Novavax's adjuvanted COVID-19 vaccine.

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In Focus: US

• FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine (FDA)
• FDA to authorize Novavax's Covid-19 vaccine (Politico)
• Novo Nordisk's new weight loss drug Wegovy needs a 'significant discount,' ICER says (Fierce)
• Endo Moving Toward Bankruptcy Filing Without Opioid Settlement Deal (WSJ) (Endpoints)
• Amazon is quietly developing cancer vaccines in partnership with Fred Hutchinson and recruiting patients for a new clinical trial (Business Insider) (Endpoints)
• U.S. accuses Fresenius Medical Care unit of fraud in dialysis treatment (Reuters)
• Sanofi must face lawsuit over 'maximum strength' IcyHot claim (Reuters)
• San Francisco reaches $58 mln opioid settlement with Teva, Allergan (Reuters)

• Adapted, two-strain vaccines to lift COVID protection - EU official (Reuters)
• EMA re-elected as chair of ICMRA from October 2022 (EMA)
• Brazil Waters Down Compulsory Licensing Law (Pink Sheet)
• Merck wagers $290M on a cancer treatment from Finnish drugmaker (BioPharmaDive)
• Antitrust Review of Illumina-Grail Deal Can Proceed, European Court Says (WSJ)
• Canada's Ontario to offer second COVID booster dose to all adults (Reuters)
• Why world's first malaria shot won't reach millions of children who need it (Reuters)

• Amgen's Lumakras/immunotherapy combo data held for August lung cancer meeting (Reuters)
• Agios CEO to step down, handing role to veteran in rare disease drug sales (BioPharmaDive)
• Pfizer jumps into bed with Agomab, leading series B extension and lending support to Crohn’s program (Fierce)
• With failed NIH Covid-19 study, Humanigen CEO points to competitors' flops before FDA nods (Endpoints)
• How interest in a single cancer drug led to Ipsen's takeover of Epizyme (Endpoints)
• TherapeuticsMD shares crater as anticipated M&A deal falls through (Endpoints)

• EC publishes IVDR guidance in absence of completed Eudamed database (MedtechDive)
• Eko secures heart murmur AI clearance for digital stethoscopes (Fierce)
• Abbott gets FDA breakthrough tag for deep brain stimulation system in depression (MedtechDive)
• Medtronic lands option to buy artery disease player CathWorks for up to $585M (MedtechDive)
• Labcorp launches blood test for a wide range of neurodegenerative diseases and brain injuries (Fierce)

• Ex-Theranos CEO Holmes' Sentencing Delayed Until October (Law360)
• Catalyst Inks Deal To End Its 'Orphan Drug' Case (Law360)
• Mylan Can't Stop AstraZeneca's Asthma Drug Patent Suit (Law360)
• On same day patent was granted, Alnylam claims Pfizer, Moderna infringed it in making COVID-19 vaccines (Fierce)
• Patent Office Opposes Ruling On Ovarian Cancer Drug, Wants Stronger Obviousness Standard (Pink Sheet)