Recon: Moderna lifts guidance on COVID vaccine sales; US backing of patent waiver causes stir

• US backs giving poorer countries access to COVID-19 vaccine patents, reversing stance (Reuters) (STAT) (NYTimes) (Endpoints) (Harvard Bill of Health) (KEI) (Patent Docs)
• Drugmakers say Biden misguided over vaccine patent waiver (Reuters) (FT)
• Global pharma shares slide as Biden backs COVID-19 vaccine IP waiver (Reuters)
• Explainer: COVID-19 vaccine patent waiver talks could still take months (Reuters 1, 2) (STAT)
• Moderna lifts COVID-19 vaccine sales forecast to $19.2 billion (Reuters) (WSJ)
• Moderna booster increases antibodies against COVID-19 variants, early data shows (Reuters)
• Three US lawmakers seek to use part of COVID stimulus money for opioid crisis – Axios (Reuters)
• Pandemic Delayed Some FDA Plant Inspections, Product Approvals (Bloomberg) (Pink Sheet)
• Bluebird names oncology spinoff, establishes leadership team (Fierce)

• EU 'ready to discuss' COVID vaccine patent waiver, says von der Leyen (Reuters)
• Novavax to deliver 350 mln COVID-19 vaccine doses to COVAX scheme (Reuters)
• Novavax vaccine 51 percent effective against South African COVID-19 variant: study (The Hill)
• Russia authorises single-dose Sputnik Light COVID vaccine for use -RDIF (Reuters)
• Confidentiality arrangement between EU and Brazilian regulatory authorities (EMA 1, 2)

• ‘Doomsday scenario’: Lagging vaccine rates stir fears of dangerous variants (Politico)
• Pfizer-BioNTech Vaccine is Highly Effective Against Variants, Studies Find (NYTimes)
• India Covid: Government says new variant linked to surge (BBC)
• Pfizer, BioNTech to provide COVID-19 vaccine to Olympic athletes (Reuters)
• Denmark, Norway study finds slightly raised blood clot rates after Astra COVID shot (Reuters)

• In quest to meet user fee goals, FDA’s performance continues downward trend (Endpoints)
• Lonza plots $935M in capacity upgrades in Europe and U.S., plans to add 550 jobs over next 3 years (Fierce)
• Taking double Covid-19 hits, Merck writes off $170M for scrapped drug, highlights $600M in missed sales (Endpoints)
• FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer (FDA)
• After ODAC: The State Of Accelerated Approval At The US FDA (Pink Sheet)
• GSK lupus treatment approved by European Commission (Pharmafile)
• CSL closes deal for UniQure gene therapy in hopeful sign for M&A (BioPharmaDive)
• Dyno raises $100 million to bring artificial intelligence to gene therapy (STAT)
• In Belgium, too many clinical trial sponsors waffle about reporting required results (STAT)
• Biogen’s Alzheimer’s drug may only be cost effective at $2,500 a year (STAT)
• Merck & Co reveals plans for women’s health spinoff Organon (PMLive)
• Preliminary NICE 'no' for Merck's Bavencio (PharmaTimes)
• OcuWho? Star dealmaker turned aesthetics czar Brent Saunders flips back into biotech. But who’s he teaming up with now? (Endpoints)
• Recall report: Acella pulls thyroid tablets after a raft of side effect reports; mislabeling causes Pfizer's Hospira to yank 2 lots of anesthetics (Endpoints)
• FDA extends research agreement with MIT-licensed organ-on-chip systems (Endpoints)
• Reps. Sherrill, Kinzinger Lead Bipartisan Letter to House Appropriations Committee Urging Them Not to Block E-Labeling of Prescription Drugs (Press)

• Medtronic debuts virtual spinal cord stimulation treatment guide (Fierce)
• Phenomix Sciences taps Mayo Clinic tech for AI-powered obesity diagnostic (Fierce)
• BD to spin off $1B diabetes care business into standalone public company (Fierce)
• Nevro raises outlook as neuromodulation market recovers from COVID-19 crisis (MedtechDive)
• Lilly inks smart insulin pen deals with Roche, Dexcom and more (Fierce)
• NeoGenomics inks $390M Inivata buyout to enter liquid biopsy space (MedtechDive)
• Newer TAVR devices linked to lower rate of permanent pacemaker use: study (MedtechDive)
• EU Extends Scope Of Electronic IFU To Medical Device Software In First Update In Nine Years (MedtechInsight)

• Incyte pays $12.6 million to resolve claims it paid drug kickbacks through charity (STAT)
• High Court's AMG Ruling Could Hinder FDA Enforcement (Law360)
• Pfizer Loses Bid To Toss COVID-19 Vaccine IP Case (Law360)
• Allergan Can't Escape NJ Defective Breast Implant Claims (Law360)
• Buchanan Ingersoll Adds Former FDA Atty, Director (Law360)
• Generic-Drug Makers Knock States' Objection To Sanctions (Law360)
• Bio-Rad Ruling Highlights IP Assignment Clause Limits (Law360)
• Accuracy of Theranos blood tests at heart of Elizabeth Holmes’ criminal case (CNBC)