Recon: FDA rebukes CytoDyn over COVID drug claims; BMS to pay up to $1.4B for Agenus cancer drug

• FDA issues major rebuke to CytoDyn over claims on Covid-19 drug (STAT) (Endpoints) (FDA)
• Biden Pledges to Export Millions of FDA-Authorized Vaccines (Bloomberg) (Reuters) (Politico)
• Bristol to pay up to $1.38B to develop, sell Agenus's cancer therapy (Reuters) (Endpoints) (Press)
• Roche COVID test receives U.S. greenlight for asymptomatic people (Reuters)
• US Supreme Court snubs Novartis appeal over arthritis drug Enbrel (Reuters) (Endpoints)
• US Supreme Court rejects J&J appeal over Risperdal drug (Reuters) (Law360)
• CDC's second-in-command Anne Schuchat to step down (Politico) (STAT)
• Feds tell drug makers to offer discounts to safety-net hospitals or face penalties (STAT)
• House committee uncovers how Humira’s price spiked by 470% as AbbVie execs cashed bonuses tied to the hikes (Endpoints) (STAT)

• G20 snubs COVID patent waiver, waters down pledge on WHO’s funding (Reuters)
• GSK and Medicago report positive Covid vaccine trial data (The Guardian) (Bloomberg) (Press)
• J&J vaccine deliveries to EU cut by half this week -EU source (Reuters)
• India unlikely to resume sizable COVID-19 vaccine exports until October (Reuters)
• Spanish study finds AstraZeneca vaccine followed by Pfizer dose is safe and effective (Reuters)
• Japan's Fujifilm says it can make new coronavirus variant detection kits in weeks (Reuters)
• Singapore approves Covid vaccine for children aged 12 to 15 as cases surge (CNBC)
• Novartis' Sandoz embarks on €150M antibiotics manufacturing upgrade in Europe (Fierce) (Press)
• Northern Ireland faces ‘huge’ rise in generic medicine prices (FT)

• How to manufacture Covid-19 vaccines without the help of J&J, Pfizer or Moderna? Biolyse sees the difficulties up close (Endpoints)
• India drops plasma therapy from Covid-19 management guidelines (Economic Times)
• They’re Vaccinated and Keeping Their Masks On, Maybe Forever (NYTimes)

• Cel-Sci CEO spoke privately with investors last week, raising doubts about long-delayed cancer drug (STAT)
• COVID-19 impact on oncology clinical trials: a 1-year analysis (Nature)
• Charles River keeps adding on to its CDMO arm, snatching up a viral vector player for a tidy $350M (Endpoints) (Fierce)
• Novo Nordisk’s ziltivekimab hits primary endpoint in CKD trial (PharmaTimes)
• Advancing FDA’s Mission by Targeting Key Areas for Regulatory Science Investment and Innovation (FDA)
• MHLW Proposes Lifting Domestic Ban on Cannabis-Derived Drugs, Seeking “Ingredient-Based” Regulation (PharmaJapan)
• Pharma to Govt: Maintain Prices of Patented Drugs, It’s the Global Standard (PharmaJapan)
• Start-up focused on painkilling effects of cannabis to list in London (FT)
• Johnson & Johnson donates Ebola vaccine amid new outbreak; Ji Xing promises more than $127M for Milestone's nasal spray for rapid heart rate (Endpoints)
• Jim Wilson and Tachi Yamada are at it again — launching a 2nd-gen gene therapy company with an appetite for risk, global vision and $200M to gamble with (Endpoints)
• Europe's new investment firm says it's on a mission to lift up the continent's 'underexploited' science (Endpoints)
• Eyeing clinical proof-of-concept for HER3 drug, Amgen-partnered biotech scores $125M for precision antibodies (Endpoints)
• The effect of generic market entry on antibiotic prescriptions in the United States (Nature)

• Device Makers In Joint FDA/MDIC Pilot Closing CAPAs Faster, Agency Reports (MedtechInsight)
• Bayer sees jump in Essure adverse event reports gleaned from social media (MedtechDive)
• Swiss Consult On Local IVDR Until July, EU MRA Awaited Still (MedtechInsight)
• European Commission Launches Specific Helpdesk Focusing On UDI For Medtech (MedtechInsight)
• Laboratory Developed Tests: Members of Congress Ask FDA to Do Their Job for Them (FDA Law Blog)
• Edwards tricuspid valve replacement cut leakage for 98% of participants in early trial results (MedtechDive)

• Kodak Says NY Has Threatened To File Insider Trading Suit (Law360)
• Shkreli Cos.' Ability To Pay Penalties Irrelevant, FTC Says (Law360)
• FTC Continues Crackdown On CBD Sellers' Cure-All Claims (Law360)