Recon: Biden and Democrats face dilemma on vaccine mandates; EU to discuss joint recognition of vaccine certificates with Russia

ReconRecon | 08 July 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • U.S. FDA narrows patient group for Biogen's Alzheimer's drug (Reuters)
  • Alzheimer antibody rush begins, as efficacy concerns remain (Nature)
  • AstraZeneca-Amgen drug gets FDA speedy review as asthma treatment (Reuters)
  • Death rates are declining for many common cancers in the U.S., report finds (STAT)
  • HHS head: 'Absolutely the government's business' to know people's vaccine status (The Hill)
  • The Memo: Biden and Democrats face dilemma on vaccine mandates (The Hill)  
  • Cancer still dominates orphan drug approvals: Data Byte (BioCentury)
In Focus: International
  • Analysis: UK PM Johnson's new COVID gamble worries some scientists (Reuters)
  • COVAX aims to deliver 520 mln vaccine doses to Africa this year (Reuters)
  • WHO sounds alarm as global deaths top 4 million, delta spreads to 100 countries (Washington Post)
  • Cuba’s New Covid-19 Vaccine Finds Testing Ground in Venezuela (WSJ)
  • Twin epidemics in Haiti, violence and coronavirus, usher in ‘critical phase’ in wake of assassination (Washington Post)
  • Vaccinated UK residents returning to England will be allowed to bypass quarantine (The Hill)
  • Kuano raises £1m to further develop AI drug discovery platform (Pharma Times)
  • Broader reimbursement supports flagging Zolgensma sales (Pharmaletter)
Coronavirus Pandemic
  • Olympics bans spectators after Tokyo declares COVID-19 emergency (Reuters)
  • EU could discuss joint recognition of COVID-19 vaccine certificates with Russia -TASS (Reuters)
  • New, deadlier COVID-19 variant 'Lambda' detected in more than 30 countries (Economic Times)
  • Japan PM Suga: coronavirus infections rising in Tokyo area due partly to Delta variant Reuters)
  • Indonesia sees record 38,391 new coronavirus infections (Reuters)
  • S. Korea eyes semi-lockdown in Seoul as COVID-19 cases hit daily record (Reuters)
  • New study on delta variant reveals importance of receiving both vaccine shots, highlights challenges posed by mutations (Washington Post)
  • Can we stretch existing Covid vaccines to inoculate more people? Experts are divided (STAT)
  • Study finds lower COVID-19 infection prevalence in fully vaccinated people (Pharma Times
Pharma & Biotech
  • CRO Parexel to be acquired by Goldman Sachs in $8.5b deal (Outsourcing Pharma)
  • Sanofi, GSK get Indian approval for late-stage trial of COVID-19 vaccine (Reuters)
  • The headwinds to making generics in the U.S. (Politico)
  • Pediatric Cancer: US FDA May Invite European Regulators To Observe ‘Type F’ Meetings With Sponsors (Pink Sheet)
  • US FDA’s In-Person Foreign Inspections Remain On House Appropriators’ Minds (Pink Sheet)
  • House Appropriations Committee Embraces Clinical Trial Issues In FY 2022 US FDA Budget Bill (Pink Sheet)
  • AstraZeneca takes a chance on the STING pathway with F-star (Endpoints)
  • HHS withdraws Trump-era plan to allow more personal drug, insulin imports (Endpoints)
  • ChemoCentryx Addresses FDA Advisory Panel Questions in Amendment to Filing on Vasculitis Drug  (Rare Daily)
  • J&J, Sid Mukherjee's Vor team up to pair bispecifics with engineered stem cells for blood cancer (Endpoints)
  • A bright future for LAG-3? Top analysts see an arms race in the making, but drugmakers need a biology breakthrough (Endpoints)
  • Phase III Analyses Prompt Partial Clinical Hold On Oncopeptides's Melflufen Studies (Scrip)
  • Humira's reign as TV ad king is over as AbbVie shifts spending to Rinvoq and Skyrizi (Fierce)
  • A Mubadala-backed biotech is using patient tumor tissue grown in a petri dish to change precision oncology (Endpoints)
  • Dow Plunges 500 Points As Delta Variant Fears Rattle Markets (Forbes)
  • Merck partners with Innervia on bioelectronic therapy development (Pharma Times)
  • Sonde’s voice health tracking comes to Qualcomm’s smartphone chips (STAT)
  • FDA Revokes EUAs for Certain Non-NIOSH-Certified Respirators (Medtech Intelligence)
  • Automated Software Validation: Fast-Tracking MES Implementations in Regulated Environments (Medtech Intelligence)
  • Romania’s Implementation Of EU MDR Tightens Local Device Advertising And Promotion Rules (Medtech Insight)
  • COVID-19 Assay’s False-Negative Results Culminate In Class I Recall Designation From FDA (Medtech Insight)
  • Surmodics in Bid to Expand its Thrombectomy Portfolio (MD+DI)
  • Report: Addiction treatment apps pose privacy risks (MedCity News)
Government, Regulatory & Legal
  • Pharmacy exec in deadly U.S. meningitis outbreak gets stiffer, 14-1/2 year prison term (Reuters)
  • Dexcom, Abbott File Dueling Lawsuits On Diabetes Management Technology (Medtech Insight)
  • A unicorn built on lies? Founders of Sanofi partner may face 20 years in prison for allegedly profiting from stolen Genentech trade secrets (Endpoints)
  • Ethicon Says Fla. Pelvic Mesh Suit Was Filed Too Late (Law360)
  • Boston Marriott Won't Get Early Win In Virus Coverage Row (Law360)
  • 5 States Reach a Deal With Purdue Pharma, Moving Toward a $4.5 Billion Opioids Settlement (NYT)
  • FDA Denies Most of BMS Petition to Block Abraxane Generics (FDA News)
  • Paper industry, drugmakers spar over requirement to print prescribing information (The Hill)
  • bluebird bio lodges counterclaim against Spark Therapeutics (PMLive)
  • RICO Claims Whacked In Another Zantac Ruling (Drug and Device Law)
  • Stryker inks $15M settlement to resolve Conformis patent dispute (MedTech Dive)
  • Alere Agrees to Pay $38.75 Million to Settle False Claims Act Allegations (DOJ)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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Tags: Coronavirus, FDA, WHO

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