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