Recon: Alnylam sues Pfizer, Moderna for patent infringement; French and German medtech groups seek two-year delay of MDR
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Lawmakers Look to Stir FDA Drug Approval for Speed, Rare Disease (Bloomberg)
- Pfizer, Moderna Sued by Alnylam in New Fight Over Covid Shots (Bloomberg) (Endpoints)
- Abbvie Says Rinvoq Gets FDA OK For Ulcerative Colitis (Bloomberg)
- Quality Concerns to Resurface as FDA Resumes Foreign Inspections (Bloomberg)
- Negotiations or price controls? Senate Finance Committee splits along party lines over drug prices (Endpoints) (STAT)
- Medicare premiums could decrease ‘soon,’ after decision on Alzheimer’s drug Aduhelm (STAT)
- Biden’s agency to ‘end cancer as we know it’ is finally real. But it has a chaotic road ahead (STAT)
- Eiger eager to send COVID-19 drug to FDA after hospitalizations, deaths slashed-including against omicron (Fierce)
- Biden picks Ashish Jha as new Covid-19 czar (Politico)
- AstraZeneca ready to scrap plans for US approval of COVID shot – FT (Reuters)
- Joint Procurement Rising Up EU Agenda As Future Access Mechanism (The Pink Sheet)
- French, German medtech groups call for at least 2-year extension of MDR's transition period (MedTech Dive) (MedTech Insight)
- EMA expects data on Omicron-specific vaccine as early as April (Reuters)
- Britain approves AstraZeneca's preventative COVID therapy (Reuters)
- Japan’s New Infertility Coverage To Drive The Market (The Pink Sheet)
- GSK falls in line with Big Pharma's reaction to Ukraine invasion, cutting off new clinical trials, donating profits and more (Endpoints) (Bloomberg)
- Moderna's COVID shot gets Canada authorization for kids aged 6 to 11 (Reuters)
- COVID IP Waiver Compromise Bashed By All Sides (Law360)
- Generic drugmakers sign on to make cheap version of Pfizer COVID pill (Reuters)
- WHO says global rise in COVID cases is 'tip of the iceberg' (Reuters)
- With infections spiking in Europe and a variant on the rise, experts warn the US could face a Covid resurgence (STAT)
- Sinovac Shot Prevents 38% of Covid Cases in Kids, Data Shows (Bloomberg)
- In Africa, a Mix of Shots Drives an Uncertain Covid Vaccination Push (NYT)
- NIH squashes Synairgen’s COVID therapy from ACTIV-2 trial after omicron shakes up study (Fierce)
- Hospitalizations of young children increased fivefold during omicron surge, but few died, says CDC report (Washington Post)
- Athenex cuts jobs, narrows focus to cell therapies in continued fallout from 2021 FDA rejection (Fierce)
- After Jardiance Heart Failure Successes, BI And Lilly Focus On Kidney (Scrip)
- Two US companies ink deals to expand biosimilar offerings (Endpoints)
- Biogen loses another bid to revive Tecfidera patent as generic keeps eating into blockbuster sales (Endpoints)
- Financial Decoupling: China Biotech Brace For Potential US Delistings, Softening Economy (Scrip)
- AstraZeneca shells out $775M to settle Ultomiris patent suit with Roche (Endpoints)
- J&J's Alex Gorsky bagged $26M in pay and perks for 2021, landing near the top of the Big Pharma CEO ladder (Endpoints)
- Silence stops enrollment in blood cancer arm of RNAi trial over ‘recruitment challenges’ (Fierce)
- EU Post-Market Surveillance: How Doing More Than Minimum Will Benefit Medtech Manufacturers (MedTech Insight)
- As White House warns of 'squandering' gains, AdvaMed sets out plan to sustain COVID-19 test capacity (MedTech Dive)
- Thermo Fisher says buoyant demand prompted clinical lab expansion (Fierce)
- Medtronic’s colonoscopy AI cuts number of missed polyps in half, study finds (Fierce)
- Drug Purchasers Seek Blessing Of Sun And Taro Deals (Law360)
- AMA Urges Lawmakers To Fix Medicare Physician Payment System (MedTech Insight)
- Rhode Island AG Opioid Trial Pushed Back (Law360)
- Balwani Trial Openings Delayed Due to COVID-19 Exposure (Law360)
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