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Posted 19 May 2022 | By Joanne S. Eglovitch 

Recon: CDC advisors discuss widening additional booster eligibility measures; Montreal sees 17 monkeypox cases as European tally increases

2703 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • C.D.C. advisers meet for discussion on whether to recommend Pfizer boosters for children 5 to 11. (NYT) (Reuters)
  • CDC: Monkeypox Case Reported in the U.S. (MedPage Today) (Reuters) (Bloomberg)
  • House Passes FDA Baby Formula Bill, But Senate Fate Is Uncertain (Bloomberg)
  • Biden invokes Defense Production Act to increase supply of U.S. infant formula  (Politico)
  • Covid Funds Slip Down Agenda as Congress Bounces Between Crisis (Bloomberg)
  • U.S. to study whether longer Paxlovid course needed to combat reinfections (Reuters)
  • Biden’s HHS Allocates $1.5 Billion for State Opioid Responses (Bloomberg)
  • NEJM, other journals: provide more transparency about conflicts of interest or don’t publish conflicted articles (STAT)
 
In Focus: International
  • 17 suspected monkeypox cases seen in Montreal, as European tally increases (STAT)
  •  
  • Britain offers smallpox shot as monkeypox cases spread in Europe (Reuters) (Endpoints)
  • What is monkeypox, the rare virus now confirmed in the U.S. and Europe? (Washington Post)
  • WHO clears COVID vaccine by China's CanSino Biologics for emergency use (Reuters)
  • EU's drug regulator accepts Valneva's COVID-19 vaccine marketing authorization filing (Reuters)
 
Pharma & Biotech
  • AstraZeneca’s ambitious vaccine dreams are finally, officially dead (STAT)
  • Merck to pay up to $1.4B in cancer deal with Kelun, but details are scarce (Fierce)
  • Going for the long haul, Resilience inks manufacturing pact with ARCH-backed cell therapy startup (Endpoints)
  • Orphazyme’s Sorry Story Ends In Fire Sale (Scrip)
  • How Amgen and AstraZeneca’s asthma drug Tezpire holds promise for colorectal cancer  (Fierce)
  • J&J-backed Locus closes $35M financing to push CRISPR-based antibacterial drug into phase 2/3 (Fierce)
  • Dermatology Pact Latest to Showcase Broad Potential of Evotec’s Platform (Biospace)
  • Zealand Pharma reports positive phase III results against congenital hyperinsulinism (Medwatch)
  • Novo Holdings establishes new firm managed by biotech veterans (Medwatch)
  • Fierce Biotech Layoff Tracker: Agios slims R&D operation, Scholar Rock in a hard place (Fierce)
  • Former top Medicare official says Medicare Advantage’s coding industry offers ‘no benefit to society’ (STAT)
 
Medtech
  • XACT ACE Robotics System Receives Expanded FDA Clearance For Ablation Procedures (MedTech Insight)
  • Cyted’s Sponge On A String May Help Diagnose Esophageal Cancer (MedTech Insight)
  • Study shows that Abbott’s Amulet, Boston Scientific’s Watchman devices are riskier for women (MedTech Dive)
Government, Regulatory & Legal
  • Moderna’s Vaccine Patent Defense Poses Shield for US Deal Makers (Bloomberg)
  • PhRMA's court win over HHS could be a boon for pharma patient assistance programs (Endpoints)
  • Allergan Kickback Claims Dismissed, Whistleblower Can Try Again (Bloomberg)
  • Even With Pandemic, Patent Suit Filings Held Steady In 2021 (Law360)
  • Many SF Walgreens Opioid Scripts Had Red Flags (Law360)
  • Infamous biotech exec Martin Shkreli gets out of prison, hits the street (Endpoints) (STAT)
 
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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