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May 12, 2021
by Michael Mezher

Recon: Emergent execs to testify before house panel; ACIP weighs Pfizer vaccine in adolescents

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer COVID-19 vaccine works for adolescents, CDC panel told (Reuters)
  • Pelosi drug price plan threatened by centrist defections (Politico) (STAT)
  • Illumina CEO insists GRAIL merger will be good for competition, and ultimately, patients (STAT)
  • AbbVie Slapped With Suit From Would-Be Humira Rival (Law360) (Fierce)
  • Sanofi is accused of ‘widespread destruction’ of company e-mails tied to Zantac recall (STAT) (Fierce)
  • States won't get Johnson & Johnson vaccines next week (Politico)
  • CDC Chief Defends Pandemic Guidance as Impatience Mounts (NYTimes)
  • The leaders of Emergent, whose factory spoiled vaccine doses, will testify before a US House panel. (NYTimes)
In Focus: International
  • More data needed before COVID-19 vaccine booster call - EU regulators (Reuters)
  • How can we stop the next pandemic? Here's what a WHO panel recommends (Reuters 1, 2) (NYTimes)
  • Australia taps Moderna for 25 million COVID-19 shots in vaccination ramp up (Reuters)
  • Samsung BioLogics, Pfizer deny report on COVID-19 vaccine production in S.Korea (Reuters)
  • Pfizer asks UK regulator to approve Covid vaccine for use in 12 to 15-year-olds (The Telegraph)
  • Pfizer to seek COVID-19 vaccine approval in Mexico for children aged 12-15 (Reuters)
  • Brazil buys 100 million more doses of Pfizer's COVID-19 vaccine (Reuters)
Coronavirus Pandemic
  • Scientists probe impact of Indian Covid variant on vaccine efficacy (FT)
  • Bahrain authorizes emergency use of one-shot Sputnik-Light COVID-19 vaccine (Reuters)
  • U.S. official says Covid booster shots will also be free to the public (CNBC)
Pharma & Biotech
  • Ginkgo plans a $17.5 billion merger with SPAC that took DraftKings public (STAT)
  • Dana-Farber receives $50 million gift to study pancreatic cancer (STAT)
  • Pandemic Urgencies Highlight Constraints in Manufacturing Change Regulatory Paradigm and Where Adjustments Are Needed (IPQ)
  • Astellas’ Xtandi bags additional MHRA approval in prostate cancer (PharmaTimes)
  • NICE rejects Pfizer’s rare heart disease treatment Vyndaqel (PharmaTimes)
  • A closer look at the FDA’s more than 700 pandemic-related record requests to replace onsite inspections (Endpoints)
  • Alexion co-founder Stephen Squinto is back in the game as CEO, this time for a small gene therapy player (Endpoints)
  • George Golumbeski signs on at a European specialist VC firm with $265M to bet on genetic diseases (Endpoints)
  • Biogen pushes in a fresh stack of chips and starts prepping a global R&D game plan after watching the cards turn on early thrombolytic data (Endpoints)
  • Can a rare immune cell offer the key to slowing down senescence? A Bay Area startup looks to find out (Endpoints)
  • Luisa Salter-Cid joins longtime Bristol Myers collaborator Paul Biondi at Flagship's new drug brewery (Endpoints)
  • With backing from Bayer, a London firm will pitch its 'hospitals at home' concept for decentralized trials (Endpoints)
  • Perceptive Advisors, Xontogeny bring the band back and then some with a $515M second fund sniffing out lead compounds (Endpoints)
  • Lederle Laboratories et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications (FDA)
Medtech
  • Commission Calls For Notified Body Applicants As It Recognizes EU IVD Industry In Some Trouble (MedtechInsight)
  • Bose gets into hearing aid business with new FDA-cleared SoundControl hearing aids (The Verge)
  • The growing liquid biopsy field sees a unicorn entrant as Caris pulls in $830M megaround (Endpoints)
  • Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues (FDA)
  • Whiterabbit emerges from stealth with FDA clearance for AI breast cancer screening tool (mobihealthnews)
  • FDA eSTAR Update: 51 Submissions, No Manufacturer Complaints (MedtechInsight)
  • Diabetes tech companies continue 2020's success with Q1 growth. Investors seem unimpressed (MedtechDive)
  • Top Dems Mount Pressure On Becerra To Reverse COVID-19 LDT Policy Stopping FDA Oversight (MedtechInsight)
Government, Regulatory & Legal
  • Antitrust Division and Fellow Members of the Multilateral Pharmaceutical Merger Task Force Seek Public Input (DoJ)
  • Study Coordinator Charged in Scheme to Falsify Clinical Trial Data (DOJ)
  • Senate Confirms Andrea Palm As HHS Deputy Secretary (Law360)
  • North Carolina Woman Arrested for Selling Unapproved Remedies for Covid-19 (FDA)
  • Insulin Pump Maker Says Roche Sneaked Into Market (Law360)
  • Walmart Wants 5th Circ. To Revive Opioid Suit Against Feds (Law360)
  • Texas Pharma Co. Settles Opioid Whistleblower Suit For $2.8M (Law360)
  • Elizabeth Holmes' Mystique Unlikely To Survive Looming Trial (Law360)
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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