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)
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)
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