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June 24, 2020
by Michael Mezher

Recon: Merck strikes deal with Yumanity for neurodegenerative disease drugs; Feds allege Regeneron used charity to pay kickbacks

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Federal prosecutors allege Regeneron used a charity to pay kickbacks to Medicare patients (STAT)
  • Yumanity Therapeutics, Merck strike deal aimed at developing new medicines for neurodegenerative disease (STAT) (Endpoints)
  • FDA urged to heighten safety warnings on common type 2 diabetes drugs (STAT) (Public Citizen)
  • By $4M, La Jolla outbids Melinta for struggling Tetraphase (BioPharmaDive) (Endpoints)
  • FDA lifts partial hold on cancer drug after Innate resolves manufacturing issue (Endpoints)
  • Fauci says White House told NIH to cancel funding for bat virus study (Politico)
In Focus: International
  • EU May Bar American Travelers as It Reopens Borders, Citing Failures on Virus (NYTimes)
  • UK Biotechs Maintain Fundraising During Pandemic (Scrip)
  • UK Supreme Court strikes down Regeneron patents, opening door for Kymab (Endpoints)
  • Sanofi's fight for a better research reputation (BioPharmaDive)
  • The ICH Plans To Propose Q14 Guideline On Analytical Testing In January (Pink Sheet)
  • UK Home office reclassifies Epidyolex as a Schedule 5 drug (Pharmafile)
  • Top UK Court Invalidates Regeneron's Lab Mice Patents (Law360)
  • A Swiss-Japanese alliance that has thrived in the crisis (Financial Times)
Coronavirus Pandemic
  • The ‘hard slog’ of waiting for a coronavirus vaccine (Politico)
  • All You Wanted To Know About Coronavirus Vaccine Science But Were Afraid To Ask (NPR)
  • UK launches new national COVID-19 test validation project (Fierce)
  • Inovio gets US government backing for vaccine delivery device (BioPharmaDive)
  • 5-minute, quantitative COVID-19 antibody test snags BARDA backing (MedtechDive)
  • In Poor Countries, Many Covid-19 Patients Are Desperate for Oxygen (NYTimes)
  • COVID-19 And IP: Companies Are 'Taking A Chance' Sharing Clinical Trial Details (Pink Sheet)
  • Rohto to Launch Stem Cell Clinical Trial for COVID-19 in August, Eyes Conditional OK (PharmaJapan)
  • Coronavirus (COVID-19) Update: Daily Roundup June 23, 2020 (FDA)
Pharma & Biotech
  • A virtual biotech incubator is launching with the help of Evotec and Samsara, looking for a few good scientists in need of seed cash for spinouts (Endpoints)
  • Competitive orphan drug market will drive down prices, OptumRx predicts (Fierce)
  • Nurturing A Culture Of “Smart Speed” To Bring Gene Therapy To The World (LifeSciVC)
  • Gene Therapies Will Be A Bigger Cost Issue In 2021, PwC Predicts (Scrip)
  • Driving CARs to clear senescent cells (Nature)
  • Sangamo R&D chief hits the exit as it splits R&D into separate units (Fierce)
  • Day one: The disruptor-in-chief at BridgeBio invites Brent Saunders onto the board (Endpoints)
  • Engineering a better immunotherapy to outwit cancer — and launch a biotech (STAT)
  • A preliminary new method could restore the brain cells Parkinson’s disease patients lost (STAT)
  • Biogeneration Ventures raises $119M for new fund, adding a personal record to series of VC raises (Endpoints)
  • Better than Eylea, as durable as gene therapy? Perceptive, Xontogeny boost ophthalmic startup's shot for best of all worlds (Endpoints)
  • With its campus expanding as gene therapy booms, Aldevron brings in a top exec from a medtech giant to steer the course (Endpoints)
  • Biohaven reports another trial failure for troriluzole; Cyclica raises C$23M for AI driven discovery platform (STAT)
Medtech
  • Baxter, B. Braun infusion pumps among millions of devices implicated in Ripple20 cyber alert (MedtechDive)
  • Mainstay wins FDA approval for chronic back pain device following mixed clinical data (MedtechDive)
  • New Guardant genomic database could be worth $2B, analysts say (MedtechDive)
  • Procedures for Conducting In-Person Usability Testing During COVID-19 Pandemic (Emergo)
Government & Regulatory
  • Biopharma Patentees Must Navigate Inherent Obviousness (Law360)
  • Obviousness Doomed Narcan Patents After NJ Bench Trial (Law360)
  • Philips Says Chinese Rivals Can't Skirt Ill. Trade Secret Suit (Law360)
  • Women With Cancer Awarded Billions in Baby Powder Suit (NYTimes) (Reuters)
  • Purdue Gets OK For $6.5M Investment In Overdose Drug (Law360)
  • Purdue Wants Sackler Claims To Stay Blocked By Ch. 11 (Law360)
  • Chicago Says Drug Cos. Shouldn't Exit Opioid Bellwether Suit (Law360)
  • Much-Needed Clarity on Disgorgement from the Supreme Court (FDA Law Blog)
  • Maryland Federal Court Holds Breast Implant Claims Preempted (Drug & Device Law)
  • Agencies Hit With FOIA Suit Over Request For DNA Docs (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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