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August 12, 2021
by Michael Mezher

Recon: Biden presses Congress to allow Medicare to negotiate drug prices; FDA poised to authorize third COVID vaccine dose for immunocompromised people

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • NIH's experimental antibody drug prevents malaria in small study (Reuters)
  • FDA poised to OK 3rd vaccine dose for immunocompromised people (NBC) (Reuters) (Politico)
  • In a new policy proposal, Biden presses Congress to let Medicare negotiate drug prices (STAT) (Reuters) (Endpoints)
  • National Academies’ Report Took Pharma-Friendly Stance After Millions in Gifts From Drugmakers (KHN)
  • FDA says it needs a little more time to decide on Merck's P2X3 for chronic cough (Endpoints)
  • First generic competition arrives for Pfizer's megablockbuster anti-smoking drug (Endpoints)
  • Merck nabs approval for Keytruda combo in kidney cancer after proving it can extend survival (Endpoints) (FDA)
In Focus: International
  • Age restrictions on AstraZeneca shot have ended reports of rare clots -UK scientists (Reuters)
  • Breast cancer drug approved for NHS after maker agrees discount (The Guardian)
  • Regulator seeks views on innovative medicines manufacture at point of care (MHRA)
Coronavirus Pandemic
  • U.S. health secretary mandates COVID-19 shots for health care staff (Reuters)
Pharma & Biotech
  • New immunotherapy approach wiped out tumors in two patients with advanced lung cancer, study reports (STAT)
  • Sen. Rand Paul reveals his wife bought Gilead stock in February 2020 — 16 months after filing deadline (Endpoints)
  • Anti-aging research pioneer Aubrey de Grey placed on leave over sexual harassment allegations (STAT)
  • Cancer Trials: Beware Of ‘Digital Exhaust’ When Planning Clinical Outcome Assessments (Pink Sheet)
  • Two data falsifiers sentenced to prison as FDA pledges to crack down on those undermining clinical trials (Endpoints)
  • A unicorn bags another $220M to fund its plans to upend the clinical trial process (Endpoints)
  • Purdue subsidiary nabs non-opioid drug for pain; OrbiMed backs small biotech's 'superior' drug (Endpoints)
  • Aprea discloses second clinical hold in a week, this time for lymphoma study (Endpoints)
  • Out to revamp plant-based drug manufacturing, Antheia locks in partnership with synthetic biology giant Ginkgo (Endpoints)
  • Peter Thiel-backed ATAI launches new Salvia-focused biotech; Purdue bankruptcy trial expected to begin today — report (Endpoints)
  • Evotec's new Washington site is ready to roll, and the U.S. has already called first dibs for COVID-19 antibody supplies (Fierce)
  • Merck partner Artiva blueprints San Diego R&D, manufacturing site to take NK cell operation to the next level (Endpoints)
Medtech
  • Study reveals stroke risk that brought down Medtronic's HeartWare HVAD (MedtechDive)
  • Portable negative pressure tent scores FDA emergency OK to stretch newly strained COVID resources (Fierce)
  • Medtech industry starts to face lack of diversity, execs of color (MedtechDive)
  • The Unintended Consequences Of The Swiss-EU Medtech MRA Failure (MedtechInsight)
  • Wise Therapeutics’ game-based app reduces anxiety in multiple sclerosis patients, NYU study finds (Fierce)
  • Q&A with Philips' head of connected healthcare on new products, hospital tech adoption in the COVID-19 era (MedtechDive)
Government, Regulatory & Legal
  • Affordable naloxone is running out, creating a perfect storm for more overdose deaths, activists say (Washington Post)
  • Concerns Persist about Opioid Overdoses and Medicare Beneficiaries' Access to Treatment and Overdose-Reversal Drugs (HHS)
  • Roche Can't Ax Ravgen's DNA Tech Patent Suit, Judge Finds (Law360)
  • Endo 'Head Shot' Penalty Mulled In Opioid Discovery Fight (Law360)
  • Mallinckrodt Asks For Another 3-Month Hold On Product Suits (Law360)
  • Endo Cases Highlight Rare Default Risk In Discovery Failures (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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