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Recon: US signs for $1.7M courses of Merck’s experimental COVID drug; FDA approves Vertex CF drug for 6-11 year olds

Posted 09 June 2021 | By Michael Mezher 

Recon: US signs for $1.7M courses of Merck’s experimental COVID drug; FDA approves Vertex CF drug for 6-11 year olds

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden says he will be announcing a vaccine plan for the world (Reuters)
  • White House urges states to seek longer shelf life for J&J shots as millions near expiration (Reuters) (KHN) (Politico)
  • US signs $1.2 bln deal for 1.7 mln courses of Merck's experimental COVID-19 drug (Reuters) (HHS)
  • Vertex cystic fibrosis treatment gets U.S. approval for use in 6-11 year olds (Reuters)
  • Government Warns Doctors and Insurers: Don’t Bill for Covid Vaccines (NYTimes)
  • Covid-19 vaccines for kids: FDA spells out questions on immunobridging, safety followup ahead of adcomm (Endpoints)
  • Biogen, FDA at odds over timing of crucial confirmatory trial of Alzheimer’s drug (STAT)
  • Member of FDA’s expert panel resigns over controversial Alzheimer’s therapy approval (STAT)
  • Senate crafts Pelosi alternative on drug prices (The Hill)
  • More than two-thirds of Congress cashed a pharma campaign check in 2020, new STAT analysis shows (STAT)
  • Pharma funded more than 2,400 state lawmaker campaigns in 2020, new STAT analysis finds (STAT)
In Focus: International
  • EU, US to agree reduction of vaccine export barriers, summit draft says (Reuters)
  • Covaxin phase 3 full trial data to be made public in July: Bharat Biotech (Economic Times)
  • China to study using CanSinoBIO COVID shots as a booster (Reuters)
  • Sinovac, Pfizer/BioNtech COVID-19 vaccines prove highly effective in Uruguay (Reuters)
  • World Bank opposes vaccine intellectual property waiver as WTO talks resume (Reuters)
Coronavirus Pandemic
  • In the US, vaccines for the youngest are expected this fall. (NYTimes)
  • The Highly Contagious Delta Variant Is On The Rise In The US (NPR)
  • J&J CEO says people will need Covid vaccine with annual flu shot for next several years as variants spread (CNBC)
  • US pharmacist jailed for three years for tampering with COVID-19 vaccines (Reuters)
  • EU to back US call for thorough study of coronavirus origins (The Hill)
  • Amazon gets EUA for direct-to-consumer, at-home COVID-19 test (MedtechDive)
Pharma & Biotech
  • Biogen Alzheimer's approval could open the door for other similar drugs (BioPharmaDive)
  • Kojin bags $60M to exploit weakness of drug-resistant cancers (Fierce)
  • Strength in Numbers: EU Cross-Country Drug Pricing Coalitions Join Forces (Pink Sheet)
  • Pharma Missing Out From Market Access Challenges In China: EU Group (Scrip)
  • Pondering The Future Of In-Person Meetings At The US FDA (Pink Sheet)
  • More US FDA Enforcement Of Clinical Trial Reporting Is Expected After Acceleron’s ‘Clerical Oversight’ (Pink Sheet)
  • ASCO21: An immunotherapy debate, an NK cell question and the next precision drugs (BioPharmaDive)
  • Pfizer rolls out next-gen pneumococcal vaccine with FDA win, beating Merck's 15-valent candidate to the punch (Endpoints)
  • Polaris, AbbVie, Bayer back Stuart Schreiber's hunt to turn cancer treatments into cures (Endpoints)
  • Roivant's data spinout merges with rival in $7B deal (Endpoints)
  • Analysts hound Biogen with questions over Aduhelm's $56K price point as news of Alzheimer's OK ripples through global markets (Endpoints)
  • On a continued hunt for Parkinson's breakthroughs, AbbVie turns to a biotech in its portfolio (Endpoints)
  • With its eyes set on an IPO raise, InCarda unrolls mid-stage data backing inhaled arrhythmia drug (Endpoints)
  • BeiGene dives in on natural killer cells with discovery pact for small biotech's stem cell-based platform (Endpoints)
  • Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) - Lot Number: NMDS210011 (FDA)
  • EU’s IVDR Plan Demands Team Effort And Flexibility From All Stakeholders (MedtechInsight)
  • Singapore’s Medtech Thought Leader Role And ASEAN Update (MedtechInsight)
  • Medtronic lands FDA approval for brain stimulation leads it expects to drive share gains (MedtechDive)
  • OraSure gets EUAs to enter shrinking COVID-19 antigen test market (MedtechDive)
  • BD doubles down on COVID-19 testing outlook, despite Abbott warning about demand drop-off (MedtechDive)
  • GlaxoSmithKline taps Progentec to bring AI, wearable tech to lupus treatments (Fierce)
  • Steril Milano EtO Deception: FDA Justifies 9-Day Gap From Import Detention To Industry Alert (MedtechInsight)
Government, Regulatory & Legal
  • Sanofi Files Opposition to Amgen’s Petition for Federal Circuit to Reconsider Decision Invalidating Praluent Patents (Big Molecule Watch)
  • Clinical Researchers Plead Guilty in Connection with Scheme to Falsify Drug Trial Data (DOJ)
  • AGs Back Bid To Close Sackler Family's Liability Loophole (Law360)
  • MSP Recovery's Opioid Claims Consolidated With Ohio MDL (Law360)
  • Parkinson's Drug Patent Ax In Del. Helps Mylan Win In Vt. (Law360)
  • Glenmark Says Glitch Calls For Supplement To DQ Testimony (Law360)
  • Hours After Getting Patents, Teva Sues Eli Lily Again (Law360)
  • 3rd Circ. Revives Trade Secrets Suit Against Aurobindo (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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