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February 22, 2022
by Joanne S. Eglovitch

Recon: Takeda signs $2B gene therapy deal exploring AAV alternatives; Baxter warns of infusion pump problems tied to three deaths

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Warren Urges Government to Seize Patents on Pfizer’s Cancer Drug (Bloomberg)
  • Public Citizen accuses Pfizer of building 'patent wall' for Covid treatment, setting up inequities again (Endpoints)
  • Takeda signs off on a $2B deal aimed at bypassing AAV roadblocks on the way to gene therapy 2.0 (Endpoints)
  • Tiny pharma hits a new low with FDA refusing to review company’s response to its CRL (Endpoints)
  • FTC votes against probing the controversial practices of pharmacy benefit managers (STAT) (BioPharma Dive)
  • Providers Upset WH COVID-19 Package Leaves Out Their $20B Request (Inside Health Policy)
  • CDC taps Palantir to support COVID-19 drug supply in U.S. (Reuters)
  • Biden to extend U.S. national emergency due to COVID-19 health risk (Reuters)
  • Cardiology Could Get A Jolt As FDA Reviews Novel Heart Failure Candidates From BMS, Cytokinetics (The Pink Sheet)
  • No Pressure: FDA Floats Threshold On Adverse Blood Pressure Effect In Chronic Drugs (The Pink Sheet)
  • Will US FDA Offer Regulatory Flexibility For ANDAs Downgraded Because Of CRO Investigation? (The Pink Sheet)
In Focus: International
  • Improving Medicines Availability Tops EU Regulators’ 2025 Workplan (The Pink Sheet)
  • End of an era at AstraZeneca as Leif Johansson preps exit as chairman. So where does that leave Soriot? (Endpoints)
  • It looks like the final round of Emergent's AstraZeneca Covid-19 doses have been released (Endpoints)
  • BioNTech jumps into PRAME game, paying Medigene $29M for preclinical T-cell therapy program (Fierce)
  • Arimoclomol & Ipique Developers To Make Their Case Before The EMA (The Pink Sheet)
  • The WHO’s chief scientist on Covid-19 vaccines, patent battles, and speeding up access in Africa (Fierce)
Coronavirus Pandemic
  • Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia to establish mRNA vaccine production (Biopharma Reporter)
  • Reinfections with Omicron subvariants are rare, Danish study finds (Reuters)
Pharma & Biotech
  • The top 10 biotech IPOs of 2021 (Fierce)
  • When the $10K brand name drug is more affordable than its $450 generic: How PBMs control the system (Endpoints
  • As Moderna adds on a host of new commercial subs, there's room for 3 more vaccine candidates in the pipeline (Endpoints)
  • GlaxoSmithKline tees up ‘Haleon’ brand name for consumer healthcare spinoff (Endpoints)
  • Bayer's Faith In Pharma Pipeline Paying Off (Scrip)
  • Lilly breaks the bank on the potential for RNA with $700M investment in Boston's Seaport (Endpoints)
  • Q&A: Astellas’ Anthony Yanni leading the charge to embed patient voices' in pharma business model (Endpoints)
  • Another biotech shuffles its C-suite as Silence CEO steps down (Endpoints)
  • Adagio CEO resigns with no explanation and the biotech plans COVID-19 antibody analysis this quarter(Fierce)
  • Biopharma has hyped AI for years. But as the first trials get underway, experts try to manage expectations (Endpoints)
  • Homology joins BioMarin in halting gene therapy studies for rare metabolic disease (Endpoints)
  • Cancer treatment toxicity affects women more than men (Nature)
Medtech
  • Six Months Of Preparation For the IVDR: Flurry Of Documents But No New Notified Bodies (MedTech Insight)
  • Baxter warns of potential blockages in infusion pumps linked to 3 deaths (Fierce)
  • UKCA Marking Debate Moves To Next Level: All Eyes On The MHRA (MedTech Insight)
  • The top 10 medtech IPOs of 2021 (Fierce)
  • Beta Bionics raises $57M to bring its artificial pancreas to the FDA (Fierce)
Government, Regulatory & Legal
  • Roche and AstraZeneca settle yearslong patent battle over Ultomiris — report (Endpoints)
  • Biosimilar Use, Cost Trends In Medicare Part B Will Be Examined By HHS Inspector General (The Pink Sheet)
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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