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)
- 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)
- 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)
- 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)
- 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)
- 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)
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