Recon: Pfizer to pay $93M to resolve Lipitor antirust complaint; FTC to examine group purchasing organizations
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
The health care system is ignoring world’s most promising approach to preventing cardiovascular disease (STAT)
Biogen, grappling with declining sales, slapped with DOJ subpoena over foreign operations (Fierce Pharma)
FTC to probe the role of middlemen in worsening drug shortage crisis (STAT)
Will slow uptake of Leqembi pose a risk to Biogen’s recovery? (Endpoints)
Exclusive: Wegovy fuels sharp rise in use of weight-loss drugs for US youth (Reuters)
Telemedicine abortion is as safe, effective as in-person care, US study finds (Reuters)
Pfizer agrees to pay $93 mln to settle Lipitor antitrust lawsuit (Reuters)
US FDA’s Needs To Fortify Supply Chain Among Legislative Priorities In 2025 Budget (MedTech Insight)
HHS Releases ‘Essential’ And ‘Enhanced’ Cybersecurity Performance Goals (MedTech Insight)
In Focus: International
Leaked version of EFTA-India free trade deal sparks alarm over access to medicines (STAT)
GSK wins appeal to only pay AstraZeneca royalties on some sales of cancer drug Zejula (Endpoints)
Alvotech settles with J&J to launch Stelara biosimilar in Europe, Canada (Reuters)
Prostate Screening: UK Industry Body Explores Role In Study, Points To Growing Diagnostics Remit (MedTech Insight)
UK Approved Body Capacity Rises But Not For IVDs (MedTech Insight)
EU Artificial Intelligence Final Text Confirmed By Parliament Committees (MedTech Insight)
Pharma & Biotech
Stem cell study offers clue to South Asians’ increased risk of cardiovascular disease (STAT)
GSK completes acquisition of Aiolos Bio for up to $1.4 bln (Reuters)
Gaming Amylyx stock reactions to the next ALS drug test, and a chat with CRISPR’s CEO about a new investor (STAT)
Biotech launches with $135 million for Vertex-competing pain medicine (STAT)
Alnylam delays highly-anticipated ATTR readout as it changes study design (Endpoints)
'Obesity plus': What’s next for GLP-1s? (Endpoints)
Apnimed, a late-stage sleep apnea biotech, eyes IPO in the second half (Endpoints)
KalVista wants to raise $160M; Prime Medicine's upsized offering; Applied Tx's PhIII data (Endpoints)
Aurinia fails to find buyer, will shed pipeline to focus on Lupkynis (Endpoints)
Carolyn Bertozzi and Versant's new biotech breaks cover with $94M to use protein degraders in ADCs (Endpoints)
Pfizer could end Lipitor antitrust saga involving Ranbaxy with $93M settlement (Endpoints)
Aurinia to stop drug trials, cut jobs after failing to find buyer; shares tank (Reuters)
Medtech
Digital tools helped lower blood pressure in marginalized patient groups (STAT)
Freenome raises $254M for early cancer detection tests (Endpoints)
Canary CEO Bill Hunter talks smart knee implant progress, new heart device (MedTech Dive)
Smiths Medical recalls syringe pumps for software malfunction (MedTech Dive)
Masimo wins first FDA clearance for OTC medical fingertip pulse oximeter (MedTech Dive)
FDA Clears AI Software Designed To Detect Early Signs Of Fatty Liver Disease (MedTech Insight)
Government, Regulatory & Legal
The Jewish American and Palestinian American scientists who’ve been partnering for 14 years on science’s toughest challenges (STAT)
Long Covid research funding at NIH gets a nearly 50% boost (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.