FDA Increasingly Halting Human Trials as Companies Pursue Risky, Cutting-Edge Drugs (WSJ)
An FDA pathway to clear medical devices is putting patients at risk, research suggests (STAT)
Illumina, the DNA sequencing giant, gives Wall Street bad news (STAT)
Most Alzheimer’s patients would pay up to $26,500 per year for new treatment Leqembi (CNBC)
In Focus: International
Germany's BioNTech buys British AI startup InstaDeep (Reuters) (FT)
Illumina challenges EU order to keep Grail separate (Reuters)
Bayer flags new blood thinner as $5 bln-plus opportunity (Reuters)
Pfizer CEO rules out generic COVID drug Paxlovid for China (Reuters)
Free access to Zolgensma curbed, says Novartis (PharmaPhorum)
Pharma & Biotech
Private equity acquires a taste for drug development (Reuters)
People hate drug ads on TV. Here’s what they complain about most (STAT)
FDA commissioner calls for more onshoring of clinical trials (Endpoints)
US Funding Law Could Speed Approval Of Drugs And Biologics Manufactured In Advanced Ways (Pink Sheet)
US FDA’s Use Of CRLs Hit A High Note In 2022: One-Third Of Novel Agent Decisions Were Not Approvals (Pink Sheet)
CVS Is Exploring a $10 Billion-Plus Acquisition of Oak Street Health (Bloomberg)
Shenzhen Kangtai Biological sees 2022 net loss on weaker COVID shot demand (Reuters)
Novotech's latest acquisitions grow its US presence and plant a European foothold (Endpoints)
Alto’s hopes for brain biomarker strategy rise on phase 2 antidepressant data (Fierce)
Fierce Biotech Layoff Tracker 2023: Editas edits workforce, plus more (Fierce)
JPM23: Mirati's post-Krazati pipeline restock to focus on 'highest opportunity for capital' (Fierce)
Voyager goes big, securing multi-billion dollar gene therapy development deal with Neurocrine (Endpoints)
Ionis sells partial stake in royalties from Spinraza and Novartis cardio drug to Royalty Pharma for $500M upfront (Endpoints)
AbbVie, following in footsteps of Lilly and Takeda, pays Anima $42M to go after undruggable targets (Fierce)
Jasper scraps pivotal plans but adds a new indication as more biotechs revise pipelines (Endpoints)
4D Molecular pauses enrollment in Fabry trials after kidney problems in three patients (Endpoints)
Sutro shells out latest update on ovarian cancer treatment, plans for pivotal trial (Endpoints)
Medtech
GE HealthCare expects 5%-7% organic revenue growth in 2023 on strong demand (Reuters)
Medtronic CEO Martha: No more divestitures planned for 2023, but review continues (MedtechDive)
UK To Fund ‘Artificial Pancreas’ Technology, But Only For Companies That Cut Prices (MedtechInsight)
ResMed responds to ‘humanitarian emergency’ over demand for CPAP devices with new factory (MedtechDive)
Beta Bionics hires Harvard diabetes expert as CMO ahead of artificial pancreas launch (MedtechDive)
JPM23: 'What has the pandemic done for us?' Freenome and other diagnostics developers on making tests more accessible (Fierce)
Government, Regulatory & Legal
Still fuming over the federal Covid response, Republicans redirect the House coronavirus committee (STAT)
Teva's opioid settlement moves forward with participation from 48 states (Endpoints)
U.S. appeals court won't revive Zofran birth defect cases against GSK (Reuters)
Jet Medical and Related Companies Agree to Pay More Than $700,000 to Resolve Medical Device Allegations (FDA)
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.