Recon: Pfizer, Lilly move to sell drugs direct to consumers; Bharat Biotech to launch oral cholera vaccine
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Centene eliminates brokers’ commissions for Medicare drug plans (STAT)
A virus bodega, DNC takeaways, and free Covid tests (STAT)
Pfizer and Lilly want to sell you drugs directly (STAT)
Lilly launches Zepbound vials in move that could ease supply constraints (STAT) (Reuters)
Pfizer launches new website for migraine, respiratory offerings (Reuters)
Delaware top court will hear drugmakers' appeal to end Zantac lawsuits (Reuters)
Jazz, Hikma must face 'reverse payment' claims over narcolepsy drug (Reuters)
In Focus: International
WHO launches plan to stanch mpox transmission and says the virus can be stopped (STAT)
To stop mpox from becoming the next pandemic, we must address global vaccine inequities (STAT) Duality Biologics, an ADC partner of BeiGene and BioNTech, files for Hong Kong IPO (Endpoints)
Responsible Antimicrobial Manufacturing A Must For UK’s Subscription Model Applicants (Pink Sheet)
Brazilian Medicines Regulator Consults On Regulatory Sandbox (Pink Sheet)
New mpox strain is changing fast; African scientists are ‘working blind’ to respond (Reuters)
India's Bharat Biotech to launch oral cholera vaccine amid global shortage (Reuters)
Pharma & Biotech
A Galapagos investor signals impatience with its turnaround efforts (STAT)
Elektrofi, a startup that helps drugmakers formulate biologics for easier delivery, is raising a $112M Series C (Endpoints)
Invivyd says new Phase 3 data on Covid antibody support prophylactic use (Endpoints)
RA Capital and Forbion set up new autoimmune biotech with bispecific from Korean startup (Endpoints)
AstraZeneca pours $135M into boosting biologics capacity in Sweden (Endpoints)
Once-promising cancer drugs appear to protect mice from Alzheimer’s (Endpoints)
Overcoming The Challenges Of Developing Hearing Loss Therapies (Pink Sheet)
Regeneron’s Linvoseltamab CRL Underlines Risks Of Third-Party Manufacturers (Pink Sheet)
Medtech
Continuous glucose monitoring for the masses is here. Are we ready for it? (STAT)
To help migraine patients — and sell more medicines — major drugmakers turn to telehealth (STAT)
Illumina wins FDA approval for test to identify treatable cancers (Endpoints)
Insulet expands Omnipod 5 pump to people with Type 2 diabetes (MedTech Dive)
Inari updates label of clot removal device linked to 6 deaths (MedTech Dive)
Siemens Healthineers to grow PET imaging with purchase of Novartis assets (MedTech Dive)
Dexcom prices first over-the-counter glucose monitor (MedTech Dive)
Co-Founder of ‘Anti-CRO’ Talks Building Better Clinical Trials (MedTech Insight)
Final Guidance Sets Date For Mandatory De Novo Electronic Submissions (MedTech Insight)
PreciseDX Aims To ‘Enrich’ Standard Of Care For Breast Cancer Recurrence Prediction (MedTech Insight)
Government, Regulatory & Legal
Glucose monitors, mpox vaccine inequity and effects of LGBTQ+ restrictions (STAT)
The importance of reducing the financial burden of participating in clinical trials (STAT)
FDA seeks feedback on predetermined change control plans (MedTech Dive)
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.