Recon: Ultragenyx Abandons UX007 for Rare Genetic Disorder After Ph. III Miss
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- EMDAC: CV risk should be assessed, but CV outcome trials due for a change (BioWorld) (BioCentury) (Pink Sheet-$)
- Trump Proposes to Lower Drug Prices by Basing Them on Other Countries’ Costs (NYTimes) (Reuters) (House E&C)
- Trump's drug price plan faces resistance on all sides (Politico) (STAT 1, 2) (Endpoints)
- Health secretary warns pharma: Administration will push ahead with drug pricing reforms (The Hill)
- Ultragenyx stumbles with UX007 PhIII, shares plunge (Endpoints)
- The FDA again adds more drugs to its valsartan recall list (CNN)
- Cancer Hospital Ads Deceive Patients About Their Chances Of Survival, New Report Finds (BuzzFeed) (TruthinAdvertising)
- Take it from a genetic counselor: 23andMe's health reports are dangerously incomplete (LA Times)
- For many grocery stores and pharmacies offering the flu shot is just a way to get you in the door (Marketplace)
- New study suggests opioid addiction in Mass. is much worse than thought (Boston Globe)
- Amazon will sell an exclusive brand of home health products called Choice, made by Arcadia Group (CNBC)
- Gilead's HIV portfolio soars, but is it enough to combat falling HCV sales? (Fierce) (PharmaTimes) (Press)
- Novartis gains US label boost for Cosentyx (PMLive)
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In Focus: International
- Deborah Dunsire kicks off her new gig as Lundbeck CEO with a key PhIII trial failure (Endpoints) (PharmaTimes) (Press)
- Novo-backed Galecto Biotech scores €79 million in Series C funding (Endpoints) (Fierce)
- NICE issues draft guidance rejecting Abbvie's Venclyxto in chronic lymphocytic leukaemia (Pharmafile) (Fierce)
- EMA quarantines drugs of sterile drugmaker in Spain (Fierce)
- EMA encourages companies to submit type I variations for 2018 by end of November 2018 (EMA)
- WuXi, CANbridge establish first known partnership in China to tackle rare diseases: CEO (Outsourcing Pharma)
- Australia To Make eCTD Mandatory From 2020 (Pink Sheet-$)
- Brazil Gets Down To Implementing ICH Guidelines (Pink Sheet-$)
- Trends in the global immuno-oncology landscape (Nature)
- Targeting macrophages: therapeutic approaches in cancer (Nature)
- Milestone Moment: A Parkinson’s Drug Moves Forward With Help From Michael J.Fox (Forbes)
- Pfizer works to get 'wait-and-see' doctors on board the Ibrance train (Fierce)
- IoT Data Could Plug Critical Gap In Pharmaceutical Industry, Says Medidata Cofounder (Forbes)
- Carving a pipeline out of troubled Teva, OrbiMed leads $60M launch of new NASH player (Endpoints)
- Shire’s ophthalmic medical lead joins Kala Pharmaceuticals as VP (Endpoints)
- Constipation drug maker Synergy looks to renegotiate bloated loan agreement — shares tumble (Endpoints) (WSJ)
- New 'peptoids' show promise in resistant prostate cancer (Fierce)
- Magic mushroom ingredient psilocybin gains breakthrough therapy designation (Pharmafile)
- Seattle Genetics Announces Multiple Data Presentations Evaluating ADCETRIS® (Brentuximab Vedotin) in Patients with Hodgkin Lymphoma at ISHL 2018 (Press)
- GenSight Biologics Enrolls First Subject in First-in-man PIONEER Phase I/II Clinical Trial of GS030 Combining Gene Therapy and Optogenetics for the Treatment of Retinitis Pigmentosa (Press)
- Alnylam Expands Alnylam Act® Program to Improve Diagnosis of Primary Hyperoxaluria Type 1 (PH1) and Aligns with FDA on Trial Design for ILLUMINATE-B Phase 3 Pediatric Study of Lumasiran (Press)
- Inositec’s INS-3001 Significantly Reduces Vascular Calcification Data Presented at Kidney Week 2018 Indicates (Press)
- Dicerna Announces Late-Breaking Data Supporting Use of DCR-PHXC in Adults with Primary Hyperoxaluria Types 1 and 2 (PH1 and PH2) (Press)
- Medical Device Makers Shut Out Of Value-Based Care Without Kickback Rule Change (Forbes)
- Earl E. Bakken, Pacemaker Inventor and Medtronic Founder, Dies at 94 (NYTimes)
- Abbott Molecular Flu, Strep Tests Get FDA Clearance (GenomeWeb)
- Pharmalittle: Will West Virginia and McKesson settle an opioid lawsuit? Trump drug price plan sparks controversy (STAT)
- Pennsylvania Preemption Win Now Final (Drug & Device Law)
- Maryland AG Seeks SCOTUS Review of Generics Price-Gouging Prohibition Struck Down by Fourth Circuit (FDA Law Blog)
- The STOP Act Won't Stop Drug Use Or Treat Addiction: Here Are Five Interventions That Will (Forbes)
- Methamphetamine Roils Rural Towns Again Across The US (NPR)
- A First Look At The Sweeping New Opioid Law (Law360-$)
- Exforge Generic Deal Is Clear Antitrust Violation, Court Told (Law360-$)
- FDA Advisory Committee Calendar
- Circulatory System Devices Panel of the Medical Devices Advisory Committee – 4-5 December 2018
- Daiichi Sankyo partners with Merck and Pfizer (PharmaLetter-$)
- 13 years after WHO guidelines, India yet to adopt guidelines on safe transport of diagnostic specimen (PharmaBiz)
- Notice: Consultation on proposed revisions to the Guidance Document: Management of Drug Submissions (Health Canada)
- Guidelines for advertisements for medicines containing Schedule 3 substances (TGA)
- Outcomes of the consultation to add substances to Appendix H of the Poisons Standard (TGA)
- Submissions received: Consultation: Proposed Schedule 3 substances proposed to be added to Appendix H of the Poisons Standard (TGA)
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