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Recon: Inside Pfizer’s Drug Supply Problem

Posted 22 May 2018 | By Zachary Brennan 

Recon: Inside Pfizer’s Drug Supply Problem

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Critical Condition: Inside Pfizer’s Drug Supply Problem (Fortune)
  • New Vermont Law Seeks to Allow Wholesale Importation of Drugs from Canada (FDA Law Blog)
  • Right to try legislation comes to the House floor (House Daily Schedule) (Baltimore Sun)
  • Allergan doubles down on NMDA depression drug development efforts, bagging an option to a small molecule followup drug (Endpoints)
  • FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses (FDA) (Reuters)
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In Focus: International
  • What It Will Take to Finally Defeat Tuberculosis (Bloomberg)
  • Two more die of Ebola in Congo, seven new cases confirmed (Reuters)
  • ‘You’re holding your breath’: Scientists who toiled for years on an Ebola vaccine see the first one put to the test (Stat)
  • Ten die in India outbreak of brain-damaging virus, spurring rush to hospitals (Reuters) (NPR)
  • Human Medicines Regulations 2012 Advisory Bodies annual report 2017 (GOV UK)
  • Addressing the Global Shortage of, and access to, medicines and vaccines (EU Statement at WHO World Health Assembly)
  • Global AMR R&D collaboration (MSF)
Pharmaceuticals & Biotechnology
  • Asco preview – A second wind for antibody-drug conjugates (EP Vantage)
  • Dova Pharma's blood disorder drug gets FDA approval (Reuters)
  • Middlemen Who Save $$ On Medicines — But Maybe Not For You (KHN)
  • Make Drugs Cheaper by Encouraging Generics (Bloomberg)
  • US clears paediatric use of GSK’s Arnuity Ellipta (PharmaTimes)
  • High Court Won't Look At 3rd Circ. Ruling On Eyedrop Size (Law360-$)
  • Fifth added FDA indication for Prolia (PharmaLetter-$)
  • Evotec and Celgene Enter into Strategic Oncology Partnership (Press) (Fierce)
  • Can an Obscure, 100-Year-Old Patent Law Take On Big Pharma? (Bloomberg BNA)
  • How A Bone Disease Grew To Fit The Prescription (NPR)
  • WuXi Biologics to Invest S$80 Million to Establish a Biologics Manufacturing Facility in Singapore (Press)
  • Ex-Valeant, Philidor executives found guilty of kickback scheme (Reuters)
  • How to Be a Good Medicinal Chemist (In the pipeline)
  • Sonoma Pharma Can Likely Pursue Trade Secret Claims (Law360-$)
  • Novartis and Par Pharmaceutical Taken to Court Over Pay-For-Delay (FDANews-$)
  • Litigation Spotlight Update: Epogen Litigation Status in Face of Retacrit Regulatory Approval (BiosimilarsIP)
  • Insys May Need Convenience Argument To Save Sublingual Buprenorphine Spray (Scrip-$)
  • Lupagen & Humanigen to explore point-of-care CAR-T therapy (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Sesen’s PhIII bladder cancer data send stock south as investors fret over safety (Endpoints)
  • Five-Year Outcomes with PCI Guided by Fractional Flow Reserve (NEJM)
  • Clinical utility of circulating non-coding RNAs — an update (Nature)
  • Pfizer Begins a Phase 1/2 Study to Evaluate Respiratory Syncytial Virus (RSV) Vaccine (Press)
  • Spark Therapeutics and Pfizer Announce Data from 15 Participants with Hemophilia B Showing Persistent and Sustained Factor IX Levels with No Serious Adverse Events (Press)
  • FDA has accepted Sanofi's regulatory filing for Type 1 diabetes oral treatment Zynquista (sotagliflozin) (Press)
  • CytomX Therapeutics Announces FDA Clearance of Investigational New Drug Application for CX-2029 (Press)
  • Acceleron Announces Initiation of PULSAR Phase 2 Trial of Sotatercept in Pulmonary Arterial Hypertension (Press)
  • BioMarin Provides 2 Years of Clinical Data in 6e13 vg/kg Dose from Ongoing Phase 1/2 Study in Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A at World Federation of Hemophilia 2018 World Congress (Press)
  • An anatomic transcriptional atlas of human glioblastoma (Science)
  • Novo’s Refixia beats rival in head to head trial (PharmaTimes)
Medical Devices
  • Why Bill Gates is betting on a start-up that prints synthetic DNA (CNBC)
  • MIT researchers devise single-injection delivery method for polio vaccine (MassDevice)
  • FDA approves a UTI test from a St. Louis startup that could help reduce antibiotic resistance (St. Louis Public Radio)
  • Abbott Recalls the HeartMate 3 Left Ventricular Assist System Due to Potential Malfunction that may Lead to Graft Occlusion (FDA)
  • Despite Only Two Parallel Review Success Stories, CMS Touts Better Coordination (Scrip-$)
  • Grail Announces $300 Million Raised in Oversubscribed Series C Financing (Press)
  • Real-World Evidence Confirms Clinical Trial Outcomes For Patients Treated With Edwards SAPIEN 3 Valve (Press)
US: Assorted & Government
  • Rudy Giuliani won deal for OxyContin maker to continue sales of drug behind opioid deaths (Guardian)
  • Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application: Guidance for Industry (FDA)
  • The South African National Department of Health Did Not Always Manage and Expend the President's Emergency Plan for AIDS Relief Funds in Accordance With Award Requirements (OIG)
  • CMS Should Take Actions to Continue Prior Authorization Efforts to Reduce Spending (GAO)
  • Are Some Tumors Just ‘Born to Be Bad’? (NIH Director’s Blog)
  • Annual Report to the Nation: overall cancer mortality continues to decline, prostate cancer mortality has stabilized (NIH)
  • The Next Big Health Care Merger: Biomedical Imaging and Artificial Intelligence (NIST)
  • Cognition Therapeutics Receives $6.6M in NIA Grants for Two Studies of Elayta to Expand Understanding of Synaptoprotective Mechanism of Action (Press)
Upcoming Meetings & Events Europe
  • £30 million of funding to tackle antimicrobial resistance (UK Gov)
  • Gates Foundation and U.K. pledge $50M to superbug treatment drive (Fierce)
  • Public consultation on the Evaluation of the European Monitoring Centre for Drugs and Drug Addiction (EC)
Asia & Australia
  • MHLW Presents Schedule for Discussions on Inclusion of 6 Vaccines in Public Vaccination Programs (Pharma Japan)
  • Inaugural Industry Forum on Good Manufacturing Practice (GMP) (TGA)
  • Deadly Chinese Fentanyl Is Creating a New Era of Drug Kingpins (Bloomberg)
General Health & Other Interesting Articles
  • A Warming Climate May Produce More Drug-Resistant Infections (Scientific American)
  • Investigating Birth Outcomes and HIV Drug Regimens (Northwestern University)
  • Every cell in your body has the same DNA. Except it doesn’t. (NY Times-$)
  • Age-Related Racial Disparity in Suicide Rates Among US Youths From 2001 Through 2015 (JAMA)
  • After long decline, death rates from prostate cancer stop falling (Washington Post)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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