Recon: Inside Pfizer’s Drug Supply Problem

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• £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)

• 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)

• 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)