Recon: Ebola Vaccine Arrives in DRC

• ALS patients losing time and hope as they wait for insurers to cover a pricey new drug (Stat)
• Nabriva goes 2 for 2 in Phase III antibiotic program, scoring on a key catalyst and teeing up an FDA pitch for lefamulin (Endpoints) (Reuters) (Fierce)
• FDA approves new drug for patients with chronic liver disease (FDA)
• Biosimilar Approval: Better, Stronger, Faster (FDA Law Blog) (Citizen Petition)
• Requiring Prices in Drug Ads: Would It Do Any Good? Is It Even Legal? (NYT-$)
• BD chief George Golumbeski is the latest top exec to exit Celgene (Endpoints)
• AstraZeneca potassium drug finally approved, threatening Vifor (Reuters)
• More Competition for Pharma (WSJ Editorial)
• Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators (FDA)
• McCaskill letters to DoD and VA on Teva (HSGAC)

• Ebola Vaccine Arrives in Democratic Republic of Congo (WSJ-$) (Reuters)
• WHO supports Ebola vaccination of high risk populations in the Democratic Republic of the Congo (WHO)
• AstraZeneca rocked by shareholder revolt over executive pay (Guardian)
• Janssen Announces European Commission Approval of Juluca (dolutegravir/rilpivirine), the First Two-Drug Regimen, Once-Daily, Single-Pill for the Treatment of HIV-1 (Press)
• Tedros Makes His Case for a Transformed WHO (Global Health Now) (Delegate List)
• MHRA, March 2018 ‘GXP’ Data Integrity Guidance and Definitions (Lachman Consultants)

• Amgen And Avalere Reports Reveal "Upside Down" Payer Biosimilar Realities (Biosimilar Development)
• Top 20 Best Selling Drugs in 2018 (IGEA Hub) (BioSpace)
• Galecto brings on GSK’s fibrosis lead as CMO (Fierce)
• Cantor Fitzgerald: 18 Drug Companies With Catalysts Worth Watching (Benzinga)
• FDA just approved the first drug to prevent migraines. Here’s the story of its discovery—and its limitations (Science Magazine)
• FTC Admin. Judge Says Endo-Impax Opana Deal Is Lawful (Law360-$)
• Bioasis and WuXi Biologics Announce Initial Strategic Collaboration for the Development and Manufacturing of xB3-001, the Company’s Lead Investigational Candidate to Treat Brain Cancer (Press)

• Beta receives FDA go-ahead for home trials of AI-guided bionic pancreas (Fierce)
• Small molecule could help modulate the microbiome (C&EN)
• Roche drug dramatically reduces bleeds in key hemophilia tests (Reuters) (Press)
• Richard Lehman’s weekly journal review—21 May 2018 (BMJ)
• Monoclonal Antibodies for Migraine Prevention: Progress, but Not a Panacea (JAMA)
• TV scientists star in AstraZeneca's first ad campaign for asthma biologic Fasenra (Fierce)
• Fixing the Clinical Trial Bottleneck by Making Patients a Priority (Xconomy)

• The Theranos deception (60 Minutes)
• Interview – Boston Scientific’s plan to keep the rhythm going (EP Vantage)
• Don’t Put That in My Heart Until You’re Sure It Really Works (NYT-$)
• Updated list of PMAs approved (FDA)
• Medtronic Recalls MindFrame Capture LP Revascularization Device Due to Wire Material That May Break or Separate During Use (FDA)
• Medtronic Faces Cybersecurity Risk for Clinical Programmer (MDDI)
• User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - May 10, 2018 (FDA)

• House Rules Committee to Talk Right-to-Try tonight (House Rules)
• Trump official on defensive as critics scoff at drug plan (The Hill)
• Trump’s New Health and Human Services Secretary Is a Joyful Regulator (NYT-$)
• HHS Seeks Public Comments on Trump Administration's Plan to Lower Drug Prices (Big Molecule Watch)
• Medicines were tainted with pesticides in sloppy drug facility, FDA warns (Ars Technica)
• Avalere Analysis Highlights Complexities of Transitioning Medicare Part B Drugs into Part D (Avalere)
• FDA Is Continuing to Crack Down on Youth E-Cigarette Use (Time)
• ACRO opposes “fatally flawed” right-to-try legislation (ACRO)
• House Appropriators Warn US FDA: Stop Working On Electronic Labeling Rule (Pink Sheet-$)
• Framework for Assessing pH-Dependent Drug-Drug Interactions; Establishment of a Public Docket (Federal Register)
• Advisory Committee; Blood Products Advisory Committee; Renewal (Federal Register)
• Proposed Collection; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development (Federal Register)
• Justice Department rescinds order stopping opioid sales by Louisiana distributor (Washington Post-$)

• FDA Advisory Committee Calendar

• PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids (EMA)
• London hospitals to replace doctors and nurses with AI for some tasks (Guardian)
• To B or not to B (MHRA Med Regs Blog)
• Europe’s open-access drive escalates as university stand-offs spread (Nature)
• Third industry stakeholder platform on research and development support (EMA)
• EMA review of Zinbryta confirms medicine’s risks outweigh its benefits (EMA)
• PM May challenges scientists to help transform Britain after Brexit (Reuters)
• ABPI responds to PM speech on plans to transform outcomes for people with chronic diseases (ABPI)
• Launch of a new partnership to improve development of new drugs for children in Europe (Press)

• Pakistan Has Just One New Polio Case, but Isn’t Declaring Victory Yet (NYT-$)
• China comes to Europe (BioCentury)
• Health Care Reforms in India (JAMA)
• Deadly Nipah virus claims victims in India (BBC)
• Submissions received: Proposal to change the medicine GMP fees and charges (TGA)

• The Opioid Crisis Is Not Just An American Epidemic (Buzzfeed)
• Death of a biohacker (NYT-$)
• When a great researcher isn’t a great person (C&EN)