Regulatory Recon: WHO Hosts 70th World Health Assembly; AstraZeneca Sells Rights to Heart Drug for $300M (22 May 2017)

Posted 22 May 2017 By Zachary Brennan

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Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                          

  • Postmarket Drug Safety: The View From the FDA (Medscape)
  • Drugs approved with limited data aren’t always well-tested later (Reuters)
  • Trump to Propose Deep Cuts to Anti-Poverty Programs and Medicaid (Bloomberg) (Washington Post-$) (Axios)
  • How a 6% Budget Increase Can Actually Be a 45% Decrease (Alliance for a Stronger FDA)
  • Top analyst says the tempest over drug prices will likely just die out without any major changes (Endpoints)
  • Is the FDA Digging Its Own Hole on Drug Pricing and Opioids? (Morning Consult)
  • FDA Briefing Document: Oncologic Drugs Advisory Committee Meeting, May 24, 2017 (FDA) (Endpoints)
  • Hospitals to HHS: Ease Up on Regulatory Burdens (Bloomberg)
  • Microsoft Has a Goal to Store Data as DNA (MIT Tech Review)
  • PhRMA doubles down on R&D but falls short in bid to rein in bad actors (Stat)
  • Medicine is going digital, FDA is racing to catch up (Wired) (Focus)
  • Medicare Could Save Millions by Eliminating the Lump-Sum Purchase Option for All Power Mobility Devices (HHS OIG)
  • FDA panel supports use of ports in Sarepta DMD trial (BioCentury-$)
  • Radius Shares Jump as Amgen’s Bone Drug Suffers a Setback in Phase 3 (Xconomy) (FiercePharma) (Forbes)
  • A Vital Drug Runs Low, Though Its Base Ingredient Is in Many Kitchens (NY Times-$)
  • Doctors Without Borders Appeals Exclusive License Granted to Sanofi for Zika Vaccine (Focus)
  • Friday Feedback: Should Opioids Be FDA's Top Priority? (MedPage Today)
  • New York State Wants Its Prescription Drug Money Back — Or Else (Kaiser Health News)
  • FDA Details How Kalydeco's Indication Expanded Without New Clinical Data (Focus)
  • A father’s plea: The FDA needs to make sure that Juno’s lethal disaster isn’t repeated (Endpoints)

In Focus: International

  • AstraZeneca sells off rights to beta-blocker for $300 million (Pharmafile) (FT-$)
  • 70th World Health Assembly Opens in Geneva (WHO) (Webcast)
  • Behind closed doors, WHO prepares to elects its next leader (Stat)
  • The candidates running for WHO director general (BMJ)
  • Margaret Chan Address to the Seventieth World Health Assembly (WHO)
  • Fourth person in probable Ebola death in Congo: WHO (Reuters)
  • China makes strides toward western drug, device standards (Bloomberg)
  • UK political parties promise science funding boost (Nature)
  • ‘I knew they were sugar pills but I felt fantastic’ – the rise of open-label placebos (The Guardian)
  • New Laws In The U.K. And EU Further Restrict Tobacco Industry (NPR)
  • Regulatory Collaboration and Emerging Issues in Generic Medicines (Agenda)
  • Dr. Reddy’s turns to single-use for biosimilar production in India (BioPharma-Reporter)
  • MHLW Council Recognizes Unmet Medical Need for Off-Label Use of 3 Drugs (Pharma Japan-$)
  • Lawmakers Hear from EFPIA, Say They Didn’t Know Japan Drug Market Would Shrink (Pharma Japan-$)
  • EMA’s CHMP Recommends Approval for Five New Medicines, Four New Biosimilars (Focus) (PMLive)
  •  Hungarian budget for meds to increase in 2018 (PharmaLetter-$)

Pharmaceuticals and Biotechnology

  • Argenx IPO haul tops out at $115M, 50% above initial goal (FierceBiotech)
  • Pharma exec says industry must get fair about pricing new drugs (Boston Herald)
  • Concert Pharmaceuticals Receives Second Request from FTC Under HSR Act (Press)
  • J&J lines up its Global Head for Actelion (Pharmafile)
  • On a deal spree, Takeda partners up with Nektar on a slate of cancer R&D combo studies (Endpoints)
  • Bill and Melinda Gates are placing bets on this biotech in the race to develop a Zika vaccine (CNBC)
  • Hospira Comes Out $40K Ahead In Verdict Against GSK (Law360-$)
  • NJ Drug Co. Dodges Class Action Over FDA Approval Claims (Law360-$)
  • IRS Looks To Enforce Teva Summons In Charity Inquiry (Law360-$)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Celgene's multiple sclerosis drug succeeds in late-stage trial (Reuters)
  • Shire writes off a shot at long-acting hemophilia drug after small study flops (Endpoints)
  • Mixed Outcomes for La Jolla Pharma Shock Drug Fuels Debate Over Sales Potential (TheStreet) (FierceBiotech)
  • First In Vivo Human Genome Editing to Be Tested in New Clinical Trial (The Scientist)
  • How much do clinical trials cost? (Nature Reviews Drug Discovery-$)
  • Merck KGaA, Ablynx push osteoarthritis asset toward clinic (FierceBiotech)
  • Otsuka Announces Results of Phase 3 Data on Tolvaptan (Press)
  • U.S. FDA Accepts for Review Supplemental New Drug Application for Aptiom (eslicarbazepine acetate) for the Treatment of Partial-Onset Seizures in Children 4 to 17 Years of Age (Press)

Medical Devices

  • UK’s first cancer fighting proton beam therapy system arrives in Wales (EU Pharma Review)
  • Indian State FDAs need to brace up for ISO 13485 audits at medical device manufacturing units: Probir Das (PharmaBiz)
  • Oil-based infertility test produces higher pregnancy rate than water-based test: study (Reuters)
  • BTG's pulmonary embolism device work faster and at lower doses in study (Reuters)
  • Gastric bands for obesity often involve multiple operations (Reuters)
  • 7 medtech stories we missed this week (Mass Device)
  • Masimo launches Early Warning Score for Root systems (Mass Device)
  • Study: New photoacoustic imaging hastens tumor imaging, holds potential for breast cancer procedures (Mass Device)

US: Assorted and Government

  • US government website for collecting adverse events after vaccination is inaccessible to most users (BMJ-$)
  • Letter to FDA Commissioner Gottlieb on Tobacco (Letter)
  • Letter to CMS’ Verma on LA Times report (Letter)
  • Sen. McConnell on fighting the opioid epidemic (McConnell)
  • A Move To Shift Part B Rx Into Part D Would Anger Oncologists, Cancer Patients (InsideHealthPolicy-$)
  • Burgess Statement on the Advancement of FDA User Fee Reauthorization and Two Bipartisan Public Health Bills (Press)
  • Implementation of 340B Final Rule Postponed Until October 1, 2017 (FDA Law Blog)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Advertisements (Federal Register)
  • Proposed Collection; Comment Request; Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-market Periodic Safety Reports in the International  Conference on Harmonisation E2C(R2) Format (Federal Register)

Upcoming Meetings and Events               

General Health and Other Interesting Articles

  • Dutchman Who Had Trouble Finding Job at Home Became CEO of a U.S. Biotech Pioneer (WSJ-$)
  • Yemen war: Major cholera epidemic feared, says charity (BBC)
  • Doctors have resisted guidelines to treat sepsis. New study suggests those guidelines save lives (Stat)
  • A Carl June Rejection and Critiques (Grant Critique)
  • Why Brain Scientists Are Still Obsessed With The Curious Case Of Phineas Gage (NPR)
  • Ethics Of Aid: Should Donated Health Dollars Go To 'Children First'? (NPR)

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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A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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