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Regulatory Recon: Jazz Pharmaceuticals' Vyxeos Approved for High Risk AML FDA Panel Votes Down J&J's Sirukumab on Safety Concerns (3 August 2017)

Posted 03 August 2017 | By Michael Mezher 

Regulatory Recon: Jazz Pharmaceuticals' Vyxeos Approved for High Risk AML FDA Panel Votes Down J&J's Sirukumab on Safety Concerns (3 August 2017)

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

In Focus: US

  • FDA offers another speedy cancer drug OK, approving Jazz's Vyxeos for acute myeloid leukemia (Endpoints) (FDA)
  • FDA Documents Reveal Depths of Internal Rancor Over Drug's Approval Process (Undark) (Endpoints) (Documents)
  • FDA panel votes against approval of J&J arthritis drug (Reuters) (Endpoints) (Fierce) (Press)
  • Shire plots an ADHD public spinoff as CEO Ornskov completes a top-to-bottom overhaul (Endpoints)
  • Why the 'gold standard' of medical research is no longer enough (STAT) (NEJM)
  • The ex-Googler who ran a company to detect cancer just stepped down as CEO (CNBC)
  • Attorney General Sessions Announces Opioid Fraud and Abuse Detection Unit (DoJ) (AP) (WSJ) (Reuters)
  • Child-Resistant Packaging Statements in Drug Labels: FDA Drafts Guidance (Focus)
  • FDA Approves First Treatment for Chronic Graft Versus Host Disease (Focus)
  • Report Highlights Cracks in the Market for Generic Competition (Focus)
  • Oversupply of pain pills after surgery helps fuel opioid epidemic (Reuters)
  • Gene Editing Study in Human Embryos Points toward Clinical Trials (MIT Technology Review) (NYTimes)
  • Regeneron beats profit estimates, lifts Eylea's growth view (Reuters)
  • When Wounds Won't Heal, Therapies Spread — To The Tune Of $5 Billion (KHN)
  • Sanofi shifts focus to internal R&D as it preps an end to a stunningly effective Regeneron alliance (Endpoints) (Fierce)
  • Top Novartis manufacturing exec jumps ship, takes charge of industrializing Moderna's mRNA tech (Endpoints)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

  • BSI's 6th Annual, full-day medical device Roadshow will guide participants to new EU Medical Device/In-Vitro Device Regulation compliance. The program examines key issues facing Med Dev Manufacturers under the new MDR/IVDR starting with an overview, then analyzing legacy products and transitional provisions. Implementation issues including conformity assessments, essential/clinical requirements, SPR, labeling and QMS impacts of these standards will be detailed.
  • Check here for specific dates, locations and the program agenda.

In Focus: International

  • MDR and IVDR transitioning – where are you in your process? (MedicalDevicesLegal)
  • Teva Shares Are Taking a Beating and Dragging Down the Generic Drugmakers (The Street) (CNBC) (Forbes)
  • Teva loses 'buyer's remorse' lawsuit over a deal to buy a Mexican drug maker (STAT)
  • European Regulatory Roundup: EMA Starts Consultation on Developing Drugs to Meet Needs of Older People (Focus)
  • Hansa Medical shares gain on good kidney transplant drug news (Reuters)
  • Takeda-Advinus R&D Alliance 'Closed' (SCRIP-$)
  • Agilis forms joint venture to advance gene therapy vectors (Fierce)
  • GSK Closes China Neuroscience Center In Latest R&D Reorganization (SCRIP-$)
  • Negative NICE draft guidance for Lutathera (PharmaLetter-$)
  • Nurofen class action could yield very small individual payments, lawyer says (The Guardian)
  • Angela Merkel and Germany are taking the lead on global health (STAT)
  • UK Industry Rebates Could Make NICE Cost-Effectiveness Assessments Unnecessary (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • After a $200M financing, Highland Therapeutics falls silent on ADHD drug's fate as PDUFA sails by (Endpoints)
  • Getting patients access to 'precision' medicines is crucial (CNBC)
  • To Grow Market Share, A Drugmaker Pitches Its Product To Judges (NPR)
  • First Generic for Women's Rogaine Approved by FDA (FDA)
  • Allergan Stock Falls Despite Recording Better-Than-Expected Second Quarter (The Street)
  • Allergan can finally sell its losing stake in Teva. Will it? (Fierce)
  • Gabapentin and Pregabalin for Pain — Is Increased Prescribing a Cause for Concern? (NEJM)
  • European regulators suspend use of MRI drugs, but why hasn't the FDA? (STAT)
  • PhRMA Backs President's Opioid Commission's Recommendations on Crisis (PhRMA)
  • Ex-Merck execs launch Cardurion, with a kick-start from Takeda (Fierce)
  • Pharma rep visits? They're redundant, doctors say in new survey (Fierce)
  • Johnson & Johnson shows off under-pressure Stelara's latest indication—Crohn's—in new DTC spot (Fierce)
  • Horizon cell line sequence released in bid to up bioproduction efficiency (BioPharmaReporter)
  • Modular single-use facilities rebalance Biopharma's capacity scales (BioPharmaReporter)
  • Gene sequencing of solid tumors sheds light on cancer metastasis (Fierce)
  • News of Note—Clementia IPO; Eloxx series C; Collidion-Plex stake (Fierce)
  • The U.S. FDA Completed Pre-License Inspection (PLI) of WuXi Biologics cGMP Manufacturing Facilities for Production of TMB-355 (ibalizumab) (Press)
  • X4 joins hands with Yale on rare disease program (Fierce)
  • New FDA Directions, Part 1 – Pricing (Eye on FDA)
  • Stopping statins after stroke may increase second-stroke risk (Reuters)
  • Does a New Hepatitis Vaccine Cause Heart Attacks? (Medpage)
  • 2016 FDA warning letters: Findings for clinical investigators (imarc)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Intec posts early data on controlled-release cannabis pill (Fierce) (Press)
  • FDA Grants Genentech's Alecensa Priority Review for Initial Treatment of People with ALK-Positive Lung Cancer (Press)

Medical Devices

  • Illumina shares sparkle on strong demand for new gene tech (Reuters) (The Street)
  • Next Generation of Patient Care: Balancing Digital Engagement with Patient and Consumer Privacy (MDDI)
  • Medtronic wins FDA nod, CE Mark for Avalus aortic valve (MassDevice) (Press)
  • Using robot assistance in neurosurgery for faster seizure mapping (MassDevice)
  • Laminate Medical wins FDA IDE nod for VasQ fistula device trial (MassDevice)
  • DexCom shares rise on Q2 beat, new CFO (MassDevice)

US: Assorted & Government

  • PTAB Life Sciences Report (Patent Docs)
  • US governors urge Trump to make insurance payments (Reuters)
  • Walgreens Takes Piece of PharMerica, Quest to Dominate Healthcare Continues (The Street)
  • Has Amgen Already Won Its BPCIA Dispute With Sandoz? (Law360-$)
  • Boehringer Biosimilar Flouts 74 Patents, AbbVie Says (Law360-$)              
  • Judge Tosses Fraud Claims In $2.3B Teva Acquisition Suit (Law360-$)
  • How Not To Create an "Exception" to the Learned Intermediary Rule (Drug & Device Law)
  • Minnesota District Court: Allegation that 100% Natural Claim Means No Glyphosate is "Simply Not Plausible" (FDA Law Blog)

Upcoming Meetings & Events


  • Statement for Meeting with Heads of Agencies/High level representatives, 13.6.2017 (EUnetHTA)
  • Denmark recalls fourth suspect Xeplion batch (Securing Industry)


  • India's Malaria Elimination Target May Be Tough To Meet, Say Experts (Pink Sheet-$)
  • Experts see draft national guidelines for stem cell research to stall unproven therapies in India (PharmaBiz)

General Health & Other Interesting Articles

  • NIH Scientists Track Zika Virus Transmission in Mice (NIH)
  • Typical adults eat enough salt to damage heart (Reuters)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

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

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