Regulatory Focus™ > News Articles > Regulatory Recon: House Ethics Report Says Congressman May Have Violated Rules With Australian Biote

Regulatory Recon: House Ethics Report Says Congressman May Have Violated Rules With Australian Biotech Investment NICE Backs Opdivo for Head and Neck Cancer (13 October 2017)

Posted 13 October 2017 | By Michael Mezher 

Regulatory Recon: House Ethics Report Says Congressman May Have Violated Rules With Australian Biotech Investment NICE Backs Opdivo for Head and Neck Cancer (13 October 2017)

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

In Focus: US

  • The FDA Needs This Nudge to Speed Along New Drugs (Bloomberg)
  • Ethics Probe of GOP Rep. Is Connected to Biotech Firm With Failed MS Drug (KQED) (NYTimes) (Report)
  • FDA Panel Votes Unanimously in Favor of Gene Therapy to Treat Rare Eye Disorder (Focus)
  • We may soon have our first $1 million drug. Who will pay for it? And how? (STAT)
  • Liquid biopsy could lead to precision therapies for children's eye tumors (STAT)
  • Allergan settles with one of four companies contesting Restasis patent (Reuters) (Law360-$)
  • Pharma companies are starting to recruit top talent from tech giants like Google and LinkedIn (CNBC)
  • PDUFA VI: FDA Explains User Fee Changes in Draft Guidance (Focus)
  • FDA Holds First Patient Engagement Advisory Committee Meeting (Focus)
  • Warren, Murkowski: Where's the emergency declaration on opioids? (The Hill)
  • Gottlieb Statement on Baxter Manufacturing Recovery in Puerto Rico (FDA)
  • CNN investigation exposes inappropriate use of Avenir drug in nursing homes (CNN) (Fierce)
  • Steps the US government should take right now against the opioid epidemic (Washington Post)
  • White House says it can't lawfully pay Obamacare subsidies (Reuters 1, 2) (NYTimes)
  • Trump administration weighs rollback of policy that supporters say helped lower drug prices (STAT)
  • Trump's not-so-quick fix to undo Obamacare (Reuters)
  • Another huge quarter for biotech flotations (EP Vantage)

Preparing for the Spring 2018 RAC Exam?

In Focus: International

  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2017 (EMA)
  • Roche's Alecensa wins EU panel's nod against mutated lung cancer (Reuters) (Press)
  • Project to tackle potential 'post-antibiotic apocalypse' launched with $3.2 million pledge (CNBC)
  • New deal secures Opdivo an NHS spot for head and neck cancer (PharmaTimes) (Pharmafile) (NICE)
  • Roche's skin cancer drug Erivedge pulled from CDF (PharmaTimes)
  • NICE backs Pfizer's Xeljanz for RA (PMlive)
  • European Regulatory Roundup: Brexit Sparks Hiring Drive at Danish Medicines Agency (Focus)
  • EU task force: Docs should favor drug-eluting stents over bioresorbable scaffolds (Drug Delivery)
  • ICH S5(R3) draft Guideline presentation available now on the ICH website (ICH)
  • Saudi Regulators Confirm New Regulations for Some Low-risk Medical Devices (Emergo)
  • No sale for Novartis' $14B Roche stake, but the revamp's not done (Fierce)
  • Speech Made by Minister Bi Jingquan at the National Videophone Conference on Deepening the Review and Approval System Reform and Encouraging the Drug and Medical Device Innovation (CFDA)
  • Australian Black Triangle Scheme To Start in 2018 (Pink Sheet-$)
  • Row Erupts Over "Third Way" For Biosimilar Approvals In Colombia (Pink Sheet-$)
  • Tension Between Quality Regulatory Paradigm and Pharma's Innovation, Acceleration and Harmonization Imperatives in Spotlight (IPQ)
  • Swedish prosecutor says will not charge Italian stem cell surgeon (Reuters)
  • Five projects shortlisted for prestigious Newton Prize (MRC)

Pharmaceuticals & Biotechnology

  • Four years after it imploded at Sanofi, John Hood is resurrecting the myelofibrosis drug fedratinib (Endpoints)
  • A Painful, Unacceptable Lack of Data (In The Pipeline)
  • OptiNose joins the biotech IPO fiesta, raises $120M in upsized offering (Endpoints)
  • How milking venomous snails could help scientists treat cancer (Washington Post)
  • ANDAs: October 23, 2017 is a Very Important Date – Ignoring it Could Cost You Dearly (Lachman Consultants)
  • Lung cancer focus – drugging the undruggable KRAS (EP Vantage)
  • Rubius Prepares Off-The-Shelf Red Cell Therapies For First Human Trial In 2018 (SCRIP-$)
  • Assessing the Economics of Single-Source vs. Multi-Vendor Manufacturing (Tufts)
  • At FDA/AACR Liquid Biopsy Meeting, Researchers Detail Concordance Challenges, Standards (GenomeWeb)
  • Pieris Pharma nabs Bayer exec as VP clinical development (PharmaLetter-$)
  • Bain, RA back InflaRx's $55M round after early study produces promising results (Endpoints)
  • Boehringer Ingelheim, Anthem partner for largest real-world COPD trial (Drug Delivery)
  • Biotech entrepreneur Saurabh Saha moves to translational research chief at Bristol-Myers; Ex-GSK pharma chief Hussain switches to private equity (Endpoints)
  • Ionis launches an early-stage tau drug study for Alzheimer's, picking up $10M from Biogen (Endpoints)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • First leprosy vaccine makes initial step towards human use (Pharmafile)
  • Prometic Announces FDA Acceptance of its Biologics License Application for Plasminogen (Ryplazim™) (Press)

Medical Devices

  • Why the medical device industry is interested in multiphysics modeling (MassDevice)
  • Biologics & auto-injectors: How West Pharma designs for evolving trends in drug delivery (Drug Delivery)
  • Spearheading Advancements in Surgical Sealants (MDDI)
  • Did CryoLife's Revenue Miss Overshadow Its Big Deal? (MDDI)
  • Things Get Ugly Between NuVasive and Alphatec (MDDI)
  • Philips receives U.S. FDA 510(k) clearance to market its solution for 'small parts' ultrasound imaging (Press)
  • Classification of the Enzyme Packed Cartridge (FDA)
  • Classification of the Automated image Assessment System for Microbial Colonies on Solid Culture Media (FDA)
  • Classification of the Nucleic Acid-Based device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens (FDA)

US: Assorted & Government

  • BPCIA At Fed. Circ.: Awaiting Guidance On Patent Dance (Law360-$)
  • Lilly under legal fire over split from Adocia (Fierce)
  • Administration's Ending Of Cost-Sharing Reduction Payments Likely To Roil Individual Markets (Health Affairs Blog)
  • Trump's Association Health Plans Are An Old Idea That Hasn't Worked (Forbes)
  • Wayne, Oakland sue drugmakers over opioid epidemic (Detroit Free Press)
  • How FDA 'Triers' and Food Sampling Have Prevented Tragedy (FDA Voice)
  • Federal Efforts to Develop Biological Threat Awareness (GAO)
  • Double Preemption Win in Amiodarone Litigation (Drug & Device Law)

Upcoming Meetings & Events


  • Cross-Border Healthcare Expert Group Meeting (EC)
  • Genomics England links with Inivata, Thermo Fisher (PharmaTimes)
  • Bayer signs agreement to sell selected Crop Science businesses to BASF for EUR 5.9 billion (Press)


  • Yuhan Replaces Merck To Market Samsung's Biosimilars In Korea (SCRIP-$)
  • Karyopharm and Ono collaboration could be worth $200 million plus (PharamaLetter-$)


  • UC-Berkeley gets in on medtech accelerator in India (MassDevice)
  • Pharma City project faces hurdle as land owners upset over poor compensation (PharmaBiz)
  • Indian Patent Act achieved balance between drug innovators & public health: Dr BR Jagashetty (PharmaBiz)
  • NPPA sends notices to 21 hospitals for not displaying prices of knee implant systems on their websites (PharmaBiz)

General Health & Other Interesting Articles

  • America's Obesity Epidemic Reaches Record High, New Report Says (NBC)

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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