Regulatory Recon: Novo Nordisk to Cut 1,000 Jobs Congress Passes $1.1B in Zika Virus Funds (29 September 2016)

Posted 29 September 2016 | By Zachary Brennan 

Regulatory Recon: Novo Nordisk to Cut 1,000 Jobs Congress Passes $1.1B in Zika Virus Funds (29 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

In Focus: US

  • Congress approves $1.1 billion in Zika funding (Stat) (NPR)
  • Most Americans believe prescription drug prices are unreasonable (Stat) (Kaiser Health News) (Politico)
  • Why big pharma wants to collect 2 million genomes (Nature News)
  • Ninth Circuit Confounds Practice of Medicine and Off-Label Use Issues (FDA Law Blog)
  • FDA slaps a full clinical hold on Alcobra’s troubled lead drug for ADHD, Fragile X (Endpoints)
  • Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA (Nature Reviews Drug Discovery-$)
  • FDA eyes new diabetes end points (Nature Reviews Drug Discovery-$)
  • Artificial Pancreas Approved by FDA Marks a Global First (Focus) (Bloomberg) (FDA)
  • Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic (Focus)
  • Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program (Focus)
  • Despite the Hype Over Gene Therapy, Few Drugs Are Close to Approval (MIT Tech Review)

In Focus: International

  • Novo Nordisk announces plans to reduce workforce by approximately 1,000 employees (Reuters) (Bloomberg) (Press)
  • China’s $5 Billion Health-Care Deal Spree Shows Global Ambitions (Bloomberg)
  • Why the $600 EpiPen Costs $69 in Britain (Bloomberg)
  • The cost of cheap drugs? Toxic Indian lake is 'superbug hotspot' (Reuters)
  • Ireland Prepares New Biosimilar Policy To Improve Access, Boost Industry (Pink Sheet-$)
  • Boehringer buys into oncolytic viruses via €210m ViraTherapeutics deal (PMLive)
  • NICE gives final backing to Novartis' Cosentyx in ankylosing spondylitis (PharmaLetter-$) (PharmaTimes)
  • EFPIA Backs Report Renewing Efforts to Tackle the Scourge of Counterfeit Medicines (EFPIA)

US: Pharmaceuticals and Biotechnology

  • Interview with Dr. Anthony Fauci on potential strategies for conducting clinical trials of Zika virus vaccines (NEJM)
  • Considerations for Developing a Zika Virus Vaccine (NEJM Perspective)
  • Influenza Virus Vaccine for the 2016-2017 Season (FDA)
  • New vaccine coalition targets epidemics (Nature Reviews Drug Discovery-$)
  • The cancer vaccine resurgence (Nature Reviews Drug Discovery-$)
  • Open data in drug discovery and development: lessons from malaria (Nature Reviews Drug Discovery-$)
  • Investigating investment in biopharmaceutical R&D (Nature Reviews Drug Discovery-$)
  • Biophysics in drug discovery: impact, challenges and opportunities (Nature Reviews Drug Discovery-$)
  • Amgen and Arrowhead team up on gene-therapies for heart disease (Reuters)
  • Horizon Pharma to pay Express Scripts $65 million to settle rebate litigation (Reuters)
  • To make big profits, drug companies turn to monopoly shenanigans (Stat Podcast)
  • Biotechs leverage patient groups in drug development (Boston Globe)
  • An Immigrant-Funded Biotech Center in Rural Vermont? What Could Go Wrong? (Bloomberg)
  • Brand biosimilar: Does Amjevita give away Amgen’s biologics strategy? (BioPharma-Reporter)
  • AbbVie opens its $300 million manufacturing plant in Singapore (Pharmafile)
  • Suit Over Weak IVF Drug Survives Dismissal Bid (Law360-$)
  • Bio Execs Talk Patient Advocacy, Duchenne Approval at BioForward Panel (Xconomy)
  • Specialty Drug Costs Soar 30% For California Pension Fund (CaliforniaHealthline)
  • Zuckerberg initiative poaches AstraZeneca board member (Reuters)
  • PharmSource Report Says Bio/Pharma Companies Prefer In-House Manufacturing (PharmTech)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • The 2nd Phase III schizophrenia study for Intra-Cellular drug is a disaster, shares shredded (Endpoints) (Xconomy) (TheStreet) (Press)
  • Amgen Announces Erenumab Significantly Reduces Monthly Migraine Days In Patients With Episodic Migraine In First Phase 3 Study (Press) (Endpoints) (Fierce)
  • Tumour-specific ablation of Treg cells induces anticancer response (Nature News Drug Discovery)
  • Flawed Research Tool Leads To Faulty Medical Findings (NPR)
  • MyoKardia raises $57M in follow-on (BioCentury)
  • Array raises $115M in bumped-up follow-on (BioCentury)
  • NeuroDerm Provides Updates on ND0612 Long-Term Safety Trial and Submission of Marketing Applications (Press)
  • Evotec Receives Further Important Pre-Clinical Milestone in Endometriosis Alliance with Bayer (Press)
  • Evotec enters into strategic multi-target alliance with C4X Discovery (Press)
  • Hanmi Pharmaceutical Enters into an Exclusive License Agreement with Genentech for a Novel Oral RAF Inhibitor (Press)
  • bluebird bio and Medigene Establish Strategic T Cell Receptor (TCR) Alliance (Press)
  • Now Enrolling: Global Phase 3 Trial to Evaluate Potential First-Line Use of Lenvatinib in Combination with Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma (Press)
  • Catabasis Pharmaceuticals and Sarepta Therapeutics Joint Research Collaboration in Duchenne Muscular Dystrophy (Press)
  • Drug to treat alcohol use disorder shows promise among drinkers with high stress (NIH)

US: Medical Devices

  • NEST update: Recommendations for early-phase projects of US medical device evaluation system (Mass Device)
  • DeviceTalks Podcast: Talking culture with Smiths Medical CEO Jeffery McCaulley (Mass Device)
  • Commentary: Diagnostic devices in clinical trials have high stakes for patient care (BMJ)
  • 3-D Printed Bone Material Acts Like Real Bone for Custom-Made Implants (NBC News) (Reuters)
  • Old heart device wires tied to complications, death risk (Reuters)
  • Updated FDA site on Expedited Access Pathway Program for devices with two examples (FDA)

US: Assorted and Government

  • Lawmakers pledge push for cures bill in lame-duck (The Hill)
  • US DOJ Letter to Mylan (Letter) (Law360-$)
  • A bill to provide for the fast track review of certain generic drugs (S. 3387)
  • A bill to allow for the expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of noncompetitive drug markets and drug shortages (S. 3455)
  • FDA and the Public Interest: The Problem With Drug Reviewers Moving to Industry (Focus)

Upcoming Meetings and Events               


  • Science spending boosted in French budget (Nature News)
  • France’s situation report on the active substance Amoxicillin (ANSM)
  • Generics Save EU 100 Billion Euros per Year (Medicines for Europe)
  • Actelion to investigate all-oral MS combination therapy (Reuters)


  • TGA presentation: 2016 Australasian Epidemiological Association (AEA) 23rd Annual Scientific Meeting, 15 September 2016 (TGA)


  • India has run out of the drug to treat the rare but fatal Wilson’s disease (CDSCO)
  • Domestic pharma firms facing challenging environment: Cipla (Times of India)
  • Pharma vets spot an opportunity in FDA mess (Economic Times)


  • Over 1000 Chinese NDAs rejected due to fabricated or incomplete trial data (Outsourcing-Pharma)

Other International

  • GE Healthcare opens $7.4 million bioprocessing technology and training centre in South Korea (Manufacturing Chemist)
  • Kenya will roll out the first child-friendly TB drug (Devex)

General Health and Other Interesting Articles

  • Clinton: My Vision for Universal, Quality, Affordable Health Care (NEJM)
  • The Americas Are Now Officially 'Measles-Free' (NPR)
  • U.S. Agencies Have Placed A Value On An Extra Year of Life (It's Higher Than You Think) (Forbes)

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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