Regulatory Focus™ > News Articles > Regulatory Recon: Amgen Beats Sanofi, Regeneron in PCSK9 Patent Trial, Court Upholds FDA's Interpret

Regulatory Recon: Amgen Beats Sanofi, Regeneron in PCSK9 Patent Trial, Court Upholds FDA's Interpretation of Drug Combo Exclusivity (17 March 2016)

Posted 17 March 2016 | By Michael Mezher 

Regulatory Recon: Amgen Beats Sanofi, Regeneron in PCSK9 Patent Trial, Court Upholds FDA's Interpretation of Drug Combo Exclusivity (17 March 2016)

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

In Focus: US

  • Amgen beats Sanofi, Regeneron in Cholesterol Drug Patent Trial (Law360-$) (SCRIP-$) (Pink Sheet-$) (BioCentury) (WSJ-$) (Reuters) (Sanofi/Regeneron Statement) (Amgen Statement)
  • FDA Stand On Drug-Combo Exclusivity Was Valid, Judge Says (Law360-$) (FDA Law Blog)
  • FDA Approves Bayer's Kovaltry to Treat Hemophilia A (Reuters) (Press)
  • Now There's Proof: Docs Who Get Company Cash Tend to Prescribe More Brand-Name Meds (ProPublica) (NPR)
  • A Strong Response to the Opioid Scourge (NYTimes)
  • Poll Finds 1 in 3 Americans Blame Doctors for Opioid Epidemic (STAT)
  • CDC Guideline for Prescribing Opioids for Chronic Pain (JAMA)
  • Patients in Pain, and a Doctor Who Must Limit Drugs (NYTimes)
  • Generic Gleevec Will Hurt Novartis -- But Save Millions In Health Costs (Forbes)
  • Podcast: How much are we willing to pay for cures? (STAT)
  • Novartis Heart-Failure Pill Hits Hurdles With Doctors (WSJ-$)
  • NIH dengue vaccine 100 percent effective in small study (Reuters)

In Focus: International

  • Using Genetically Modified Mosquitoes To Fight Zika Is The Right Thing To Do (Forbes)
  • Japan PMDA To Kick Off New Asia Training Center (PharmAsiaNews-$)
  • UK cost agency rejects Amgen's virus-based cancer drug (Reuters)
  • Skyhigh drug prices made Romania mull patent break (Politico Pro)
  • EMA Management Board elects Christa Wirthumer-Hoche as chair (EMA)
  • 'World's largest healthcare incentive scheme' launched to cut inappropriate antibiotic prescribing (Pharmaceutical Journal-$)

US: Pharmaceuticals & Biotechnology

  • One way to save Valeant – stop being Valeant (EP Vantage) (Forbes)
  • Australian Clinical Evidence Guidance Tackles 'A Leading Cause' Of Rejections For Medtech (SCRIP-$)
  • A 'Roadmap' for Navigating Patient Advocacy (FDA Voice)
  • Scientists develop new human stem cells with half a genome (Reuters)
  • Why some drug prices should be high (STAT)
  • Clinical Trials Ignore Sex Differences in Outcomes: Clin Onc News Report (MedpageToday)
  • Immunotherapy Drug Performs Better Than Chemotherapy in Lung Cancer (DD&D)
  • Cholesterol pill boosts cancer immunotherapy, at least in mice (Reuters)
  • Race and income affect responses to FDA drug safety warnings (MNT)
  • Biomarkers can help guide immune-suppressing treatment after organ transplantation (MNT)
  • FDA advisory committee to discuss Novo's Xultophy (BioCentury)
  • 3-D technology enriches human nerve cells for transplant to brain (NIH)
  • FDA panels to discuss two more pain products (BioCentury)
  • Getting Our Corporate-Suites And Boardrooms Ready For Alzheimer's Disease Prevention (Forbes)

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

  • Cerus Receives FDA Approval for Use of the INTERCEPT Blood System for Platelets Suspended in 100% Plasma (Press)
  • OPKO Health Announces Dosing of First Subject in Phase 1 Clinical Study of a Long-Acting Oxyntomodulin for the Treatment of Obesity and Type II Diabetes (Press)
  • Bristol-Myers Squibb to Present New Overall Survival Data for Opdivo (nivolumab) as Monotherapy and in Combination with Yervoy® (ipilimumab) at the AACR 2016 Annual Meeting (Press)
  • Antibodies from unconventional B cells less likely to neutralize HIV, NIH study finds (Press)

US: Medical Devices

  • FDA warns SureTek on sterilization, QC issues (MassDevice)
  • 21 clinical trials that are using Fitbit activity trackers right now (mobihealthnews)
  • Network-connected Medical Devices: In the Cyber Crosshairs (Pharmaceutical Compliance Monitor)
  • FDA: Abbott's Mitraclip recall is Class I (MassDevice)
  • Brief Summary of the Circulatory System Devices Panel Meeting on Abbott Bioresorbable Stent (FDA)
  • TandemLung Oxygenator for Extracorporeal Life Support FDA Cleared (medGadget)
  • Intuitive Surgical wins FDA nod for new da Vinci Xi single-site instruments (MassDevice)
  • Medical device tax suspension leads Boston Scientific to continue partnership with Mayo Clinic (MedCityNews)

US: Assorted & Government

  • Examining The Amarin/FDA Off-Label Promotion Settlement (Drug and Device Law)
  • Health Care Tax Inversions — Robbing Both Peter and Paul (NEJM-$)
  • Senate blocks bill that would override state GMO labeling laws (Reuters)
  • Senate advances bill to aid drug-dependent newborns (Reuters)
  • Zubik v. Burwell, Part 1: Why Paperwork Does Not Burden Religious Exercise (Harvard Bill of Health)
  • Biosimilar Makers Turn To IPRs Despite Mixed Results (Law360-$)
  • SCOTUS pick has history in healthcare-related cases (Modern Healthcare) (Law360-$)
  • Calif. Asks Innovator Drug Brands To Do The Impossible (Law360-$)
  • Shkreli Says Retrophin Must Pick Up $5M Legal Tab (Law360-$)
  • How Ways and Means will tackle health care (Politico)

Upcoming Meetings & Events


  • Superbugs: curb use of today's antibiotics, and develop new ones, urge MEPs (EuroParl)
  • Finland Changes to price notifications beginning from 1 April 2016 (HILA)
  • Germany's Grünenthal to acquire Almirall's Mexican operations (PharmaLetter-$)
  • GlaxoSmithKline CEO Witty to bow out in March 2017 (Reuters)
  • NHS England unveils plans for new 'footprint' areas (PharmaTimes)


  • Lilly Leaps Into China Broad Diabetes Market, Echoing Sanofi, Novo (PharmAsiaNews-$)
  • Chugai receive orphan drug status in Japan for autoimmune disease treatment (Pharmafile)
  • Poorly-Managed Hypertension Rampant in China (MedpageToday)
  • Notice Regarding Discontinuation Of Sales And Voluntary Recall Of Egg White Lysozyme Preparation Neuzym (Press)


  • India Avastin Off-Label Use: Roche Defines Responsibility (SCRIP-$)
  • Biocon links with Mexico's PiSA to tap US insulin market (Economic Times)
  • FDA warns Emcure Pharma, cites repeated data fudging at plant (Economic Times) (Reuters) (Focus)
  • Orchid Pharma gets final nod from USFDA for Parkinson's drug (Economic Times)
  • Fixed- dose combos ban adds to burden of new essentials list (Economic Times)
  • Karnataka pharma industry upset over ban on FDCs as it will seriously hit its profitability (PharmaBiz)
  • IDMA urges health ministry to allow sale of manufactured drugs as sudden recall will lead to shortage (PharmaBiz)
  • Sudden ban of FDCs to impact more on patient-community rather than industry: TN IDMA (PharmaBiz)
  • Overnight ban on FDC drugs will cripple domestic market growth: PWA (PharmaBiz)


  • Reasons for scheduling delegate's final decisions, March 2016 (TGA)
  • Changes to adrenaline and noradrenaline labels (TGA)
  • GMP clearance process for MRA countries (TGA)


  • Jump on the Development Safety Update Report (DSUR) Bandwagon! (CATO)
  • Ottawa Hospital hit with ransomware, information on four computers locked down (Ottawa Citizen)

Zika Virus

  • Bug-Spray Makers Take Aim at Zika (WSJ-$)
  • Zika-hit Cape Verde identifies first case of microcephaly (Reuters)

Other International

  • WHO statement on end of Ebola flare-up in Sierra Leone (WHO)
  • 25 Cases of MERS in Saudi Arabia are Reported to WHO (ICT)

General Health & Other Interesting Articles

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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