Regulatory Recon: Amgen Sues FDA Over Sensipar Pediatric Exclusivity Congo Clears Use of Merck Ebola Vaccine in Latest Outbreak (30 May 2017)

Posted 30 May 2017 | By Michael Mezher 

Regulatory Recon: Amgen Sues FDA Over Sensipar Pediatric Exclusivity Congo Clears Use of Merck Ebola Vaccine in Latest Outbreak (30 May 2017)

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

In Focus: US

  • Sunovion's COPD ambitions dented as FDA rejects phase 3 candidate (Fierce) (Press)
  • Things to watch for at world’s biggest cancer research meeting (Financial Times)
  • On ASCO’s Eve, Experts Fret Over Backlash to Cancer Combo Frenzy (Xconomy)
  • Reauthorizing PDUFA Is Key to a Healthier US (Morning Consult)
  • FDA Expands Zykadia's Label To First-Line NSCLC (BioCentury) (Press) (PharmaTimes) (FDA)
  • New Maryland Law to Restrict Generic Drug Price Increases (Focus)
  • A Look at Major Drug Pricing Proposals (NYTimes)
  • Drug Lobbyists’ Battle Cry Over Prices: Blame the Others (NYTimes)
  • Drug Rebates Reward Industry Players — And Often Hurt Patients (KHN)
  • High-Price Drugs Raise Costs for Seniors in Medicare Part D (WSJ)
  • Pharmaceuticals Accounted for Only 11% of the Rise in Health Care Costs in 2016 (PPI)
  • CRISPR gene editing can cause hundreds of unintended mutations (PhysOrg) (Pharmafile)
  • Science Needs a Solution for the Temptation of Positive Results (NYTimes)
  • CVS's Omnicare to pay $23m to resolve U.S. drug kickback case (Reuters)
  • Amgen Sues FDA Over Pediatric Exclusivity For Blockbuster Sensipar (Law360-$) (LSIPR)
  • ‘This is not the end’: Using immunotherapy and a genetic glitch to give cancer patients hope (Washington Post)
  • Trump’s Proposed Budget Cuts Trouble Bioterrorism Experts (NYTimes)
  • States Fear Price Of New Zika Vaccine Will Be More Than They Can Pay (NPR)
  • Court Documents Shed Light on Theranos Board’s Response to Crisis (WSJ)
  • Industry Pulse: R&D spending in charts (BioPharmaDive)
  • BMS and Array BioPharma partner up to tackle colorectal cancer (Pharmafile) (Press)
  • The addict brokers: Middlemen profit as desperate patients are ‘treated like paychecks’ (STAT)

In Focus: International

  • Entry into Force Milestone Reached for European Medical Device, IVD Regulations (Emergo)
  • Report highlights value of EU-UK research partnerships (PharmaTimes)
  • Congo approves use of Ebola vaccination to fight outbreak (Reuters)
  • Bayer's Weinand On Broadening Value-Based Pricing Views (SCRIP-$)
  • China’s Ill, and Wealthy, Look Abroad for Medical Treatment (NYTimes)
  • Europe’s Bellwether Challenge (BioCentury)
  • Ge Li melds WuXi VC with Frontline, creating an $800M trans-Pacific powerhouse fund now hunting fresh biotech capital (Endpoints)
  • Asia Regulatory Roundup: India’s NPPA Withdraws List of Pricing Rule Violators (Focus)
  • Seventieth World Health Assembly update, 29 May 2017 (WHO)
  • Novartis has assets to sell, investors wary of what it might buy (Reuters)             
  • Eisai, Charles River double down on drug discovery pact (Fierce) (Press) (PharmaLetter-$)
  • MSF criticizes Swiss pharma aims at upcoming India-EFTA trade talks (PharmaLetter-$)
  • Greek pharma trade group bemoans new measures that keep clinical trials away (PharmaLetter-$)
  • Modernized Pharmacovigilance Database Nears In Switzerland (Pink Sheet-$)
  • South Korea's Drug Approvals In 2016: An Infographic (Pink Sheet-$)
  • European Commission Approves Pfizer's Trumenba for Meningococcal Group B Disease (Press)

Pharmaceuticals & Biotechnology

  • Aerie Raises $125m Via Pair Of Offerings (BioCentury)
  • The Good News; the Bad News; and What’s Next? (Alliance for a Stronger FDA)
  • Sarepta Trial Protocol Change Could Spur More IRB Referrals To US FDA (Pink Sheet-$)
  • Gottlieb Unlikely To Make Major Changes Right Away, Former Official Says (Pink Sheet-$)
  • Direct Relief and Pfizer donate 1 million doses of naloxone to health providers (Modern Healthcare)
  • Misalignment In Autism (BioCentury)
  • Concert Pharmaceuticals Announces Departure of Chief Financial Officer, Ryan Daws (Press)
  • US Outcomes-Based Contracts In Oncology? CAR-T Could Be Case Study (Pink Sheet-$)
  • FDA designation 'really big deal' for Athersys (Modern Healthcare)
  • ANDA Approval Times Get Optimistic Estimate In Budget Request (Pink Sheet-$)
  • Up Front Or Back End? Considering The Best Structure For Milestone Fees (SCRIP-$)
  • A New Drug for A.L.S., but the Diagnosis Remains Dire (NYTimes)
  • Pharma Digitalisation: Challenges and opportunities in transforming the pharma industry (EPR)
  • Lupin Pharmaceuticals Inc. Announces a Nationwide Recall of Mibelas™ 24 Fe  (FDA) (Press)
  • Roche, Boehringer tout new idiopathic pulmonary fibrosis analyses to boost their rival medications (Fierce)
  • If Everyone’s Unhappy, Maybe You’re Doing Something Right… Comment Period on FDA’s Biosimilar Interchangeability Guidance Closes (FDA Law Blog)
  • FSH-Blocking Antibody Could Treat Osteoporosis, Obesity (BioCentury)
  • Bain & Gain (BioCentury)
  • Anderson Stepping Down At FasterCures (BioCentury)
  • Leerink talks up Gilead’s R&D shift from virology to NASH, cancer remains tricky proposition (Fierce)
  • Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances (Policy & Medicine)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Advaxis and Bristol-Myers Squibb Announce Clinical Collaboration to Evaluate ADXS-DUAL and Opdivo (nivolumab) in Metastatic Cervical Cancer (Press)
  • Merck Receives FDA Approval of ISENTRESS® HD (raltegravir), a New Once-Daily Option, in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Appropriate Patients (Press)
  • Intensity Therapeutics, Inc. Successfully Administers INT230-6 to First Patient in a Phase 1/2 Trial (Press)
  • Novo seeks to strengthen Tresiba label in US (PMLive)

Medical Devices

  • Case Study: Choosing a Sensor That Gets the Job Done (MDDI)
  • The Zen of Anytime Audit Readiness (MDDI)
  • Diagnostics: What if the disease you’re targeting isn’t economically viable? (MedCityNews)
  • Class 1 Device Recall SpFXL IIB 2/DM Implantable Stimulator (FDA 1, 2)
  • Purdue Developing Self-Cleaning, Magnet Powered Implantable Catheters (MedGadget)
  • Medtronic increases stake in Saluda Medical (MassDevice)
  • Presbia touts preliminary data from Microlens PMA trial (MassDevice)
  • Masimo Announces FDA 510(k) Clearance of O3™ Regional Oximetry for Pediatric Patients (Press)
  • FDA Grants Market Clearance to Ra Medical Systems for New Peripheral Artery Disease Treatment (Press)

US: Assorted & Government

  • AP Exclusive: Suspected drug thefts persist at VA centers (AP)
  • White House Acts to Roll Back Birth-Control Mandate for Religious Employers (NYTimes)
  • We All Have Pre-existing Conditions (NYTimes)
  • Trump's Health Agencies Continue Issuing Political Statements (Medpage)
  • Supreme Court Expands Forum-Shopping Crackdown (Drug & Device Law)
  • Target Of Medicare Insider Trading Case Boasted He Was Unstoppable ‘Beast’ (KHN)
  • Ethicon Seeks High Court Review In $3M Pelvic Mesh Suit (Law360-$)
  • J&J Hit With $2.16M Verdict In 4th Philly Mesh Case (Law360-$)
  • Bard Ends 97 More Suits In Pelvic Mesh MDL (Law360-$)
  • Lawsuit says Novo, OptumRx 'mutually benefited' from rebate scheme, while consumers paid the price (Fierce)
  • Alternative Facts on Patent-Eligibility from the Electronic Frontier Foundation (Patent Docs)
  • How AHCA Hurts States That Voted For Trump (Forbes)
  • North Carolina Rejects Stengel in Complete Preemption Win (Drug & Device Law)
  • California’s Coverage Expansion: Fiscal And Political Risks (HealthAffairsBlog)

Upcoming Meetings & Events


  • Stimwave Tech wins CE Mark for SandShark neurostim anchor system (MassDevice) (Press)
  • More Harm From Anti-Vaxxers: Germany Takes Action To Stem Measles Outbreak (Forbes)
  • Spain arrests 14 on suspicion of making, selling performance-enhancing drugs (Reuters)
  • Danish/Spanish collaboration on skin disease research (PharmaLetter-$)
  • Aspen concludes strategic MoU in Russia (PharmaLetter-$)
  • MEB starts technical validation of electronic submissions as from 1 June 2017 (CBG MEB)


  • FiercePharmaAsia—Gardasil’s Chinese approval, Lupin’s financials, CANbridge’s $25M series B (Fierce)
  • Taiwanese biotech submits NDA for new antibiotic formulation in China (PharmaLetter-$)


  • Glenmark greenlighted to market hypertension generic in US (Pharmafile)
  • Strides Shasun gets 3 observations from USFDA for Bangalore plant (Economic Times)
  • Cipla gets favourable ruling from DoP on its review petition on amlodipine, ciprofloxacin & azithromycin formulations (PharmaBiz)
  • Civil society organizations ask University of California to withdraw efforts to obtain patent on prostate cancer drug enzalutamide in India (PharmaBiz)
  • Sun Chief Sees ‘New Normal’ For First-To-File ANDAs Amid US Price Pressure (SCRIP-$)
  • Offshore transfer of IP assets by pharma firms under RBI radar (Economic Times)
  • DoP clarifies on implementation of prices fixed and notified under the provisions of DPCO, 2013 (PharmaBiz)


  • Compounded medicines and good manufacturing practice (GMP) (TGA)

Other International

  • Yemen cholera death toll rises, but number of infections drop: WHO (Reuters)
  • Aché and Ferring explore nanotechnologies in Brazil (PharmaLetter-$)

General Health & Other Interesting Articles

  • Radio-Controlled Genes (IEEE)
  • Negotiating cancer: Tips from one who’s done it (Washington Post)
  • Scientists Link a Gene Mutation to Rheumatic Heart Disease (NYTimes)
  • The trauma of a breast cancer diagnosis can have cognitive effects (Reuters)
  • How A Gene Editing Tool Went From Labs To A Middle-School Classroom (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.

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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