Regulatory Recon: NICE Gives Final OKs to Amgen's Kyprolis, Teva's Cinqaero Ablynx, Sanofi Sign Immunology Deal Worth Up to $2.8B (20 July 2017)

Posted 20 July 2017 | By Michael Mezher 

Regulatory Recon: NICE Gives Final OKs to Amgen's Kyprolis, Teva's Cinqaero Ablynx, Sanofi Sign Immunology Deal Worth Up to $2.8B (20 July 2017)

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

In Focus: US

  • FDA's flashing green light boosts novel drug approvals (EP Vantage)
  • What's holding back biotech M&A? SVB tracks a trend and calls a comeback (Endpoints)
  • FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings (Focus)
  • How do you measure value in a drug — or anything else in medicine? (STAT)
  • AbbVie SVP: How scientists should talk to the C-suites (STAT)
  • FDA's Kopcha Presses Ahead On Quality Metrics Despite Industry Pushback (Pink Sheet-$)
  • FDA's New Chief Of Staff Is Former CDRH Policy Head Silvis (Pink Sheet-$)
  • ASCO Advocates Value in Drug Pricing (Medpage) (BioCentury)
  • Merck Wins Tentative FDA Approval for Lusduna (GEN) (Press)
  • Ironwood claims a blockbuster success for its heartburn drug, but questions linger (Endpoints) (Reuters) (Press)
  • Unapproved stem-cell treatments touted on federal database, study says (Washington Post)
  • Biotech is moving beyond the 'disaster' of the past 2 years, says Michael Yee (CNBC)
  • For Biogen's Spinraza launch, things are looking up on the coverage front: analyst (Fierce)
  • Senate makes 'progress' on revived bill, but path to 50 votes still far from clear (Politico)
  • Senator John McCain diagnosed with brain tumor (CBS) (NYTimes)
  • More states pour into generics price-fixing probe, suing Mylan, Teva and others (Fierce)
  • Pharma's US reputation is bad—and Trump may be to blame: survey (Fierce)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

In Focus: International

  • Ablynx signs Sanofi deal potentially worth up to $2.8 billion (Reuters) (Endpoints)
  • Spanish biotech Oryzon slumps as Roche ditches cancer drug (Reuters) (Endpoints)
  • Teva asthma treatment scores NICE approval (Pharmafile)
  • Final NHS green light for Amgen's Kyprolis (PharmaTimes)
  • Japan to take 'strict action' against Bayer over patient-data scandal (STAT)
  • Stada receives second takeover bid from Bain and Cinven (Financial Times) (NYTimes)
  • EMA Can Do More With Its Guidance On Multiplicity Issues In Clinical Trials, Says EFPIA (Pink Sheet-$)
  • EU approves LEO Pharma's psoriasis biologic (PharmaTimes)
  • Scales tip in AIDS fight as death rates decline, treatment rates rise (Reuters)
  • WHO urges action against HIV drug resistance threat (WHO)
  • South Korean pharma rapidly becoming manufacturing export hub (PharmaLetter-$)
  • To win blockbuster spots on China's coverage list, Big Pharma offers big discounts (Fierce) (Financial Times)
  • Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2016 to 2017 (MHRA)
  • C-Bridge Closes $400m Chinese Fund (BioCentury)
  • GSK to cut 320 jobs amid manufacturing revamp (PharmaTimes) (The Guardian) (PMLive)
  • US Cardinal Health puts $1.5 billion China business on block: Sources (CNBC)

Pharmaceuticals & Biotechnology

  • Langer-backed Kala scores $90M IPO as it lines up a pair of NDAs (Endpoints)
  • Certain Antibiotics May Increase Risk of Birth Defects (NYTimes)
  • When Older Drugs are Better Drugs (Scientific American)
  • Sarepta Raises Full-Year Guidance (BioCentury)
  • Sarepta Launches Exondys 51 Managed Access Program (BioCentury)
  • Inovio prices $75m public offering (Drug Delivery)
  • Pfizer Stock Downgraded On Expiring Viagra, Lyrica Patents (The Street)
  • Brand 'Evergreening' Piques FDA Interest, But Solutions Remain Elusive (Pink Sheet-$)
  • Abuse Deterrent Opioids: Which Studies Will Show Real World Effect? (Pink Sheet-$)
  • Biosimilarity Margin Change By FDA Might Give Amgen's Avastin Copy Big Head Start (Pink Sheet-$)
  • Takeda and Schrödinger Announce Multi-Year, Multi-Target Research Collaboration (Press)
  • GAO Provides Report Card on FDA's Expanded Access Program (FDA Law Blog)
  • Seqirus Begins Shipping 2017-2018 Influenza Vaccines to the U.S. Market (Press)
  • 2016's Top Retail Pharmacy Chains, According to Drug Store News (Drug Channels)
  • Expanding his medical empire is good for Patrick Soon-Shiong. But is it good for patients? (STAT)
  • Lilly firms up Adimab R&D alliance, bringing its Ab platform in-house (Fierce)
  • Vaccines Protect Against Fetal Zika Transmission (BioCentury)
  • Novartis, Sanofi-backed NeuroVia closes $14M series A for X-ALD work (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Theravance COPD drug clears safety study, setting up NDA (Fierce)
  • Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Acute Graft-Versus-Host Disease (Press)
  • Kite Highlights Durable Complete Remissions Up to 56+ Months in Patients with Chemorefractory Aggressive Non-Hodgkin Lymphoma (NHL) after Anti-CD19 CAR T-Cell Therapy at the National Cancer Institute (Press)
  • Centrexion Therapeutics to Present Phase 2b Data on CNTX-4975 for the Treatment of Chronic Pain Associated with Morton's Neuroma at the American Podiatric Medical Association 2017 Annual Scientific Meeting (Press)
  • FDA Accepts CSL Behring's Supplemental Biologics License Application for Hizentra® Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Indication (Press)

Medical Devices

  • Alere, St. Jude Deals in Focus as Abbott Releases Q2 Earnings (The Street)
  • Biotronik wins FDA nod for atrial lead-less Intica ICD line (MassDevice)
  • Novo Nordisk and Glooko unveil first comarketed app for diabetes solutions (Fierce)
  • Absorb's Risk for Very Late Events Affirmed Across Trials (Medpage)
  • DorsaVi shares rise on FDA nod for ViMove2 (MassDevice)
  • Alcresta Therapeutics Receives 510(k) Clearance For Use of RELiZORB® in Children (Press)
  • FDA Warns Phototherapy Device Maker for Quality System Issues (Focus)
  • TAVR Costs Rising As SAVR Price Falls (Medpage)
  • How to Control Those Extra Robotic Limbs You've Always Wanted (IEEE)

US: Assorted & Government

  • Martin Shkreli trial put on hold as defense and prosecution duel over witnesses, evidence (CNBC)
  • Fraud And Billing Mistakes Cost Medicare — And Taxpayers — Tens Of Billions Last Year (KHN)
  • 32 million people lose insurance under U.S. Senate Obamacare repeal plan: CBO (Reuters)
  • UnitedHealth Group Predicts 50% Of Seniors Will Choose Medicare Advantage (Forbes)
  • Removal Before Service Lives On (Drug & Device Law)

Upcoming Meetings & Events


  • The shadow of diclofenac hangs over European vultures (Nature)
  • Uphill Climb For Gedeon Richter's Cariprazine After Delayed EU OK (SCRIP-$)
  • Pfizer Completes License Agreement For The Exclusive Commercialization Rights In Europe For CRESEMBA (isavuconazole), A Novel Treatment For Potentially Life-Threatening Fungal Infections Among Immunocompromised Patients (Press)


  • Warning letters and Indian pharma (BioSpectrum)
  • Merck sees market for novel therapies, to focus on its oncology pipeline (Economic Times)
  • Govt to implement intensive ADR monitoring to report adverse events in specific drugs (PharmaBiz)


  • Innovus Pharma's Partner Luminarie Receives Approval for Zestra® for Female Sexual Arousal Disorder as a Medical Device I from Australia's Therapeutic Goods Administration (Press)

Other International

  • WHO report finds dramatic increase in life-saving tobacco control policies in last decade (WHO)
  • Australia helps Sri Lanka to control dengue fever after 250 die (Reuters)
  • Why Zika Is Especially Hard On The Women Of Brazil (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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles