Regulatory Recon: Sanofi to Buy Hemophilia Specialist Bioverativ for $11.6B; Celgene to Acquire Juno for $9B (22 January 2018)

Posted 22 January 2018 | By Michael Mezher 

Regulatory Recon: Sanofi to Buy Hemophilia Specialist Bioverativ for $11.6B; Celgene to Acquire Juno for $9B (22 January 2018)

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

In Focus: US

  • Celgene to buy Juno for $9 billion to boost CAR-T expertise (Reuters) (Endpoints) (CNBC) (Financial Times)
  • Sanofi digs deep to buy US hemophilia group Bioverativ for $11.6 billion (Reuters) (Endpoints) (NYTimes)
  • Here's where the shutdown fight stands (Politico)
  • Is Pharma's Data Problem Technical Or Cultural? (Forbes)
  • FDA Extends Shelf Life of Baxter IV Solutions in Wake of Shortage (FDA)
  • US Government Shutdown: Almost Half of FDA Staff Furloughed, No Submissions (Focus)
  • How To Prevent Drug Price Shenanigans (Forbes)
  • Teva restructuring hits American HQ, claiming 200-plus Pennsylvania jobs (Fierce)
  • Gilead's Kite to buy ex-Agensys R&D site for $135M: report (Fierce)
  • Celgene Needs a Boost, But Juno Isn't It (Bloomberg)
  • Why Hospitals Aren't in the Drug Business (Bloomberg)
  • Trump hasn't attacked drug prices, as he promised he would, during his first year in office (CNBC)
  • FDA's tobacco stance faces test with Philip Morris iQOS device (Reuters)
  • A Dose of Accountability for the FDA (WSJ)
  • Scientists have yet to find the Holy Grail of cancer tests (Financial Times) (STAT) (In the Pipeline)
  • Did the government overpay for hundreds of drugs? It's complicated (STAT)

In Focus: International

  • Heptares co-founder Fiona Marshall grabs the helm at Merck's upcoming UK drug discovery center (Endpoints)
  • Teva's asthma treatment fails late-stage studies (Reuters) (Press)
  • Success for Amgen as Europe welcomes first Avastin biosimilar (BioPharmaReporter) (SCRIP-$)
  • Industrial Strategy boost for UK medicines with £70 million of funding to help develop new treatments (GOV.UK)
  • EC Approves BMS' Yervoy for Patients 12 and Older With Unresectable or Metastatic Melanoma (Press)
  • How Wockhardt Chairman Habil Khorakiwala plans to pull the company out of trouble (Economic Times)
  • WHO Director-General addresses the Executive Board (WHO)
  • How Roche's Syapse Deal Supports The Pharma's Precision Medicine Strategy (BioCentury)
  • Why C-Bridge Is Writing Big Checks To Bring Western Platforms Into China (BioCentury)
  • CFDA Issues Guidance On Drug Review And Approval Transparency (BioCentury) (PharmaLetter-$)
  • AZ's Lynparza Receives Japanese Approval (BioCentury)
  • Pfizer blames Canadian EpiPen shortage on manufacturing complexities (InPharma) (Drug Delivery)
  • Brazil's ANVISA Streamlines Medical Device Importation Processes (Emergo)
  • French Govt Must Act To Stop 'Inexorable Decline' Of Pharmaceutical Industry (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • The Year in New Drugs (C&EN)
  • Fresh from the biotech pipeline—2017 (Nature)
  • Why do biopharma's elites make the annual pilgrimage to Davos? (STAT)
  • The One-Year Anniversary of the Oncology Center of Excellence (FDA Voice)
  • Citing an 'ever-changing' market, Sanofi to lay off 400 in US sales (Fierce)
  • What are the top 10 corporate VCs in biopharma today? And what do they want to fund — or steer clear of? (Endpoints)
  • Price controls would stifle innovation in the pharmaceutical industry (STAT)
  • FDA policy wades into battles between drug makers and compounders (STAT) (FDA Law Blog)
  • Some Branded Drugs Going Generic In 2018 (RTT)
  • ANDA Complete Responses Spike In FY 2018, But Why? (Pink Sheet-$)
  • FDA Form 483 Issued to Daewoong Pharmaceuticals (FDA)
  • Abcam acquires rights to over 700 Roche products in new licensing deal (Pharmafile)
  • How well can you predict the outcome of clinical trials? Not as well as you may think (STAT)
  • Disease-Specific Drug Development Guidances Coming From US FDA In 2018 (Pink Sheet-$)
  • Idera, Biocryst to merge, rebrand and focus in rare disease programs (Endpoints)
  • How Spark And Express Scripts Are Innovating To Ensure Access To Expensive Cures (BioCentury)
  • Big Pharma vet John Hohneker takes the reins at Anokion; Heptares co-founder Fiona Marshall resigns from parent company Sosei (Endpoints)
  • Ablynx investor opens door to Novo deal at a higher price (Fierce)
  • FDA Panel To Discuss Pfizer's Xeljanz In UC (BioCentury)
  • Oral Contraceptives Reduce Risk for Ovarian and Endometrial Cancers (NYTimes)
  • Electronic Study Data Submission; Data Standards; Timetable for Updates to the Food and Drug Administration Data Standards Catalog for Study Data Submitted Electronically Under the Federal Food, Drug, and Cosmetic Act (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Clinical Activity in Previously Treated Patients with dMMR or MSI-H Metastatic Colorectal Cancer (Press)
  • In the latest setback to Vical/Astellas partnership, lead CMV vaccine fails a pivotal PhIII study (Endpoints) (Press)
  • Baxter Announces U.S. FDA Approval of Ready-To-Use Cardiovascular Medication Bivalirudin (Press)
  • Pharmamar's Zepsyre Misses In First Phase III TRIAL (BioCentury)
  • European Medicines Agency Issues Orphan Drug Designation Positive Opinion for Omeros' OMS721 in the Treatment of IgA Nephropathy (Press)
  • AVEO Oncology Announces Presentation of Data from Phase 1b/2 Study of Tivozanib in Patients with Advanced Hepatocellular Carcinoma (Press)
  • SymBio Pharmaceuticals: Initiation of Phase I Clinical Trial for Oral TREAKISYM in Progressive Solid Tumors (Press)
  • Exelixis Announces Presentation of Updated Phase 1b Results for the Combination of Cobimetinib and Atezolizumab in Metastatic Colorectal Cancer at the 2018 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (Press)
  • Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Receives European Commission Approval for CD30-Positive Cutaneous T-Cell Lymphoma after at Least One Prior Systemic Therapy (Press)

Medical Devices

  • FDA clears Medrobotics' robotic surgical platform for expanded use (Fierce) (Press)
  • Technical Considerations for Additive Manufactured Medical Devices - January 10, 2018 (FDA)
  • Women rushed to get IUDs fearing Trump's threats to repeal Obamacare (CNBC)
  • Honda wins CE Mark for Walking Assist Device (MassDevice)
  • SurModics wins FDA nod for Telemark crossing microcatheter (MassDevice)
  • Devices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Reopening of the Comment Period (FDA)

US: Assorted & Government

  • Delaware sues opioid manufacturers, distributors over epidemic (Reuters)
  • Key House Republican seeks changes in right-to-try legislation (STAT)
  • Court fines Dr Reddy's for improperly packaging products (Pharmafile) (DoJ)
  • Amazon and Nvidia are hiring people to cozy up to health VCs (CNBC)
  • CDC's flu tracking program to continue if US government shuts down (Reuters)
  • Trump Passed a Cognitive Exam. What Does That Really Mean? (NYTimes)
  • US health agency revokes Obama-era Planned Parenthood protection (Reuters)
  • Missouri Faces Costly Dilemma: How To Treat Inmates With Hepatitis C? (NPR)
  • 7th Circ. Won't Revive Claims Of 1,000 Pfizer Suits In MDL (Law360-$)
  • Janssen Sues Teva for Infringing Invega Sustanna Patents (FDA News-$)
  • Applying the "Arising Out of or Relating to" Personal Jurisdiction Test (Drug & Device Law)

Upcoming Meetings & Events


  • NICE finally starts review of Biogen's Spinraza for SMA (PMlive) (PharmaTimes)
  • 20,000 left disabled in UK due to sodium valproate use during pregnancy (Pharmafile)


  • Pharmacists Stall Turkey's Launch Of Regulated Consumer Health Market (Pink Sheet-$)


  • Deaths of Canadian billionaire, wife a tantalizing mystery (CNCB)
  • Notice: Adoption of International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: M7 (Health Canada)


  • TGA opens consultation on the use of prescription opioids for pain (TGA)

General Health

  • Surfers may be swallowing antibiotic-resistant bacteria (Reuters)
  • Self-guided course helps women manage menopause symptoms at work (Reuters)

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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