Regulatory Recon: Samsung, Biogen Humira Biosimilar Approved in Europe FDA Approves Adamas Parkinson's Dyskinesia Drug (25 August 2017)

Posted 25 August 2017 | By Michael Mezher 

Regulatory Recon: Samsung, Biogen Humira Biosimilar Approved in Europe FDA Approves Adamas Parkinson's Dyskinesia Drug (25 August 2017)

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

In Focus: US

  • Pfizer set to move into The Spiral on far West Side (NYPost) (Endpoints)
  • After a long clinical odyssey, the FDA tapped this PhIII anti-CCR4 as a 'breakthrough' lymphoma drug (Endpoints) (Press)
  • Adamas Pharma secures approval for Parkinson's dyskinesia drug (Reuters) (Endpoints)
  • A new Parkinson's drug is a long-acting version of a cheap generic. Should it cost $30,000 a year? (STAT)
  • Opioids, China and Washington: Fentanyl's Deadly Reach (NBC)
  • Bavarian Nordic says first milestone payment under J&J deal could be in 2019 (Reuters)
  • The 'worst solution' to high drug prices is political interference, says former pharma CEO (CNBC)
  • September preview: More Senate HELP committee hearings coming (Politico)

In Focus: International

  • Samsung, Biogen version of AbbVie's Humira approved in Europe (Reuters) (Press)
  • Vertex files new CF combo in the US, EU (PharmaTimes) (Press)
  • Novartis returns to the discount aisle, buys Xoma's failed PhIII drug for $31M (Endpoints)
  • Under pressure, Gilead expands Sovaldi licensing deal to four middle-income countries (STAT)
  • After a long, painful revamp, Merck KGaA scores key OK for once-defunct MS drug cladribine (Endpoints) (PharmaTimes)
  • Irish Brexit Event A Chance For Originator And Biosimilar Firms To Air Their Concerns (Pink Sheet-$)
  • NICE U-turn on Adcetris disappoints because of added restriction, says Takeda (PharmaLetter-$) (PMLive)
  • Can Novartis' Kisqali beat Pfizer's market-leading Ibrance to reimbursement in England? (Fierce)
  • Generics market in Germany set to reach $9.5 billion by end 2021 (PharmaLetter-$)
  • Rare eye disease drug Holocar to be reimbursed in the UK (PharmaLetter-$) (PharmaTimes)
  • Korea Takes Its First Step Reimbursing IO Drugs (Pink Sheet-$)
  • Health Ministers Boost Patient-First Investment (APEC)
  • News from Abroad -- Mexican Antitrust Authority Study on Generic Drug Entry -- On Patents and Marketing Authorizations -- Part III (Patent Docs)

Pharmaceuticals & Biotechnology

  • Crossing The Sea: Adventures In Transatlantic Biotech Operations (LifeSciVC)
  • Novartis recruits a global digital chief; Shire CFO jumps ship (Endpoints)
  • Another Brick in the Wall: A New Commitment Implementing the Mutual Recognition of Inspections (FDA Law Blog)
  • The pharmacovigilance market dynamic (Pharmafile)
  • GlaxoSmithKline, Propeller widen respiratory sensor collaboration for COPD edge (Fierce)
  • Bioverativ taps patient social network for input on hemophilia trial design (Fierce)
  • Sanofi And Regeneron To Present New Analyses From Praluent® (Alirocumab) Injection Trials At The ESC Congress 2017 (Press)
  • Why do so many millennials struggle to take their pills consistently? (STAT)
  • Ionis urges investors to reject TRC Capital mini-tender (Fierce)
  • Second Nasdaq compliance notice adds to Auris' woes (Fierce)
  • Upcoming events – GSK's shingles panel and Axovant takes on Alzheimer's (EP Vantage)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Kedrion Biopharma and Kamada Receive FDA Approval of KEDRAB™ for Post-Exposure Prophylaxis Against Rabies Infection (Press)
  • Apellis sets up another phase 3 program for lead drug APL-2 (Fierce)
  • Genmab Up After Darzalex Meets In Phase III For First-Line MM (BioCentury)
  • Boehringer Ingelheim initiates Phase IIa study of compound acquired from Pharmaxis in debilitating liver disease NASH (Press)

Medical Devices

  • FDA Clarifies Early Feasibility Study (EFS) Program for Early-stage Medical Devices (Emergo)
  • Consolidating Strategic Suppliers? Successful Tooling Transfer is Key (MDDI)
  • One Specialty? Not for This Device Company (MDDI)
  • NxStage Medical's Todd Snell talks FDA, Brexit & regulatory strategy (MassDevice)
  • Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market (FDA)

US: Assorted & Government

  • Last 'bare county' in U.S. to get health insurer next year (Reuters)
  • Congress facing deadline to renew healthcare for children (The Hill)
  • Arkansas decision poses conundrum for HHS (Politico)
  • The Opioid Commission: Ringing The Right Alarm To Respond To The Overdose Epidemic (Health Affairs Blog)
  • Amazon has no fear about entering the health business, say former leaders at the company (CNBC)
  • InvaGen Infringed Diabetes Drug Patent, Pharma Cos. Say (Law360-$)
  • Good Testimony from Neutral Prescriber Leads to Summary Judgment in Plavix Litigation (Drug & Device Law)
  • Oral Argument before the Fifth Circuit Starts in a Couple of Hours on the Writ of Mandamus Filed in the Pinnacle Hip Implant Litigation (Drug & Device Law)
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA's role in ensuring Americans have access to clear and consistent calorie and nutrition information; forthcoming guidance will provide greater clarity and certainty (FDA)

Upcoming Meetings & Events


  • Otsuka enters deal with Mylan to bring MDR TB drug to India (Economic Times)


  • Draft Guidance Consults On Viability Of Canada's Proposed 48-Hour Reporting Rule (Pink Sheet-$)
  • GenDx Receives Canadian License for HLA Typing Software (GenomeWeb)

General Health & Other Interesting Articles

  • Candida Auris: A New Fungal Superbug Emerging As A Global Threat (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.

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