Regulatory Recon: FDA Refuses Acorda's Application for Parkinson's Drug AZ Offloads Early Stage Drug to Takeda in $400m Co-Development Deal (29 August 2017)

Posted 29 August 2017 | By Michael Mezher 

Regulatory Recon: FDA Refuses Acorda's Application for Parkinson's Drug AZ Offloads Early Stage Drug to Takeda in $400m Co-Development Deal (29 August 2017)

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

In Focus: US

  • FDA derails Acorda's marketing pitch, creating a crisis as flagship drug founders (Endpoints) (STAT) (Press)
  • For Gilead Kite is no Pharmasset (EP Vantage)
  • AstraZeneca strikes $400 million Parkinson's drug deal with Takeda (Reuters) (Endpoints)
  • AstraZeneca taps AI for drug discovery in deal with Berg (Reuters) (Financial Times)
  • Merck hits a bloop single in an epic PhIII CETP cardio contest. Now what? (Endpoints) (EP Vantage) (Fierce)
  • Seven years in the making, Seattle Genetics picks up early option on Genmab's ADC effort (Endpoints) (Press)
  • FDA's Gottlieb Wants To Rein In Risk Info In Drug Ads, But Will He Succeed? (Forbes)
  • What Can A Company Justifiably Charge For A Cancer Cure? (Forbes)
  • Bristol-Myers, Daiichi Sankyo to test Opdivo combo for cancers (Reuters) (Press)
  • FDA to Unveil New Regulatory Framework for Stem Cell Therapies (Focus)
  • Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018 (Focus)
  • FDA Approves 6th Biosimilar in US, Second for Humira (Focus)
  • Medical Journals Have a Fake News Problem (Bloomberg)

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In Focus: International

  • Special Report—The top 10 cardiovascular drugs in the world (Fierce)
  • Electroceuticals: the 'bonkers' gamble that could pay off for GlaxoSmithKline (The Guardian)
  • Germany will be first EU launch market for new Soliris indication (PMLive)
  • Asia-Pacific hepatitis C market to surpass $8.3 billion by 2023, says new report (PharmaLetter-$)
  • Cutting US foreign aid for HIV would cost lives, without much savings (Reuters)
  • NHS to assess data-recording insulin pen device (PharmaTimes)
  • EUSA bags EU approval for kidney cancer drug (PharmaTimes)

Pharmaceuticals & Biotechnology

  • Profits in the 2017 Fortune 500: Manufacturers vs. Wholesalers, PBMs, and Pharmacies (rerun) (Drug Channels)
  • Genetic Studies Help Clarify the Complexities of Lipid Biology and Treatment (JAMA)
  • Bad Medicine: (Drug) Trials and Tribulations (Part 1 & 2)
  • Rise of MSLs: Medical professionals stand in for sales representatives on complex drug launches (Fierce)
  • Celgene antes up $195M more to stay close to Forma, adding neurodegeneration focus (Endpoints)
  • Celgene, Google double down on Armo's PhIII immuno-oncology drug with $67M round (Endpoints)
  • New research reports first-ever response of central nervous tumour to CAR T therapy (Pharmafile)
  • Shire launches new ADHD drug Mydayis as it weighs a neuroscience exit (Fierce)
  • Drugmakers tackle 'ick' factor with fecal transplant therapies (Reuters)
  • NFL All-Pro Richard Sherman joins Oxeia board as it readies phase 2 concussion drug research (Fierce     )
  • Boosting immunotherapy by targeting cells' recycling centers (Fierce)
  • CSL Behring buys Calimmune for early stem cell, gene therapy boost (Fierce)
  • Jazz gambles $175M on a triple-pronged armed antibody pact with ImmunoGen (Endpoints)
  • Daiichi Sankyo hands off cancer drug to Boston Pharma (BioPharmaDive)
  • FDA Marks Down Compounder for Aseptic Shortfalls (FDA News-$)
  • In Alaska, Hepatitis C Rate Rises Due To Injection Opioid Use (NPR)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Fulvestrant Gains New Breast Cancer Indication (Medpage)
  • FDA Accepts NDA For Lutathera (BioCentury) (Press)
  • Sorrento seeks FDA nod for lidocaine patch (Drug Delivery)
  • New Phase 3 Data for Abemaciclib and Ramucirumab Presented at ESMO 2017 Congress (Press)
  • U.S. FDA and European Medicines Agency Accept Regulatory Submissions for BOSULIF® (bosutinib) for the Treatment of Patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia (Press)
  • Bristol-Myers Squibb and Pfizer Alliance Announce Real-World Observational Analysis of the Effectiveness and Safety of Direct Oral Anticoagulants Compared to Warfarin in Elderly Patients with Non-Valvular Atrial Fibrillation (Press)
  • Protalex Doses First Patient in Third Cohort of European Phase 1b Study of PRTX-100 in ITP (Press)
  • Chi-Med Initiates a Phase I Clinical Trial of Selective PI3Kδ Inhibitor HMPL-689 in Lymphoma Patients in China (Press)

Medical Devices

  • Philips to open 800-job health technology center in Tenn. (MassDevice)
  • Innovating Regulation: FDA's PreCert Pilot Program (MDDI)
  • NuVasive unveils new San Diego HQ expansion (MassDevice)
  • Biotronik's Orsiro drug-eluting stent tops Abbott's Xience in study (MassDevice)
  • Leica FL560 achieves First FDA Clearance for cerebrovascular fluorescence with fluorescein (Press)
  • FDA clears NxStage Medical's System One, allowing for solo home hemodialysis (MobiHealthNews) (MassDevice)
  • FDA clears Second Sight IDE trial of next-gen Orion cortical visual prosthesis (MassDevice)

US: Assorted & Government

  • Janssen V. Celltrion: CAFC & District Court Litigation Update (BigMoleculeWatch)
  • Federal Court Says VA Can't Block Prescriber's Deposition (Drug & Device Law)
  • Before the Flood: Fifth Circuit Oral Argument on Writ of Mandamus From Pinnacle Hip Implant MDL (Drug and Device Law)
  • OIG Issues an Advisory Opinion on Providing Replacement Product (FDA Law Blog)
  • Class action lawsuit filed against Dr Reddy's Laboratories in US (Economic Times)
  • $235M Patent Award Spurs Teva Redo Request, GSK Fees Bid (Law360-$)
  • HHS Moves to Set Up Pain-management Task Force (FDA News-$)
  • Consumers Seek J&J Docs In Contact Lens Antitrust MDL (Law360-$)
  • Lilly Loses Bid To Escape $20M Cialis Patent Verdict (Law360-$)

Upcoming Meetings & Events


  • Hunt says Hawking is 'wrong' over NHS (OnMedica)


  • Zydus Cadila gets EIR from USFDA for Pharma SEZ plant at Ahmedabad (Economic Times)
  • Draft pharma policy's focus on ensuring affordability of drugs a welcome step: AICDF (PharmaBiz)
  • Maha FDA seizes illegal products worth over Rs. 17 cr based on 427 raids across state (PharmaBiz)
  • AIOCD expresses reservations over trade aspects of draft pharma policy (PharmaBiz)
  • Sun Pharma gets favourable ruling from DoP on its review petition against price fixation of "Volitra Enzo tablet" (PharmaBiz)


  • Notice: eCTD Pilot for Clinical Trial Regulatory Activities – Extension (Health Canada)
  • Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use (Health Canada)


  • TGA presentations: Industry information and consultation sessions on medicinal cannabis - Adelaide and Brisbane - July 2017 (TGA)
  • Presentation: Update on regulatory developments for medicinal cannabis (TGA)

Other International

  • Sixty-Seventh WHO Regional Committee for Africa (WHO)

General Health & Other Interesting Articles

  • With a Simple DNA Test, Family Histories Are Rewritten (NYTimes)

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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