Regulatory Focus™ > News Articles > Regulatory Recon: Gottlieb Prioritizes Release of CRLs; FDA Approves Portola's Blood Clot Prevention

Regulatory Recon: Gottlieb Prioritizes Release of CRLs FDA Approves Portola's Blood Clot Prevention Drug (26 June 2017)

Posted 26 June 2017 | By Michael Mezher 

Regulatory Recon: Gottlieb Prioritizes Release of CRLs FDA Approves Portola's Blood Clot Prevention Drug (26 June 2017)

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

In Focus: US

  • FDA Getting Reg Slashing Directive In Trump Executive Order (Pink Sheet-$) (Public Citizen, Draft Order)
  • Bipartisan Group of Senators Urge FDA Commissioner to Address Prescription Drug Costs (Letter)
  • Interview with FDA Commissioner Scott Gottlieb: Releasing CRLs a Priority (BioCentury)
  • Senate Leaders Try to Appease Members as Support for Health Bill Slips (NYTimes)
  • What You Don't Know About Generic Drugs, and How It Can Hurt You (Bloomberg)
  • Feeling the pain of rising drug prices? Blame the middle man (CBS)
  • Seattle Genetics, Takeda lymphoma drug succeeds late-stage trial (Reuters) (Forbes) (Endpoints)
  • Portola shares soar after FDA approves clot preventing drug (Reuters) (Endpoints) (PharmaTimes)
  • Novo Nordisk says obesity drug helps up to 13.8 percent weight loss in phase 2 trial (Reuters) (BioCentury) (Pharmafile)
  • New Roche haemophilia drug prevents bleeds but questions remain (Reuters) (Endpoints) (Press)
  • Medtronic deal with Aetna ties insulin pump payment to patient results (Reuters)
  • ICER Updates Value Assessment Framework (BioCentury)
  • 'Pharma bro' Martin Shkreli heads into fraud trial (Reuters) (Financial Times)
  • Pharmacy executive tied to 2012 U.S. meningitis outbreak to be sentenced (Reuters) (AP) (Law360-$)
  • Who will pay for CRISPR? (STAT)
  • FDA to study whether enough doctors understand claims in ads for cancer drugs (STAT)

In Focus: International

  • Doctors Without Borders Urges India's Modi to Remain Committed to Affordable Medicines During White House Meeting (MSF)
  • Decision on EMA Relocation Set for November, Council Agrees on Bidding Procedure (Focus)
  • EFPIA, ABPI Reach to Postponement of Resolution on EMA Relocation (EFPIA) (ABPI)
  • EMA Recommends New HCV, Cancer and MS Drugs for Approval (Focus)
  • More people who can get the flu jab for free should be vaccinated, says NICE (NICE, Draft Guideline)
  • EU tests limits of drug pricing freedom in landmark probe (Reuters)
  • UN Human Rights Council Adopts Access To Medicines Resolution (IP Watch)
  • Takeda's Modality Operandi (BioCentury)
  • Australia ready to launch its Priority Review pathway for drugs (PharmaLetter-$) (TGA 1, 2)
  • Pluristem's Deal With Chinese Investor Falls Through (BioCentury)
  • Bayer's Stivarga approved for hepatocellular carcinoma in Japan (Reuters)
  • EU regulators reviewing Shire's bleeding disorder drug (PharmaTimes)
  • Pfizer, Cipla Pledge Better Access To Affordable Cancer Therapies In Africa (SCRIP-$)
  • Asia Executives To Watch: New FDA China Director Named Amid ICH Push (Pink Sheet-$)
  • CFDA Joins ICH (CFDA) (ICH)

Pharmaceuticals & Biotechnology

  • Notes from ASCO 2017 – another year of stagnation (Open Reading Frame)
  • TRuCS VS. CARS (BioCentury)
  • MaPP Undergoes First Revision Since 2006 (Lachman Consultants)
  • Drug Combinations and Emerging Interactions (Pharmafile)
  • Red Teaming: What Pharma Can Learn From The US Military (SCRIP-$)
  • Appointments: New Executives At GSK, Leo Pharma, Valeant, Verona, Ocugen And Peptinnovate (SCRIP-$)
  • OTC Sleep Drug Named after Antidepressant is Misbranded and Misleading, Warns FDA (FDANews-$)
  • FDA Tussles With Combination Products, Fires Up Oncology Center Of Excellence (Pink Sheet-$)
  • Field Alert Reports – FDA Introduces the Automated Form 3331a (FDA Law Blog)
  • New Pain Drug Likely To Face Price Challenges From Payers (Forbes)
  • How Medical Centers And Pharmas Respond To Technological Innovation: The Four Rs (Forbes)
  • Aveo soars as long-beleaguered cancer drug nears approval (Fierce)
  • Neothetics decimated by submental fat failure test (Fierce)
  • Novartis-backed GenSight gets cash for gene therapy launch (Fierce)
  • High hopes ride on marijuana painkillers amid opioid crisis (Reuters)
  • Issuance of Priority Review Voucher; Rare Pediatric Disease Product (FDA)
  • Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Amag reports U.S. FDA acceptance of supplemental new drug application for Makena (Reuters)
  • Matinas Bio shares are crushed on disappointing PhII antifungal data (Endpoints) (Fierce)
  • Camarus, Braeburn tout Phase II data for long-acting buprenorphine depot (Drug Delivery)
  • Synlogic Receives Fast Track Designation in U.S. for Lead Candidate, SYNB1020 (Press)
  • Lipocine announces submission of special protocol assessment request to FDA on LPCN 1107, an oral alternative for prevention of preterm birth (Reuters)
  • Icon Bioscience Annouces FDA Acceptance of NDA Filing for DEXYCU, a Noval Drug Therapy for Treating Inflammation Associated with Cataract Surgery (Press)
  • Four-Year Follow-up with Empliciti (elotuzumab) Plus Lenalidomide/Dexamethasone (ELd) in Patients with Advanced Multiple Myeloma Shows Long-term Efficacy in ELOQUENT-2 Trial (Press)
  • Verastem Reports Phase 2 Long-Term Follow-Up Data for Duvelisib in Patients with Double-Refractory Follicular Lymphoma and Small Lymphocytic Lymphoma at the 22nd Congress of the European Hematology Association (Press)
  • ImmunoGen Presents Data from Phase I Study of IMGN779 in Acute Myeloid Leukemia (Press)
  • Xenetic Biosciences Commences Patient Enrollment in Phase 2 Study Evaluating XBIO-101 in Conjunction with Progestin Therapy for the Treatment of Endometrial Cancer (Press)

Medical Devices

  • Electronic Submission of 806 Reports of Corrections and Removals (FDA CDRH)
  • Report: Mystery snafu takes out Medtronic's computers (MassDevice)
  • No Easy Money: To secure funding, medtech companies think strategically (MDDI)
  • Five Questions For … Houston Medical Device Investor Larry Lawson (Xconomy)
  • Abbott warns on communication issue with HeartMate 3 pump (MassDevice)
  • Envisioning how FDA could shake up digital health (MedCityNews)
  • Implanet wins CE Mark, FDA nod for next-gen Jazz braid (MassDevice)
  • Teleflex says Venture Cath recall is FDA Class I (MassDevice)
  • FDA approves diagnostic that simultaneously screens for multiple cancer biomarkers (Drug Delivery)
  • Korea's Wontech wins FDA nod for Picocare tattoo removal device (MassDevice)

US: Assorted & Government

  • Lawmakers push White House for action after HIV panel resignations (STAT)
  • Fuzzy Math and New Score (but Not on Goal) (Alliance for a Stronger FDA)
  • A doctor prescribed so many painkillers, she's been charged with murdering her patients, authorities say (Washington Post)
  • GlaxoSmithKline LLC v. Glenmark Pharmaceuticals Inc. (D. Del. 2017) (Patent Docs)
  • Failure To Contraindicate Claims and Preemption (Drug & Device Law)
  • AbbVie Fights Hedge Funds' Bid To Return To State Court (Law360-$)
  • House Debates Whether Atty 'Bad Drug' Ads Harm Patients (Law360-$)
  • Protect Innovation By Making FDA Compliance Admissible (Law360-$)

Upcoming Meetings & Events


  • Concept paper on revision of the guideline on clinical development of vaccines (EMA)
  • First ever guidance for stem cell therapies in animals published (EMA)
  • Takeda prepping to take over EU production of stem cell therapy from 2021 (BioPharmaReporter)
  • Pulled From EU Assessment Process: Orphan Drugs For Kidney Disease, Mesothelioma (Pink Sheet-$)
  • Ireland's pharma industry to deliver further saving to the state of 15 million euros (PharmaLetter-$)
  • Brexit hardly the medicine for a Europe craving innovation (PharmaLetter-$)


  • Lupin founder Desh Bandhu Gupta passes away at 79 (Economic Times)
  • DCGI issues procedure for subsequent applicants for FDCs declared rational by Kokate panel, approved by DCGI (PharmaBiz)


  • Chinese Pharma Licenses Two Drugs from UT Schools For $4.5M Upfront (Xconomy)
  • Japanese plant padded paracetamol with cheap Chinese imports (PharmaLetter-$)


  • Orphan drug program reforms (TGA)
  • Prescription medicines minor variations e-Form: Information sessions (TGA)

General Health & Other Interesting Articles

  • Hitting cardiovascular health targets can help elderly live longer (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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