Regulatory Recon: NIH Committee to Review First Human CRISPR Test NICE Gives Speedy OK to BMS Melanoma Combo (17 June 2016)

Posted 17 June 2016 | By Michael Mezher 

Regulatory Recon: NIH Committee to Review First Human CRISPR Test NICE Gives Speedy OK to BMS Melanoma Combo (17 June 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Gates Says Altered Mosquito Is Next Weapon to Fight Malaria (Bloomberg)
  • First Human Test of CRISPR Proposed (MIT Technology Review) (NIH, Agenda)
  • Reining in the supersized Phase I cancer trial (Nature)
  • FDA Issues Draft Guidance on Critical Quality Attributes for Chewable Tablets (Focus)
  • FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions (Focus)
  • CDC Reports 234 Pregnant Women in US With Zika (NYTimes) (Reuters)
  • Direct-To-Consumer Clinical Lab Testing Won't Kill Us - It Will Make Us Stronger (Forbes)
  • Paratek Shares Climb After Antibiotic Clears First Phase 3 Hurdle (Xconomy) (BioCentury) (Press)
  • FDA Issues Two Emergency Use Authorizations for Zika Tests (FDA)
  • Lifting US curbs on gay blood donors seen years away: experts (Reuters)
  • Amicus Briefs in Support of Sequenom's Petition for Certiorari: Eli Lilly and Company et al. (Patent Docs)

In Focus: International

  • 'Brexit' Would Put EU Drug Regulator's Headquarters in Play (WSJ-$)
  • Factory snag hits GSK supply, causing Danish anaesthetic shortage (Reuters)
  • WHO/PAHO Release Strategic Response Plan for Zika (WHO)
  • Scancell slumps as drug problem disrupts melanoma trial (Reuters) (Fierce)
  • UK cost agency speeds approval of Bristol melanoma drug cocktail (Reuters)
  • Handling of unexpected deviations (MHRA Inspectorate Blog)
  • Pharma licensing deals soared to record $46.2 billion 2015, report shows (PharmaLetter-$)
  • Final Nice appraisal says no to cystic fibrosis drug, Orkambi (Pharmafile)
  • WHO backs cut in yellow fever vaccine dose to eke out supplies (WHO)
  • WHO says 122 million dollars needed for global response to Zika virus (Reuters)
  • Brazilian Medical Device Regulators Moving to Electronic Submission System (Emergo)
  • European Regulatory Roundup: MHRA Offers Draft Guidance on Device and Combo Products (Focus)
  • Two Indian Contract Pharma, API Manufacturers Refuse FDA Inspections (Focus)
  • MHRA Cites Pharmaceutics International for GMP Issues at Two US Sites (Focus)
  • EU Council conclusions on the next steps under a One Health approach to combat antimicrobial resistance (EU Council)

US: Pharmaceuticals & Biotechnology

  • Therapy focus – Sickle cell therapies creep closer to market (EP Vantage)
  • Isotope Labeling For Fun and Profit (In the Pipeline)
  • Excipient Regulatory Approaches Globally Differ Widely in Registration, GMP, DMF, and Application Submission Expectations (IPQ)
  • Biosimilarity statement unnecessary according to industry (GaBI)
  • Invokana, Farxiga New Safety Warning May Give Jardiance Market Edge (Pink Sheet-$)
  • Pfizer begins construction on $200M manufacturing plant to employ 75 (Boston Biz Journal)
  • Immunogenicity of biologicals: the role of post-translational modifications (GaBI)
  • CEOs Should Set Tone for Corporate Culture (The Street)
  • The CREATES Act Would Create a Cause of Action to Obtain Restricted Product Sample and to Facilitate Shared REMS (FDA Law Blog) (Focus)
  • Quality issue could set back biosimilars in the US, says BIO panel (BioPharma-Reporter)
  • How (and why) CROs are collecting and using patient-centric data (Outsourcing-Pharma)
  • Pfizer, Novartis, BMS join $45M round for early fibrotic disease startup (Fierce)
  • Pharma loses one battle over drug take-back programs, but wins another (STAT)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ORBACTIV (FDA)
  • Expanded Access — A Regulatory Balancing Act For Drug Cos. (Law360-$)
  • Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Guidance for Industry; Availability (FDA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Sanofi Genzyme and Regeneron present positive dupilumab data in inflammatory conditions (PharmaLetter-$)
  • Shire receives FDA nod for self-infusion of Glassia (PMLive)
  • ARIAD Initiates Submission of New Drug Application for Brigatinib to the U.S. Food and Drug Administration Ahead of Plan (Press)
  • Upcoming events – Phase III data for plecanatide and Zoptrex (EP Vantage)
  • Ganymed Pharmaceuticals' IMAB362 to bring hope to gastric cancer patients, says analyst (PharmaLetter-$)
  • AmoyDx ROS1 Diagnostics Test Contributed to a Phase 2 Clinical Study of Crizotinib in Lung Cancer (Press)
  • Perrigo Announces FDA Approval Of The Generic Version Of Ofirmev Acetaminophen Injection (Press)

US: Medical Devices

  • What Industry Built at FDA, Doctors Try to Unbuild (MDDI)
  • FDA's Patel: Time for a Paradigm Shift in Software Review (MDDI)
  • Spectral Medical touts PMA acceptance for sepsis treatment (MassDevice)
  • Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format; Republication (FDA)
  • SpineGuard receives US FDA clearance to market PediGuard Threaded DSG device (Press)
  • New Clinical Study Will Evaluate MRI-Guided Laser Ablation for a Common Form of Epilepsy (Press)
  • Canadian micro-cap starts PMA submission for novel sepsis device (Fierce)
  • Si-Bone touts updated 510(k) clearance indications, MAC reimbursement wins for iFuse (MassDevice)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT (FDA)

US: Assorted & Government

  • Calif. Jury Finds For Flu Remedy Maker In False Ad Trial (Law360-$)
  • The First Big Company to Say It's Serving the Legal Marijuana Trade? Microsoft. (NYTimes)
  • Report From Key Calif. Agency Raises Concerns About Proposal To Cut Drug Prices (KHN)
  • U.S. top court puts some limits on contractor fraud lawsuits (Reuters) (Forbes)
  • More Generics And Negotiating Leverage Could Slow Medicare Drug Spending (NPR)
  • A new Medicare plan to hold drug-cost line (EP Vantage)

Upcoming Meetings & Events


  • EMA Management Board: highlights of June 2016 meeting (EMA)
  • UK pharma contribution to NHS medicines bill almost £1.3 billion (PharmaLetter-$)
  • Curetis Gets CE-IVD Mark for Blood Culture Cartridge (GenomeWeb)
  • MHRA Drug Safety Update  June 2016 (MHRA)
  • SMC approves Amgen orphan drug for use in NHS Scotland (PMLive)
  • Famar will consider more plant acquisitions in Europe and North America (In-PharmaTechnologist)


  • China Pharma Billionaires' Hepalink Invests $60 Mln in TPG Fund (Forbes)


  • Indian Regulator Warns Pharma Firms Not To Miss Expert Panel Meetings (SCRIP-$)
  • DCGI Again Calls on Companies to Submit Phase IV Trial Protocols for FDCs (Letter)
  • IFC plans to invest $ 75 million in Glenmark Pharmaceuticals (Economic Times)
  • India eyes barter for drugs for African countries hit by weak oil prices (Fierce)
  • Karnataka drugs control dept urges state govt to fill up 81 drug inspector vacancies (PharmaBiz)
  • Devices industry wants Centre to adopt Japanese MAAH model to protect interest of domestic cos (PharmaBiz)


  • Shortage: Metformin extended release tablets (TGA)
  • Safety Advisory: Mercaptamine (cysteamine) and mercaptopurine (TGA)

Other International

  • More than 1,000 suspect cases of yellow fever in DR Congo: WHO (Reuters)

General Health& Other Interesting Articles

  • Does a journal of homeopathy belong in science? (STAT)
  • With dementia, cognitive tests may not predict safe driving (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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