Regulatory Recon: La Jolla Low Blood Pressure Drug Succeeds in Phase III Shock Study WHO Calls for Drugs Needed for 12 'Priority Pathogens' (27 February 2017)

Posted 27 February 2017 | By Michael Mezher 

Regulatory Recon: La Jolla Low Blood Pressure Drug Succeeds in Phase III Shock Study WHO Calls for Drugs Needed for 12 'Priority Pathogens' (27 February 2017)

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

In Focus: US

  • Does Trump pose a threat to the FDA's future? (Pharmafile)
  • Facing Criticism, Drug Makers Keep Lid On Price Increases (WSJ)
  • How to Get Patients to Take More Control of Their Medical Decisions (WSJ)
  • Pharma heads write to Congress... and put foot in mouth (Forbes)
  • Pfizer subpoenaed in US over patient assistance plans (Reuters)
  • Capturing the value of good quality in medical devices (McKinsey&Co)
  • The quest for one of science's holy grails: artificial blood (STAT)
  • Arrakis launches to develop RNA-targeting small-molecule drugs (C&EN) (Xconomy) (Endpoints)
  • La Jolla Pharma Drug Raises Blood Pressure in Late Stage Study of Shock Patients (The Street) (Reuters) (Fierce) (Press)
  • Merck's letermovir aces bone marrow transplant study, cutting death rate (Fierce) (Press)
  • Exonics to use CRISPR in an effort to treat majority of DMD boys (Xconomy) (Fierce)
  • FDA Urges Full Participation In Quality Metrics Program (Pink Sheet-$) (PharmTech)
  • FDA Office of Generics Points to Record-Setting 2016 Ahead of Next Week's Hearing (Focus)
  • Pharma urges FDA to delay rule on policing off-label marketing (STAT)
  • FDA Officials Defend Agency's Flexibility Under Current Regulatory Framework (Focus)
  • FluMist May Not Get CDC Seal Of Approval For Several Years (Pink Sheet-$)
  • US Weighs In On High Court Biosimilars Battle (Law360-$)
  • Johnson & Johnson closes $4.3B Abbott Medical Optics buy (MassDevice)
  • Merck Takes $2.9B Charge on Dampened Outlook for HCV Drug (The Street) (Fierce)
  • Details emerge of Republicans' plans to replace Obamacare (Reuters) (Forbes)
  • GOP's New Plan to Repeal Obamacare: Dare Fellow Republicans to Block Effort (WSJ)
  • The Adults a Medicaid Work Requirement Would Leave Behind (NYTimes)
  • Overhaul of Medicaid expansion could cost states $32 billion (Reuters)
  • Most Americans want US to keep funding expanded Medicaid (Reuters)
  • Opinion: A National Right to Life (WSJ)

In Focus: International

  • ICH To Fix Inconsistencies With RCTs, Address Use Of Alternate Designs And Data Sources (SCRIP-$)
  • WHO says new drugs urgently needed to fight 12 'priority pathogens' (Reuters) (WHO)
  • Sanofi and Lonza to build new $285 million Swiss biologics facility (Reuters)
  • South African Regulators Set Licensing Deadlines for Medical Device Companies (Emergo)
  • EMA Adds Potential for Toe Amputation to SGLT2 Inhibitor Prescribing Info (Focus)
  • GSK 'real world' study offers new model for drug trials (Financial Times)
  • Cuba begins Phase 1 testing of HIV vaccine (Pharmafile)
  • Mexico's COFEPRIS: A Friend Or Foe To Industry? (Pink Sheet-$)
  • EMA's Post-Brexit Home 'Could Be Decided This Year' (Pink Sheet-$)
  • New measures proposed in Greece could mean a pharmaceutical "Grexit," says trade group (PharmaLetter-$)
  • Lundbeck Mulls Alzheimer's Combo Therapy in Wake of Drug Failure (Bloomberg)
  • $288 million Franco-Swiss biologics production facility collaboration (PharmaLetter-$)
  • Indian Pharmaceutical Firms Focus On Automation & Work Culture To Improve Quality Standards (Bloomberg)
  • Novartis Combo On Track To Be First Targeted BRAF NSCLC Therapy (SCRIP-$)
  • AstraZeneca's hyperkalaemia treatment rebounds with European recommendation (Pharmafile) (SCRIP-$)

US: Pharmaceuticals & Biotechnology

  • Ampio receives guidance from the FDA (Reuters)
  • Advice From Patients On A Study's Design Makes For Better Science (NPR)
  • FDA Confirms Rule on Ozone Depleting Substances Not Delayed by Regulatory Freeze (Federal Register)
  • One Immediate Impact of President Trump On The FDA (RxTrace)
  • Otsuka and Lundbeck revive Rexulti mask campaign as US uptake soars (Fierce)
  • Bristol-Myers Squibb Expands International Immuno-Oncology Network (II-ON) With Addition of Columbia University Medical Center and Peter MacCallum Cancer Centre (Press)
  • Studies Raise Questions About Why Young Mothers Are Being Prescribed Opioids (Forbes)
  • Pharma company Incyte is moving to the S&P 500, and the stock is rallying (CNBC)
  • Ohr Pharmaceutical Inc. shuts sustained release tech lab (InPharmaTechnologist)
  • FDA Cites Sovereign Pharmaceuticals for Building Failures, Unwritten Procedures (FDANews-$)
  • FDA's Meeting on Promotion - Can We Glimpse the Future? (Policy & Medicine)
  • Therapy focus – against the odds, cancer vaccines plough on (EP Vantage)
  • Pharma's Orphan Drug Activity, An Infographic (SCRIP-$)

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

  • Sangamo says receives rare pediatric disease designation from FDA for SB-318 (Reuters)
  • OncoSec Granted FDA Fast Track Designation for ImmunoPulse® IL-12 for the Treatment of Metastatic Melanoma Following Progression on Pembrolizumab or Nivolumab (Press)
  • Antares Pharma announces FDA acceptance of new drug application for Quickshot testosterone (Reuters)
  • Exelixis and Bristol-Myers Squibb Enter Clinical Collaboration for Late-Stage Combination Trial in First-Line Renal Cell Carcinoma (Press)
  • Sanofi And Regeneron To Present New Data On Dupixent® (Dupilumab) For Moderate-To-Severe Atopic Dermatitis At Upcoming Medical Congresses (Press)
  • TheraVida Announces Publication of Phase 2 Results for THVD-102 in Hyperhidrosis (Press)
  • Bracco Diagnostics Inc. Receives U.S. FDA Approval for VARIBAR® PUDDING (barium sulfate) oral paste for Fluoroscopy (Press)
  • ASIT biotech Will Publish the Results of the Phase 3 Clinical Trial with Its gp-ASIT+ Product Candidate for Treating Grass Pollen Rhinitis on 28 February, 2017 (Press)
  • RegeneRx Licensee Receives FDA Permission to Conduct a Phase 3 Trial of RGN-137 for Epidermolysis Bullosa in U.S. (Press)

US: Medical Devices

  • How to Exempt Your Firm from Cybersecurity Reporting Requirements (MDDI)
  • 7 disruptive innovations from medical device suppliers (MassDevice)
  • Check-Cap Is Ready for the Next Phase (MDDI)
  • Cagent Vascular Announces FDA 510(k) Clearance of Next Generation Device for Vessel Dilatation in Peripheral Artery Disease Interventions (Press)
  • Philips receives FDA 510(k) clearance to market its ElastQ imaging shear wave (Press)
  • AV Medical's Chameleon Receives Expanded Indication to Include Infusion of Diagnostic or Therapeutic Fluids (Press)

US: Assorted & Government

  • Hatch Announces Executive Session to Consider CMS Nominee (Senate Finance)
  • There Is No Secret Plan … And No "Secret Sauce" Either! (Alliance for a Stronger FDA)
  • AP: VA data show low rate of discipline for drug loss, theft (Washington Post)
  • Making a Moral Case for Regulation (Harvard Bill of Health)
  • Drug Debarment Actions: Beware (FDA Law Blog)
  • Pfizer announces pricing of $1.07B debt offering (Reuters) (Press)
  • Sequoia Fund wins dismissal of lawsuit over huge Valeant stake (Reuters)
  • Medtronic Hit With NJ Suit Over Shoddy Placement Of Device (Law360-$)
  • On Alternative Design, Take Two – Negligence (Drug & Device Law)
  • Overdoses skyrocket as Trump considers eliminating office of 'Drug Czar' (Modern Healthcare)
  • Second Wind For Importation (BioCentury)
  • Administrator of Miami-Area Home Health Agency Sentenced to 126 Months in Prison for Involvement in $2.5 Million Medicare Fraud Scheme (DoJ)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa; Public Workshop – 1 March 2017
  • European Medicines Agency / DIA signal management information day – 17 October 2017
  • Health Canada Scientific Advisory Panel on Opioid Use and Contraindications – 24 March 2017


  • Commission improves funding conditions for EU-funded researchers (EC)
  • Bayer CEO On Europe's 'Identity Crisis' (Pink Sheet-$)
  • Products containing cannabidiol (CBD) – overview (SwissMedic)
  • Overview of comments received on ' Guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches'  (EMA)
  • TxCell raises cash for first-in-man CAR-Treg cell therapy study (BioPharmaReporter)


  • Chugai's ALK Inhibitor "Alecensa®" Approved in Taiwan (Press)
  • Kyowa and Astellas enter into an Agreement for Exclusive Distribution and Promotion of Extended-Release Tablets of Quetiapine Fumarate in Japan (Press)


  • 'Govt must scale up production of active ingredients of drugs' (Economic Times)
  • India's pharma barons are reporting delays in digitizing labs (Economic Times)
  • 70% needy patients in India can't access dialysis: Study (Economic Times)
  • Sun Pharma arm SPARC gets I-T demand notice for Rs 32.87 (Economic Times)
  • Sun Pharma resets goals, to focus on quality (Economic Times)
  • Zydus subsidiary receives USFDA nod to market Tamiflu drug (Economic Times)
  • WHO supported govt report reveals growth of Indian medical device market at CAGR of 16% in 2020 (PharmaBiz)
  • Gujarat FDCA sets up cell for detection of price violations in drugs & devices (PharmaBiz)


  • Medicines Safety Update, Volume 8, Number 1, February 2017 (TGA)

Other International

General Health & Other Interesting Articles

  • Dangerous antibiotic-resistant infections on the rise for children in the US, study finds (Washington Post)
  • Potential dangers and dubious history of alternative medicine are often unknown to its consumers (MinnPost)

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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