Regulatory Recon: House and Senate Weigh Zika Funding Bills India Updates Patent Policy for Drugs and Devices (17 May 2016)

Posted 17 May 2016 | By Michael Mezher 

Regulatory Recon: House and Senate Weigh Zika Funding Bills India Updates Patent Policy for Drugs and Devices (17 May 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

  • Lapses in infection control found at two Los Angeles hospitals (Modern Healthcare)
  • Dogs Test Drug Aimed at Humans' Biggest Killer: Age (NYTimes)
  • Hashtag Prescription: The hidden cost of crowd-sourcing a cure (Harpers)
  • Senate To Vote On Zika Funding: Ten Things You Should Know (Forbes) (Senate)
  • U.S. House to weigh $622.1 million in new Zika funding (Reuters) (House PR)
  • Why Obama Is Throwing Money at the Microbiome (MIT Technology Review)
  • Expedited Compassionate Use for Investigational Drugs Coming Soon, FDA Says (Focus)
  • EHR Data in Clinical Trials: New FDA Draft Guidance (Focus)
  • Roche, Genentech sued for allegedly overfilling Herceptin vials (Fierce)
  • Was Harvard meeting on synthesizing human genome too "secretive"? (Genetic Literacy Project)
  • How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives (Focus)
  • Examining Congressional comments regarding Medicare's Part B pilot proposal (Drug Abacus) (Report)
  • Bill to kill CMS drug demo gets congressional hearing (Politico)
  • House Challenge to Health Law Could Raise Premiums, Administration Says (NYTimes)
  • What '60 Minutes' Still Isn't Saying About The 'Miracle' Glioblastoma Drug (Forbes)

In Focus: International

  • New European Regulations Could Be Made Public In August (Gray Sheet-$)
  • Faced with shortages, Egypt lifts cheap drug prices by 20 percent (Reuters)
  • B-MS will not seek UK reimbursement for Empliciti (PharmaLetter-$)
  • GSK Vaccines: Injecting Visibility (In Vivo-$)
  • Canada Genetic testing bill perpetuates myths and fears (Globe and Mail)
  • India updates patent policies for medical devices and drugs (MassDevice) (SCRIP-$)
  • Actelion's Uptravi receives EC marketing nod for PAH (PharmaLetter-$)
  • EU membership accelerates medical innovation and protects patients (The Guardian)
  • Malaysian Low-Risk Devices Exempted From Conformity Assessment Process, But Registration Mandatory (Clinica-$)

Drug Approval - Speed your time to market with FDA's Expedited Programs

US: Pharmaceuticals & Biotechnology

  • Back to Basics: 505(b)(2) FAQs Part 1 (The 505(b)(2) Blog)
  • In Pursuit Of An HIV Vaccine And The AIDS-Free Generation (Forbes)
  • Mirror-image enzyme copies looking-glass DNA (Nature)
  • Magic mushroom ingredient may ease severe depression, study suggests (Reuters)
  • Proton-Beam Therapy for Cancer Gets Renewed Attention (WSJ-$)
  • T. Rowe Price Sells 90% Of Its Big Stake In Valeant Pharmaceuticals (Forbes)
  • Valeant Pharmaceuticals Hands Out Million Dollar Bonuses As Compensation For 'Challenging Times' (Forbes)
  • Errol Morris: 'Demon in the Freezer' (NYTimes)
  • FDA/Industry Track and Trace Pilot Planning Sheds Further Light on Complex Web of DSCSA Implementation Challenges (IPQ)
  • Friedreich's Ataxia Research Alliance on the importance of investing in a natural history study (Faster Cures)
  • Rare cancers may masquerade as ADHD in children, NIH researchers suggest (NIH)
  • IBM Macromolecule Kills Ebola, Herpes, Dengue, Influenza in Tests (DD&D)
  • Biogen signs licensing deal for Penn gene therapy technology (Boston Business Journal) (BioCentury)
  • ​Sanofi Genzyme doubles down on recent success in multiple sclerosis (Boston Business Journal)
  • Do Opioid-Related Overdoses Place Additional Burdens On ICUs? (Forbes)
  • Choice Of Regulatory Pathway Is Key Inflection Point In US Drug Reviews (SCRIP-$)

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

  • AstraZeneca's asthma biologic hits PhIII target, but still behind rivals (Reuters )(Fierce) (Press)
  • Trevena's TRV027 misses heart failure endpoint (BioCentury)
  • Aduro pancreatic cancer combo fails Phase IIb test (BioCentury) (Reuters)
  • Takeda and Lundbeck Present Vortioxetine Data at the American Psychiatric Association (APA) 2016 Annual Meeting (Takeda)
  • Ziarco planning atopic dermatitis Phase IIb (BioCentury)
  • Increased physical activity associated with lower risk of 13 types of cancer (NIH)
  • AXIM Biotech To Begin Human Clinical Trials on CBG For Psoriasis (Forbes)
  • Novo Nordisk files for US approval nonacog beta pegol (PharmaLetter-$)
  • Duke's Poliovirus Therapy Wins "Breakthrough" Status (DD&D)
  • Afferent Pharmaceuticals Presents Updated Positive Results with AF-219 from Phase 2B Chronic Cough Study at the 2016 American Thoracic Society (ATS) International Conference (Press)
  • Humacyte claims phase II success and heads into phase III (EP Vantage)
  • GNT Pharma Receives IND Approval for Phase II Clinical Trial for Stroke Patients with Endovascular Treatment with First in Class Multi-Target Neuroprotection Drug Neu2000 (Press)
  • Allergan Announces Positive Pivotal Trial Results for Oculeve Intranasal Tear Neurostimulator (Press)
  • Trevena flubs heart failure trial, will focus on 'breakthrough' pain drug (Fierce) (Press)
  • PBM Capital Acquires Phase 3 Platelet Drug for Chronic Liver Disease Patients (Press)

US: Medical Devices

  • FDA '522' Guidance: 15-Month Deadline To Comply With Postmarket Order (Gray Sheet-$)
  • Portable System Uses Light to Diagnose Bacterial Infections Faster (NIH)
  • US FDA Issues Technical Guidance for Medical Devices using 3-D Printing (Emergo)
  • GE Healthcare CEO Sheds Dealmaking Image to Seek Growth Within (Bloomberg)
  • Class 1 Device Recall NeuroBiate System SideFireTM Select 2.2 mm Directional Laser Probe (FDA)
  • Connected Healthcare Systems Are a Cybersecurity Nightmare (MDDI)
  • Software Poses Unique Challenges For Both Device Firms And FDA; Recurrent Troubles With Software Testing, Design Control, Documentation A Concern (Gray Sheet-$)
  • BioVentrix touts 1st-in-human procedure for Revivent device (MassDevice)
  • Luminex pays $83m for Nanosphere (MassDevice)

US: Assorted & Government

  • New York Appellate Division Rejects Parallel Violation Claims Based on Off-Label Promotion (Drug and Device Law)
  • Is Your Food 'Natural'? F.D.A. to Weigh In (NYTimes)
  • Insurers Quitting Health Law Exchanges May Still Sell Plans To Individuals (KHN)
  • Final EEOC Rule Sets Limits For Financial Incentives On Wellness Programs (KHN) (Reuters)
  • Veterans can't catch a break as "solution" to delayed medical appointments causes new set of problems (MedCityNews)
  • Amgen sues Sandoz over Neulasta biosimilar (BioCentury)
  • How Congress And The VA Left Many Veterans Without A 'Choice' (NPR)
  • What to Expect When You're Expecting at Least Another Year of Contraception Litigation (Harvard Bill of Health)
  • Yates' Update on Yates Memo (FDA Law Blog)
  • Plaintiffs Argue Against Quest, Athena's Motion to Dismiss Negligence Case (GenomeWeb)
  • Guest Post − Implied Certification: An Eradicated Pest or Here to Stay? (Drug and Device Law)

Upcoming Meetings & Events


  • Medtech Advised To 'Pay Close Attention' To China's New Mandatory Standards (SCRIP-$)
  • Chugai gets positive outcome from Actemra Subcutaneous Injection trials (BioSpectrum)


  • Leading drug container supplier opens Indian station (PharmaLetter-$)
  • Health ministry invites views on easing the drug regulation process (Economic Times)
  • US drugmaker Bristol Myers Squibb out of Biocon's oral insulin project (Economic Times)
  • Indian Patent Office's Patent to Gilead's Sovaldi Challenged at Delhi High Court (National Law Review)
  • India's IPR Policy Protects Its Generic Pharma Sector At All Costs (24 Insight)
  • Arrow Enters Supply Deal With Pharmacy Alliance (24 Insight)
  • Generic Approval Of Zomig Adds More Competition To Market (24 Insight)
  • Nostrum Scores USFDA Approval For Generic Dapsone (24 Insight)
  • Aurobindo Lands USFDA Approval For Generic Marcaine (24 Insight)
  • Aurobindo Pharma gets USFDA nod for opioid analgesic tablets (Economic Times)
  • Strides Shasun plans to divest British subsidiary for Rs 240 crore (Economic Times)


  • Staar Surgical wins Health Canada nod as shares hit 52-week low (MassDevice)
  • Question and Answer Document: Regulatory Activities in eCTD Format (Health Canada)
  • Regulatory Decision Summary – JARDIANCE (Health Canada)
  • Regulatory decision summary: FORXIGA (Health Canada)


  • Updating medicine ingredient names - information for sponsors (TGA)
  • HeartWare external controller (TGA)
  • Therapeutic goods determinations (TGA)
  • Regeneus clears procedures to initiate Progenza trial for osteoarthritis treatment (BioSpectrum)


  • Australia's Starpharma develops Zika-proof condoms for athletes ahead of Rio Olympics (BioSpectrum)
  • FDA Releases Fact Sheet for Interpreting RealStar Zika Diagnostic Results (FDA)

Other International

  • New WHO guidelines to improve care for millions living with female genital mutilation (WHO)

General Health & Other Interesting Articles

  • Paint-On GMOs Could Create Cattle, Dogs with Custom Fur (MIT Technology Review)
  • NIH-funded study reveals how differences in male and female brains emerge (NIH)
  • Silent heart attacks strike more men but kill more women (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

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