Regulatory Recon: Inovio Cleared for First Human Trial of Zika Vaccine India to Release Revised Biosimilar Guidelines in July (20 June 2016)

Posted 20 June 2016 | By Michael Mezher 

Regulatory Recon: Inovio Cleared for First Human Trial of Zika Vaccine India to Release Revised Biosimilar Guidelines in July (20 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

  • Inovio Pharma gets green signal to test Zika vaccine in human trial (Reuters) (Press)
  • Getting new drugs to terminally ill — more to story than bashing FDA (Washington Post)
  • Supreme Court's ruling in patent case a blow to drug industry (STAT) (Reuters)
  • Make it easier to give life than to take life (The Hill)
  • White Oak deal stirs hopes and doubts for eastern Montgomery (Washington Post) (Pink Sheet-$)
  • Visium Insider-Trading Scheme Brought Down by Tip on Mismarking (Bloomberg)
  • Supreme Court asks the SG to Weigh in on Sandoz v. Amgen and Amgen v. Sandoz Petitions (Big Molecule Watch)
  • Something May Be Working At Theranos, But You Don't Know What It Is (Forbes)
  • A Market-Based Proposal For Controlling Drug Prices (Forbes)
  • Device Clinical Studies: FDA Outlines How to Evaluate and Report Age, Race & Ethnic Group Data (Focus)
  • Powerful Shot Against Believers In "No Safe Dose" Of Radiation (Forbes)

In Focus: International

  • Secret Deal Squeezes Mexico's Drug Sector (WSJ-$)
  • Interrogating research to protect public health (MHRA)
  • EMA Tries to Assuage Professors on Assumptions Linked to Adaptive Pathways Pilot (Focus)
  • Dutch Presidency Registers EU Regs With Council, Making 2016-End Adoption Tenable (Clinica-$)
  • GlaxoSmithKline says lung drug meets late-stage study goals (Reuters)
  • EC Seeks to Update Scientific Opinions on Non-Human Primate Research, Safety of Breast Implants (Focus)
  • Indian Gov't to Release Revised Biosimilar Guidelines in July (Economic Times)
  • Roche announces availability of LightMix modular Zika Virus Assay (Reuters)
  • Cat allergy flop sinks high-profile UK biotech Circassia (Reuters) (Fierce)
  • Global drugmakers call on Russian government to ease current conditions for clinical trials (PharmaLetter-$)
  • Novartis aims to nearly triple biosimilar drugs on market by 2020 (Reuters) (PharmaTImes)

US: Pharmaceuticals & Biotechnology

  • Scientists discover mechanism of thalidomide (MNT)
  • Cell Medica, Baylor partner on next-gen CAR-T cancer therapies (Fierce)
  • BioMarin Pharmaceuticals Jumps on Takeover Talk (The Street 1, 2)
  • Merck's Edge on Bristol-Myers Won't Last (Bloomberg)
  • Is Valeant Stock a Safe Short? (The Street)
  • Cancer doctors leading campaign to boost use of HPV vaccine (Washington Post)
  • Why Novartis' new heart med could reverse slow start (BioPharmaDive)
  • GDUFA II: FDA, Industry Reach Tentative 'Alignment' On ANDA Review Issues (Pink Sheet-$)
  • FDA mulling Emergent Biosolutions' request to make anthrax vaccine at second plant (BioPharmaReporter)
  • FDA's Califf On Real World Evidence: 'Use It For The Right Purposes' (Pink Sheet-$)
  • Let's Praise FDA for What is Going Well! (Alliance for a Stronger FDA)
  • FDA Ushers In Era of New Drug Manufacturing Technologies (Pink Sheet-$)
  • FDA Publishes Final "Interim Policy" for Both Sections 503A and 503B Compounding from Bulk Substances: Section 503B Bulks (FDA Law Blog)
  • FDA Prescription Drug User Fee Program Could Go OIG Scrutiny (Tan Sheet-$)
  • REMS Standardization Could Help Opioid Education Efforts (Pink Sheet-$) (RPM Report-$)
  • In Silico Drug Design: Finally Ready For Prime Time? (In Vivo-$)
  • Teva sells products to Sagent Pharma to fulfil Allergan Generics deal conditions (PharmaLetter-$)
  • Amgen appoints Esteban Santos as executive VP of operations (Pharmafile)
  • Research may point to new ways to deliver drugs into bacteria (MNT)
  • Roche Builds Hematology Pipeline Beyond B-Cell Disease (Pink Sheet-$)
  • FDA Accentuates Venclexta Superiority To Imbruvica (Pink Sheet-$)

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

  • A Novel, Targeted Drug Yields Promising Results In Stomach And Esophageal Cancer (Forbes) (Abstract)
  • AmoyDx ROS1 Diagnostics Test Contributed to a Phase 2 Clinical Study of Crizotinib in Lung Cancer (Press)
  • Seventeen Days after Receiving FDA Approval, Braeburn Pharmaceuticals Announces First Patients Have Received Probuphine® (buprenorphine) Implant (Press)
  • Kite Pharma Expands Development of T-Cell Receptor (TCR) Therapies Targeting HPV-Associated Cancers in Partnership with the National Cancer Institute (NCI) (Press)
  • Epizyme Touts Early Data From Key Trial Of Blood Cancer Drug (Xconomy) (Press)
  • Gilead Presents Preliminary Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV (Press)
  • Sangamo BioSciences Announces FDA Clearance of Investigational New Drug Application for ZFN-Mediated Genome Editing Treatment of MPS II (Press)
  • Savolitinib Global Phase II Trial Initiated in EGFR Mutant Non-Small Cell Lung Cancer (Press)
  • Ophthotech Completes Patient Recruitment in Phase 3 Trial of Fovista Anti-PDGF Therapy in Combination with Eylea or Avastin in Wet Age-Related Macular Degeneration (Press)
  • Catabasis Pharmaceuticals to Present Edasalonexent (CAT-1004), an Oral Agent Targeting NF-kB: MoveDMDSM Trial in Duchenne Muscular Dystrophy (DMD) at the 2016 PPMD Annual Connect Conference (Press)

US: Medical Devices

  • New Guidance Details FDA's Benefit-Risk Framework for Device Compliance, Enforcement Decisions (Focus)
  • Device for irregular heartbeat may be more cost-effective than medication (MNT)
  • Medical Devices: Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System (FDA)
  • Cybersecurity Experts Expand Focus on Devices, Defend FDA's Efforts (Gray Sheet-$)
  • FDA OKs epilepsy trial for MDT's Visualase MRI-guided laser (MassDevice)
  • Q&A: Digital Rights Group Worries Device Firms Could Abuse Digital Copyright Act (Gray Sheet-$)
  • Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format; Republication (FDA)
  • New Clinical Study Will Evaluate MRI-Guided Laser Ablation for a Common Form of Epilepsy (Press)
  • Roche launches the new cobas e 801 module, helping hospitals meet the demand for increased diagnostic testing (Press)

US: Assorted & Government

  • Former Warner Chilcott Executive Acquitted of Kickbacks Charge (WSJ-$)
  • FedEx Beats Drug Shipping Case As Charges Dropped Midtrial (Law360-$) (WSJ-$)
  • Employers Cut Down on Wellness Benefits (WSJ-$)
  • Antitrust Regulators Concerned About an Anthem-Cigna Merger (WSJ-$)
  • Federal Program That Helps Patients Navigate Medicare May Be Cut (NPR)
  • Struggling for Profit Selling Health Insurance in State Marketplaces (NYTimes)
  • Medicare Drug Payment Changes Should Be 'Physician-Driven' – Former Official Blum (Pink Sheet-$)
  • Thoughtful CREATES Act May Help Speed Generic Drug Approvals (Harvard Bill of Health)
  • Despite Overdose Epidemic, Georgia Caps The Number Of Opioid Treatment Clinics (KHN)

Upcoming Meetings & Events


  • Merck & Co to launch production of four drugs in Russia (PharmaLetter-$)
  • European generics group demands action on EU calls for greater pharma competition (PharmaLetter-$)
  • State of Health in the EU: Commission pools expertise to support health policies in EU countries (European Commission) (EFPIA)
  • Pharmaceutical companies drive transparency and underline industry investment in European Healthcare (EFPIA)
  • New Left Atrial Appendage Closure Device From China Gets EU Clearance (medGadget)
  • Medicines Evaluation Board: Public consultation informed consent application procedure (CBG MEB)
  • SMC rejects Amgen's Repatha over lack of outcomes data (PMLive)
  • How To Cope With The New EU Scrutiny System for IVDs (SCRIP-$)
  • Compromise Agreement on IVDs is a Solid Step in the Right Direction to enable Personalised Medicine (EFPIA)
  • Industry Welcomes the European Commission Workshop on the Uptake of Biosimilar Medicines (EFPIA)
  • Consultation launches the next phase of additional safety in the UK medicines supply and distribution (ABPI)
  • 'Skyrocketing' Drug Prices, Access And Availability In Line For EU Scrutiny (SCRIP-$)
  • EMA recruits patient voices for its management board (PMLive)


  • INTERVIEW: Bayer's Zieler On Building An Asian Alliance Trove (PharmasiaNews-$)
  • AbbVie, Eisai, and EA Pharma Obtain Additional Approval for New Dosing Regimen of Fully Human Anti-TNF-α Monoclonal Antibody Humira® in Patients with Crohn's Disease (Press)
  • What To Expect From China's Drug Pricing Investigation (Law360-$)
  • Accessing Turkey's Medical Device Market (MDDI)
  • What Slowdown? Chinese Maker Splashing Big On Promotion To Bolster Prices, Growth (PharmasiaNews-$)


  • Indian drugmakers gearing up for slice of global biosimilars market (PharmaLetter-$)
  • Medical device sector to have separate rulebook under D&C Act (Pharmabiz)
  • Cipla in pact with Russian firm for HIV, Hepatitis C drugs (Economic Times)
  • Zydus Healthcare buys 2 ANDAs from Teva (Economic Times)
  • Centre to notify revised Sch M III for medical devices by June end (Pharmabiz)
  • Aurobindo Pharma launches new website, rebranding initiative (DSN)
  • Karnataka govt set to introduce an expired drug disposal policy, draft getting ready (Pharmabiz)
  • Indian Pharmacovigilance Day 2016 to be observed in Mumbai on July 29 (Pharmabiz)


  • Deadlock Over Canada's Law Regulating Physician-Assisted Suicide Broken (WSJ-$)
  • Valeant plots significant investment in Canadian operations (Pharmafile)

Other International

  • Congo declares yellow fever epidemic, 1,000 suspected cases (Reuters) (Reuters)


  • Number of Zika-Positive Puerto Ricans Surprises Health Officials (NYTimes) (Reuters)
  • Hologic, Grifols say FDA allows Zika diagnostic test under IND (Reuters) (Press)
  • FDA Grants Emergency Authorization for Hologic Zika Test (WSJ-$) (Reuters) (MassDevice) (Press)
  • Why women and babies in the South and Southwest are at risk from Zika (Washington Post)
  • Potential Drug Target Identified for Zika, Similar Viruses (ICT)
  • Exclusive: In Zika-struck Puerto Rico, trouble delivering donated contraceptives (Reuters)

General Health& Other Interesting Articles

  • Beth Israel researchers say AI can lower error rate in breast cancer diagnosis (Boston Biz Journal)
  • Doctors blame many factors for futile care, themselves included (Reuters)
  • Science Magazine Prize Has Ties to Researcher Who Disgraced Its Pages (MIT Technology Review)

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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