Regulatory Focus™ > News Articles > Regulatory Recon: Top Research Institutes Fail to Report Clinical Trial Results On Time (14 December

Regulatory Recon: Top Research Institutes Fail to Report Clinical Trial Results On Time (14 December 2015)

Posted 14 December 2015 | By Michael Mezher 

Regulatory Recon: Top Research Institutes Fail to Report Clinical Trial Results On Time (14 December 2015)

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

  • Drug approvals top 2014 high but R&D returns still struggle (Reuters)
  • STAT Investigation Finds Top Research Institutions Fail to Report Study Results (STAT)
  • Senator Cruz's RESULT Act Unlikely to Achieve Results (Harvard Bill of Health) (Focus)
  • FDA approves new oral therapy to treat ALK-positive lung cancer (FDA) (Pink Sheet-$) (Reuters) (Press)
  • Nearing its Sunset, Pediatric Voucher Program Gains Momentum (FDA Law Blog)
  • Are Device Manufacturers Playing Bait-And-Switch With The FDA? (Forbes)

In Focus: International

  • Bulk drugs from China floods Indian market, leaves indigenous products in dire straits (Economic Times)
  • Brazilian Lawmakers Limit ANVISA Medical Device Fee Increases (Emergo)
  • Indian Pharma industry looks at avenues beyond generics (PharmaLetter-$)
  • Natco settles patent suit with Gilead, others over Tamiflu (Economic Times)
  • NICE says 'yes' to heart failure drug sacubitril valsartan (EPR)

US: Pharmaceuticals and Biotechnology

  • Atara Biotherapeutics stops development of kidney drug (Reuters)
  • You Can Buy Insulin Without A Prescription, But Should You? (NPR)
  • IND Sponsors Should Not Contact FDA Reviewers Directly, Draft Guidance Asserts (Pink Sheet-$) (Focus)
  • NIH Seeking Information on Rollout of Precision Medicine Initiative (GenomeWeb)
  • New York Pharma Forum explores 'The Reinvention of Pharma' (DSN)
  • Merck Silence On OTC Singulair Speaks Volumes On Switch Outlook (Pink Sheet-$)
  • Cefotan Inj Regains Approval After Discontinuation (MPR)
  • Digitizing The Pill: Proteus Pioneer Explains How  (SCRIP-$)

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

  • Sangamo reports promising preliminary trial data on HIV drug (Reuters)
  • Encouraging fibromyalgia study results now available at (MNT)
  • FDA puts Avita Medical's ReCell burn treatment on the fast track (MassDevice)
  • BTG gets triple dose of good news on new products (Reuters)
  • FDA grants Roche's Alecensa (alectinib) accelerated approval for people with a specific type of lung cancer (Press)
  • Initiation of first multinational study to evaluate safety of OFEV (nintedanib) with add-on of pirfenidone in patients with IPF (Press)
  • Wellstat Announces FDA Approval of VISTOGARD (Uridine Triacetate), the First Antidote to Treat Overdoses and Early-Onset Severe Toxicities Due to 5-Fluorouracil (5-FU) and Capecitabine Chemotherapies (Press)
  • NephroGenex Announces FDA Clearance of IND Application for Clinical Study of Intravenous Pyridorin in the Treatment of Acute Kidney Injury (Press)
  • Ocular Therapeutix Announces Encouraging Top-Line Results from Exploratory Phase 2 Trial for DEXTENZA™ in Patients with Inflammatory Dry Eye Disease (Press)
  • Antares Pharma Announces FDA Approval of Sumatriptan Injection USP (Press)
  • BTG Announces FDA Clearance for LC Bead LUMI, the First Commercially Available Radiopaque Embolic Bead in the US (Press)
  • X4 Pharmaceuticals Announces FDA Allowance of X4P-001 IND for Phase 1b/2a Study of in Refractory Clear Cell Renal Cell Carcinoma (Press)
  • Bristol-Myers Squibb and UCLA Enter into a Collaboration Agreement as Part of US Immuno-Oncology Rare Population Malignancy Research Program (Press)
  • Seres Therapeutics Announces Initiation of a Phase 1b Clinical Trial of SER-287 in Mild-to-Moderate Ulcerative Colitis (Press)
  • AcelRx Pharmaceuticals Conducts Pre-NDA Meeting with U.S. Food and Drug Administration for ARX-04 (Press)
  • Zogenix Announces FDA Acceptance of Investigational New Drug Application for ZX008 Phase 3 Clinical Trial in Dravet Syndrome (Press)
  • ALS: Treeway announces positive data from two separate Phase I TW001 clinical trials (MNT)
  • Unum Therapeutics Announces Recombinant DNA Advisory Committee's (RAC) Unanimous Approval of Phase 1 Study Protocol to Evaluate ACTR Cell Therapy in Non-Hodgkin Lymphoma (Press)

US: Medical Devices

  • Novilase laser treatment shows promise for early-stage breast cancer instead of lumpectomy (MedCityNews)
  • Two More Companies Questioned by FDA Over DTC Genetic (Focus)
  • Class 1 Device Recall Perseus A500 Anesthesia Workstation (FDA)
  • FDA OKs StimRelieve chronic migraine trial (MassDevice)
  • International researchers find quite disparate results in genomic cancer analysis (FierceMedicalDevices) (Nature)
  • Boston Scientific touts improved back pain relief in Spectra SCS trial (MassDevice)

US: Assorted and Government

  • Florida Federal Court Rules that Apotex Must Give Amgen Notice Upon Biosimilar Licensure (National Law Review) (SCRIP-$)
  • Celgene, Astellas Sue Teva Over Cancer Drug Patents (Law360-$)
  • Boston Scientific recalls select Acuity guide catheters (MassDevice)
  • J&J Found Liable In 3rd Risperdal Breast-Growth Case (Law360-$)
  • Lilly's Lung-Cancer Drug Portrazza to Cost $11,430 a Month (WSJ-$)
  • Texan Says 3M Device Led to Infection, Amputation (Law360-$)
  • Valeant hires attorney, crisis management firm as US scrutiny mounts (Reuters)
  • Martin Shkreli's Latest Plan to Sharply Raise Drug Price Prompts Outcry (NYTimes)
  • UnitedHealth Selects Praluent as Preferred New Cholesterol Drug (WSJ-$)
  • Why The Wall Street Journal's US Drug Price Comparison Misses The Mark (Life Sciences Leader)
  • Kaiser bans antimicrobials in the name of infection control (MedCityNews)
  • Dems fear thin end of wedge in proposed medical device tax delay (MassDevice)

Upcoming Meetings and Events


  • NHS pairs up with dating app Tinder to promote organ donation (OnMedica)
  • How England Might Just Solve The Cancer Drugs Problem (SCRIP-$)
  • Advaxis Receives Orphan Drug Designation in the European Union for Axalimogene Filolisbac for the Treatment of Anal Cancer (Press)
  • NICE changes decision on AstraZeneca's olaparib (EPR)


  • Product Liability Coming to India (24 Insight)
  • Hetero receives drug controller approval for generic Daclatasvir (Economic Times)
  • Natco Pharma gets DCGI nod to sell hepatitis C treatment drug (Economic Times)
  • Japanese company loses patent bid for diabetes drug (Economic Times)
  • India lands $500M for vaccination program from Gavi alliance (FiercePharmaAsia)



  • Poxel Announces Imeglimin Phase 2b Initiation in Japan (Press)



  • Summary of fees and charges from 1 January 2016 (TGA)
  • Reckitt Benckiser misled consumers on Nurofen painkillers: Australian court (Reuters)

Other International

  • Cancer rates on the rise in lower-income countries (Economic Times) (Forbes) (Study)
  • Liberia's last Ebola contacts finish quarantine (Reuters)
  • Latin America Ploughs Ahead With Joint Pricing Strategy (SCRIP-$)

General Health and Other Interesting Articles

  • Jury still out on routine skin cancer screening (Reuters)
  • Engineering the Better Baby (Project Syndicate)
  • Scientists Identify Effective and Novel Mechanisms to Block Chikungunya Virus (ICT)
  • UCLA study finds advanced thyroid cancer rate in some California counties is well above national average (MNT)

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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