Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Roche Bladder Cancer Immunotherapy; Theranos Withdraws Two Years of E

Regulatory Recon: FDA Approves Roche Bladder Cancer Immunotherapy Theranos Withdraws Two Years of Edison Test Results (19 May 2016)

Posted 19 May 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves Roche Bladder Cancer Immunotherapy Theranos Withdraws Two Years of Edison Test Results (19 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

  • FDA approves Roche's immunotherapy for bladder cancer (Reuters) (NYTimes) (FDA) (Press)
  • Theranos Voids Two Years of Edison Blood-Test Results (WSJ-$)
  • Heron and the Never-Ending FDA Drug Review (The Street)
  • Why is Congress trying to weaken the FDA's oversight of dangerous drugs? (LA Times)
  • Specialty Drugs Added $87 More To Each Enrollee's Tab, Blue Cross Says (Forbes)
  • Precision medicine approach to cancer improves on older methods: study (Reuters) (ASCO)
  • B. Braun Admits Tainted Syringe Sales In $7.8M Settlement (Law360-$) (DoJ)
  • The Real Reason Big Pharma Wants to Help Pay for Your Prescription (Bloomberg)
  • FDA: Canagliflozin Linked to Amputations in Post-Marketing Trial (Medpage) (FDA)
  • Essential Medicines in the United States — Why Access Is Diminishing (NEJM)
  • Actions by Congress on Opioids Haven't Included Limiting Them (NYTimes)
  • Amgen Finds Anti-Heart Attack Gene (MIT Technology Review) (WSJ-$) (CardioBrief) (Reuters)
  • Florida Town Wary of Fighting Zika With Biotech Mosquito (WSJ-$)
  • House approves $622 million to combat Zika virus (Reuters)

In Focus: International

  • NICE proposes abbreviated appraisal pathway (BioCentury)
  • U.N.'s rights chief urges firms to follow Pfizer's lead on death penalty (Reuters)
  • How drug whistle-blowers in India have to fight a long battle (Economic Times)
  • Dispute with Swiss drugmaker has Colombian officials worried about U.S. peace funding (Washington Post)
  • U.K. Proposal to Fight Drug-Resistant Bacteria Has Some Doubters (WSJ-$) (Reuters)

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

US: Pharmaceuticals & Biotechnology

  • Biopharma CEOs shifting focus (BioPharma-Reporter)
  • Spark Surges After Gene Therapy Helps 3 Hemophilia Patients (Bloomberg)
  • Aegerion Juxtapid Settlement Shows REMS Have Teeth: Alternate Route To Enforce Off-Label? (RPM Report-$)
  • MicrobeNet: A tool to detect rare germs (CDC)
  • Cigna plans to cut opioid use among U.S. customers by 25 pct (Reuters)
  • Physicians React to New FDA Warning on Cipro, Similar Drugs (Medpage)
  • RLD Designation Citizen Petitions: One Item on Our GDUFA II Wish List (FDA Law Blog)
  • The Generic Drug Market (NYTimes)
  • Shkreli's former company beats Impax demand to block drug sales (Reuters)
  • How Sex Hormones Might Treat Certain Diseases (WSJ-$)
  • Drug Commonly Used For Pain And Anxiety May Be Linked To Major Birth Defects (Forbes)
  • Ziarco gears up for Series C, PhIIb to advance atopic dermatitis drug (Fierce)
  • Health Data Is A Public Good, But How Do We Make It A Utility For Consumers? (Forbes)
  • FDA Hits Puerto Rican Drugmaker with 13-observation Form 483 (FDANews-$)
  • FDA Slaps Massachusetts Drugmaker with Form 483 (FDANews-$)
  • Posted for Public Comment until Wednesday, June 1, 2016: Sequential Analysis of Gardasil 9 Safety Surveillance Plan (Mini-Sentinel)
  • Islexa to grow islets in lab to make transplants available to more Type I diabetes patients (BioPharma-Reporter)
  • Drug price increases lower so far in 2016: Analysts (Fierce)
  • Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance (FDA)

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

  • New KEYTRUDA (pembrolizumab) Data from KEYNOTE-006 and KEYNOTE-001 in Advanced Melanoma, Including Updated Survival Data, To Be Presented at 2016 ASCO Annual Meeting (WSJ-$) (Press)
  • Merck, Bristol drugs show longer survival for deadly cancers (Reuters)
  • Anti-tumor activity of PEGylated human IL-10 (AM0010) in patients with pancreatic or colorectal cancer. (Abstract)
  • Clinical activity and safety of pegylated human IL-10 (AM0010) in combination with anti-PD1. (Abstract)
  • A multi-center, randomized, double-blind phase II study comparing temozolomide (TMZ) plus either veliparib (ABT-888), a PARP inhibitor, or placebo as 2nd or 3rd-line therapy for patients (Pts) with relapsed small cell lung cancers (SCLCs). (Abstract)
  • Efficacy analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable stage IIIB-IV melanoma. (Abstract)
  • RUCAPANC: An open-label, phase 2 trial of the PARP inhibitor rucaparib in patients (pts) with pancreatic cancer (PC) and a known deleterious germline or somatic BRCA mutation. (Abstract)
  • Clinical activity and safety of cobimetinib (cobi) and atezolizumab in colorectal cancer (CRC). (Abstract)
  • A first in human phase I study of receptor tyrosine kinase (RTK) inhibitor MGCD516 in patients with advanced solid tumors. (Abstract)
  • A phase 1 dose escalation study of RXDX-105, an oral RET and BRAF inhibitor, in patients with advanced solid tumors. (Abstract)
  • Phase I study of the PD-L1 inhibitor, durvalumab (MEDI4736; D) in combination with a PARP inhibitor, olaparib (O) or a VEGFR inhibitor, cediranib (C) in women's cancers (NCT02484404). (Abstract)
  • A phase Ib dose escalation study of the OX40 agonist MOXR0916 and the PD-L1 inhibitor atezolizumab in patients with advanced solid tumors (Abstraact)
  • Merck KGaA, Darmstadt, Germany, and Pfizer to Present Avelumab Data in Seven Different Cancers at ASCO Annual Meeting (Press) (Reuters)
  • Two-Year Overall Survival Data from Two Pivotal Opdivo (nivolumab) Trials Demonstrate Sustained Benefit In Patients with Advanced Non-Small Cell Lung Cancer (Press)
  • Phase III study of Roche's Alecensa (alectinib) showed superior efficacy versus crizotinib in Japanese people with a specific type of lung cancer (Press)
  • Pfizer cancer drug shows promise in combo with Merck's Keytruda (Reuters)
  • In Search For Cures, Scientists Create Embryos That Are Both Animal And Human (NPR)
  • Pfizer's Ibrance delays breast cancer progression: study (Reuters)
  • FDA grants priority review status to Arzerra combination (PharmaLetter-$)
  • Tonix shares soar as PTSD drug shows promise in study (Reuters)
  • Concert Pharmaceuticals Initiates Phase 1 Trial of CTP-543 as a New Treatment for Alopecia Areata (Press)

US: Medical Devices

  • Medtronic Nabs Smith & Nephew's Gynecology Business (Gray Sheet-$)
  • Siemens Makes First Molecular Dx Buy In Nine Years (Gray Sheet-$)
  • What's Behind the Decline in Device Recalls? (MDDI)
  • Evidence Often Weak for Ob/Gyn Device Approvals (Medpage)
  • Roche receives FDA Approval for novel PD-L1 biomarker assay (Press)
  • Presbia touts 6-month data for Flexivue microlens (MassDevice)
  • Edwards touts multi-trial heart valve data (MassDevice)
  • What Medtronic's Agreement with Mazor Robotics Means (MDDI)

US: Assorted & Government

  • Supplement Pre-market Approval Resurfaces From Blumenthal, Durbin (Pink Sheet-$)
  • CMS Proposed Patient Relationship Categories for MACRA (Policy and Medicine)
  • Armed With Patent, Foundation Med Sues Diagnostic Rival Guardant (Exome)
  • US Urges High Court To Take Patent Case Claiming Overseas Inducement (Gray Sheet-$)

Upcoming Meetings & Events


  • EuroPCR 2016: Study casts doubt on long-term TAVR durability (MassDevice)
  • Lung cancer breathalyzer in UK clinical trials (Reuters)
  • New findings on the risks of the antiepileptic agent pregabalin in pregnancy (SwissMedic)
  • Bayer Confirms Preliminary Discussion Regarding Acquisition of Monsanto (Press)
  • Minutes of the Stakeholder Engagement Meeting (StEM) (MHRA)
  • ABPI, EFPIA and IFPMA issue joint statement following publication of the final report by the Review on AMR (ABPI)
  • SMEs Are Keen Users Of EMA Regulatory Support, But Say They Want More (SCRIP-$)


  • Chinese Pharma firm Fosun bids to buy Gland Pharma: Reports (BioSpectrum)
  • China and India Burdened by Untreated Mental Disorders (NYTimes)


  • Maha FDA detects cases of professional misconduct during surprise checks at drug retail stores (PharmaBiz)
  • New Indian IPR Policy to establish an ecosystem that is conducive to foster innovation and creativity: Patent expert (PharmaBiz)
  • Glenmark gets final nod by USFDA to sell Rufinamide drug (Economic Times)


  • Snapshots of Life: Portrait of Zika Virus (NIH)
  • WHO Zika Situation Report (WHO)
  • Kill All the Mosquitoes?! (Smithsonian)

General Health & Other Interesting Articles

  • HIV Rates Among Gay Men Are Higher in South, Study Finds (NYTimes)
  • Drop in birth defects slowed after folic acid fortification (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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