Regulatory Recon: Merck, Roche Drugs Pressure BMS' Lead in Lung Cancer Pfizer & Exelixis Square Off in Kidney Cancer (10 October 2016)

Posted 10 October 2016 | By Michael Mezher 

Regulatory Recon: Merck, Roche Drugs Pressure BMS' Lead in Lung Cancer Pfizer & Exelixis Square Off in Kidney Cancer (10 October 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

  • Keytruda vs. Opdivo: No Contest (In The Pipeline) (Forbes) (Endpoints) (WSJ) (NEJM) (Press)
  • Roche's lung cancer success spells competition for BMS' Opdivo (Press) (Pharmafile) (Bloomberg) (Fierce 1, 2)
  • Bristol drug flop opens big cancer opportunity: AstraZeneca CEO (Reuters)
  • No silver lining in failed Bristol cancer drug trial (Reuters)
  • Exelixis and Pfizer drugs compete in kidney cancer trial (Reuters) (Pfizer) (Exelixis)
  • Doctors grapple with best use of potent new cancer drugs (Reuters)
  • Tesaro's ovarian cancer drug benefits all patients in study (Reuters) (The Street) (BiotechStrategyBlog) (Endpoints)
  • Live Blog: Expert Updates From ESMO 2016 (Medscape)
  • The race to create a new class of ovarian cancer drugs heats up (STAT)
  • Novartis challenges Pfizer with strong breast cancer drug data (Reuters) (Press)
  • Ziopharm Breast Cancer Gene Therapy Tied to 'Higher Than Expected' Toxicity (The Street)
  • Insulin Prices Soar While Drugmakers' Share Stays Flat (WSJ)
  • Mylan's Stock Jumps After $465 Million EpiPen Settlement (Bloomberg) (WSJ) (Reuters)
  • FDA Expands Label for Merck HPV Vaccine to Patients Nine to 14 (FDA)
  • Beware Of Unapproved Stem Cell Treatments (KHN)
  • Anthem says will not cover Sarepta's approved Duchenne drug (Reuters) (STAT) (Anthem)
  • The Sarepta dilemma: Bioethics expert Arthur Caplan says it's time to rethink how to regulate compassion (Endpoints)
  • No, $75 Million Won't Cure Heart Disease Or Reinvent Science (CardioBrief)
  • Bad Blood: The Decline And Fall Of Elizabeth Holmes And Theranos (Forbes)
  • Biotech IPOs slow in Q3 despite improvement in general markets (BioWorld)
  • Hearing: EpiPen Price Increases: How Regulatory Barriers Inhibit Pharmaceutical Competition (Senate HELP)
  • 7-figure pay for part-time job: Nice work, if you can get it (CBS)

In Focus: International

  • Goal of FDA/EU Mutual Inspection Reliance is Nearing Realization (IPQ)
  • Pollution puts pharmaceutical supply chains under the spotlight (Financial Times)
  • Foreign tycoons inject $50m into Genomics Medicine Ireland (The Times)
  • Takeda adds a $790M discovery deal to an ongoing R&D overhaul (Endpoints)
  • Health Canada to Reclassify Medical Device Sterilizers and Disinfectants (Emergo)
  • Piramal to buy select injectable brands from Janssen for up to $175 million (Economic Times)

US: Pharmaceuticals & Biotechnology

  • More Clarity Sought in FDA's Inactive Ingredient Database Regarding Drug Delivery Devices (IPQ)
  • Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170 (Press)
  • FDA app would direct overdose victims to nearest Narcan (Eagle Tribune)
  • Helsinn sets up a boutique investment fund with a roving eye for oncology upstarts (Endpoints)
  • Writ large: Genomic dissection of the effect of cellular environment on immune response (Science)
  • Amgen rehiring for Longmont facility as sale of property approaches (Daily Camera)
  • Guidance - Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request (FDA)
  • Guidance - Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process (FDA)
  • Dale Schenk, Who Saw Immune System as Weapon Against Alzheimer's, Dies at 59 (NYTimes)
  • FDA Updates List of Drugs that May Not Be Compounded Under 503A and 503B: Preamble Reminds Industry when Listed Drugs Can Still Be Compounded (FDA Law Blog)
  • Little evidence that antibiotics help open surgical wounds heal (Reuters)
  • Genetic Test Aims to Better Match Pancreatic Cancer Patients to Treatments (MIT Technology Review)
  • FDA reviewing Coherus' biosimilar of Neulasta (BioCentury)
  • Reporting of adverse events in targeted therapy and immunotherapy trials is "suboptimal" (MNT)
  • Lundbeck: FDA approves Carnexiv injection (Reuters) (Press)

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

  • Yervoy (ipilimumab) Improves Overall Survival in Fully Resected Stage III Melanoma Patients From Phase 3 Study (Press)
  • Merck's Keytruda achieves 24 percent response in bladder cancer study (Reuters) (Press)
  • Results From CheckMate-275 Validate Further Study of Opdivo (nivolumab) in Patients With Advanced Form of Bladder Cancer (Press)
  • Bristol-Myers Squibb Presents Results From CheckMate -026, a Phase 3 Study of Opdivo (nivolumab) Monotherapy Versus Chemotherapy as First-Line Therapy in a Broad PD-L1 Positive Population With Advanced Lung Cancer (Press)
  • Updated Results Presented for the Opdivo (nivolumab) and Yervoy (ipilimumab) Combination in Metastatic Renal Cell Carcinoma From Phase 1 Study (Press)
  • Opdivo (nivolumab) Stabilized Patient-reported Outcomes in Patients With Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck in Pivotal Phase 3 CheckMate -141 Study (Press)
  • Pfizer Presents Promising New Immunotherapy Combination Data With INLYTA® (axitinib) In Advanced Renal Cell Carcinoma (RCC) (Press)
  • Opdivo (nivolumab) Shows Durable Response in Longest Follow-up for a PD-1 Inhibitor in Previously Treated Advanced Non-Small Cell Lung Cancer (Press)
  • Merck Announces Longer-Term Follow-Up of Overall Survival Data for KEYTRUDA® (pembrolizumab) in Patients with Advanced Melanoma from KEYNOTE-002 Presented at ESMO 2016 Congress (Press)
  • Clovis reveals ovarian cancer data underlying upcoming FDA review (Fierce)
  • Xenetic Biosciences Reports Positive Topline Data from Third Cohort of Phase 2 Dose-Escalation Trial of ErepoXen® for Anemia (Press)
  • ARIAD Presents Updated Long-Term Follow-up Results from the Phase 1/2 Trial on Investigational Drug Brigatinib at 2016 ESMO Meeting (Press)
  • Phase III nintedanib trial results in patients with metastatic colorectal cancer announced at ESMO 2016 (Press)
  • AveXis Reports Interim Data from Ongoing Phase 1 Clinical Trial of AVXS-101 in Spinal Muscular Atrophy Type 1 as Presented at the International Annual Congress of the World Muscle Society (Press)
  • New Data Presented at World Muscle Society Congress Support Potential Benefit of Investigational Treatment Nusinersen in Spinal Muscular Atrophy (Press)
  • Kite Pharma Presents 12-Month Follow-Up Data from ZUMA-1 Phase 1 at the European Society for Medical Oncology (ESMO) Annual Congress (Press)
  • Vtessa doses first patient in Phase 2b/3 Niemann-Pick Type C1 trial (EPR)

US: Medical Devices

  • US FDA Grants Approval for LBT's APAS (Press)
  • St. Jude Medical Announces FDA Clearance and Launch of the New PressureWire X Guidewire Designed to Optimize PCI Procedures in Patients With Complex Anatomies (Press)
  • Fresenius Kabi wins FDA nod for Aurora Xi plasmapheresis system (MassDevice)
  • Teleflex Receives FDA Clearance for ARROWJACC with Chlorag+ard Technology and Tunneler (Press)

US: Assorted & Government

  • The Learned Intermediary Rule in Consumer Protection Claims (Drug and Device Law)
  • Supreme Court Refuses to Consider Patents Invalidated Under Mayo/Alice Framework: High Court Takes High Road on Patent Eligibility (National Law Review)
  • District Court Dismisses State Law Unfair Competition Claim as Preempted by Federal Copyright and Patent Law (Inside Medical Devices)
  • Trump vows to kill Obamacare, Clinton wants to 'fix' it (CNBC)

Upcoming Meetings & Events


  • The list of medicinal products to be stocked as mandatory reserve supplies has been updated (FIMEA)
  • EU Policy Update, October 2016: Brexit and the EU's Response; Communication and Media Policies; Energy and Climate Change Policies; Trade Policy and Sanctions (National Law Review)


  • US pharmaceutical association head visits Beijing (China Daily)
  • Merck opens testing plant in latest Korean bioprocessing investment (BioPharmaReporter)
  • Teva and Celltrion announce exclusive biosimilar commercial partnership (BiosimilarNews)


  • Bharat Biotech's Zika vaccine to enter phase-I trials (BioSpectrum)
  • Cancer medicines, antibiotics become cheaper as NPPA slashes prices (Economic Times)
  • Dr Reddy's launches generic Lamotrigine tablets in US (Economic Times)


  • Conference participation by the TGA (TGA)

General Health & Other Interesting Articles

  • Launched: A Factory for Making Weird New Organisms (IEEE Spectrum)

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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