Regulatory Recon: Bayer, Novartis Fight With UK Doctors Over Avastin Use for AMD OPDP Enforcement Letters at Record Low (1 November 2017)

Posted 01 November 2017 | By Michael Mezher 

Regulatory Recon: Bayer, Novartis Fight With UK Doctors Over Avastin Use for AMD OPDP Enforcement Letters at Record Low (1 November 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Pharma industry faces hypocrisy charge over patents (Financial Times)
  • Pfizer expects broad interest for consumer health business (Reuters)
  • FDA Panel Backs Indivior Opioid Addiction Drug (Reuters) (Financial Times) (Endpoints)
  • OPDP Enforcement Letters at Record Low (EyeOnFDA)
  • Innovating at the speed of the 21st century in pharmaceuticals (McKinsey)
  • Rx Marketplace Quarterly: Q3 2017 Pharmaceutical and Life Sciences (PwC)
  • Drugmaker set to profit from an opioid it said was unsafe (CNN)
  • The US Has A Fentanyl Shortage...In The Clinic, Not On The Streets (Forbes)
  • Allergan swings to quarterly loss on write down in Teva stake (Financial Times) (Reuters)
  • US experts set research agenda to meet 'Cancer Moonshot' goals (Reuters)
  • AstraZeneca wins early US approval for blood cancer drug (Reuters) (FDA)
  • AstraZeneca discloses 'disappointing' results from asthma drug trial (Financial Times) (Endpoints)
  • Ultragenyx, Kyowa Hakko Kirin Say No Advisory Panel for Burosumab BLA (Press)
  • Botox is a multi-billion dollar, potentially deadly monopoly (Marketplace)
  • Drugmaker Novo Nordisk warns of US legislation, cautious on 2018 (Reuters)
  • Neos Therapeutics to consider other offers after PDL snub: sources (Reuters)
  • With tweaks to gene therapy, Bluebird Bio makes progress in sickle cell (STAT) (Endpoints)
  • Novartis' 6-month Kymriah data in DLBCL sets up a head-to-head fight with Gilead (Endpoints)
  • Juno Therapeutics could shake up CAR-T market with strong lymphoma data (STAT) (Endpoints)
  • Senators Introduce Bill to Reduce 'Colossal and Completely Preventable Waste' (ProPublica)
  • New Jersey sues OxyContin maker, links marketing to opioid crisis (Reuters)

Sponsored Content: Advice from Regulatory Leaders

In Focus: International

  • Bayer, Novartis clash with UK doctors over use of cheap eye drug (Reuters) (The Guardian)
  • UK's NICE gives Roche drug green light for bladder cancer (Reuters) (PharmaTimes) (Pharmafile)
  • FDA to Recognize 8 EU Regulators to Conduct GMP Inspections (Focus) (FDA) (EMA) (MHRA) (EC)
  • Sanofi plans four-fold increase in insulin production in Russia (PharmaLetter-$)
  • Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps (Nature)
  • Pakistan advances 2D barcode plans for drug products (Securing Industry)
  • Greek Health Minister Takes Issue With Roche's Withdrawal of Cancer Medicine Due to Mandatory Discount (Focus)
  • Asia Regulatory Roundup: Australia's TGA to Tighten Regulation of Autologous Cell Products, Ban Ads (Focus)
  • EMA Drafts Guideline on RSV Treatments and Vaccines (Focus)
  • SCHEER: Scientific Advice on breast implants and health published today (EC)
  • Dutch policy for labelling of medicinal products amended (CBG MEB)
  • Undeterred by Pfizer's looming OTC sale, Merck KGaA scouts consumer health bidders (Fierce)

Pharmaceuticals & Biotechnology

  • Bacteria Can Evolve Resistance to Drugs Before Those Drugs Are Used (The Atlantic)
  • Presentations for ASH 2017 (ASH)
  • Value-Based Contracting for Oncology Drugs: A NEHI White Paper (NEHI)
  • Cystic Fibrosis: Draft Scoping Document (ICER)
  • Patient Voices: Cystic Fibrosis (NYTimes)
  • Agios unveils new leukemia drug data to support end-of-year FDA approval filing (STAT) (Endpoints)
  • AstraZeneca inks a cardio drug development pact with mRNA specialist Moderna (Endpoints)
  • FDA Warns Canadian, Indian Drugmakers (Focus)
  • Drugs for alcoholism go largely unused (Chicago Tribune)
  • Heartburn Drugs Tied to Stomach Cancer Risk (NYTimes)
  • California upstart Xyphos wants to tackle CAR-T's big problems (Endpoints)
  • CAR-T is bringing true precision to the fight against cancer (Pharmafile)
  • Frazier boosts next pure-play biotech fund to $419M, readies new bets for a practiced strategy (Endpoints)
  • Generic User Fee Transition A Little Bumpy For Contract Manufacturers (Pink Sheet-$)
  • Opinion: Drug company sales reps should be banned from hospitals (STAT)
  • Grid picks Catalent to make mAb for solid tumours (BioPharmaReporter)
  • Bristol-Myers Squibb, BioLabs Announce Founding Sponsorship in Support of Promising Biotech Companies in New York (Press)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA Grants Fast Track Designation to Visterra's VIS410 for Treatment of Hospitalized Patients with Influenza A (Press)
  • Momenta and Mylan Report Initial Results from Phase 1 Clinical Trial for M834, a Proposed Biosimilar of ORENCIA® (abatacept) (Press)
  • FDA Grants Rare Pediatric Disease Designation to ArQule's Miransertib (ARQ 092) for the Treatment of Proteus Syndrome (Press)
  • Agile Therapeutics touts late-stage trial for once-weekly contraceptive patch (Drug Delivery)
  • Otsuka and Lundbeck Will Initiate a Third Phase 3 Trial to Evaluate Brexpiprazole in the Treatment of Agitation in Patients with Dementia of the Alzheimer's Type (Press)
  • Quark Pharmaceuticals, Inc. Phase 2 Data on the Efficacy and Safety of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery to Be Presented at the American Society of Nephrology Meeting (Press)
  • New Phase 1/2 Study Data for ALXN1210 as a Potential Future Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to Be Presented at American Society of Hematology (ASH) Meeting (Press)
  • Verastem Announces Data from Phase 3 DUO Study Selected for Oral Presentation at the American Society of Hematology 2017 Annual Meeting (Press)

Medical Devices

  • FDA's Role in Medical Device Cybersecurity (FDA Voice)
  • Advisory Committee; Patient Engagement Advisory Committee, Renewal (FDA)
  • Reps Question Gottlieb on Bayer's Follow-Up Essure Studies (Focus)
  • CDRH Issues Draft Guidance Regarding Breakthrough Devices (FDA Law Blog)
  • Zimmer Biomet misses the mark with Q3 results (MassDevice)
  • Owens & Minor to buy Halyard Health's infection prevention biz for $710m (MassDevice)
  • TCT 2017: OrbusNeich's dual therapy stent non-inferior to Abbott's Xience DES in 1-year follow-up (Drug Delivery)
  • FDA clears Abbott's Alinity diagnostic analyzers (MassDevice)
  • Digital Transformation May Be Key for Medical Device Compliance (MDDI)
  • IntraFuse Receives FDA 510(k) Clearance for FlexThread™ Fibula Pin System (Press)
  • Luminex Receives FDA Clearance for Aries Group A Strep Assay (GenomeWeb) (Press)
  • New Analyses Reinforce Hemodynamic Benefits of Medtronic Evolut(TM) TAVR Platform in Intermediate Risk Aortic Stenosis Patients (Press)

US: Assorted & Government

  • States Expand Price-Fixing Accusations Against Generic Drug Companies (WSJ) (CT AG)
  • Mylan Top Executive Engulfed in Alleged Price-Fixing Ring (Bloomberg) (Fierce)
  • As Open Enrollment for Obamacare Begins, Confusion Reigns (NYTimes)
  • C an The Feds Nail The Fentanyl Billionaire? (Forbes)
  • Opioids: GAO Calls on HHS to Assess Effectiveness of Expanding Medication-Assisted Treatment (Focus)
  • Drugmakers Want Chicago's Opioid Suit Paused Pending MDL (Law360-$)
  • Gary Gilliland, MD, PhD, Testifies Before Congress on NIH Funding System (ASCO Post)
  • Court Says New Jersey Must Recognize 'Glaringly Apparent' Value Of Cannabis Medicine (Forbes)
  • Second Circuit Affirms Exclusion of Plaintiffs' Experts – and Summary Judgment for Defendant – in Mirena MDL (Drug & Device Law)
  • Mallinckrodt stifled Acthar competition, payer lawsuit claims, clearing path for 85,000% rise in prices (Fierce)
  • Accutane Amici Say: Relax Somewhere Else – Expert Testimony in New Jersey Should Be Held to a Higher Standard (Drug & Device Law)

Upcoming Meetings & Events


  • Concept paper on the need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease (EMA)
  • Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Axial Spondyloarthritis (EMA)



  • New dengue virus confirmed in India (Economic Times)
  • Cases of illegal sale, misuse of Oxytocin detected in West Bengal, Bihar following DCGI directive (PharmaBiz)
  •  DoP raps NPPA for its decision in fixing ceiling price on methyldopa-500mg (PharmaBiz)
  • US FDA bans APIs made by Fleming Labs (InPharmaTechnologist)


  • Industry report provides overview of Australian biotech sector (PharmaLetter-$)

Other International

  • NIH establishes new research in social epigenomics to address health disparities (NIH)

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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