Regulatory Recon: India Plans Crackdown on Drug Promotion Daiichi Sankyo Offers $300M to Settle US Benicar Suits (2 August 2017)

Posted 02 August 2017 | By Michael Mezher 

Regulatory Recon: India Plans Crackdown on Drug Promotion Daiichi Sankyo Offers $300M to Settle US Benicar Suits (2 August 2017)

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

In Focus: US

  • Is the FDA telegraphing a rejection for PTC Therapeutics' DMD drug? (STAT)
  • Pfizer hits pause on deals amid US tax reform uncertainty (Financial Times) (The Street) (Endpoints)
  • Fiscally challenged Daiichi Sankyo offers $300 million to settle 2,300 Benicar lawsuits (Fierce) (Reuters) (Pharmafile)
  • FDA Has 6 Inspectors for 3 Million Shipments of Cosmetics (NYTimes) (Rep. Pallone, FDA  Letter)
  • Following PhIII breakdown, AstraZeneca cruises toward an FDA decision for its BTK blockbuster hopeful acalabrutinib (Endpoints) (Fierce)
  • Senate to Finish FDA User Fee Reauthorization Bill Ahead of Summer Recess (Focus) (Senate)
  • FDA Finalizes Guidance on Antibacterial Therapies for Unmet Needs (Focus)
  • How Quantum Physics Is About to Revolutionize Biochemistry (MIT Technology Review)
  • Theranos settles lawsuit brought by Walgreens over blood tests (LA Times) (Law360-$)
  • Seattle Genetics to buy Bothell plant from Bristol-Myers Squibb (Reuters) (GEN)
  • Spark offers a glimpse of efficacy in first two hemophilia A gene therapy patients (Endpoints)
  • Little-Known Middlemen Save Money On Medicines — But Maybe Not For You (KHN)
  • Drug Puts A $750,000 'Price Tag On Life' (KHN)
  • Denial, Appeal, Approval … An Adult's Thorny Path To Spinraza Coverage (KHN)
  • Republicans in Congress Bypass Trump to Shore Up Health Law (NYTimes) (Reuters) (Politico)
  • Does Puma's quick Nerlynx launch play into its buyout prospects? (Fierce)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

  • BSI's 6th Annual, full-day medical device Roadshow will guide participants to new EU Medical Device/In-Vitro Device Regulation compliance. The program examines key issues facing Med Dev Manufacturers under the new MDR/IVDR starting with an overview, then analyzing legacy products and transitional provisions. Implementation issues including conformity assessments, essential/clinical requirements, SPR, labeling and QMS impacts of these standards will be detailed.
  • Check here for specific dates, locations and the program agenda.

In Focus: International

  • No more freebies: India plans crackdown on marketing by drugmakers (Reuters)
  • UK reimbursement setback for Tecentriq comes with a silver lining (PharmaLetter-$) (NICE)
  • Record number of drug-related deaths, as opioid crisis hits UK (Pharmafile) (Independent)
  • Bayer Offers Concessions in $66 Billion Monsanto Deal to Ease Competition Concerns (The Street)
  • UK Diabetes prescriptions rocket 80 percent in a decade (PharmaTimes)
  • MRC forges two new deals with industry to speed drug discovery (MRC)
  • Novartis faces vexing decisions over asset sales (Financial Times)
  • India raises concerns at Fosun's $1.1bn deal to buy Gland Pharma (Financial Times)
  • After French drug trial tragedy, European Union issues new rules to protect study volunteers (Science)

Pharmaceuticals & Biotechnology                                  

  • Clementia keeps the biotech IPO party going with $120M play on an upsized offering (Endpoints)
  • Pharma tightens its belt on jobs as markets fall (EP Vantage)
  • FDA Details Draft Goals for OTC Monograph User Fee Program (Focus)
  • Refuse-to-Receive Actions – Lowest in 9 Months! (Lachman Consultants)
  • Reining in Drug Prices: Easier Said than Done (Medpage)
  • UCL-developed stem therapy culled from Pfizer's pipeline (Fierce)
  • Exclusive Remicade Contracts Are Slowing Biosimilar Uptake (SCRIP-$)
  • Earnings Preview: What To Expect From Regeneron Pharmaceuticals On Thursday (Forbes)
  • Ocular Therapeutix to eliminate 26 positions across organization (Reuters)
  • New CRISPR R&D head; Homology raises $83.5M; Cellectar collaboration (Fierce)
  • Antibiotic Stewardship Needs More than Guidelines (Medpage)
  • US drug distributor Cardinal Health's profit beats estimates (Reuters)
  • Safety: Pharma's New Pharmacopoeia (Pharmaceutical Manufacturing)
  • Drug makers fund more compassionate use programs than you may think (STAT)
  • Cancer Immunotherapy: When To Stop Treatment Remains Unanswered Question (Pink Sheet-$)
  • Express Scripts hobbles new Synergy med Trulance with Allergan-favoring formulary maneuver (Fierce)
  • Radius' Tymlos gets another big break as Express Scripts boots Lilly's Forteo (Fierce)
  • FDA Warns Four Compounders for Lacking Valid, Individual Prescriptions (FDANews-$)
  • Amplyx grabs $67M to fund a pivotal drive to the FDA with an anti-fungal aimed at a lethal threat (Endpoints) (Fierce)
  • Running out of cash and kicked out of its HQ by the landlord, PixarBio hunkers down and slashes staff (Endpoints)
  • FluGen, Startup Developing Universal Flu Vaccine, Raises $5.5M (Xconomy)
  • Outsourcing Facility Fee Rates for Fiscal Year 2018 (FDA)
  • B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application (FDA)
  • Mallinckrodt enrolls first infant in registry for inhaled nitric oxide gas (Drug Delivery)
  • Thermo Fisher: Modest Q2 for life sciences due to 'lumpiness' of bioproduction (BioPharmaReporter)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV (Press)
  • Kite Doses First Patient in the Phase 2 Trial of Axicabtagene Ciloleucel in Indolent B-Cell Non-Hodgkin Lymphoma (ZUMA-5) (Press)

Medical Devices

  • Medtronic touts reduced costs, rehospitalizations in cryoballoon vs RF AF ablation trial analysis (MassDevice) (Press)
  • Lack of takeovers sees medtech hiring staff again (EP Vantage)
  • New Startup Aims to Stamp out Diabetic Foot Ulcers (MDDI)
  • Can a genetic test really boost your odds of becoming pregnant? (STAT)
  • Xavant Tech wins FDA nod for Stimpod non-invasive pain relief neuromod (MassDevice)
  • Laminate Medical Technologies Receives IDE Approval from FDA to Initiate Clinical Study of the VasQ Device (Press)
  • FDA Clears Xavant Technology's Stimpod NMS460 Non-Invasive Neuromodulation Device for Treatment of Chronic Intractable Pain (Press)
  • EDAP submits FDA 510(k) for Ablatherm Fusion HIFU device (MassDevice)

US: Assorted & Government

  • Celgene Pays $280m in False Claims Act Case in Which U.S. Did Not Intervene (FDA Law Blog)
  • Anthem to cut back Obamacare plan offerings in California (Reuters)
  • KKR to take PharMerica private in $1.4 billion deal (CNBC)
  • An FDA Petition Denial Preempts A Failure-To-Warn Claim (Law360-$)
  • New Jersey Appellate Court Very "Relaxed" About Expert Testimony in Accutane Litigation (Drug & Device Law)
  • The Latest Motion In House v. Price Has A Significant Impact On The Future Of CSR Payments (Health Affairs Blog)
  • Blumenthal Introduces Legislation to Protect Confidential Medical Information (Blumenthal)
  • I watched my childhood home go from idyllic to drug-ravaged. Trump's opioid commission isn't going to fix it (LA Times)

Upcoming Meetings & Events


  • Podcast: Patient access to cancer medicines in Europe - a UK perspective (ABPI)
  • LivaNova wins MRI-safe CE Mark for VNS Therapy systems (MassDevice)


  • Japan's pharma market growth set to lag world average (PharmaLetter-$)


  • USFDA gives final nod to Glenmark Pharma for anti-herpes drug (Economic Times)
  • Karnataka govt forms Vision Group for pharma & medical devices to fast track projects and spur job growth (PharmaBiz)

Other International

  • WHO delivers medicines and medical supplies to Al-Qamishli to support Ar-Raqqa response (WHO)
  • Babies and mothers worldwide failed by lack of investment in breastfeeding (WHO)

General Health & Other Interesting Articles

  • Biological Teleporter Could Speed Outbreak Response, Seed Life Through Galaxy (MIT Technology Review)
  • Gum infections linked to several cancers in women (Reuters)
  • Florida confirms first sexually transmitted Zika case in 2017 (CBS)
  • People Who Use Cannabis CBD Products Stop Taking Traditional Medicines (Forbes)

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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