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Regulatory Recon: Ohio Sues Five Drugmakers Over Opioid Epidemic Tesaro Reportedly Exploring Sale (1 June 2017)

Posted 01 June 2017 | By Michael Mezher 

Regulatory Recon: Ohio Sues Five Drugmakers Over Opioid Epidemic Tesaro Reportedly Exploring Sale (1 June 2017)

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

In Focus: US

  • Ohio sues five drug companies over opioid crisis (Reuters) (NYTimes) (STAT)
  • Did This 100-Word Letter Help Spark The Opioid Epidemic? (Forbes)
  • The Role of Science in Addressing the Opioid Crisis (NEJM) (NIH)
  • Abuse-Deterrent Opioid Formulations — Putting the Potential Benefits into Perspective (NEJM)
  • Tesaro Explores Sale (WSJ) (Endpoints)
  • Spending on cancer drugs is forecast to rise in the single digits (STAT)
  • Mylan may have overcharged U.S. for EpiPen by $1.27 billion: HHS (Reuters)
  • Acne antibiotic delays development of multiple sclerosis in small trial (Reuters) (NEJM)
  • Express Scripts Sues Maker of Overdose Drug, Intensifying Feud (NYTimes)
  • FDA Approves Novo's Rebinyn For Hemophilia B (Biocentury) (Press)
  • As Drug Prices Soar, Value-Based Pay Hits Pharmaceutical Industry (Forbes)
  • Puma May Face Marketing Hurdles Even If Neratinib Wins Final Approval (SCRIP-$)
  • ASCO CAR-T Highlights: Exploring New Frontiers For The Field (SCRIP-$)
  • Nicox's Zerviate Wins FDA Nod For Ocular Itching (BioCentury)
  • Immuno-oncology combinations surge as sector seeks the fairy dust (EP Vantage)
  • Patient Assistance Programs: Why Pharmaceutical Manufacturers Operate the Biggest U.S. Charities (Drug Channels)
  • A Drug Quintupled in Price. Now, Drug Industry Players Are Feuding Over the Windfall. (ProPublica)
  • Philips in deals with U.S. hospitals on use of its gene data platform for cancer research (Reuters)
  • Grail Merging With Cirina (BioCentury)
  • AbbVie Tops Pharma Reputation Report, Pfizer Ranks Last (Law360-$)

In Focus: International

  • EU approves Biogen's Spinraza for lead genetic cause of infant death (Reuters) (Press)
  • Novartis sees gaps in cancer pipeline but is adamant it doesn't need an I-O deal (Fierce)
  • What the life sciences industry wants from the next UK government (Pharmafile)
  • Europe vs USA: New drug approvals (Pharmafile               )
  • Nigerian government to set up vaccines joint venture with May & Baker (Reuters)
  • Roche's Valium hit by tampering in Australia (Securing Industry)
  • NICE u-turn backs Sanofi's Gaucher disease drug (PharmaTimes)
  • Canada Plans To Force Firms To Disclose Confidential Pricing Deals (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Merck KGaA taps Selexis cell line tech for immuno-oncology antibodies (BioPharmaReporter)
  • Bicycle raises £40M to take cancer drugs into the clinic (Fierce) (PharmaTimes)
  • Finally, An FDA Commissioner Who Tweets (Pink Sheet-$)
  • This map will help biologists learn more about the human body than ever before (STAT)
  • Biosimilar Switching Studies, Human Factors Analyses Are Flashpoints For Industry (Pink Sheet-$)
  • Interchangeable Biosimilar Designations Shouldn't Be Forever, Innovators Say (Pink Sheet-$)
  • US Comparator Requirement For Interchangeable Biosimilars Would Hurt Industry (Pink Sheet-$)
  • GSK investors cheer as Gilead's HIV candidate bictegravir fails to beat their own Tivicay (Fierce)
  • Reviewing the progress of the biosimilars that could help answer the cost questions that are underpinning ASCO discussions (PharmaLetter-$)
  • AstraZeneca's 13 Outcomes-Based Contracts Show "Proactive" Engagement On New Models (SCRIP-$)
  • Derica Rice to Retire as Lilly Chief Financial Officer (Lilly)
  • AstraZeneca's ASCO pledge? Be a better social media citizen (Fierce)
  • AmpliPhi Biosciences Appoints Paul C. Grint, M.D. as Chief Executive Officer (Press)
  • Letter Signed by 65 Members of Congress Urges FDA to Reconsider "Office Stock" Restrictions for Section 503A Compounders (FDA Law Blog)
  • At ASCO 2017 Clinicians Present New Evidence about Watson Cognitive Technology and Cancer Care (IBM)
  • Team Atlas Expands Its Roster With Kevin Bitterman (LifeSciVC) (Endpoints)
  • Lilly edges towards the bladder cancer queue (EP Vanatage)
  • Bureaucratic barriers to cystic fibrosis treatment in USA (PharmaLetter-$)
  • Mycobacteria use protein to create diverse populations, avoid drugs (NIH)
  • NIH researchers find potential genetic cause of Cushing syndrome (NIH)
  • Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer (Federal Register)
  • J&J confident of retaining Remicade rewards as biosimilar clouds gather (BioPharmaReporter)
  • Outcome Health valued at $5.5B with first financing round of $500M (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Lilly Announces Phase 3 RANGE Urothelial Cancer Trial of CYRAMZA (ramucirumab) Met Primary Endpoint, Improving Progression-Free Survival (Press)
  • Jazz Pharmaceuticals Announces FDA Acceptance of NDA for VYXEOS™ (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status (Press)
  • Pfizer Announces Acceptance of Regulatory Submissions by U.S. FDA and European Medicines Agency for SUTENT® (sunitinib) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery (Press)
  • vTv Therapeutics Completes Enrollment of Part B of Pivotal Phase III STEADFAST Trial Evaluating Azeliragon for the Treatment of Patients with Mild Alzheimer's Disease (Press)
  • BioLineRx Reports Regulatory Submissions of Three Phase 1b Trials for BL-8040 in Combination With Atezolizumab for Solid Tumors (Press)
  • Celgene and Acceleron Complete Target Enrollment in the MEDALIST and BELIEVE Phase 3 Studies of Luspatercept in Myelodysplastic Syndromes and Beta-Thalassemia (Press)

Medical Devices

  • Intuitive's New Budget Friendly da Vinci X Robotic Surgical System Cleared in U.S. (MedGadget)
  • Bayer wins FDA nod for connected MS auto-injector (MassDevice)
  • Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients (Press)
  • Nanoparticles: An industry buzzword meets reality (Medical Design & Outsourcing)
  • Countering Cybersecurity Turnover: 57 Companies That Do It Best (Xconomy)
  • X marks the spot for Intuitive (EP Vantage)
  • Medtronic Initiates PRODIGY - a Global Study to Identify Those at High Risk for Opioid Induced Respiratory Depression, a Preventable Form of Respiratory Compromise (Press)
  • Interview With Director of Biomaterials Research Innovation Center, Prof. Ali Kadhemhosseini (MedGadget)
  • Fitness trackers versus medical devices: What's the difference? (Medical Design & Outsourcing)
  • Abbott's MitraClip can be implanted through the jugular vein, too (MassDevice)

US: Assorted & Government

  • Poll: Americans Increasingly Think Their Health Care Will Get Worse (NPR)
  • Electronic Health Records Vendor to Pay $155 Million to Settle False Claims Act Allegations (DoJ)
  • Kentucky Trial Court follows U.S., not Kentucky, Supreme Court Precedent to Hold that Claims Against Investigational Device Were Preempted (Drug & Device Law)
  • Boston Scientific, St. Jude Medical must face University of California patent suits (MassDevice)

Upcoming Meetings & Events


  • Lithuania's Biotechpharma jumps on the 2,000L single-use seed train (BioPharmaReporter)
  • Aptar Pharma's electronic lockout device approved by EMA (EPR)
  • Akari CEO quits amid false data and report scandal (PharmaLetter-$)
  • Saratha Rajeswaran joins ABPI as Executive Director of Government Affairs and Devolved Nations (ABPI)
  • Collaboration will be 'game changer' in delivering cell and gene therapies to patients says industry expert (ABPI)


  • Japan clears Augmenix's SpaceOAR (MassDevice)
  • Japanese firm Rohto Pharma plans to expand base in India (Economic Times)
  • Chiltern buys Japanese CRO IDA, boosting its Asia footprint (Fierce)
  • Shanghai deal sign of growing confidence in Chinese biotech (PharmaLetter-$)


  • CDSCO seeks additional studies to evaluate safety of BVS cardiac stents in India following its restricted use in Europe (PharmaBiz)
  • DoP directs NPPA to re-fix ceiling price of Ranitidine 25mg/ml (PharmaBiz)

General Health & Other Interesting Articles

  • Draper's Genetically Modified Cyborg DragonflEye Takes Flight (IEEE)

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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