Regulatory Recon: J&J Discloses Federal Probes House Committee Questions Companies, DEA Over Opioid Dumping in WV (9 May 2017)

Posted 09 May 2017 | By Michael Mezher 

Regulatory Recon: J&J Discloses Federal Probes House Committee Questions Companies, DEA Over Opioid Dumping in WV (9 May 2017)

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

In Focus: US

  • J&J discloses U.S. probe related to arthritis drugs (Reuters) (Law360-$)
  • Trump's Pick to Lead FDA Has Backing of Big Pharma (WSJ)
  • Bipartisan Committee Leaders Demand Answers About Alleged Pill Dumping in Midst of Opioid Crisis (E&C) (Letters)
  • Sanofi vows to limit 2017 price hikes to 5.4% as part of new 'holistic' policy (Fierce) (Press)
  • Express Scripts to Offer Cheaper Drugs for Uninsured Customers (NYTimes)
  • How low does DMD med Emflaza's price need to go? PTC hopes $35,000 is low enough (Fierce) (Pharmafile) (CNBC)
  • Drug pricing didn't come up in White House biomedical meeting, NIH director says (CNBC) (Politico)
  • Just what Sanofi and Regeneron wanted: A Dupixent rollout so zippy, it's fueling bigger sales forecasts (Fierce)
  • Interview – Pieris blooms with Astra deal (EP Vantage)
  • Biotech Execs Promote Biomedical R&D At White House Meeting (Pink Sheet-$)
  • User Fee Reauthorization Bill Amended Ahead of Wednesday Vote  (Focus) (FDA Law Blog) (Pink Sheet-$)
  • CBER Director Focuses on Flexibility to Advance Regenerative Medicines (Focus)
  • FDA Drug Approvals on Limited Evidence: Follow-Ups Lacking, Study Finds (Focus)
  • Pediatric Study Timelines Could Change Under Senate PDUFA Bill (Pink Sheet-$)
  • Why a Court Ruling on Faxing Matters to the Device Industry (MDDI)
  • GOP Bill Could Affect Employer Health Coverage, Too (NYTimes)
  • Divided Senate Republicans Turn to Health Care With a Rough Road Ahead (NYTimes)
  • Weighing the Ethics of Artificial Wombs (NYTimes)
  • Public Restrooms Become Ground Zero In The Opioid Epidemic (NPR)

In Focus: International

  • New five year plan for Australian pharma industry (PharmaLetter-$)
  • How Thailand Is Building Drug Discovery, Innovation And Investment (SCRIP-$)
  • Thailand Readying Clinical Research Reform, Improved IPR (Pink Sheet-$)
  • Sanofi in 250 million euro 'end-to-end' drug discovery deal using AI (PharmaLetter-$) (Fierce)
  • Mystery illness in Liberia appears to be meningitis: minister (Reuters)
  • EMA to Continue to Allow Patient Involvement in CHMP Meetings (Focus)
  • Blocked by China, Taiwan Presses to Join U.N. Agency's Meeting (NYTimes)
  • Brazilian authorities raid Alexion office in another sales-practices probe (Fierce) (BioCentury)
  • Pan-Canadian ODR recommendation supports use of Tagrisso for NSCLC subset (PharmaLetter-$)
  • Australia Proposes More Proportionate Sanctions And Penalties (Pink Sheet-$)
  • France's New President Will Support A Pharma Industry That Produces Innovation At Fair Prices (Pink Sheet-$)
  • 'Momentous' UK trial to explore statin for MS (PharmaTimes) (Pharmafile)
  • Three new medicines cleared for use by NHS Scotland (PharmaTimes)
  • Ireland reiterates bid to host the European Medicines Agency post-Brexit (EPR)
  • Sanofi, Exscientia link to develop bispecific small molecule drugs (PharmaTimes)
  • UK pharma apprehensive about post-Brexit investment (PM Live)
  • Takeda pens GammaDelta Therapeutics $100M pact, with M&A option (Fierce)
  • Feldan Therapeutics, Elasmogen in Amgen tie-up for intracellular biologics (Fierce)
  • Torrent Pharma Open To Strategic Acquisitions (Bloomberg)

US: Pharmaceuticals & Biotechnology

  • Arizona's Off-Label Promotion Law May Hinge On Gottlieb (Law360-$)
  • Sen. Wyden to HHS: Upcoming FDA Opioid Meeting Full of Conflicts of Interest (Focus)
  • Doing Good To Feel Better: The Expanding Role Of Philanthropy In Drug Development (LifeSciVC)
  • Systemic therapy outperforms intraocular implant for treating uveitis (NIH)
  • Endo profit tops estimates on strong sales of new generic drugs (Reuters)
  • EpiPens should work at least a while past expiration dates (Reuters)
  • Former NIMH Director Insel Leaving Verily (BioCentury)
  • The Building Blocks of Cataracts (NYTimes)
  • Reducing Serialization's Impact On Capital Costs, Equipment Effectiveness (Pink Sheet-$)
  • Industry Needs To Be Aware of Serialization Challenges Under DSCSA (Pink Sheet-$)
  • 'Do Not Flush' Labels For Acne, Hemorrhoid Wipes Won't Stop Consumers – CHPA (Pink Sheet-$)
  • Government-imposed price controls threaten innovation and access (PhRMA)
  • Tracking opioid supply chain "not enough" to fight illicit trade (Securing Industry)
  • Merck and Array to test Keytruda in combo with binimetinib (PharmaLetter-$)
  • C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Amitriptyline HCL Tablets, USP 50mg and Phenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg Due to Potential Label Mix-Up (FDA)
  • Real World Data Help Build Case For New Migraine Drugs (SCRIP-$)
  • FDA Cites API Manufacturer Over Inadequate Records and Testing (FDANews-$)
  • AB Science Seeks to Shed Skepticism With ALS Drug Data Reveal (The Street)

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

  • Takeda presents real-world data supporting efficacy of Entyvio in IBD (PharmaLetter-$) (Press)
  • Santalis Pharmaceuticals Enrolls First US Subject Into a Phase 2 Clinical Study of Mild to Moderate Atopic Dermatitis (Press)
  • NantKwest and NantCell Announce FDA Authorization for the NANT Cancer Vaccine Clinical Trials, the First Novel Combination of Innate and Adaptive Immunotherapy in Patients with Pancreatic Cancer (Press)
  • PureTech Health Announces Initiation of Phase 2b mTORC1 Inhibitors Study in Elderly Patients at Increased Risk of Respiratory Tract Infections (Press)
  • Biscayne Readies Phase 1b Trial for Novel Antiepileptic Agent BIS-001 and Receives FDA Orphan Drug Designation for Dravet Syndrome (Press)

US: Medical Devices

  • FDA approves Boston Scientific's Resonate defibrillators (MassDevice)
  • INSIGHTEC Receives FDA Approval for Exablate Neuro for 1.5T MRI in the Treatment of Essential Tremor (Press)
  • MagVenture wins FDA nod for entry-level MagVita TMS device (MassDevice)
  • Si-Bone wins US Military Tricare coverage for iFuse (MassDevice)
  • Novocure touts quality of life data for Optune, chemo combo (Drug Delivery)

US: Assorted & Government

  • The 'Medicaidization' Of The Health Insurance Marketplaces: A Necessary Trend (HealthAffairsBlog)
  • The Case For Patient-Centered Assessment Of Value (HealthAffairsBlog)
  • Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc. (Fed. Cir. 2017) (Patent Docs)g
  • Medical Doctors Aren't Jacks-of-all-Trades (Drug & Device Law)
  • Most GOP members not holding town halls (Politico)
  • Bristol-Myers, AstraZeneca in legal hot seat over Onglyza heart failure warning (Fierce)
  • Takeda, Generics Push To Toss Actos Buyers' Antitrust Suit (Law360-$)
  • J&J Opens 4th Pelvic Mesh Trial In Philadelphia (Law360-$)
  • GSK Seeks To Strike Fraud Claims In Zofran MDL (Law360-$)
  • Pa. Court Upholds Pfizer Win In Zoloft Birth Defect Suit (Law360-$)
  • Feds Chide Meningitis Fraudster's 'Unhinged' Acquittal Bid (Law360-$)
  • Stryker hits enrollment milestone in 2nd metal-on-metal hip implant settlement (MassDevice)

Upcoming Meetings & Events


  • Early access to medicines scheme applications: pending, refused, granted (MHRA)
  • Kymab instates first Chief Medical Officer (Pharmafile)
  • Valproate-containing medicines – new EU review initiated (HPRA)
  • The Manufacturer's Organisation calls for robust industrial strategy with new manifesto (Pharmafile)
  • Abbott lands French reimbursement win for FreeStyle Libre glucose monitor (MassDevice)
  • Abbott wins CE Mark for Confirm Rx cardiac monitor (MassDevice)


  • China Investment Roundup: Active Deal-Making And A Record Overseas Acquisition (SCRIP-$)


  • Torrent completes acquisition of Novartis brands (Economic Times)
  • Wockhardt reports growing Q4 loss as FDA issues skewer its US sales (Fierce)
  • USFDA makes 8 observations after Lupin's Aurangabad unit visit (Economic Times)
  • India needs to build indigenous drug safety database: Pharmacovigilance expert (PharmaBiz)
  • Gujarat FDCA to have India's first drug price monitoring cell to detect ceiling price violations (PharmaBiz)
  • 73% doctors opposed to prescribing generic drugs: Curofy Survey (Economic Times)

Other International

  • Collaboration Helps Broaden Access to Pfizer's Contraceptive, Sayana® Press (medroxyprogesterone acetate), for Women in Some of the World's Poorest Countries (Press)

General Health & Other Interesting Articles

  • U.S. life expectancy varies by two decades depending on location (Reuters)
  • Greater total pollution exposure tied to higher cancer risk (Reuters)
  • Humanity's strange new cousin is shockingly young — and shaking up our family tree (NYTimes)

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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