Regulatory Recon: Dr. Reddy's US Suboxone Patent Win Sends Indivior's Share Price Tumbling; St. Kitts Launches Probe of Controversial Offshore Herpes Vaccine Study (1 September 2017)

Posted 01 September 2017 By Michael Mezher

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

In Focus: US

  • Feds scoop up a band of biotech insiders who allegedly bagged a windfall, and now criminal charges (Endpoints) (Law360-$) (SEC)
  • St. Kitts Launches Probe Of Herpes Vaccine Tests On US Patients (KHN)
  • FDA is urged to withdraw 'ultra' high-dose opioids over risks (STAT) (CNN) (Petition)
  • Neurotoxicity kills a CAR-T rival pushed by J&J, MacroGenics in $700M deal (Endpoints) (Fierce) (EP Vantage)
  • Pfizer, Celgene and Roche are climbing pharma VC league table (Fierce)
  • Troubled Acorda hurries to bar the door against a takeover attempt (Endpoints)
  • Arizona accuses drugmaker Insys of fraudulent opioid marketing (Reuters)
  • Profit on $475,000 Novartis cancer drug could be a while coming (Reuters)
  • Medical Device Tax Repeal Likely on Congress's Fall Agenda (Medpage)
  • Steadymed Falls On Trevyent NDA Refusal (BioCentury) (Press)               
  • New Steps To Strengthen FDA's Inspection And Oversight Of Drug Manufacturing (FDA) (Focus)
  • A Cancer Doctor Weighs In On CAR-T, Precision Medicine And Pricing Debates (Forbes)

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In Focus: International

  • The top 10 biopharma CROs in the world—mid-2017 edition (Endpoints)
  • Dr. Reddy's Wins Rulings Over Three Patents For Suboxone Drug (Bloomberg) (The Guardian) (Financial Times)
  • Innate Immunotherapeutics likely to shutter, CEO says (STAT)
  • NICE rejects AstraZeneca's breast cancer drug Faslodex (Pharmafile)
  • AstraZeneca aims to offset drug setback at big cancer congress (Reuters)
  • Bain and Cinven select pharma veteran Albrecht as Stada's next CEO (Fierce) (Press)
  • Activist Investor Elliott Demands More For Stada Stake (Law360-$) (Reuters) (Financial Times)
  • EMA Opens Consultations of Two Revised ICH Guidelines (Focus)
  • IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018 (Focus)
  • European Regulatory Roundup: Industry Seeks Post-Brexit System Prioritizing Ties to EMA (Focus)
  • Pharma Given Just Days To Say Whether Australian Bills Make Sense (Pink Sheet-$)
  • Turkey's Fast-Track Licensing System To Drive Local Drug Production (Pink Sheet-$)
  • Nestle shuts Swiss skin health products factory (Reuters)
  • Arrow Pharma acquires Australian operations of Amneal Pharma (Economic Times)
  • Indian Drug Price Regulator Opposes Plans To Clip Its Wings (Pink Sheet-$) (Economic Times)

Pharmaceuticals & Biotechnology

  • Fresenius closes Merck biosimilar biz purchase (Drug Delivery)
  • Flexibility in the FDA approach to orphan drug development (Nature)
  • Can You Stop Photography During An FDA Inspection? (Law360-$)
  • How pharma sales reps help me be a more up-to-date doctor (STAT)
  • Antidepressants work, so why do we shame people for taking them? (The Guardian)
  • Life Sciences SMEs Need Scale-Up Support – Immunocore CEO (SCRIP-$)
  • How World's Largest Drug Distributor Is Helping Harvey Victims Treat Snakebites (The Street)
  • Kite chief Arie Belldegrun up for $600M-plus payday from Gilead buyout (Fierce)
  • Here are top biotech stock ideas with upcoming catalysts: Jefferies (CNBC)
  • Proceeds From Chagas Treatment Priority Review Voucher Will Help Ensure Access (Pink Sheet-$)
  • Tick saliva-based drug could lower heart disease risk in HIV patients (Fierce)
  • Few young cancer survivors are up to date with HPV vaccines (Reuters)
  • Why HPV Vaccination Rates Remain Low in Rural States (MIT Technology Review)
  • Hormone Treatment for Prostate Cancer Tied to Heart Risks (NYTimes)
  • Get more from your pharma commercial spend using advanced analytics (McKinsey)
  • Tasly, FDA Discuss Approval Path For Chinese Medicine Product (BioCentury)
  • In wake of opioid crisis, Joint Commission issues new pain standards for hospitals (Fierce)
  • 'Gentler' CRISPR sheds light on autoimmune disease (Fierce)
  • Biogen vet Alpna Seth jumps to George Scangos' biotech startup; Top FDA scientist makes a leap to PhRMA (Endpoints)
  • NEA-backed Nightstar Therapeutics sets sights on an $86M IPO to fund PhIII gene therapy study (Endpoints) (Fierce)
  • Navigating the Research-Clinical Interface in Genomic Medicine: Challenging the Traditional Dichotomy Between Research & Clinical Care (Harvard Bill of Health)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Amyloid Publishes Long-Term Data Analysis from Pfizer Suggesting Tafamidis Delays Progression of TTR-FAP, a Rare Disease (Press)
  • Heptares doses first subject in Alzheimer's drug trial (PharmaTimes)
  • Akcea Submits NDA For Volanesorsen (BioCentury)

Medical Devices

  • 3D-Printed Anatomical Models: FDA Explains Regulatory Framework (Focus)
  • Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance (Focus)
  • How to Qualify for 2018 FDA Small-Business Medical Device User Fees (Emergo)
  • Atty Allegedly Caught Stealing Secrets In Medical Device Co. (Law360-$)
  • Dextera Surgical wins expanded FDA nod for MicroCutter 5/80 stapler (MassDevice)
  • CSA Medical wins another FDA expansion for TruFreeze cryotherapy (MassDevice)

US: Assorted & Government

  • DC Circuit Rules for FDA in 3-Year Exclusivity Dispute; Hashes Out ABILIFY's "Zone of Exclusivity" vis-à-vis ARISTADA (FDA Law Blog)
  • Nixing Discovery on Foreign Regulatory Submissions (Drug & Device Law)
  • How The 'Impossible Burger' Revealed Some Disturbing FDA Practices (Forbes)
  • FTC Orders Claris Lifesciences to Divest Certain Assets Before Baxter Can Acquire It (The Street) (FTC)
  • Mylan, Other Drugmakers Must Pay $67M In Antitrust Suit (Law360-$)
  • Unclear Grammar Lands AbbVie-Novartis IP Row In Arbitration (Law360-$)
  • While Congress is away, this bipartisan group of governors is trying to fix Obamacare (Washington Post)
  • Advertising budget for Obamacare to be cut 90 percent: US health agency (Reuters)
  • Pa. Mayor To Sue Pharma Cos. Over Opioid Crisis (Law360-$)
  • Pfizer, Teva Among Latest Opioid Makers In Mo. Probe (Law360-$)
  • High Court Bristol-Myers Ruling: Direction For State Courts (Law360-$)
  • Uncertainty Remains For Pharma Product Hopping Liability (Law360-$)
  • Pharmacists say Medicaid cuts could force them to close their doors (Dayton Daily News)
  • Express Scripts, other PBMs named in lawsuit over pricey EpiPens (Drug Delivery)

Upcoming Meetings & Events

Europe

  • OTC Device Claims For COPD 'Therapy' Put Patients At Risk – UK Regulator (Pink Sheet-$)
  • The launch of the Life Sciences Industrial Strategy is an important milestone for the industry (ABPI)
  • Pharma is hiding data breaches, claims UK survey (Securing Industry)
  • Apollo Endosurgery wins CE Mark for 12-month Orbera weight loss balloon (MassDevice)

Asia

  • Abbott's FreeStyle Libre wins reimbursement in Japan (Drug Delivery)

India

  • Writ petition against hospitals for stent price violation to come up for hearing at Delhi HC in September first week (PharmaBiz)
  • Govt needs to consider setting up of IDA on par with US FDA to implement new Pharmaceutical Policy: Dr Jagashetty (PharmaBiz)
  • Kerala govt to frame long term strategy to develop pharma sector in the state (PharmaBiz)

Australia

  • Australia Consults On Advertising Reforms, Allowing Direct Promotion Of Pharmacist-Only Drugs (Pink Sheet-$)
  • Submissions received: Strengthening monitoring of medicines in Australia (TGA)
  • Submissions received: Provisional approval pathway for prescription medicines (TGA)
  • Pharmacovigilance Inspection Program (TGA)

Other International

  • First Raxone approval outside Europe for disease causing blindness (PharmaLetter-$)
  • Brazil: Spending On Meds Acquired Through Law Suits Rockets (Pink Sheet-$)

General Health & Other Interesting Articles

  • One third of Americans are headed for diabetes, and they don't even know it (CNBC)
  • Some Thyroid Cancer Patients Can Safely Delay Surgery (KHN)
  • An 'Army Of People' Helps Houston Cancer Patients Get Treatment (NPR)
  • Short Answers to Hard Questions About Health Threats From Hurricane Harvey (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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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