Regulatory Recon: FDA Approves Otsuka, Proteus' Digital Pill; Janssen Drops Suit Against Samsung Bioepis' Remicade Biosimilar (14 November 2017)

Posted 14 November 2017 By Michael Mezher

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

In Focus: US

  • FDA approves digital pill that tracks when patients take it (Reuters) (NYTimes) (WSJ) (STAT) (Press) (FDA)
  • Health officials lay out progress toward regulatory reform under Trump (STAT)
  • Hospitals Sue to Block HHS From Slashing Lucrative Drug Subsidies (WSJ)
  • Neurodegeneration upstart Denali outlines $100M IPO for its growing clinical work (Endpoints) (Fierce) (Xconomy)
  • Oh, No, a Pharma Exec (WSJ)
  • Janssen drops US lawsuit against Samsung Bioepis' Remicade copy (Reuters)
  • Fed. Circ. Clears Apotex In Neulasta Biosimilar Patent Row (Law360-$)
  • FDA warns against using kratom for opioid addiction (Reuters) (STAT) (FDA)
  • The FDA Warns Against Injectable Silicone for Body Contouring and Enhancement (FDA)
  • Amazon to regulators: We won't use state licenses to sell prescription drugs (CNBC)
  • New blood pressure range means half of Americans have hypertension (Reuters)
  • Cost of diabetes epidemic reaches $850 billion a year (Reuters)
  • Taking A Page From Pharma's Playbook To Fight The Opioid Crisis (KHN)
  • US Hospitals Face a Shortage of This Most Basic Necessity (Bloomberg)
  • Vaccine Shortage Complicates Efforts To Quell Hepatitis A Outbreaks (KHN)

In Focus: International

  • Loxo, Bayer to co-develop cancer drugs in up to $1.55 billion deal (Reuters) (Endpoints) (Press)
  • Amgen drops two-brand Avastin biosimilar strategy in Europe (BioPharmaReporter)
  • Why Don't EMA and FDA Speak With the Same Voice on Flu Treatments? Researchers Investigate (Focus)
  • MDR, IVDR: Competent Authorities Lay Out Road Map (Focus)
  • EMA, EUnetHTA Sign Off on Three-Year Work Plan (Focus)
  • French Govt Calls For 70% Biosimilar Prescribing Rate; Substitution Groups Published (Pink Sheet-$)
  • Sandoz says new clinical data support two biosimilars (Reuters)
  • Boehringer Ingelheim's adalimumab biosimilar Cyltezo approved in Europe (Biosimilar News) (PharmaTimes) (Press)
  • EU PRIME status for Mereo's brittle bone drug (PharmaTimes)
  • Scotland approves three new meds for NHS use (PharmaTimes)
  • NICE turns down Shire's Revestive for bowel condition (PharmaTimes)
  • Novartis launches heart drug counter-offensive (Reuters)
  • PTC Readies China Plan Amid US FDA Translarna Setback (Pink Sheet-$)
  • Asia Regulatory Roundup: Pakistan Proposes Strengthening Quality Control Unit Requirements  (Focus)
  • Biocon arm widens partnership terms with Bristol-Myers Squibb (Economic Times)
  • Why Industry Wants ICH To Harmonize Process Validation Guidance (Pink Sheet-$)
  • USFDA Inspecting Sun Pharma's Injectibles Plant (Bloomberg)
  • Mallinckrodt Stock Lowered to 'Neutral' at UBS Over Persisting Concerns (The Street)
  • Valeant Stock Tumbles on $750 Million Debt Offering Announcement (The Street)

Pharmaceuticals & Biotechnology

  • Biotech firms race to recruit good bugs in war on cancer (Reuters)
  • Nanotech, gene editing used to edit cholesterol gene in mice (Reuters)
  • Enhanced understanding of the microbiome is helping medicine (The Economist)
  • Forget BMS. Pfizer should chase a Biogen buy, analyst suggests (Fierce)
  • San Diego's stealthy Odonate surfaces with $173M IPO (Endpoints)
  • Alnylam: The $12bn company with the $2bn war chest (EP Vantage)
  • Quality-by-design: How to mitigate risk in drug development (OutsourcingPharma)
  • Dual Injection Approvals? A Comparison Of Indivior, Braeburn Buprenorphine Products (Pink Sheet-$)
  • New ANDA Review Pathways: Should You Be A Priority Or Expedited? (Pink Sheet-$)
  • Lilly Appoints Philip Johnson to Senior Vice President and Treasurer (Press)
  • Small viruses could accelerate cell and gene therapy research (Novartis)
  • Seres teams with cancer heavyweights for microbiome-checkpoint inhibitor combination trial (Fierce)
  • Torque takes tumor tech out of stealth with $25M backing, new CEO (Endpoints) (Fierce)
  • ImmusanT scores a $40M round for PhII celiac study, with biotech vet Tom Daniel joining the board (Endpoints)
  • Stunning Video Is the First to Show CRISPR Editing DNA in Real Time (Gizmodo) (Nature)
  • FDA Renews and Expands Its Portfolio of Simcyp Simulator (PBPK) Licenses (Press)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Jardiance® reduced risk of cardiovascular death in adults with type 2 diabetes and peripheral artery disease (Press)
  • Puma Biotechnology's 5-Year Analysis of Phase III ExteNET Study Published Online in The Lancet Oncology (Press)
  • Novartis targets specific patient population with strong Ilaris Phase 3 data (Pharmafile)

Medical Devices

  • MedShape Announces FDA Clearance for the DynaNail® XL (Press)
  • These 5 surgical startups want to build the OR of the future (Medical Design & Outsourcing)
  • How to Identify Crossover Technologies That Work for Medtech (MDDI)
  • Medtech Employers Need to Keep Pace with Job Market (MDDI)
  • Avinger slashes jobs, Q3 sales down 61% (Medical Design & Outsourcing)
  • Urotronic launches feasibility trial of drug-coated balloon (Drug Delivery)
  • FDA clears Cianna Medical's Savi Scout breast cancer locator for long term implants (MassDevice)

US: Assorted & Government

  • US transportation workers to face testing for prescription opioids next year (CNBC)
  • Opinion: Leave drug safety to the FDA, not the assistant secretary of Defense (The Hill)
  • Preventing Drug Abuse: Low Participation by Pharmacies and Other Entities as Voluntary Collectors of Unused Prescription Drugs (GAO)
  • Pharma Case Highlights Importance Of Unrebutted Evidence (Law360-$)
  • Pharma Salesman Cops To Defrauding NJ Insurance Programs (Law360-$)
  • FDA Denies Millennium Petition on Generic VELCADE and . . . Yada, Yada, Yada . . . Permits ANDA Labeling "Carve-in"/"Carve-up" ( FDA Law Blog)
  • Forum Non Conveniens and Choice of Law – Issues Post BMS (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Hansa Medical mourns death of CEO (Pharmafile)
  • PIP breast implant scandal: A story that triggered change (MassDevice)
  • MSD collaboration: the role of vaccines in helping combat antimicrobial resistance (AMR) (ABPI)
  • Most UK supermarkets falling short in fight against antibiotics crisis (The Guardian)
  • Recipharm cutting Swedish manufacturing but 'unlikely' to sell facilities (InPharmaTechnologist)
  • Q & A on PSUSA: Guidance document for assessors (EMA)
  • Explanatory Note to GVP Module VII (EMA)
  • Former Sanofi UK head joins Pertinax Pharma as chairman (PharmaLetter-$)
  • Orthocell wins CE Mark for CelGro device (Drug Delivery)

India

  • Hetero launches FDC combination of key HIV drugs (Economic Times)
  • India signals shift on stent pricing cap (MassDevice)
  • Over 50% cut in stent prices has not lowered treatment cost for patients (Economic Times)
  • Only 'immaterial dent' due to FDA action: Lupin (Economic Times)
  • DRL launches anti-cancer drug in US market (Economic Times)
  • Indian Pharmaceutical Alliance pitches for exception of GST on expired and damaged drugs (PharmaBiz)
  • AMTZ soon to house eight medical device testing labs in India's first medical device park (PharmaBiz)

Other International

  • Delivering medical supplies into the remote Amazon is a big challenge, but drones could help (CNBC)

General Health & Other Interesting Articles

  • The Secret to Long Life? It May Lurk in the DNA of the Oldest Among Us (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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