Regulatory Recon: Amgen to Delay Launch of Humira Biosimilar in Settlement With Abbvie; FDA Rejects Intarcia's Diabetes Drug-Device Combo (28 September 2017)

Posted 28 September 2017 By Michael Mezher

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

In Focus: US

  • FDA's New Drug Tracking System May Be Going Off The Rails (Bloomberg)
  • Amgen Delaying US Launch of Humira Biosimilar in Settlement with AbbVie (GEN) (Endpoints) (Financial Times)
  • FDA rejects Intarcia's hotly promoted diabetes drug/device, citing manufacturing issues (Endpoints)
  • FDA approves Abbott's continuous blood glucose monitoring device (Reuters) (MobiHealthNews) (FDA)
  • AmerisourceBergen To Pay $260M After Mislabeling Drugs (Law360-$)
  • Live updates from the FDA advisory panel for PTC's Duchenne muscular dystrophy drug (STAT)
  • PTC's Translarna: US FDA Opts For Simplicity When It Comes To Panel Questions (Pink Sheet-$)
  • Novartis forges UC Berkeley pact, sees drug hopefuls in three years (Reuters) (Endpoints) (Press)
  • Senators want probe of Allergan transfer deal with tribe: letter (Reuters) (Endpoints)
  • After getting crushed by bad data, Zynerba says its cannabis-based drug worked on Fragile X symptoms (Endpoints) (Reuters)
  • Q&A: Biotech analysts explain which CEOs know their stuff & why pharma should be wary of a friendly FDA (STAT)
  • PhRMA CEO announces support for limiting opioid prescriptions (STAT) (The Hill)

In Focus: International

  • Novartis Is Said to Consider Deal for Radioactive-Drug Maker AAA (Bloomberg) (Endpoints)
  • Roche chalks up Swiss approval for multiple sclerosis drug Ocrevus (Pharmafile) (Press)
  • Vaccine order boosts Bavarian Nordic after cancer drug flop (Reuters)
  • EU approves Sanofi and Regeneron's dupilumab in eczema (Reuters) (PharmaTimes) (Press)
  • NICE knocks-back Janssen's Imbruvica in mantle cell lymphoma (PharmaTimes)
  • Could the new EU Medical Devices Regulation put the UK MedTech industry in peril? (Pharmafile)
  • WHO reports 25 million unsafe abortions a year; expert sees higher risk from US cutbacks (Reuters) (WHO)
  • Merck KGaA eyes up to 700 million euro Mavenclad sales in EU (Reuters)
  • Abiomed invests in Israeli medical device maker Magenta (Reuters)
  • China Approves Novo's Tresiba (BioCentury)

Pharmaceuticals & Biotechnology

  • Regenerative Medicine Advanced Therapy: FDA's Newest Expedited Program Evolves to Keep Pace with Recommendations (FDA Law Blog)
  • FDA's Approach to Analytical Similarity for Proposed Biosimilars (FDA Law Blog)
  • FDA Brass, BigLaw Attys Dish On New Promo Policies (Law360-$)
  • Spotlight – How politics has affected the timing of drug price rises (EP Vantage)
  • CETP Inhibitors — A New Inning? (NEJM)
  • Pharma's pricing pledges? Maybe they weren't such a good idea in the first place, experts say (Fierce)
  • PPD to run first-in-human trial of Treos' lead cancer vaccine (Fierce)
  • Many adults with diabetes delay insulin therapy (Reuters)
  • Priority Review Voucher Fees to Rise in FY2018 (FDA: Rare Pediatric Disease, Tropical Disease)
  • Merck adds real patient to 'TRU' Keytruda TV ad (Fierce)
  • Boehringer's new risk-prediction model will tap patients who could be good Jardiance candidates (Fierce)
  • Mateon cuts cancer combo test, costs as it refocuses efforts (Fierce)
  • Gilead Sciences (GILD) Says COO Kevin Young to Retire (Street Insider)
  • Students Look to Vending Machines for Better Access to Morning-After Pill (NYTimes)
  • Biotech researchers chart progress in fighting substance abuse (Fierce)
  • The thinking process behind biopharma companies' outsourcing management (Fierce)
  • Indications for and Adverse Effects of Red-Cell Transfusion (NEJM)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Tricida Initiates Phase 3 Study of TRC101 for the Treatment of Metabolic Acidosis Associated With Chronic Kidney Disease (Press)
  • Entasis Therapeutics to Present Phase 1 Data on ETX2514 at IDWeek 2017 (Press)
  • CBT Pharmaceuticals Announces First U.S. Patient Dosed in Phase 1 Clinical Trial of c-Met inhibitor, CBT-101, for Advanced Solid Tumors with c-Met Dysregulation (Press)
  • ERYTECH Reports Determination of the Recommended Pivotal Phase 3 Dose of eryaspase in its US Phase 1 Study in First Line Adult ALL (Press)
  • SciFluor Announces Positive Results of Phase 1/2 Study of SF0166 Topical Ophthalmic Solution in Diabetic Macular Edema Patients (Press)

Medical Devices

  • Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee (FDA)
  • Why Cybersecurity Must be Part of Medical Device Architecture (MDDI)
  • Should the medical device industry pay user fees to CMS? (MassDevice)
  • It All Starts with Feasibility (MDDI)
  • FDA Approves Medtronic HeartWare VAD for Destination Therapy (Medpage) (Press)
  • Dexcom CEO: Bringing meaningful data to the diabetes community (MassDevice)
  • FDA clears app-driven, easy-to-clean ECG device (MobiHealthNews)
  • Qualcomm out-licenses single-use, biometric patch for patient monitoring (MassDevice)
  • EOI Announces FDA Clearance for the FLXfit15, the Only 3D Articulated Expandable Cage With 15 degrees of Lordosis Correction (Press)
  • Avita Medical Announces Submission of FDA Premarket Approval (PMA) Application for the ReCell® Device for Treatment of Burn Injuries (Press)

US: Assorted & Government

  • Trump 'not happy' with U.S. health chief Price over private travel (Reuters)
  • FDA Not Doing Enough To Fix Serious Food Safety Violations, Report Finds (NPR)
  • US brings new charges over Tenet Healthcare fraud scheme (Reuters)
  • NIH Clinical Center provides one of the largest publicly available chest x-ray datasets to scientific community (NIH)
  • The hunt for illegal opioids in the U.S. starts inside JFK airport (CBS)
  • Illinois and Colorado Courts Reject Stengel/Hughes Failure to Warn Claims (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • BD offers EU concessions in $24B Bard acquisition (MassDevice)
  • Ergomed makes moves to acquire Dutch CRO (PharmaTimes)
  • Stallergenes Greer joins the ABPI as a full member (ABPI)
  • A 'fourth industrial revolution' under a Labour Government (ABPI)
  • Measles eradicated in the UK, according to WHO (Pharmafile)
  • CardioFocus lands CE Mark for next-gen atrial fibrillation balloon (MassDevice)
  • TVA Medical wins CE Mark for EverlinQ 4 endoAVF (MassDevice)

Asia

  • MilliporeSigma opens Chinese bioprocessing centre to showcase tech (BioPharmaReporter)
  • Amgen and Simcere announced collaboration to develop and commercialize biosimilars in China (Biosimilar News) (Fierce)
  • LivaNova, Microport win approval for Rega pacemakers in China (MassDevice)

India

  • Pharma companies lag in digital journey against global counterparts (Economic Times)
  • India Pharma in pain again, investors dump stocks (Economic Times)
  • Hilleman Laboratories receives Swedish grant for oral cholera vaccine (Economic Times)
  • Divi's Labs gets US FDA Form 483 for Vizag API plant (InPharmaTechnologist)
  • Aurobindo hit with US FDA Form 483 for cephalosporin plant (InPharmaTechnologist)
  • Pharmacists and experts urge govt to frame an Act for pharmaceutical waste management (PharmaBiz)
  • Gujarat FDCA trains 50 drug inspectors for auditing manufacturing units on cGMP, GLP (PharmaBiz)

Australia

  • Labelling changes: information for sponsors (TGA)

Other International

  • Novo Nordisk Egypt promotes new General Manager (Pharmafile)

General Health & Other Interesting Articles

  • Creative Minds: Mapping the Biocircuitry of Schizophrenia and Bipolar Disorder (NIH)

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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