Regulatory Recon: FDA Approves New Indication for Roche Immunotherapy EU Court Rules Against German Drug Price Floor (19 October 2016)

Posted 19 October 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves New Indication for Roche Immunotherapy EU Court Rules Against German Drug Price Floor (19 October 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Kite Pharma Details CAR-T Therapy Launch, Floats Pricing Benchmarks (SCRIP-$) (Endpoints)
  • Roche's lung cancer drug wins U.S. approval (Reuters) (Medpage) (Medscape) (Press) (FDA)
  • J&J prepares for drug price war with Pfizer (Financial Times) (PMLive) (WSJ)
  • Novel Cholesterol Drugs Move Forward In Clinical Trials (CardioBrief) (Fierce)
  • St. Jude and Abbott to sell some medical devices for $1.12 billion (Reuters)
  • Election Surprise: Hillary Wins Biotech Popularity Contest (WSJ)
  • Drug Company Falsely Claimed Patients Had Cancer, Feds Allege (C-HIT)
  • Gene Therapy in U.S. Is On Track for Approval as Early as Next Year (MIT Technology Review)
  • Celgene Skips the Placebo, Fails Drug Development 101 (The Street)
  • Biosimilar Clinical Trials Face Enrollment Challenges (Pink Sheet-$)
  • CRISPR Therapeutics Raises $56M In IPO, Half Its Rivals' Haul (Xconomy)
  • Merck's antiviral drug meets main goal in late-stage trial (Reuters) (Press)
  • Regeneron and Teva to bar OA patients from fasinumab trials after US study halt (In-PharmaTechnologist)
  • Illumina, Genentech And BIO Weigh In On FDA Draft Guidance On Companion Diagnostics (Focus)
  • Boston Scientific Urges High Court To Nix $308M IP Verdict (Law360-$) (MassDevice)
  • J&J eyes immuno-oncology with 15 R&D assets (Fierce)
  • FDA Proposes To Withdraw Two Generic Versions Of ADHD Drug Concerta (Focus)
  • Despite Promising Early Data, The New Cholesterol Lowering Drug - PCSK9si - Has Significant Hurdles (Forbes)
  • Review/Inspection Control Strategy Communications Key to Advancing Biotech Regulation, FDA Biotech Official Stresses (IPQ)
  • As the Patient-Focused Drug Development "Pilot" under PDUFA V Concludes, Is FDA Passing the Baton to Patient Organizations? (FDA Law Blog)

In Focus: International

  • EU court quashes German prescription drug price floor (Reuters)
  • UK losing out on global R&D investment, says ABPI report (PharmaLetter-$)
  • Cancer paper flagged due to "credible" concerns over its reliability, journal says (Retraction Watch)
  • India Releases Draft Medical Device Rules (CDSCO)
  • Abbott's vascular tech is big in Japan (EP Vantage)
  • DMC halts Daiichi's 'breakthrough' PhIII Enliven trial (Fierce)
  • UNICEF clinches vaccine deal to protect children from five diseases (Reuters)
  • Positive real world evidence on physician-led switching to biosimilar meds; NOR-SWITCH study (PharmaLetter 1, 2-$) (BioPharmaReporter) (EFPIA)
  • Does India's Perpetual Licensing Plan Risk Backfiring? (Pink Sheet-$)
  • IMDRF Advances Three Device Guidelines For Public Consultation (Focus)

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US: Pharmaceuticals & Biotechnology

  • FDA's Opioid Crisis Response: More Pressure For Treatment Drugs (Pink Sheet-$)
  • Drug Trials Snapshots: EXONDYS 51 (FDA)
  • Ethical Pharma's Code of Ethics (IDEA Pharma via LinkdedIn Pulse)
  • Doctors Can't Sue FDA Over Drug's Approval(Courthouse News Service)
  • Is Pricing the New Frontier? (Policy and Medicine)
  • Coherus, In Ring As A Biosimilar Contender, Hopes To Smack Down Humira (SCRIP-$)
  • Women report vaginal ring for preventing HIV had little effect on sexual intercourse (NIH)
  • Novartis, late to the Advair generics party, urges FDA to block rival copycats (Fierce)
  • Medicare formularies add to the squeeze on key Novo Nordisk, Sanofi insulins (Fierce)
  • Celgene partners to develop ResearchKit app for observational study (Fierce)
  • Can this new drug slow the progression of Alzheimer's? (CNBC)
  • NIH contributes to global effort to prevent and manage lung diseases (NIH)
  • NIH study determines key differences between allergic and non-allergic dust mite proteins (NIH)
  • Biotech venture funding shrinks as post-boom shape emerges (EP Vantage)
  • Is It A Buyer's Market For Private Biotech Deals? (Forbes)
  • Legal Battle Over 100-Year-Old Drug Previews Big Price Hike (Law360-$)
  • 7th Circ. Backs Teva In Atty's Breast Cancer Suit (Law360-$)
  • Lannett Comments On FDA Proposal Regarding Methylphenidate Extended Release Tablets (Press)
  • Pfizer Awarded Grant to Evaluate Vaccine to Protect Newborns Against Group B Streptococcus Infection (Press)
  • Certara's Simcyp Division Awarded Modeling and Simulation Grant From the US FDA's Office of Generic Drugs (Press)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; PRILOSEC OTC (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; REPATHA (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; PLEGRIDY (FDA)

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

  • Success for Clementia's Phase II Fibrodysplasia Ossificans Progressiva trial (EPR)
  • Keystone Nano Announces The US FDA Has Awarded Orphan Drug Designation For Ceramides For The Treatment Of Liver Cancer (Press)
  • Omeros Announces Positive Data from Phase 2 Clinical Trial Evaluating PPAR-gamma Agonist in Cocaine Abuse (Press)

US: Medical Devices

  • US FDA Adopts IMDRF Software as Medical Device Clinical Evaluation Proposals (Emergo) (Focus)
  • Imaging Advance Offers New View on Allergic Asthma (NIH)
  • FDA to med device makers: We must work together on security (Fierce)
  • New Company RPRD Seeking to Test DNA, Anticipate Reactions to Drugs (Xconomy)
  • Class 1 Device Recall Rusch TracheoFlex Tracheostomy Tube (FDA)
  • Merck Manuals' Robert Porter: Mobile tech a 'must have' for docs (Fierce)
  • St. Jude Medical launches pediatric trial for Amplatzer Duct Occluder II AS cardiac implant (MassDevice) (Press)
  • Johnson & Johnson, Texas Medical Center launch medical device accelerator (MassDevice) (Xconomy)
  • Study finds mixed results for use of mesh for hernia repair (MNT)
  • Sony to Release 4K 3D Medical Monitors for Surgical Applications (MedGadget)

US: Assorted & Government

  • Rate Increases for Health Plans Pose Serious Test for Obama's Signature Law (WSJ)
  • Medicare Spent $359 Million on Unnecessary Chiropractic Care in 2013, Audit Finds (WSJ)
  • Andy Slavitt on MACRA, Minnesota and more (Politico)
  • No More Vaginal Mesh Suits, MDL Judge Says (Law360-$)
  • S.D. Cal. Shows No Love for Aphrodisiac Class Certification (Drug and Device Law)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Priority Review Voucher Summit – 2-3 November 2016
  • CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Overview of GDUFA II and Implementation of GDUFA II User Fees – 28 October 2016
  • Webinar - Final Guidance Documents: "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" and "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use" – 21 November 2016


  • BASF halts production at Ludwigshafen plant after deadly explosion (In-PharmaTechnologist)
  • HiberGene Receives CE Mark for Group B Strep Test (GenomeWeb)
  • TiGenix's Crohn's disease drug granted Swiss orphan drug designation (EPR)
  • Swedish Orphan Biovitrum AB: European Commission Grants SOBI003 Orphan Designation for the Treatment of MPS IIIA (Press)
  • More than a million Norwegians demand government action on clinical trial transparency (AllTrials)
  • September 2016: Multiple sales of analgesic-containing in retail outlets (MHRA)
  • UK processing training centre to boost pharma manufacturing sector (In-PharmaTechnologist)
  • Burden of Six Healthcare-Associated Infections on European Population Health: Estimating Incidence-Based Disability-Adjusted Life Years through a Population Prevalence-Based Modelling Study (PLOS)
  • Organs, Blood, Tissues & Cells In The EU (EC)


  • Sinovac Take-Private Deal Facing Challenges (SCRIP-$)
  • Zai picks up GSK inflammation candidates (BioCentury)
  • AMED-A*STAR Joint call for Strategic International Collaborative Research Program (SICORP) (AMED)
  • Clinigen makes foray into Japan (BioSpectrum)
  • China Approval Watch: September Dominated By Generics And Vaccines (Pink Sheet-$)
  • Turkey Prepares For Great Leap Forward In IPR (Pink Sheet-$)
  • Astellas Termination of Business Transfer Discussion with Kaketsuken (Press)


  • Maha FDA suggests to NPPA to bring imported cardiac stents & drug eluting stents under price control (PharmaBiz)
  • IDMA suggests simplification of labelling to avoid confusion among stakeholders including patients and govt authorities (PharmaBiz)
  • Recipharm commits SEK5m to bioanalysis lab citing lack of Nordic capacity (In-PharmaTechnologist)
  • Sun Pharma partners with ICGEB to develop dengue vaccine (Pharmafile)
  • Mandatory norms for health products soon (Economic Times)


  • U.S. health officials outline Zika spending priorities (Reuters)
  • Zika Virus Found in Woman's Vagina for Weeks (NBC)

General Health & Other Interesting Articles

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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