Regulatory Recon: Kite Submits First CAR-T Application in Europe; FDA Reviewers Raise Safety Concerns for J&J's RA Drug Sirukumab (31 July 2017)

Posted 31 July 2017 By Michael Mezher

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

In Focus: US

  • AstraZeneca fights back in cancer with new hires, breakthrough designation for Imfinzi (Reuters) (Financial Times) (The Street) (Fierce)(Press)
  • J&J Arthritis Drug Sirukumab Raises Safety Concerns: FDA Reviewers (Reuters) (Endpoints)
  • The FDA's War on (Expensive) Drugs (Bloomberg)
  • FDA approvals for the first 6 months of 2017 (Nature)
  • Trump's FDA Chief Charts a Policy Shift Beyond Tobacco Products (Bloomberg) (FDALawBlog) (Reuters) (NYTimes)
  • Bristol-Myers, Clovis leap into PhIII combo studies in a PD-1/PARP play as rivals circle (Endpoints) (Press)
  • Biogen poaches Pfizer vet Villalobos for biotherapeutics lead (Fierce) (Press)
  • Data supports safety of Dynavax hepatitis B vaccine: US FDA panel (Reuters) (Endpoints)
  • FDA to review Teva and Celltrion's cancer biosimilar drug (Reuters) (Press)
  • Amgen And Allergan Submit Biosimilar Biologics License Application For ABP 980 To US Food And Drug Administration (Press)
  • Express Scripts' 2018 National Preferred Formulary (Express Scripts)
  • Trump threatens to end insurance payments if no healthcare bill (Reuters) (Politico)
  • Majority of Americans want Congress to move on from healthcare reform (Reuters)
  • How to Repair the Health Law (It's Tricky but Not Impossible) (NYTimes)
  • About That "First Gene-Edited Human Embryos" Story..... (Scientific American)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

  • BSI's 6th Annual, full-day medical device Roadshow will guide participants to new EU Medical Device/In-Vitro Device Regulation compliance. The program examines key issues facing Med Dev Manufacturers under the new MDR/IVDR starting with an overview, then analyzing legacy products and transitional provisions. Implementation issues including conformity assessments, essential/clinical requirements, SPR, labeling and QMS impacts of these standards will be detailed.
  • Check here for specific dates, locations and the program agenda.

In Focus: International

  • Kite shoots for first CAR-T OK in Europe, staying one step behind Novartis in US race (Endpoints) (Press)
  • AbbVie's drug for all types of hepatitis C wins EU approval (Reuters) (BioCentury)
  • Sanofi raises 2017 outlook on strong Q2 sales (Financial Times) (Press)
  • Nearly 500 researchers guilty of misconduct, says Chinese gov't investigation (Retraction Watch)
  • Evotec expands global discovery, development ops with $300M Aptuit buyout (Endpoints)
  • NICE bars obesity pill from routine NHS use (PharmaTimes)
  • Pharma companies' reputations nosediving in the UK, finds report (Pharmafile)
  • South American Pricing Coalition Sets Sights On Alexion's Soliris and Monoclonal Antibodies (Pink Sheet-$)
  • India set to block $1.3 billion Gland Pharma-Fosun deal: Report (Economic Times)
  • Dutch-Led Fund Raises $300 Million To Replace U.S. Funding For Sexual Health (NPR)'
  • Denmark presents its official bid to host EMA in Copenhagen (Denmark Ministry of Foreign Affairs)

Pharmaceuticals & Biotechnology

  • Loxo beefs up its genetics-based cancer drug pipeline with an unusual $40M deal (Endpoints) (Fierce)
  • InVivo Therapeutics shares tank after a third patient death in lead study (Endpoints) (Press)
  • Q&A: Regulating Stem Cell Therapy (Medpage)
  • Doctors often don't tell you about drug side effects, and that's a problem (NYTimes)
  • CPhI Annual Reports — how accurate were they 5 years on? (Manufacturing Chemist Pharma)
  • Real World Data and Evidence – FDA to Take Another Look (Lachman Consultants)
  • Biopharmaceutical industry policies aim to increase access to clinical trial data (PhRMA)
  • LabCorp nabs Chiltern, boosting its big Covance CRO group to 20K-plus staffers in $1.2B deal (Endpoints)
  • By the Numbers: Getting to Know U.S. Pain Patients (Medpage)
  • AstraZeneca and MedImmune strengthen immuno-oncology leadership with appointment of two renowned experts (Press)
  • Challenges and Threats to FDA Resources: An Update (Alliance for a Stronger FDA)
  • Aerie swoops on DSM tech for eye disease candidates (Fierce)
  • Cyclobenzaprine HCl and Amantadine HCl by Apace Packaging: Recall - Potential Mislabeling (FDA)
  • Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported (FDA)
  • ICU Medical Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter (FDA)
  • Personalization expert Pandora's pharma practice takes off after patient-data partnership (Fierce)
  • FDA Offers Sage Advice On Contract Manufacturers: Don't Mix Drugs And Car Wax (Pink Sheet-$)
  • Invenra Signs On With Merck in Antibody Discovery Partnership (Xconomy)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • PellePharm readies hedgehog inhibitor for phase 3, plans series C after claiming success in small rare disease study (Fierce) (Press)
  • Actelion spinout Idorsia hits goals in insomnia phase 2, sparking stock rise and talk of partnering up for pivotal trial (Fierce)
  • Ra Pharmaceuticals Receives Orphan Drug Designation from the U.S. FDA for RA101495 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (Press)
  • Alcresta Therapeutics Announces Positive Results, RELiZORB® Increased Fat Absorption in Both Adult and Pediatric Patients with Cystic Fibrosis Receiving Enteral Nutrition (Press)
  • Veracyte Announces Pivotal Clinical Validation Data for Afirma Genomic Sequencing Classifier Presented at World Congress on Thyroid Cancer (Press)
  • Galera Therapeutics Announces Promising Innovative Medicines Designation from the United Kingdom's Medicines and Healthcare Products Regulatory Agency for GC4419 for the Reduction of Oral Mucositis in Head and Neck Cancer Patients (Press)

Medical Devices

  • When Robots Become Specialists (MDDI)
  • These New Devices Promise to Fight Pain without Opioids (MIT Technology Review)
  • Hearing-aid firm Amplifon is loud & clear: we are predator, not prey (Reuters)
  • Quantitative Insights wins FDA de novo nod for QuantX machine learning cancer diag (MassDevice)
  • Medtronic Completes Sale of a Portion of Its Patient Monitoring & Recovery Division to Cardinal Health (Press)
  • Accuray Receives 510(k) Clearance for iDMS™ Data Management System Upgrade for the TomoTherapy® System (Press)
  • Haemonetics wins FDA 510(k) for NexSys PCS plasmapheresis system (MassDevice)
  • Bruker Announces US FDA Clearance of Expanded 3rd Claim for MALDI Biotyper (Press)
  • Immunalysis Receives FDA Clearance for SEFRIA™ Fentanyl Urine Drug Screening Test (Press)
  • QT Vascular launches pivotal trial for drug-coated peripheral balloon (MassDevice)

US: Assorted & Government

  • The Next Big Healthcare Battle: Kids (Medpage)
  • Anthem reports data breach impacting 18,500 members (Fierce)             
  • Patent watch: Supreme Court decision favours biosimilars (Nature)
  • C.R. Bard faces DoJ FCA probe, posts Q2 earnings (MassDevice)
  • Arkansas limits on abortion pill can proceed: appeals court (Reuters)
  • NJ Appeals Court Revives 2K Cases In Accutane Litigation (Law360-$)
  • Gilead Says Macleods India Infringed HIV Medication Patents (Law360-$)
  • PTAB To Review 3 Herceptin Patents In Hospira Challenge (Law360-$)

Upcoming Meetings & Events

Europe

  • An unsurprising case of software qualification (MedicalDevicesLegal)
  • Drugs to be subjected to total labeling in Russian pharmaceutical market (Law360-$)
  • Medtronic Announces CE Mark and European Launch of CoreValve(TM) Evolut(TM) PRO Transcatheter Valve with Advanced Sealing (Press)

Asia

  • Myanmar H1N1 swine flu death toll rises to 10 (Reuters)
  • Astellas Submits Application for Approval of fidaxomicin for the Treatment of Infectious Enteritis Caused by Clostridium difficile in Japan (Press)

India

  • Cipla eyes filing over 20 ANDAs in US this fiscal (Economic Times)
  • CDSCO all set to launch portal to regulate online pharmacy trade (PharmaBiz)
  • Board seat: Alembic junks small shareholder plea (Economic Times)
  • Experts see EU Track & Trace Regulations a blessing in disguise for Indian pharma industry (PharmaBiz)
  • Revised draft norms for stem cell research marks many restrictive areas (PharmaBiz)
  • Lupin's Aurangabad plant undergoes USFDA inspection (Economic Times)
  • After 'perfect storm', Dr Reddy's seeks recovery this fiscal (Economic Times)
  • Alembic Pharma gets USFDA go-ahead for anti-bacterial drug (Economic Times)

Canada

  • Notice: Validation rules for regulatory transactions provided to Health Canada in the "non-eCTD electronic-only" format (Health Canada)
  • Canadian Health Minister Considering Forced Transparency (Policy & Medicine)

Australia

  • Opdivo added to Australia's PBS, making it one of the biggest ever listing (PharmaLetter-$) 

    General Health & Other Interesting Articles

    • Doctors frustrated that electronic records steal time from patients (Reuters)

    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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