Regulatory Recon: Valeant to Sell Sprout Back to Former Owners Novartis Submits Kymriah for EU Review (6 November 2017)

Posted 06 November 2017 | By Michael Mezher 

Regulatory Recon: Valeant to Sell Sprout Back to Former Owners Novartis Submits Kymriah for EU Review (6 November 2017)

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

In Focus: US

  • Valeant to hand back maker of 'female Viagra' to former owners (Financial Times) (Reuters) (Endpoints)
  • Earnings Preview: What To Expect From Valeant Pharmaceuticals On Tuesday (Forbes)
  • Amgen is shaking up R&D (again), chopping 200 as Genentech targets 130 layoffs (Endpoints)
  • CVS to offer nationwide next-day delivery in preemptive shot at Amazon (USA Today)
  • The Promise of Ecstasy for PTSD (NYTimes)
  • J&J's Stelara shows promise against lupus in study (Reuters)
  • TherapeuticsMD to Resubmit Menopause Pain Drug (Fierce) (Endpoints) (Press)
  • US House approves funding for children's healthcare program (Reuters)
  • Ryan says Obamacare mandate repeal on table in tax debate (Reuters)
  • CDC Reports a Record Jump in Drug Overdose Deaths Last Year (NYTimes)
  • Mumps Makes a Comeback, Even Among the Vaccinated (NYTimes)
  • Drug price regulations are coming state-by-state. Is the industry exposed? (MedCityNews)
  • How science is moving toward diagnosing and treating the NFL's biggest problem: Brain injuries (CNBC)
  • Mylan shares trade higher after full-year forecast raised, shrugging off lower third-quarter sales (CNBC)
  • Current FDA approach to genetically engineered animals is flawed (The Hill)
  • Trump takes on hospitals: the facts behind fight over 340B drug discounts (STAT)

In Focus: International

  • Novartis seeks European approval for cell therapy Kymriah (Reuters) (Pharmafile)
  • Bayer in bid to broaden use of anti-clotting drug Xarelto (Reuters)
  • Speedy EMA review for Jazz' high-risk AML chemo (PharmaTimes)
  • Merck, Pfizer launch Bavencio in UK for rare skin cancer (PharmaTimes)
  • Johnson & Johnson break ground on Chinese factory (MassDevice)
  • Celgene gains French reimbursement for Revlimid in multiple myeloma (PMLive)
  • Teva Seeks Tie Up With Producer of Chinese Viagra (Bloomberg)
  • China's Annoroad Raises Series C Round (BioCentury)
  • WHO Director Address to the G7 Health Ministers (WHO)
  • Briton held in Egypt over drugs made 'honest mistake' (BBC)
  • Roche gives free access to cancer drug after clash with Greek government (PharmaLetter-$)

Pharmaceuticals & Biotechnology

  • Fresenius investing in US to prep for injectables surge (InPharmaTechnologist)
  • Bill Gates and rich allies help fund an alt-biotech startup path for the gene expression experts at Exicure (Endpoints)
  • Many drivers ignore or don't receive warnings about prescription meds (Reuters)
  • Collegium Notified that FDA Will Not Meet PDUFA Goal Date for sNDA for Xtampza® ER (Press)
  • Pfizer's Staph Vaccine: Can Narrow Trial Population Support Broader Claim? (Pink Sheet-$)
  • The atopic dermatitis market (Nature)
  • New Biotech Viscient Partners with Organovo on Fatty Liver Disease (Xconomy)
  • NousCom bags €42M to trial off-the-shelf cancer vaccine (Fierce)
  • Ann Barbier says adios to Agios as she takes up Translate Bio role (Fierce)
  • Allergan CEO Saunders claims 'tenacity' led company into tribal licensing deal (Fierce)
  • JAK inhibition as a therapeutic strategy for immune and inflammatory diseases (Nature)
  • Orphan Drug Pricing Doesn't Drive Healthcare Costs, NORD Argues (Pink Sheet-$)
  • AmerisourceBergen sees end in sight for industrywide generics woes (Fierce)
  • Data Integrity is 'Mission Critical,' FDA Enforcer Says (FDA News-$)
  • Gut bacteria may be key to efficacy of immunotherapies (Pharmafile)
  • Unlocking the Secrets of the Microbiome (NYTimes)
  • Clinical trial transparency: Letting the light in (Pharmafile)
  • Fujifilm Expands Biopharmaceutical Contract Development and Manufacturing Business, Increasing Monoclonal Antibody Capacity for Process Development and GMP Production at U.S.A. and U.K. Sites (Press)
  • Fresenius Kabi Issues Voluntary Nationwide Recall of Midazolam Injection, USP, 2 mg/2 mL Due to Reports of Blister Packages Containing Syringes of Ondansetron Injection, USP, 4 mg/2 mL (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Merck KGaA posts promising osteoarthritis data (Pharmafile)
  • GlaxoSmithKline's Anoro tops Boehringer's Stiolto in head-to-head COPD tilt (Fierce)
  • Efficacy and safety maintained in patients who switched from Humira® to biosimilar Cyltezo® (Press)
  • UCB's VIMPAT® (lacosamide) now approved by FDA to treat partial-onset seizures in pediatric epilepsy patients (Press)
  • Opdivo (nivolumab) Demonstrates Superior 3-Year Survival Benefit for Patients with Previously Treated Advanced Renal Cell Carcinoma (Press)
  • Artemis Receives Orphan Drug Designation From FDA For Artemisone For The Treatment Of Malaria (Press)
  • Otsuka Announces Phase 3 Results for Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease (Press)
  • ACR/ARHP 2017: New Analysis Shows Rheumatoid Arthritis Patients Treated with Baricitinib Reported Greater Improvements in Pain Compared to Adalimumab or Placebo (Press)
  • Six Clinical Presentations on Novocure's Phase 3 Pivotal EF-14 Trial Data in Newly Diagnosed Glioblastoma (Press)
  • ACADIA Presents Data from the Phase II Study of Pimavanserin in Alzheimer's Disease Psychosis (Press)
  • Alcresta Therapeutics, Inc. Presented Results from the ASSURE Study: An Evaluation of the Long-Term Use of RELiZORB® (Press)
  • Phase 3 Studies of the Tezacaftor/Ivacaftor Combination Treatment in People with Cystic Fibrosis Ages 12 and Older Published in the NEJM (Press)
  • Concert Pharmaceuticals Announces Completion of Enrollment in First Cohort of CTP-543 Phase 2a Trial (Press)
  • Flex Pharma Reports Positive Topline Data from Exploratory Phase 2 Trial of FLX-787 in ALS (Press)
  • The Medicines Company and Alnylam Pharmaceuticals Announce Initiation of Phase III Clinical Trials of Inclisiran (Press)
  • AVEO Oncology and EUSA Pharma Announce Promising Phase 1 Results from the Phase 1/2 TiNivo Study of Tivozanib and Nivolumab in Renal Cell Carcinoma (Press)
  • Quark Pharmaceuticals Presents Results from a Positive Ph 2 Study of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery (Press)

Medical Devices

  • Should Medical Devices Come with Expiration Dates? (MDDI)
  • Wearable Tech Emerging For Chronic Pain Relief (Forbes)
  • First US FDA Submission of Wearable Drug-Device Combination Product Based on Sensile Medical's SensePatch Drug Delivery Technology (Press)
  • Neovasc surges on news of appeal, FDA nod for clinical trial (MassDevice) (Press)
  • Medacta wins FDA nod for 3DMetal knee revision implants (MassDevice)
  • Masimo crushes the Q3 earnings forecast, raises outlook (MassDevice)
  • Hill-Rom's Q4, 2017 earnings top estimates, sales miss (MassDevice)
  • Intersect ENT beats Q3 sales estimates, raises full-year forecast (Drug Delivery)
  • Medtronic Receives CE Mark for the World's Smallest Fully Implantable Spinal Cord Stimulator and Announces European Launch of the Intellis Platform (Press)
  • Baxter Highlights New Clinical Data Showing HDx Enabled By THERANOVA Removed Mid-Sized Uremic Toxins During Dialysis (Press)

US: Assorted & Government

  • Sixth Circuit Affirms Dismissal of Off-Label Promotion FCA Case for Lack of Rule 9(b) Specificity (FDA Law Blog)
  • Standing Out (Drug & Device Law)
  • AbbVie Says Evidence Doesn't Back $140M AndroGel Verdict (Law360-$)
  • Janssen, Marketing Co. Can't Escape TCPA Suit After Spokeo (Law360-$)

Upcoming Meetings & Events


  • Alexion Receives New Japanese Patent for Soliris® (eculizumab), Extending Patent Protection Into 2027 and Strengthening Global Patent Portfolio (Press)


  • Price caps to keep Abbott's Xience Sierra off the Indian market (Drug Delivery)
  • Torrent Pharma gets green nod for Rs 300 crore project (Economic Times)
  • Health ministry notifies Rules to make licences for manufacture and sale of drugs valid for ever (PharmaBiz)
  • DCGI issues classification of medical devices & in vitro diagnostics under provisions of Medical Devices Rules, 2017 (PharmaBiz)


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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles