Regulatory Recon: FDA Warns of Deaths From Incorrect Ocaliva Dosing; Versartis' Shares Plummet After Growth Hormone Fails in Phase III (22 September 2017)

Posted 22 September 2017 By Michael Mezher

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

In Focus: US

  • FDA warns of death, liver injury risks from Intercept's drug (Reuters) (Medpage) (FDA)
  • Versartis shares hammered by a PhIII flop as growth hormone flunks key test (Endpoints) (Reuters) (Fierce)
  • State funding changes in spotlight in Republican healthcare bill (Reuters)
  • 'Clinical Trials System is Broken,' FDA Drug Chief Says (Bloomberg) (Focus)
  • AbbVie's top execs paint a rosy pic of the mega-blockbuster future looming for Humira and PhIII drugs (Endpoints)
  • AbbVie pairs up another ADC cancer drug with Bristol-Myers Squibb's Opdivo (Fierce) (Press)
  • Two years on, Allergan's $1.7B NASH drug still looks weak — at best (Endpoints)
  • The opioid crisis can't be blamed on Big Pharma alone (CNBC)
  • FDA Offers Draft Guidance on Statistical Approaches to Evaluating Similarity for Biosimilars (Focus)
  • Five Ways to Get CRISPR into the Body (MIT Technology Review)
  • A drug maker wants to use Botox technology to cure America's opioid addiction (Quartz)
  • To advance medicine's future, the NIH tries to win the trust of communities mistreated in the past (STAT)
  • Public Citizen Sues FDA Over OTC Drug Risks (Focus)

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

  • Japan health minister to consider US drug firms' views in pricing overhaul (Reuters)
  • Roche receives EU approval for Gazyvaro, European approval for Actemra (Reuters) (Press)
  • EMA's Future Home: Assessment Of Bids Nears Completion Amid Growing Staff Concerns (Pink Sheet-$)
  • NICE recommends Bayer's Eylea for myopic chorodial neovascularization (Pharmafile)
  • Turkey Finds Permanent Solution To Tamoxifen Shortage (Pink Sheet-$)
  • Sanofi's Kevzara will be funded for NHS use (PharmaTimes)
  • EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias (Focus)
  • EU allows use of UCB's anti-epileptic Vimpat in children (PharmaTimes)
  • Addressing The Gap In Noncommunicable Disease Data With Technology And Innovation (Health Affairs Blog)

Pharmaceuticals & Biotechnology

  • Pharma Executives Need Convincing About Value-Based Contracts (SCRIP-$)
  • NIH Aims to Ease Access to Genomic Summary Results (GenomeWeb)
  • Revisions to Compounding Guidance?  Where Will That Take Us? (Lachman Consultants)
  • Pfizer's fast-growing Ibrance romps toward an early $5B payoff: analyst (Fierce)
  • OrbiMed, RA Capital back a $26M raise for Realm's two mid-stage drugs (Endpoints)
  • The U.S. Drug Price Catastrophe and the Central Planner (Harvard Bill of Health)
  • Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem (Nature)
  • Celgene-backed FLX picks CCR4 antagonist for clinical trials (Fierce)
  • FDA to Hold Meeting on Home Collection of Pap Smears: Possible Broader Implications? (FDA Law Blog)
  • Daiichi, Inovalon Exploring Abuse-Deterrent Opioid Outcomes (BioCentury)

Medical Devices                                                   

  • First Percutaneous Pump Approved for Right Heart Failure (Medpage)
  • After a 'game changing' FDA approval, a former HHS official says mobile apps will reshape addiction treatment (Fierce)
  • FBI OKs Genetic Profiles Generated by Thermo Fisher Scientific Kit (GenomeWeb)
  • Zapping the brain for stroke rehab: Pivotal clinical trial begins (STAT)
  • Abbott Secures FDA Approval for MRI-Compatibility for the Company's Ellipse ICD (Press)
  • Medtronic Announces Clinical Study to Evaluate the CoreValve(TM) Evolut(TM) PRO System in 'Everyday' Clinical Practice (Press)
  • Brainlab wins FDA nod for Elements Spine, Cranial SRS radiosurgery planning software (MassDevice)
  • Convenience, compliance & control: How Insulet is changing insulin delivery tech (Drug Delivery)

US: Assorted & Government

  • Johnson & Johnson challenges $417M talc verdict, its largest defeat yet (Fierce)
  • Awful Missouri Venue and Warnings Opinion Affirmed—But Maybe Some Hope (Drug & Device Law)
  • High On Drugs? Anthem Cites Soaring Drug Costs To Justify 35% Rate Hike in California (KHN)

Upcoming Meetings & Events

Europe

  • Endologix wins refined CE Mark indications for Nellix stent graft (MassDevice)

Asia

  • Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Gastric Cancer Which Has Progressed After Chemotherapy (Press)
  • Counterfeits part of 'triple threat' facing pharma in China (Securing Industry)

India

  • India's drug prices regulator calls for better oversight of private hospitals (Reuters)
  • NPPA fixes ceiling prices of 39 scheduled formulations of Schedule-I under DPCO, 2013 (PharmaBiz)
  • Soon, Centre to add 100 more drugs to over-the-counter list (Economic Times)
  • Health ministry sensitizes pharma cos to set up PV cells for monitoring ADRs (PharmaBiz)
  • Things should normalise for pharma sector from FY20-21: S Ramesh, Lupin (Economic Times)
  • Abbott allowed to discontinue dissolvable stent in India (Economic Times)

Canada

  • Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of sleep walking and sleep-related eating disorder (Health Canada)
  • Summary Safety Review - Birth control hormone systems (intrauterine) - Assessing the potential risk of less breast milk production (Health Canada)

Other International

  • Regulatory pathways for approval of biological products in Brazil (GaBI)

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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