Regulatory Focus™ > News Articles > Regulatory Recon: Spanish Regulator Ramps Up Hiring Ahead of Brexit; FDA Delays Decision on Biocon,

Regulatory Recon: Spanish Regulator Ramps Up Hiring Ahead of Brexit FDA Delays Decision on Biocon, Mylan Herceptin Biosimilar (31 August 2017)

Posted 31 August 2017 | By Michael Mezher 

Regulatory Recon: Spanish Regulator Ramps Up Hiring Ahead of Brexit FDA Delays Decision on Biocon, Mylan Herceptin Biosimilar (31 August 2017)

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

In Focus: US

  • FDA Delays Decision On Biocon, Mylan's Breast Cancer Biosimilar (Bloomberg) (Economic Times)
  • 'Historic Action': FDA Approves First CAR-T Therapy (Focus) (Reuters) (NYTimes) (KHN) (MIT Technology Review)
  • Novartis CEO's Dilemma: Is $475,000 Too Much For A Leukemia Breakthrough? Or Is It Not Enough? (Forbes)
  • In a Sign of Gene-Editing Frenzy, Startup Pitches Editing without CRISPR (MIT Technology Review)
  • FDA Finalizes Guidance on Using Real World Evidence for Medical Device Regulatory Decisions (Focus)
  • Pharma may win a big victory in New York over a drug take-back program (STAT)
  • Novartis, UCSF researchers urge FDA to clean up its messy adverse events database (
  • Top FDA trial expert Richard Moscicki jumps to a senior post at PhRMA (Endpoints) (Pink Sheet-$) (PhRMA)
  • Incyte's good week continues with an encouraging update on IDO1 star epacadostat (Endpoints) (STAT)
  • SteadyMed shares slammed as FDA tosses its NDA for PAH drug-device (Endpoints)
  • Daiichi Sankyo punts $650M collaboration pact as Charleston Labs preps a comeback attempt on spurned pain drug (Endpoints)
  • Recent Settlements Suggest Off-Label Cases Aren't Extinct (Law360-$)
  • Has Trump's power over pharma come to an end after Charlottesville? (Pharmafile)
  • Teva takes on Neurocrine with TD nod for Austedo (Fierce) (PharmaTimes) (Press)

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In Focus: International

  • Spain hires more staff at drug agency to prepare for Brexit disruption (Reuters)
  • With US Generic Drug Market in Chaos, Indian Upstarts Rise (Bloomberg)
  • Daiichi Sankyo douses a puzzling report about an AstraZeneca buyout offer (Endpoints)
  • Parties Vie For Place At EMA's First Ever Public Hearing On Medicines Safety (Pink Sheet-$)
  • AZ Chief Scientist Wants Britain To Be Like Boston (SCRIP-$)
  • Precision Diagnosis and Treatment for Advanced Non–Small-Cell Lung Cancer (NEJM)
  • Global biosimilars market forecast to hit $13.1 billion by 2024 (PharmaLetter-$)
  • Brazil's New Essential Medicines List Says Hello to Alzheimer's Patch And Goodbye To Older Hep C Drugs (Pink Sheet-$)
  • Investment Plan for Europe: EIB grants financing to Apeiron (EC)
  • Egypt promotes birth control to fight rapid population growth (Reuters)
  • MSF takes next steps to lower vaccine prices: Launch of innovative tool to help countries negotiate lower pneumonia vaccine prices (MSF)

Pharmaceuticals & Biotechnology

  • Settle down, biotech! It's back to school time. Let's review your strengths. And where you'd better knuckle down (STAT)
  • Sequencing all 24 human chromosomes uncovers rare disorders (NIH)
  • Florida executes prisoner with etomidate despite drug maker's concerns (BMJ)
  • A Reality Check on Amazon's Pharmacy Ambitions (rerun) (Drug Channels)
  • Live In Hawaii, And Odds Are You'll Need Fewer Prescription Meds (NPR)
  • FDA approvals: the good, the bad and the ugly (PharmaLetter-$)
  • 'Reprogrammed' stem cells fight Parkinson's disease in monkeys (Reuters) (Nature)
  • Sanofi looks to mobile data to power behavioural analysis (PM Live)
  • Hospira Recalls Lot of Vancomycin Hydrochloride due to Presence of Particulate Matter (FDA)
  • Tantalizing clues point to inflammation's role in an array of diseases. But will treatments follow? (STAT)
  • Sanofi, Shire, Vertex and more back first-ever rare disease film festival (Fierce)
  • SNL veteran Vanessa Bayer joins Allergan for birth control Q&A on streets of NYC (Fierce)
  • Shire disputes employee dissatisfaction report as UBS slashes price target (Fierce)
  • Mid Valley Pharmaceutical LLC Issues Voluntary Recall of Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup Due to Potential Contamination with Burkholderia Cepacia. (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Accepts Amgen's Filing Of A Supplemental New Drug Application To Add Overall Survival Results To KYPROLIS® (Carfilzomib) Label (Press)
  • Sunovion Submits New Drug Application for Dasotraline to the FDA for the Treatment of Patients with ADHD (Press)
  • Oragenics Doses First Patient in Phase 2 Clinical Trial of AG013 for Oral Mucositis (Press)
  • Syros to Present PK and PD Data from Ongoing Phase 2 Clinical Trial of SY-1425 at ESMO 2017 Congress (Press)
  • Bayer submits Biologics License Application in the U.S. for BAY94-9027 – a long-acting factor VIII for the treatment of Hemophilia A (PipelineReview)

Medical Devices

  • Selecting Adhesives for Medical Devices (MDDI)
  • Early Feasibility Studies for Devices: FDA Highlights Success From Pilot (Focus)
  • Abbott Recalls 465,000 Pacemakers for Cybersecurity Patch (Focus)
  • Insulet breaks ground on new manufacturing plant in Mass. (MassDevice)
  • For this 3D printing manufacturer, a complex implant is a piece of cake (MedCityNews)
  • Abbott launches Amplatzer newborn congenital heart defect trial (MassDevice)
  • MRI Inside NICU: Interview with Uri Rapoport, CEO of Aspect Imaging (MedGadget)
  • Siemens, ISA ink industrial, automation cybersecurity deal (MassDevice)
  • Ethicon touts progress on multi-year bariatric surgery evidence initiative (MassDevice)
  • FDA clears Danaher's Leica Microsystem's FL560 cerebrovascular fluorescence microscope filter (MassDevice)
  • Smiths Medical wins 510(k) approval for wireless ambulatory infusion pump (MassDevice)
  • Philips subsidiary Spectranetics recalls Bridge occlusion balloon (MassDevice)

US: Assorted & Government

  • Trump Administration Wants to Stabilize Health Markets but Won't Say How (NYTimes)
  • Amarin Seeks ITC Action Against Products 'Cloaked' As Dietary Supplements (Pink Sheet-$) (FDA Law Blog) (Law360-$)
  • Dental Device Class Action Bites The Dust (Drug & Device Law)
  • Apotex Cleared To Intervene In Eagle's Orphan Drug Suit (Law360-$)
  • Teva Hit With Investor Suit Over $40.5B Actavis Merger (Law360-$)

Upcoming Meetings & Events

Europe

  • Roche, Merck & BMS to Present at ESMO 2017
  • Medicines manufacturers welcome Life Sciences Industrial Strategy (ABPI)

Asia

  • iCad wins Chinese approval for Xoft Axxent balloon applicators (MassDevice)
  • Sumitomo Dainippon seeks new indication for PD drug in Japan (PharmaLetter-$)
  • Fosun Purchasing 65% Of Medical Marketing Company Sinomedcare (BioCentury)

India

  • Indian pharma cos prefer Recruitment Process Outsourcing to select pharmacists (PharmaBiz)
  • US FDA adds Mahendra Chemicals to import alert "Red List" (InPharmaTechnologist)

Australia

  • Making more life-changing medicines available to all Australians (PharmaLetter-$)
  • Exposure drafts: Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 and Therapeutic Goods (Charges) Amendment Bill 2017 (TGA)

Other International

  • South Africa hit by 24 bird flu outbreaks since June (Reuters)

General Health & Other Interesting Articles

  • IBM, Scientists Seek Public's Help With Millions Of Virtual Experiments Mapping The Human Microbiome (Forbes)
  • 'This Is Surreal': Houston Dialysis Center Struggles To Treat Patients (NPR)
  • Flame retardants linked to infertility in women (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.


Categories: Recon, Regulatory News

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