Regulatory Recon: CA Governor Expected to Sign Drug Price Transparency Bill; China Embraces Foreign Clinical Trial Data to Speed Approvals (9 October 2017)

Posted 09 October 2017 By Michael Mezher

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

In Focus: US

  • Flexion's knee pain drug gets FDA nod, shares hit life high (Reuters) (Endpoints)
  • Pressure mounts to lift FDA restrictions on off-label drugs (Washington Post)
  • California Drug Price Bill Becomes Law as Legal Fight Looms (Bloomberg) (STAT) (CA.gov)
  • What California's New Drug Transparency Law Does – And Doesn't – Do (Policy & Medicine)
  • Drug chains tumble on reports Amazon eyeing their pie (Reuters)
  • Spark's novel gene therapy for blindness is racing to a historic date with the FDA (STAT)
  • Amgen Sues Genentech To Shield Avastin Biosimilar (Law360-$)
  • Real-World Evidence: Advice, Principles And Examples Emerge From FDA (Pink Sheet-$)
  • Bristol-Myers lures Saha back from biotech to take SVP post (Fierce) (Endpoints) (Press)
  • Roche's Tecentriq cedes bladder-cancer share to Keytruda in wake of trial misfire (Fierce)
  • FDA approves implantable device to treat moderate to severe central sleep apnea (FDA)
  • The other overdose crisis: over-the-counter pain medications (STAT)
  • Woodcock: Throwing Out International Clinical Trial Standards Not An Option (InsideHealthPolicy-$)
  • Waxman hits out at Allergan patent deal with Mohawk tribe (Financial Times)
  • Allergan CEO Defends Company's Patent Deal, Says IPR Unfair to Biopharma Companies (WSJ)

In Focus: International

Pharmaceuticals & Biotechnology

  • FDA's Getting a Complex (FDA Law Blog)
  • FDA Finalizes Guidance on Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies (FDA Law Blog)
  • Status Updates for ANDAs: FDA Spells Out GDUFA II Provision (Focus)
  • Rare Diseases: FDA Awards Grants for 21 Clinical, Natural History Studies (Focus)
  • What keeps pharma execs up at night? Apparently a lot, says new report (BioPharmaDive)
  • Meet the 30 biotech leaders under 40 who are searching for breakthrough treatments and shaping the future of medicine (Business Insider)
  • Amgen's Imlygic doubles response rate when added to checkpoint therapy (Fierce)
  • Rhythm Pharma strikes a chord with oversubscribed $120M IPO (Fierce)
  • Third Rock-backed Allena looks to springboard a $92M IPO off of a failed PhIIb (Endpoints) (Fierce)
  • Erytech seeks $100M IPO for pivotal tumor starvation trial (Fierce)
  • Arthritis Burden over $303 Billion Annually in US (Medpage)
  • Fewer newborns get whooping cough when moms get vaccinated (Reuters)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • AstraZeneca's Tagrisso secures Breakthrough Therapy Designation in first-line NSCLC (Pharmafile) (Press)
  • Lilly MONARCH 3 Study Published in Journal of Clinical Oncology Demonstrates Benefit of Verzenio (abemaciclib) Plus NSAI in Advanced Breast Cancer (Press)
  • Safety and immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine in adults and children in Lambaréné, Gabon: A phase I randomised trial (PLOS)
  • Arsanis Presents Phase 1 and Preclinical Pharmacokinetic Data on Lead Product Candidate, ASN100, at IDWeek 2017 (Press)
  • Entasis Therapeutics Highlights Positive Phase 1 Data for ETX2514 at IDWeek 2017, Announces Plans to Advance Combination with sulbactam (ETX2514SUL) into Phase 2 Trials (Press)

Medical Devices

  • Medtronic Provides Update on Impact from Hurricane Maria (Press)
  • Xtant Medical to shut down Dayton, Ohio facility (MassDevice)
  • Peerbridge's wireless multi-channel ECG cleared by FDA (MobiHealthNews)
  • Medtronic Endurant(TM) II/IIs Stent Graft System Receives FDA Approval to Treat Short Neck Anatomies When Used with Heli-FX(TM) EndoAnchor(TM) System (Press)
  • LivaNova Receives FDA Approvals for SenTiva Device and Next-Generation VNS Therapy Programming System for Treatment of Epilepsy (Press)
  • Lab Industry Reacts to USPSTF Recommendation Against Cervical Cancer Co-testing (GenomeWeb)

US: Assorted & Government

  • FDA Halts Monkey Study on Nicotine Dosing (Focus)
  • MDL May Be On The Horizon In Opioid Litigation (Law360-$)
  • GM Apples That Don't Brown to Reach US Shelves This Fall (MIT Technology Review)
  • Can the US Repair Its Health Care While Keeping Its Innovation Edge? (NYTimes)
  • Lucky Seven – Multi-Plaintiff Misjoinder Fails in Illinois Post-BMS (Drug & Device Law)

Upcoming Meetings & Events          

Europe

  • Medidata opens new London EMEA headquarters (PMLive)
  • Bruker Invasive Fungal Disease Products CE-IVD Marked (GenomeWeb)
  • IntelliJoint Surgical wins CE Mark for Hip 3D hip arthroplasty nav system (MassDevice)

India

  • India plans to lessen its drug reliance on China (Economic Times)
  • BSE Healthcare Index dips by 8.9% in first 9 months of 2017, Sensex moves up by 17.6% (PharmaBiz)
  • India specific study for intensive ADR monitoring on pioglitazone to start soon (PharmaBiz)
  • DCGI directs drug testing labs across country to do self-audit before CDSCO inspections (PharmaBiz)
  • Lupin gets USFDA nod to market hypertension treatment tablets (Economic Times)
  • Zydus Cadila gets USFDA nod to market antidepressant drug (Economic Times)
  • Marksans Pharma gets EIR from USFDA for its Goa facility (Economic Times)

Australia

  • Australia Moves Forward With Biovigilance Guidelines (Pink Sheet-$)
  • Submissions received and TGA response: Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS) (TGA)

Other International

  • Strategies For Protecting Biotechnology In Brazil And China (Law360-$)

General Health & Other Interesting Articles

  • Researchers Predict a Quarter-Million New Cases of Breast Cancer in the US (NYTimes)

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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