Regulatory Recon: AstraZeneca Bags Approvals for Fasenra, Faslodex Shanghai Pharma to Buy Cardinal's China Business for $557M (15 November 2017)

Posted 15 November 2017 | By Michael Mezher 

Regulatory Recon: AstraZeneca Bags Approvals for Fasenra, Faslodex Shanghai Pharma to Buy Cardinal's China Business for $557M (15 November 2017)

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

In Focus: US

  • Long-awaited study finds monthly Vivitrol as effective as daily pill for opioid addiction (STAT) (Endpoints) (NYTimes) (NIH) (The Lancet)
  • AstraZeneca's scores FDA OK for a blockbuster severe asthma drug (Endpoints) (Reuters) (PMLive) (Press)
  • FDA Approves AstraZeneca's Faslodex Combo for Advanced Breast Cancer (Press)
  • FDA Clears First Device to Reduce Opioid Withdrawal Symptoms (FDA)
  • Sangamo claims a major milestone in gene editing, treating first patient with its zinc finger nuclease tech (Endpoints) (STAT) (Press)
  • House passes $692B defense policy bill (The Hill) (Politico)
  • If An Alzheimer's Drug Succeeds Could Our Health System Handle It? (Forbes)
  • Genentech inks $650M deal with protein degradation pioneer Arvinas (Endpoints) (Fierce)
  • Acorda reports five deaths in Parkinson's trial, shares plunge (Reuters) (Endpoints) (Fierce)
  • Trump's HHS secretary nominee boosted drug prices while at Eli Lilly (Politico)
  • On drug importation, Trump and his pick to lead HHS are on opposing sides (STAT)
  • ICER Publishes Final Framework For Orphan Drug Assessment (BioCentury) (ICER)
  • Fears of Amazon drug push rattle US healthcare industry (Financial Times) (STAT)
  • 'Just Say It!' – New Streamlined Guidance Format Coming, FDA's Woodcock Says (Pink Sheet-$)
  • Senate tax plan repeals Obamacare's individual mandate (Politico) (The Atlantic) (NYTimes)
  • What does the Orphan Drug Tax Credit tell us about the Costs of Clinical Trials? (Harvard Bill of Health)
  • How Big Pharma Sandbags Generic Competition (WSJ)
  • FDA Launches Tool to Track Antibiotic Resistance Genes (FDA)

In Focus: International

  • Shanghai Pharma to buy Cardinal Health's China business for $557m (Financial Times) (Reuters) (Press)
  • Peter Sands Named Head of Global Disease-Fighting Agency (NYTimes) (WHO)
  • UK Biobank Supercharges Medicine with Gene Data on 500,000 Brits (MIT Technology Review)
  • GE pumping up to $350m in Swedish site to support biopharma demand (BioPharmaReporter)
  • Spain's Almirall warns of delay in approval for psoriasis drug (Reuters)
  • Bayer hires new blood to stem 'Amazon effect' in consumer health (Reuters) (Bayer)
  • Prospects for passive immunity to prevent HIV infection (PLOS)
  • PLOS Medicine Special Issue on HIV (PLOS)
  • What's In Store For Roche's New India Boss? (SCRIP-$)
  • Half of over-65s take at least five drugs a day  (The Telegraph)
  • EMA Advises Drug Companies How to Transfer Orphan Designations (FDANews-$)
  • Statement by EMA Head Guido Rasi on Antibiotic Awareness Day (EMA)
  • EMA Reminds Drugmakers to Submit Type I Variations for 2017 by End of Month (EMA)

Pharmaceuticals & Biotechnology

  • Gene Editors, Cancer Killers And Smartphone Apps: The 2018 30 Under 30 In Healthcare (Forbes)
  • High Costs of FDA Approval for Formerly Unapproved Marketed Drugs (JAMA)
  • $49M round; experienced team; A-list VCs — Inozyme launches with rare disease strategy and a yen for bigger things to come (Endpoints) (Fierce)
  • Treating modestly high blood pressure may not boost survival odds (Reuters)
  • Investor group warns U.S. farm antibiotic policy lagging (Reuters)
  • Bayer Recalls Lot of Nexterone Injection Due to Presence of Particulate Matter (FDA)
  • With only 2 warnings in 2017, pharma's ad police hits historic low (Fierce)
  • CRISPR Gene-Editing Technology Could Hold Key To Understanding Addiction (Forbes)
  • Three decades of responding to infectious disease outbreaks (NIH)
  • Novartis looks past psoriasis for even bigger Cosentyx growth frontier (Fierce)
  • Tweet up? Twitter move to 280 characters opens new frontiers for pharma, agency says (Fierce)
  • Turnstone Biologics nabs Bristol-Myers R&D exec as new research chief (Fierce)
  • Germano lands spot on The Medicines Company's board (Fierce)
  • Using quality as a lever for transformation (EPR)
  • Promising new CAR-T therapy able to target T-cell lymphoma (Pharmafile)
  • Award-winning sepsis project gets $13M and a shot at reopening an R&D avenue as FDA pitches out old gold standard (Press)
  • Mirati bails on lead drug, shifts focus to I/O program (Endpoints)
  • Takeda leverages lung cancer awareness month to highlight ALK variant (Fierce)
  • PAREXEL Expands Global Regulatory Services with Addition of Senior Executives from FDA and Oncology Industry (Press)
  • Locus raises $19M to take CRISPR-based antimicrobial 'Pac-Man' into clinic (Fierce)
  • Moving beyond Cas9, Excision licenses CRISPR gene editors (Fierce)
  • BioCorRx inks deal with Nat'l Institute on Drug Abuse (Drug Delivery)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial (PLOS) (Perspective)
  • Moderna Announces First-in-Human Dosing for Phase 1 Study (KEYNOTE-603) of mRNA-4157, a Personalized Cancer Vaccine, for the Treatment of Solid Tumors (Press)
  • Nektar's IL-2 Impresses In Combination With Bristol's Opdivo (SCRIP-$)
  • BioTime Presents Updated OpRegen® Phase I/IIa Trial Data at AAO (Press)

Medical Devices

  • DHS Warns of Cybersecurity Vulnerabilities in Philips IntelliSpace Cardiovascular System, Xcelera System (DHS ICS-CERT)
  • Electronics 'like a second skin' make wearables more practical and MRIs safer for kids (STAT)
  • FDA Finalizes Guidance on When to Submit a 510(k) for a Change to an Existing Device (FDA Law Blog)
  • FDA Warns RTI Surgical (MassDevice) (FDA)
  • Stryker touts NEJM publication of Trevo thrombectomy device trial results (MassDevice)
  • How to Reduce the Burden of Iterative Design and Evaluation (MDDI)
  • Could CDC's New Catheter-Site Dressing Advice Curb Infections? (MDDI)
  • Q&A: How to Evaluate New Technologies for Success (MDDI)
  • MedShape wins FDA nod for DynaNail XL TTC fusion system (Press)
  • Roche receives FDA clearance for the VENTANA MMR IHC Panel for patients diagnosed with colorectal cancer (Press)
  • Alcyone Lifesciences Receives FDA Clearance for the Alivio System for the Treatment of Hydrocephalus (Press)
  • Neovasc shares fall on Q3 sales miss (MassDevice)

US: Assorted & Government

  • AMA opposes any weakening or pullback of Obamacare's minimum health benefits (CNBC)
  • Some CVS pharmacies are blocking prescription refills, exec blames 'internal network' issues (CNBC)
  • ACRO Urges Modernization Of The R&D Tax Credit (ARCO)
  • Cherokee Opioid Fight Should Inspire Other Tribes, AG Says (Law360-$)
  • Ex-FDA Commissioner Slams Xarelto Warnings In Philly Trial (Law360-$)
  • Non-News: Warnings Claims For A Generic Drug Preempted (Still) (Drug & Device Law)
  • Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat (Drug Delivery)

Upcoming Meetings & Events


  • The Grass Is Green for Medtech on the Emerald Isle (MDDI)


  • Chugai sheds older products to focus on innovation (PharmaLetter-$)


  • Health gains since 1990, but progress not uniform (Economic Times)
  • Centre releases 3 drafts seeking changes to D&C Rules on import permission for personal use, labelling provisions (Fierce)


  • Decisions to withdraw medicines advertising approval (TGA)

General Health & Other Interesting Articles

  • Immigrant workers in U.S. have tripled risk for heat-related death (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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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