Regulatory Focus™ > News Articles > Regulatory Recon: Roche Nabs Priority Review for Hemophilia A Drug; Novartis Gets EU Approval for Br

Regulatory Recon: Roche Nabs Priority Review for Hemophilia A Drug Novartis Gets EU Approval for Breast Cancer Drug Kisqali (24 August 2017)

Posted 24 August 2017 | By Michael Mezher 

Regulatory Recon: Roche Nabs Priority Review for Hemophilia A Drug Novartis Gets EU Approval for Breast Cancer Drug Kisqali (24 August 2017)

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

In Focus: US

  • Roche says FDA grants priority review to hemophilia drug emicizumab (Reuters) (Endpoints) (Fierce) (Press)
  • The pharmaceutical industry's false dilemma (Financial Times)
  • Key figure in notorious biopharma insider case loses an appeal — broadening scope for future cases (Endpoints)
  • AstraZeneca researchers plumb positive data to back extended use of Brilinta (Endpoints) (Reuters)
  • Omeros defends its drug, but still won't answer basic questions (STAT) (Omeros' Response)
  • How to tell if the price is right on your next prescription (AP)
  • Patients Not Always Informed of Study's Purpose in Noninferiority Trials (Focus)
  • States Take on Drug Price Transparency, Gouging (Focus)
  • New tool helps physicians learn if their opioid prescribing is appropriate (STAT)
  • 7 things to know about Sage Therapeutics' pivotal trial of a drug for severe epilepsy (STAT)
  • What Trump's FDA Commissioner Could Teach Trump About Twitter (Pink Sheet-$)
  • Trump Calls Opioid Crisis a National Emergency But Still Hasn't Made It Official (NBC)
  • Many addicts seeking opioid recovery find relapse and fraud (ABC)
  • Cost-Effectiveness of Intensive versus Standard Blood-Pressure Control (NEJM)
  • Fewer antibiotic prescriptions are being filled, a new analysis finds (Washington Post)

In Focus: International

  • EMA and FDA to Begin Sharing Commercially Confidential Information (Focus)
  • Novartis receives EU approval for breast cancer drug Kisqali (Reuters) (PharmaTimes)
  • India's proposed pharma marketing rules hit legal roadblock (Reuters)
  • Threat of infectious disease outbreaks haunts Africa (Financial Times)
  • Pharma Calls On UK Govt To Fund Centers of Excellence (SCRIP-$)
  • Eisai Fortifies Play With India-Specific Priced Fycompa (SCRIP-$)
  • Argentina Expands Access To Meds With Public Production (Pink Sheet-$)
  • Revised Saudi Guide Addresses Frequent Questions On New Expedited Drug Registration Process (Pink Sheet-$)
  • Batches of NovoPen Echo & NovoPen 5 recalled due to risk of fault (MHRA)
  • European Pharmacopoeia Has Turned Up Heat on ICH Q3D Implementation and Biotherapeutics (IPQ)

Pharmaceuticals & Biotechnology

  • Meet Bertrand Bodson, Novartis' new global digital strategy maestro for all things Big Pharma (Endpoints) (Pharmafile)
  • We Have Ruined Late-Breaking Clinical Trials in Cardiology (Medpage)
  • Merck sees promise in Macrophage Pharma (PharmaTimes)
  • Pfizer's Eucrisa beats Dupixent to the DTC punch in eczema, thanks to first-to-market status (Fierce)
  • Ironwood zeroes in on primary care doctors with new gout combo med Duzallo (Fierce)
  • With IBD market set for major growth, AbbVie stands to benefit: analyst (Fierce)
  • Former Apple engineers sold their 'smart' pill bottle start-up to a prescription delivery company (CNBC)
  • Profit finally in sight for gene therapy specialist Oxford Bio (Reuters)
  • McDonald's to cut global antibiotic use in chickens (Reuters)
  • PetMed CFO says allegations of marketing to opioid addicts are 'bogus' (Reuters)
  • Amid dwindling cash and a Nasdaq warning, MabVax seeks 'strategic options' (Fierce)
  • Gone to the dogs? Shire sells vaccine plant to Merck Animal Health (BioPharmaReporter)
  • Accelerated Pharma puts the brakes on IPO (Fierce)
  • ESC 2017 preview – What outcomes might mean for incomes (EP Vantage)
  • Petition Asks FDA to Prioritize Generic Trientine ANDAs (FDANews-$)
  • Pfizer Rare Disease Launches Two First-of-Its-Kind Innovative Technologies for People Living with Hemophilia at National Hemophilia Foundation Annual Meeting (Press)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • On a roll, Apellis adds positive PhII C3 data for AMD drug, preps for PhIII (Endpoints)
  • Chugai's Emicizumab Receives Priority Review Designation by FDA for Hemophilia A with Inhibitors (Press)
  • Genmab gains on promising early success for daratumumab PhIII in multiple myeloma, but questions linger (Endpoints)
  • Boehringer Ingelheim initiates Phase IIa study of compound acquired from Pharmaxis in debilitating liver disease NASH (Press)
  • Titan Pharmaceuticals Receives FDA Clearance To Begin Clinical Study Of Parkinson's Disease Treatment (Press)
  • Genentech Reports Preclinical Data For P300/CBP Inhibitor In Prostate Cancer (BioCentury)

Medical Devices                                                                                   

  • Learning from Experience: FDA's Treatment of Machine Learning (MobiHealthNews)
  • Robotic exoskeletons show promise as tool to help kids with cerebral palsy walk easier (STAT)
  • Stryker slips on Sage Products recall (MassDevice)
  • Medtronic's Attain Stability Quad MRI SureScan Cardiac Lead Cleared in Europe (MedGadget)

US: Assorted & Government

  • Stand Up to "Bully" Trump: Bio CEOs Levin, Holtzman Call to Their Peers (Xconomy)
  • FSIS Updates Guidance Concerning Labels Not Eligible for Generic Approval (FDA Law Blog)
  • Oral Argument before the Fifth Circuit Starts in a Couple of Hours on the Writ of Mandamus Filed in the Pinnacle Hip Implant Litigation (Drug & Device Law)

Upcoming Meetings & Events


  • iCubate Receives CE Mark for Dx Platform, Bloodstream Infection Assay (GenomeWeb)


  • Astellas Announces Personnel Changes and Organizational Changes (Press)
  • Takeda files for vedolizumab approval in Japan (PharmaLetter-$)
  • Rodent faeces and damaged equipment land Chinese OTC maker FDA warning (InPharmaTechnologist)


  • USFDA clears marketing of Zydus Cadila anti-hypertension drug (Economic Times)
  • Lupin initiates recall of tablet Mibelas 24 Fe from US market (Economic Times)
  • Maha FDA directs Sch M units in state for doing self-audit for GMP preparedness (PharmaBiz)
  • Union environment ministry issues draft guidelines on bar code system for disposal of bio-medical waste (PharmaBiz)
  • NPPA steps up efforts to ensure availability of knee implants after price cap (PharmaBiz)


  • Shortage of Neo-Mercazole (carbimazole) (TGA)

General Health & Other Interesting Articles

  • Hunting a Killer: Sex, Drugs and the Return of Syphilis (NYTimes)
  • Are We Getting Closer To A Cheap, Simple Alzheimer's Test? What Would It Mean? (Forbes)
  • Lithium in drinking water may affect Alzheimer's risk (Reuters)
  • Many heart failure patients don't recognize the risks of their illness (Reuters)
  • Blacks with prostate cancer less likely to get ideal treatment (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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