Regulatory Recon: ROCKET AF Investigators Say Analysis Supports Original Results NICE Backs Pfizer's Bosulif in First Cancer Drug Fund Reappraisal (7 July 2016)

Posted 07 July 2016 | By Michael Mezher 

Regulatory Recon: ROCKET AF Investigators Say Analysis Supports Original Results NICE Backs Pfizer's Bosulif in First Cancer Drug Fund Reappraisal (7 July 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Medivation confident drugs pipeline will win over suitors (Financial Times)
  • New Health Policy Brief: Off-Label Drug Promotion (Health Affairs Blog) (Health Affairs)
  • ROCKET AF Investigators Say New Analysis Supports Original Trial Results (CardioBrief) (NEJM)
  • Big Pharma Is So 2015. Welcome to the Era of Big Software (Wired)
  • FDA Assails AstraZeneca's Attack On Crestor Generics (Law360-$)
  • FDA Issues Emergency Use Authorization for Hologic Zika Diagnostic, Biocartis Ebola Test (FDA 1, 2)
  • Standing On The Shoulders Of Stem Cell Gene Therapists: History, Hyperbole And Hope For The Future (LifeSciVC)
  • I-SPY 2 — A Glimpse of the Future of Phase 2 Drug Development? (NEJM)
  • White House proposes measures to speed genomic test development (Reuters) (Forbes)
  • Blood Tests That Spot Cancer DNA Offer "Quantitative Peace of Mind" for Survivors (MIT Technology Review)
  • Blockbuster hopes grow for Ablynx drug backed by AbbVie (Reuters)
  • US judge cuts $500 million verdict over J&J hip implants (Reuters) (MassDevice)
  • Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results (Focus)
  • New Jersey Medical Device Manufacturer Admits Selling Contaminated Ultrasound Gel; Court Orders Permanent Injunction (DoJ)
  • US Republicans reject Democratic funding proposals for opioids (Reuters)
  • NIH awards $55 million to build million-person precision medicine study (NIH)

In Focus: International

  • EMA on Brexit: New Headquarters Locale Will be Decided by Member States (Focus) (EMA)
  • Pfizer Drug Wins UK Support Following Overhaul of Cancer Fund (Bloomberg) (BioCentury) (SCRIP-$)
  • EC Report Analyzes Regulatory Frameworks for Advanced Therapies in US, Canada, Japan and Korea (Focus) (EC)
  • UK could quit EU drug regulation system – minister (PharmaPhorum)
  • Report on the Use of Numerical Analysis for Strength Evaluation of Orthopedic Implant (PMDA)
  • Spain a 'prime candidate' to host post-Brexit EMA, Farmaindustria says (PharmaLetter-$)
  • India Issues Draft Medical Device Regulations Separate from Drug Law (Emergo)
  • China Deadline Nears in Crackdown On Medical Device Distributors (SCRIP-$)
  • In Brief: Brazil's ANVISA Updates Modification Process for Lower-risk Cadastro Devices (Emergo)
  • How Brexit Could Hurt Walgreens Boots Alliance's UK Pharmacies (Forbes)

US: Pharmaceuticals & Biotechnology

  • Could Brain Research From The Past 15 Years Really Be Wrong? (Forbes)
  • Wyden Disappointed in Multi-Million Dollar Windfall for Drug Makers Instead of Care for Pregnant Women in Opioid Conference Report (Senate)
  • Leading researchers recommend major change in prostate cancer treatment (Washington Post)
  • AbbVie Requires An Extraordinary Rescue; What Are The Options? (Forbes)
  • Amicus Takes Aim at Rare Brain Disorder with MiaMed Acquisition (Xconomy)
  • TransCelerate Companies Lead the Way in Adopting Risk-Based Monitoring (Bioclinica)
  • Smaller medtechs in charge of their own destiny (EP Vantage)
  • HPV vaccination reduces abnormal Pap tests (Reuters)
  • KaloBios Deals With Shkreli After Exiting Bankruptcy With New Cash (Xconomy)
  • Unraveling the Mystery of Medication Errors: Pharmacy Practice News (Medpage)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Seres Therapeutics Announces Initiation of a Phase 1b Clinical Trial of SER-262 for Primary Clostridium difficile Infection (Press)
  • 'Special K' party drug to be trialled as treatment for alcoholics (Reuters)
  • ColonaryConcepts Successfully Completes Phase 2 Study for a New Approach to Colonoscopy Prep for Colorectal Cancer Screening (Press)
  • Puma Biotechnology Announces I-SPY 2 Phase II Study of Neratinib Published in The New England Journal of Medicine (Press)
  • New Data from Phase 3 REGAIN Study of Eculizumab (Soliris®) in Patients with Refractory Generalized Myasthenia Gravis (gMG) Presented at ICNMD Annual Congress (Press)

US: Medical Devices                                                                                                                                                                     

  • Expedited Access Pathway Devices (Gray Sheet-$)
  • Thermo Fisher Scientific Trial Design Helps Accelerate FDA Clearance Process for B·R·A·H·M·S PCT License Partners (Press)
  • Pfizer, Brigham and Women's test remote monitoring app for arthritis in clinical trial (MobiHealthNews)
  • Prism Medical & Design wins FDA nod for ProteXsure anti-needle stick device (MassDevice)
  • Top execs retire as LivaNova retools, adds COO role (MassDevice)

US: Assorted & Government

  • History Repeating – Is Insys a Warner Chilcott Clone? (Policy and Medicine)
  • House G.O.P. Returns Focus to Obamacare's Spending Authority (NYTimes)
  • Pew urges Congress to require UDIs on claim forms (Fierce)
  • Gilead Wants $15.5M In Fees From Merck After Hep C Upset (Law360-$)
  • Seniors with access to medical marijuana use fewer prescription drugs (Reuters)
  • Court Strikes Down Obama Health Care Rule on Insurance Standards (NYTimes)
  • Study: Brand-Name Drugs' High Copays Soak Medicare Part D Patients (KHN)
  • Middle District of Louisiana Gets it Wrong: A Different Product is not an "Alternative Design" (Drug and Device Law)
  • The Biggest Park Doctrine Ruling in Over 40 Years? (FDA Law Blog)

Upcoming Meetings & Events


  • Drug price cooperation features prominently in Council of EU pharma plan (InPharmaTechnologist)
  • Bristol Myers' small deal underscores how hot immuno-oncology is (MedCityNews)
  • Shire gets extended market authorization in Europe for drug to treat children with a rare gastrointestinal condition (Pharmafile)
  • UK's commercial DNA foundry a step on path to 'bioeconomy'  (BioPharmaReporter)
  • Questions & answers on Article 30 referral procedures (EMA)
  • Questions & answers on Article 31 non-pharmacovigilance referrals (EMA)
  • Questions & answers on Article 20 non-pharmacovigilance Procedures (EMA)
  • Questions & answers on Article 13 referral procedures (EMA)
  • Questions & answers on Article 29(4) referral procedures (EMA)
  • QT Vascular wins CE Mark for Chocolate Heart DCB (MassDevice)
  • Changes to cervical cancer screening (UK DOH)


  • Japanese firms eye sale of patent-expired drugs to fund new blockbusters (Fierce)
  • Sovaldi Among New HCV Drugs In Turkey Reimbursement Pact (PharmAsiaNews-$)


  • West Bengal to set up three biotechnology hubs (Economic Times)
  • Lupin gets Establishment Inspection Report from USFDA for Goa facility (Economic Times)
  • Zydus Cadila inks pact with Medicines Patent Pool for Hepatitis C drug (Economic Times)
  • 61% of people prefer buying drugs online: Study (Economic Times)
  • Brick-and-mortar pharmacies selling medicines without demanding prescription: Study (Economic Times)


  • TGA Stakeholder Survey 2015-16 - questions and answers (TGA)


  • US Senate leader says will try again to pass Zika bill (Reuters)

Other International

  • Merck Animal Health Expands in Brazil in Quest to Overtake Zoetis as World Animal Health Leader (The Street)
  • NZ's PHARMAC proposal to award sole supply to Zoladex and reference price leuprorelin (PharmaLetter-$)
  • Angola battling worst yellow fever outbreak in decades needs help, says Red Cross (Reuters)

General Health & Other Interesting Articles

  • More Americans living with congenital heart defects (Reuters)
  • Apple urges organ donation via new iPhone software (STAT)

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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