Regulatory Recon: AZ Sells Remaining Anesthetic Rights to Aspen for $766M; FDA Panel Unanimously Backs GSK Shingles Vaccine (14 September 2017)

Posted 14 September 2017 By Michael Mezher

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

In Focus: US

  • How should the FDA use 'real world' data? It can be a 'touchy phrase' (STAT)
  • 'Impressed' FDA panel unanimously recommends GSK shingles vaccine (Reuters) (Endpoints)
  • Moderna, AstraZeneca heart drug succeeds early-stage trial (Reuters) (Endpoints) (Financial Times) (Fierce)
  • Tragedy, Perseverance, and Chance — The Story of CAR-T Therapy (NEJM)
  • Aspen to buy remaining AstraZeneca US anesthetic rights for up to $766 million (Reuters)
  • Astra's Farxiga results may open up type 1 diabetes opportunity (Reuters) (Fierce)
  • Looking for an I/O edge, Bristol-Myers fronts $105M to partner with Halozyme as Roche expands pact (Endpoints) (Fierce) (Reuters) (Press)
  • New PhIII data in hand, Pfizer, Astellas hustle ahead in bid to expand US market for Xtandi (Endpoints) (Reuters) (Press)
  • Vanda's atopic dermatitis drug misses mark in mid-stage trial (Fierce) (Endpoints)
  • Discrepancy between trial goals, results may mask treatment risks (Reuters)
  • LivaNova heater-cooler implicated in infections in 12 pediatric heart surgery patients (MassDevice)
  • The Crisis in Gynecological Cancer Research (NYTimes)
  • Welcome to the Narcan Capital of America (Bloomberg)
  • Reporter's Notebook: In Health Care, A Good Price Is Hard To Find (KHN)

In Focus: International

  • Bayer taps Berkeley Lights to automate drug discovery (Fierce)
  • Teva to sell women's health assets to CVC Capital Partners: report (Reuters)
  • Japan's Push to Cut Drug Costs Risks US Trade Friction (Bloomberg)
  • Millions Could Die If Foreign Aid Is Cut, Gates Foundation Warns (Forbes)
  • Novo Nordisk Eagerly Prepares To Launch Victoza Nationally In China (SCRIP-$)
  • GDPR and Human Data Samples: Being 'somewhat prepared' is not enough (Pharmafile)
  • EASD: Novo Nordisk's combo Xultophy beat rivals at cutting LDL, blood pressure (Fierce)
  • Russian Regulators Amending Medical Device, IVD Registration Requirements (Emergo)
  • Outbreak of disease carried by mosquitoes halts blood donation in Rome (Reuters)

Pharmaceuticals & Biotechnology

  • Can the culprit for cancer spreading also boost immuno-oncology treatments? (Fierce)
  • OPQ Updates MAPP on Environmental Assessments and Claims of Categorical Exclusion (FDA)
  • DeLauro Condemns Alexion's Headquarters Leaving New Haven (DeLauro)
  • Hemo-oncology newbie Bayer gears up for copanlisib launch (Fierce)
  • Using Real-World Evidence to Deliver Innovation in Cancer Care (Lilly)
  • Mustang ties the knot with Fred Hutch on next-gen CAR-T for lymphoma (Endpoints)
  • Dogs' Immune Systems are Much Like Ours And That's A Boon To Cancer Research (Forbes)
  • Alzheimer's Guidance Coming From US FDA, Part Of Broader OND Reform (Pink Sheet-$)
  • Otonomy axes staff, hits brakes on R&D after phase 3 flop (Fierce)
  • Childhood cancer survivors face lifetime of chronic health conditions (Reuters)
  • FDA Issues Draft Guidance on the Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species # 210 (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Patient-Driven Dose Titration With Sanofi's Toujeo Improved Blood Glucose Control Without Increasing Hypoglycemia Risk In Real-Life Clinical Practice (Press)
  • ESMO: Pfizer boosts Ibrance's class with positive neutropenia data (Fierce)
  • Interim Analysis from Phase 3 Open-Label Extension Study Shows Sustained Benefits of Soliris® (Eculizumab) Treatment for Patients with Refractory Generalized Myasthenia Gravis (Press)
  • Poxel to Present Results for Imeglimin Phase 2b Study in Japan for the Treatment of Type 2 Diabetes at the European Association for the Study of Diabetes 53rd Annual Meeting (Press)
  • Imara Reports Favorable Preclinical and Phase 1 Data on IMR-687 in Sickle Cell Disease (Press)

Medical Devices

  • LivaNova mulls sale for CRM biz (MassDevice)
  • Bipartisan 'Problem Solvers' healthcare reform bill would kill medtech tax (MassDevice)
  • CDRH Issues Final Guidances Regarding Use of Real-World Evidence and Procedures for Advisory Committee Meetings (FDA Law Blog)
  • New Five-Year Gender Subset Data from the Medtronic Engage Registry Presented in VIVA Late Breaking Trials (Press)
  • Agilent Obtains U.S. FDA Approval for GenetiSure Dx Postnatal Assay (Press)
  • FDA Approves Two Ortho Clinical Diagnostics Specialty Hepatitis B Assays (Press)

US: Assorted & Government

  • GOP Sen. Orrin Hatch Pushes Medical Marijuana As Opioid Alternative (Forbes)
  • ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II: A Follow-Up (FDA Law Blog)
  • Northern District of New York (Quickly!) Holds that the MDA Expressly Preempts Essure Suit (Drug & Device Law)
  • Abbott Must Pay $38M Depakote Verdict, Mo. High Court Says (Law360-$)
  • AbbVie's Humira Patents Are Noninventive, Boehringer Says (Law360-$)

Upcoming Meetings & Events

Europe

  • Cell and gene therapies of the future are here today (ABPI)
  • Last call for marketing authorisation holders to submit information about in-use shelf life of OTC medicinal products (CBGMEB)
  • New bill to improve patient safety (UK DOH)
  • Fujifilm Diosynth Biotechnologies opens new UK lab (InPharmaTechnologist)
  • Bluebird bio joins the ABPI as a full member (EPR)

Asia

  • South Korean court's view on dosage regime drugs' patentability (PharmaLetter-$)

Australia

  • Medicines Safety Update, Volume 8 Number 4, August-September 2017 (TGA)
  • Breast implants and anaplastic large cell lymphoma (TGA)

General Health & Other Interesting Articles

  • A Simple Smell Test Might Be Able To Predict Parkinson's Disease 10 Years Before Diagnosis (Forbes)
  • Counting Sepsis, an Imprecise but Improving Science (JAMA)

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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