Regulatory Focus™ > News Articles > Regulatory Recon: Google Backs UK Universal Vaccine Company; Shire Wins EU Approval for Long Acting

Regulatory Recon: Google Backs UK Universal Vaccine Company Shire Wins EU Approval for Long Acting Hemophilia A Treatment (15 January 2018)

Posted 15 January 2018 | By Michael Mezher 

Regulatory Recon: Google Backs UK Universal Vaccine Company Shire Wins EU Approval for Long Acting Hemophilia A Treatment (15 January 2018)

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

In Focus: US

  • Gene Therapy Could Make Cancer Care More Unequal, and This Map Shows Why (MIT Technology Review)
  • States require doctors to use prescription drug monitoring systems for patients (Washington Post)
  • FDA Delays Implementing Parts of 'Intended Use' Rule (Focus) (STAT) (Pink Sheet-$) (Law360-$)
  • Billionaire-owned Hearing Aid Manufacturer's Former Executives On Trial For Embezzlement, Fraud (Forbes)
  • Inside the Global Relay Race to Deliver Moly-99 (NYTimes)
  • Annual Asthma-Related Expenditures in US Exceed $80 Billion (Medpage)
  • Maryland Health Care Coalition To Announce Proposals On Prescription Drugs (CBS)
  • Warren, Markey debut legislation to end ACA's medical device tax (Fierce)
  • At CES, Wearable Tech Blurs Line Between Gadgets and Medical Equipment (US News)
  • Spark's price for Luxturna blindness gene therapy too high: ICER (Reuters) (STAT) (Forbes)
  • Pursuing breakthroughs in cancer-drug development (McKinsey)
  • FDA, Pentagon To Announce Agreement (BioCentury)

In Focus: International

  • Google venture arm backs UK universal flu vaccine company (Reuters) (Endpoints) (PharmaTimes)
  • EU nod for Shire's longer-acting haemophilia A therapy (PharmaTimes)
  • Parliament offers Italians one last shot at winning EU drugs regulator (Politico) (Express)
  • Moody's joins Fitch in junking Teva, citing debt load (Financial Times)
  • Teva settles with Israeli authorities over international bribery (Pharmafile)
  • A $300 Billion Reason to Keep Drugs Cheap in India (Bloomberg)
  • Sanofi agrees to reimburse Philippines' Dengvaxia stockpiles (Pharmafile)
  • Stars In China (BioCentury)
  • Brexit bad for orphans: Concerns about cost to rare disease-focused UK pharma (InPharmaTechnologist)
  • Hikma names ex-Fresenius scientist as global R&D chief (Fierce)
  • Global drugmakers complain over violations of patent rights in Russia (PharmaLetter-$)
  • PAHO's scientific journal explores the past, present and future of vaccination in the Americas (PAHO)

Pharmaceuticals & Biotechnology

  • Which drug patents expire in 2018? (MedCityNews)
  • Why Halving The Orphan Drug Tax Credit Won't Have Much Impact On Investment (BioCentury)
  • Spark CEO Marrazzo on Gene Therapy Pricing & Paving the Way for the Field (Xconomy)
  • Here's what people talked about at JP Morgan's health-care conference (CNBC)
  • CRISPR Recovery? "Furor" Briefly Snips $500M From Companies' Values (Xconomy)
  • Tesaro's injected chemo nausea med Varubi can cause anaphylaxis, company warns (Fierce)
  • New Evidence in JAMA Shows Insurance Gaps Leave Some Cancer Patients Without Treatment (The Health Care Blog)
  • The Here and This and Now review – drug reps find humour is best medicine (The Guardian)
  • AbbVie, Pfizer drive 2017 pharma TV ad spending above 2016's tally (Fierce)
  • BioPharma Dive's 3 predictions for 2018 and beyond (BioPharmaDive)
  • Merck's Keytruda nabs new data to rival Bristol-Myers' Opdivo at fending off melanoma's return (Fierce)
  • For Now, Sequencing Cancer Tumors Holds More Promise Than Proof (NPR)
  • Aviragen Vaxart merger to create $264m tablet vaccine firm (InPharmaTechnologist)
  • The coming of age of gene therapy: A review of the past and path forward (NIH)
  • Sanofi CMO offers window on ways pharma is integrating tech into drug development (MedCityNews)
  • Dr. Ronald Fieve, 87, Dies; Pioneered Lithium to Treat Mood Swings (NYTimes)
  • Seizing opportunities in the next steps for real world evidence (Pharmafile)
  • Sartorius inks deal for Quad's T cell activation tech (BioPharmaReporter)
  • Biofrontera files for IPO to run skin cancer clinical trials (Fierce)
  • Baxter Updates on Hurricane Maria Recovery (Baxter 1, 2)
  • Fresh insights into a giant protein could improve heart health (Fierce)
  • FDA 2017 Year in Review (National Law Review)
  • NAS Emerging Science Committee Holds Workshop on Genome Editing Tools (National Law Review)
  • Is the FDA Now Shifting its Focus to South Korea? (FDAZilla)
  • CardioBrief: Nuance and the Healthcare Apocalypse (Medpage)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia (Press)

Medical Devices

  • Young doctors struggle to learn robotic surgery – so they are practicing in the shadows (The Conversation)
  • Abbott launches new ablation catheter in Europe (MassDevice)
  • What Products Will Ultimately Win in Diagnostics? (MDDI)
  • Developing a Medtech Product? Consider These 4 Essentials (MDDI)
  • Dexcom, UnitedHealth team up for wearable glucose management pilot program (Drug Delivery)
  • Guerbet to pay $23.7m for Accurate Medical Therapeutics (MassDevice)

US: Assorted & Government

  • Tribe Says Immunity Unscathed By Joining Allergan IP Suit (Law360-$)
  • Applying BMS To Federal Class Actions: Due Process Matters (Law360-$)
  • Pfizer's Hospira Billed Gov't For Faulty Pumps, Suit Says (Law360-$)
  • Investors Want Abbott To Explain Delay In Alere Deal (Law360-$)
  • Message to Trump: Alnylam CEO proud to be a 'shitholer' (Fierce)
  • CDC looks to bring its clinical guidance into the digital age (Fierce)
  • Kentucky becomes first U.S. state to impose Medicaid work provisions (Reuters)
  • Mapping How The Opioid Epidemic Sparked An HIV Outbreak (NPR)
  • Valeant Says Insurers Must Defend Allergan, Stock-Drop Suits (Law360-$)
  • PTAB To Review Tyvaso Patents Despite Time-Bar Protest (Law360-$)
  • No Old Kentucky Home for Parallel FDCA-Based Tort Claims (Drug & Device Law)
  • Insights into the 2018 individual exchange market (McKinsey)
  • In the healthcare industry, profit pool growth has varied widely over the past five years (McKinsey)
  • The Medicaid Agency of the Future: What capabilities and leadership will it need? (McKinsey)
  • The Quality Payment Program under MACRA: Strategic implications for providers and payers (McKinsey)

Upcoming Meetings & Events

Europe

  • Spain's government and Farmaindustria renew pact (PharmaLetter-$)
  • Russian government to subsidize labeling costs of pharma producers (PharmaLetter-$)
  • Dutch collaboration to create large exome dataset for analysis (PharmaLetter-$)
  • PHE confirms measles outbreaks in five areas of England (PharmaTimes)

Asia

  • Asia Executives To Watch: GSK, Kyowa Hakko, PeptiDream (SCRIP-$)
  • Eisai completes oral solid dose production facility in China (PharmaLetter-$)
  • WuXi Biologics Appoints Dr. Chiang Syin, a Former FDA Officer as Chief Quality Officer (Press)

India

  • Device firms pull back from India following price caps (Fierce)
  • India Presses Chinese API Firms Over Quality Concerns (Pink Sheet-$)
  • Lupin forays into OTC segment;eyes Rs 300 crore turnover in 5 years (Economic Times)
  • After Fortis, government panel to probe Medanta (Times of India)

Australia

  • New Recall Procedures For Australian Therapeutic Goods Come Into Play (Pink Sheet-$)
  • Medical Devices Safety Update, Volume 6, Number 1, January 2018 (TGA)
  • For now, Australia's plans for cannabis market dominance are more smoke than fire (Reuters)

Other International

General Health

  • Flu in U.S. now widespread but season may be peaking: CDC (Reuters)
  • After a clot, shorter treatment with compression stockings may be OK (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 news@raps.org.

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


Categories: Recon, Regulatory News

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