Regulatory Focus™ > News Articles > Regulatory Recon: AZ's Tagrisso First to be Approved Under China's Priority Review Pathway; House He

Regulatory Recon: AZ's Tagrisso First to be Approved Under China's Priority Review Pathway House Hearing on Device User Fees Set for Tuesday (27 March 2017)

Posted 27 March 2017 | By Michael Mezher 

Regulatory Recon: AZ's Tagrisso First to be Approved Under China's Priority Review Pathway House Hearing on Device User Fees Set for Tuesday (27 March 2017)

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

In Focus: US

  • Examining FDA's Medical Device User Fee Program (House Energy & Commerce)
  • The Trump Administration's War on Science (NYTimes)
  • In Major Defeat for Trump, Push to Repeal Health Law Fails (NYTimes)
  • Bracing for the Fallout of the Health Bill's Collapse (NYTimes) (Forbes)
  • Some Lawmakers Now Look to Bipartisanship on Health Care (NYTimes) (Forbes)
  • In a Call to The Times, Trump Blames Democrats for the Failure of the Health Bill (NYTimes)
  • Ryan on Pulling Health Bill: 'A Setback, No Two Ways About It' (NYTimes)
  • Soon-Shiong's promotion of 'breakthrough' cancer therapy raises questions (STAT)
  • 'I'm Willing To Try Anything': Compassionate Use Access To Experimental Drugs And The Misguided Mission Of Right-To-Try Laws (Health Affairs Blog) (Washington Post)
  • House Committee Probes Restricted Distribution Systems Delaying Generics (Focus)
  • CDRH Seeks Participants for Staff Training Program (Focus)
  • Controversial Pharma CEO To Chair AHA Charity Ball (CardioBrief)
  • Judge dismisses two Express Scripts claims in Anthem drug pricing lawsuit (Reuters) (Law360-$)
  • FDA Warning Letters to Foreign Facilities Soar in 2017 (FDA News-$)
  • Medtronic Urges High Court To Open PTAB Up To More Review (Law360-$)
  • Biopharma Asks US Supreme Court Not To Limit Patent Litigation Venue (Pink Sheet-$)
  • Allergan, Paratek hit late-stage acne goals, preps for sarecycline NDA (Fierce) (Press)
  • Novartis-backed Ionis subsidiary Akcea maps a $100M IPO as it steers a lead drug to regulators (Endpoints) (GEN)
  • Amgen triggers yet another revamp, moving researchers to two big hubs (Endpoints)

In Focus: International

  • Chinese drug approval boosts AstraZeneca's lung cancer hopes (Reuters) (Pharmafile) (Bloomberg)
  • Foamix's acne drug misses main goal in late-stage study (Reuters) (Endpoints)
  • Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars (Focus)
  • UK funds creation of antibiotic drug discovery unit (Fierce) (Press)
  • HIV testing should be seen as routine practice, says NICE in new draft quality standard (NICE)
  • Venezuela's Maduro asks UN to help ease medicine shortages (Reuters) (PBS)
  • Japan Price Reforms Will Be Pro-Innovation, Inclusive – Official (Pink Sheet-$)
  • South Africa to try Japanese drug against resistant form of TB (Reuters)
  • Pfizer receive European approval for arthritis drug (Pharmafile) (PharmaTimes) (Press)
  • India Eases Approval Process For HIV, Hepatitis Combinations (Pink Sheet-$) (PharmaBiz)
  • Black Triangle Scheme And Formal Inspections On the Cards In Australia (Pink Sheet-$)
  • Multi-Company Product Listing Agreements On The Rise In Canada (Pink Sheet-$)
  • MSD's Keytruda closer to classical Hodgkin Lymphoma nod (Pharmatimes)
  • Fraction of TB patients getting most effective drugs, but pharma companies stress access efforts (PharmaLetter-$)
  • Five worrying facts about fake medicine (Pharmafile)

US: Pharmaceuticals & Biotechnology

  • Ex-Baxalta CEO Ludwig Hantson gets the top job at a troubled Alexion (Endpoints)
  • ICER releases draft evidence report on crisaborole and dupilumab for atopic dermatitis (PharmaLetter-$)
  • Ignyta agrees new terms with Lilly for troubled cancer alliance (Fierce)
  • Lost $700m Opportunity As PTC Bids Farewell to Translarna in CF (SCRIP-$)
  • Abbott divests 60% of its stake in Mylan (Drug Delivery)

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

  • FDA Grants Priority Review for Eagle Pharmaceuticals' Ryanodex NDA for the Treatment of Exertional Heat Stroke (Press)
  • Sumagen's World First Killed Whole HIV Vaccine Set For Phase II (SCRIP-$)
  • Newron Presents Encouraging Detailed Results of Its Phase IIa Study with Evenamide in Patients with Schizophrenia (Reuters)
  • Erytech reports positive Phase 2b data for eryaspase (Reuters) (Press)

US: Medical Devices

  • FDA: Philips HeartStart MRx recall is Class I (FDA 1, 2)
  • Class 1 Device Recall 7F Prelude Short Sheath Introducer (FDA)
  • CBP, ICE seize more than 40k Counterfeit Condoms (CBP)
  • New Guidelines Support Use of Cardiac Monitoring for Patients with Unexplained Fainting (Press)
  • Mirabilis Medica wins CE Mark, FDA IDE for Mirabilis system (MassDevice)
  • Bovie Medical Receives 510K Clearance for Its Cool-Coag™ Generator and Open Handpiece (Press)
  • iCAD Receives FDA PMA For PowerLook Tomo Detection (Press)
  • HAART 300 Aortic Annuloplasty Device Cleared by FDA to Repair Aortic Valves (MedGadget)

US: Assorted & Government

  • Eleventh Circuit Affirms A Very Unhappy Unverdict Against Hip Manufacturer (Drug & Device Law)
  • Maryland legislation would rein in prescription drug costs (Medium)
  • More States To Expand Medicaid Now That Obamacare Remains Law (Forbes)
  • Chugai gets favorable final ruling on Oxarol patent dispute (PharmaLetter-$)
  • Pa. Judge Tosses Actiq Off-Label Marketing Suit (Law360-$)

Upcoming Meetings & Events

Europe

  • Impact report shows healthy return on public medical research spending (MRC)
  • EPHA joins Europe-wide challenge to patent for Hepatitis C treatment (EPHA)
  • Bone Therapeutics strengthens leadership with new CMO (Pharmafile)
  • Draft guidance on provision of data on antimicrobial use by animal species from national data collection systems (EMA)
  • Creo Medical wins expanded CE mark for Speedboat RS2 electrosurgical device (MassDevice)
  • Eurofins pumping $5m into a UK biopharmaceutical testing site (BioPharmaReporter)
  • Sanofi reviews consumer health business media buying and planning account post-Boehringer swap (Fierce)

Asia

  • CFDA Minister Bi Jingquan meets Bill & Melinda Gates Foundation Co-Chair Bill Gates (CFDA)
  • Sihuan Pharma to acquire fellow Chinese drug firm (PharmaLetter-$)
  • ASEAN Pharma Packaging Conference concludes in Singapore (BioSpectrum)

India

  • DCGI issues circular to pharma trade on proper record keeping, sourcing & sale of drugs (PharmaBiz)
  • Drug retailers objects health ministry's proposed e-registration plan to regulate sale of drugs (PharmaBiz)
  • Indian packaging market expected to reach $32 billion by 2020 (PharmaBiz)

Australia

  • Medical devices and IVDs: Cancellations from the ARTG (TGA)
  • Safety Alert - Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS) (TGA)
  • Antibiotic resistance guidance (TGA)

Other International

  • French generics major moves into Africa (PharmaLetter-$)
  • WHO concerned at deteriorating health situation in East Ghouta, Syria, calls for immediate and unimpeded access (WHO)

General Health & Other Interesting Articles

  • Gut Check: Scientists are Wary of At-Home Microbiome Tests (MIT Technology Review)
  • I did everything the doctors said, but for 20 years my symptoms only got worse (Washington Post)
  • Living With Zika In Puerto Rico Means Watching, Waiting And Fearing Judgment (NPR)

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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