Regulatory Recon: Amgen Gets NICE Backing for Parsabiv; House Committees Begin Healthcare Bill Markup (8 March 2017)

Posted 08 March 2017 By Michael Mezher

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

In Focus: US

  • A Tale Of Two Desmopressins: Trial Design Gave Noctiva Advantage Over Nocdurna, US FDA Says (Pink Sheet-$)
  • J&J, Celltrion Remicade Biosimilar Dispute Could Settle, Analyst Says (Bloomberg)
  • Roche tops biosimilar defence league by a 'country mile' (BioPharmaReporter)
  • How To Get Rid of The "Totality of the Evidence" Amendment to The Intended Use Regulation (FDA Law Blog)
  • Alliance of Companies Unveil First Steps Aimed at Cutting Health-Care Costs (WSJ)
  • Orphan Drug Act: Congressional, FDA, NORD Reviews Come Amid Pricing Debate (Pink Sheet-$)
  • Report: Boston Scientific's US hiring flat despite device tax pause (MassDevice)
  • High-profile biotech leader Deborah Dunsire takes the helm at XTuit, focused on cancer and fibrosis (Endpoints)
  • CDER Goals for 2017: Improved Informatics, Cures Act Implementation and User Fees (Focus)
  • FDA Warns Megafine Over Data Integrity Violations at Second Facility (Focus)
  • When Does CDER Consult With Controlled Substance Staff? Revised MAPP Explains (Focus)
  • FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication (FDA)
  • Trump Working on 'New System' to Increase Drug Competition (Focus)
  • Obamacare Repeal Bill Would Eliminate Tax on Device Companies (Focus)
  • GOP's Health Plan Draws Skepticism on Capitol Hill (WSJ) (Politico) (NYTimes)
  • House Committees Meet to Markup Healthcare Bill (Ways and Means) (Energy and Commerce)
  • BPCIA Appears Unaffected By Proposed New Healthcare Law (Big Molecule Watch)
  • Health-Care Companies See Big Risks in Plan to Replace Obamacare (WSJ) (STAT)
  • The Parts of Obamacare Republicans Will Keep, Change or Discard (NYTimes)
  • Millions Risk Losing Health Insurance in Republican Plan, Analysts Say (NYTimes)
  • Who Wins and Who Loses Under Republicans' Health Care Plan (NYTimes)
  • Obamacare Took Months to Craft; Repeal May Be Much Swifter (NYTimes)
  • Gene Therapy in a Box (MIT Technology Review)

In Focus: International

  • EU Council Unanimously Adopts MDR, IVDR: Next Stop EU Parliament (Focus)
  • NICE set to back Parsabiv for kidney disease complication (Pharmafile) (PharmaLetter-$) (PMLive)
  • NICE backs Vectibix for MCC in previously untreated patients (PharmaLetter-$) (Press)
  • WHO expands vaccination advice as yellow fever covers southeast Brazil state (Reuters)
  • Turkey Plans To Facilitate Orphan Drug Licensing (Pink Sheet-$)
  • Asia Regulatory Roundup: TGA Increases Inspections Following Adoption of Risk-Based Approach (Focus)
  • Japan's Taiho Pharma sets up operations in Canada (PharmaLetter-$)
  • Establishing a Medical Device Presence in China? Be Very Careful (Pacific Bridge Medical)
  • Russian government to allow production of anti-HIV drugs bypassing patent-holders rights (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Genentech Wants Other Firms' Compounds For Mass Pediatric Cancer Screening (Pink Sheet-$)
  • GSK's asthma biologic hits quality of life goal (PharmaTimes)
  • Intellia fine tunes its CRISPR/Cas9 tech ahead of human studies (Endpoints)
  • Kite public offering looks to raise $350m for CAR T cell therapy support (BioPharmaReporter) (Press)
  • How is data changing the pharmaceutical industry? (PharmaLetter-$)
  • Vaxess granted $6m to develop sustained release vaccine patches (BioPharmaReporter)
  • Merck aims to put Amazon's Alexa to work on voice-enabled diabetes tools (Fierce)
  • Diabetes drug could be key to treating aggressive breast cancer, research suggests (Pharmafile)

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

  • FDA Accepts sBLA Filing of Soliris® (Eculizumab) as a Potential Treatment for Patients with Refractory Generalized Myasthenia Gravis (gMG) (Press)
  • FDA Grants Orphan Drug Designation to CSRA's DynPort Vaccine Company for Plague Vaccine (Press)
  • FDA Accepts Supplemental New Drug Application (sNDA) For VRAYLAR (cariprazine) (Press)
  • Glenmark Pharmaceuticals Receives FDA Clearance of IND for GSP 304 (Press)
  • PolyPid Announces Receipt of Qualified Infectious Disease Product (QIDP) Designation from FDA for D-PLEX™ in Post-Cardiac Surgery Sternal Infection (Press)
  • Intersect ENT Submits New Drug Application to FDA for Office-Based RESOLVE Steroid Releasing Implant for Recurrent Chronic Sinus Disease (Press)
  • Teligent, Inc. Announces FDA Approval Of Clobetasol Propionate Gel, 0.05% (Press)

US: Medical Devices

  • Surgical Robot Nearing FDA Submission (MDDI)
  • Use-Case Testing and Data Help Device Company Drive Patient Adherence (MDDI)
  • Ethicon goes ahead with Enseal X1 launch (MassDevice)
  • Med device recalls remain high as new era of convergence begins (MedCityNews)
  • Beckman Coulter Diagnostics Receives FDA Clearance for its DxC 700 AU Chemistry Analyzer (Press)

US: Assorted & Government

  • Generics account for 32% greater market share since Medicare Part D (PharmaLetter-$)
  • Amgen Alleges 'Massive Conspiracy' By Employees Who Joined Coherus And KBI (Pink Sheet-$) (Fierce)
  • Attorney General Jeff Sessions Delivers Remarks at New Hampshire Youth Summit on Opioid Awareness (DoJ)
  • A Pair of Pain Pump PMA Preemption Cases (Drug & Device Law)
  • PTAB Life Sciences Report -- Part I (Patent Docs)
  • Management Challenges at the Departments of Labor, Health and Human Services, and Education and the Social Security Administration: Views from the Inspectors General  (House Appropriations)
  • Veterans' Health Care: Preliminary Observations on Veterans' Access to Choice Program Care (GAO)

Upcoming Meetings & Events

Europe

  • Bioversys, Aptuit team up to find novel antibiotic targets (Fierce)

Asia

  • Taiwan FDA seeks Crestor recall after counterfeit finds (Securing Industry) (Taiwan FDA)
  • Kitov Announces License Agreement for KIT-302 in South Korea (Press)
  • BeiGene to develop $330 million biologics plant (Pharmafile)

India

  • Delhi High Court favours Natco, Alembic; allows them to export generics of Bayer's drugs (Economic Times)
  • Govt needs to spend more on public health to achieve universal health coverage: Prof Sundararaman (PharmaBiz)
  • Wockhardt says Ireland's HPRA has recommended GMP cert renewal for Shendra site (InPharmaTechnologist)
  • US FDA says Wockhardt's oversight of drug production inadequate (InPharmaTechnologist)
  • Zydus Cadila gets USFDA nod to market muscle relaxant in US (Economic Times)

Canada

  • Biodefense: Canada develops novel live virus smallpox vaccine from horsepox (BioPharmaReporter)

Australia

  • Submissions received: Guidance on biovigilance responsibilities of sponsors of biologicals (TGA)
  • Industry Dismisses Report's Claim That Australians Pay Too Much For Medicines (Pink Sheet-$)
  • Zostavax vaccine Safety advisory – not to be used in patients with compromised immune function (TGA)

General Health & Other Interesting Articles

  • Arthritis' toll rises as too few take steps to reduce pain: CDC (Reuters) (CDC 1, 2)
  • Gene activity in the nose may signal lung cancer (Reuters)
  • US doctors not sure all women need pelvic exams (Reuters)
  • Poor diet tied to nearly half of U.S. deaths from heart disease, stroke, diabetes (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.

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