Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Newron's  Xadago as Add-On for Parkinson's Disease; Novartis Heart Dr

Regulatory Recon: FDA Approves Newron's  Xadago as Add-On for Parkinson's Disease Novartis Heart Drug Serelaxin Fails in Phase III Trial (22 March 2017)

Posted 22 March 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Newron's  Xadago as Add-On for Parkinson's Disease Novartis Heart Drug Serelaxin Fails in Phase III Trial (22 March 2017)

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

In Focus: US

  • FDA approves Newron's drug as add-on therapy for Parkinson's (Reuters) (FDA) (Press)
  • CDER, CDRH and CBER Directors Stress Importance of User Fee Reauthorizations Before Senate Committee (Focus)
  • FDA Warns Two Drugmakers in China and India for Data Integrity Violations (Focus)
  • Trump blasts Big Pharma again, promises drug price legislation (Endpoints)
  • Trump's Promise To Rein In Drug Prices Could Open Floodgate To Importation Laws (KHN)
  • This is Not a Test: RMAT Designation Goes Live (FDA)
  • GAO To Launch Investigation Of FDA's Orphan Drug Program (KHN)
  • UCSF Cardiologist Is Distrustful Of Amgen's Cholesterol Drug Study (Forbes)
  • Supreme Court gets rid of delay defense in patent cases (Reuters) (Forbes)
  • For Rare Disease Patients, A Pathway To Hundreds Of New Therapies (Health Affairs Blog)
  • FDA Concurs With WHO on Rare Lymphoma Linked to Breast Implants (Focus) (Medpage) (NYTimes) (FDA 1, 2)
  • FDA Expert Says GSK In Charge Of Paxil Label Changes (Law360-$)
  • TV Ads Pushed Inappropriate Use of Testosterone (CardioBrief) (Reuters)
  • A year after a patient death, Akashi gets FDA all-clear to resume DMD trial (Fierce) (Press)
  • Novartis heart drug portfolio hit by failed serelaxin study (Reuters) (Fierce)
  • Biosimilar interchangeability: Do you know your switching from your substitution? (BioPharmaReporter)
  • Sanofi, Regeneron sue Amgen to protect eczema drug from patent claims (Reuters)
  • Biogen wins ruling in Tecfidera IP case; shares rise (Reuters)
  • Freedom Caucus threatens formal opposition to Obamacare replacement bill barring dramatic changes by Wednesday night (CNBC)
  • Trump Warns House Republicans: Repeal Health Law or Lose Your Seats (NYTimes)

Sponsored Content: IDMP is Delayed Again

In Focus: International

  • Lilly CEO Ricks in China: Free trade good, antiglobalization moves 'dangerous' (Fierce)
  • GSK begins £92 million expansion of UK site (Pharmafile)
  • GSK breaks ground on $175m German Bexsero vaccine facility (BioPharmaReporter)
  • Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (Focus)
  • Drugmakers, including multinationals, to cut prices in Russia (PharmaLetter-$)
  • US bans Indian drugmaker Divi's factory, shares hit three-year low (Reuters)
  • Australian Provisional Approval Pathway To Get Tough On Sponsors Upfront (Pink Sheet-$)
  • Spain Probes Pharma Giants For Restricting Competition (Law360-$)
  • Korean Pharma Calls For New Policy 'Control Tower', More Support (Pink Sheet-$)
  • Pharma Patents Are Vulnerable In Canada As Lilly Loses NAFTA Challenge (Pink Sheet-$)
  • Need For Consensus On Pharmacovigilance For Drugs In Pregnancy Delays New EMA Guideline (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • Drug shortage in 2011 tied to increased deaths (Reuters)
  • Therapeutic efficacy and safety of PCSK9-monoclonal antibodies on familial hypercholesterolemia and statin-intolerant patients: A meta-analysis of 15 randomized controlled trials (Nature)
  • Califf To Head New Clinical Research Foundation (BioCentury)
  • Prostate, hair loss drugs tied to mental health risk, but not suicide (Reuters)
  • Investors left feeling blue as Cerulean admits defeat on cancer pipeline (Fierce)
  • Combo Products Won't Get Special Review Pathway At US FDA Anytime Soon (Pink Sheet-$)
  • C-PATH Consortium Seeks To Qualify Diabetes Biomarkers (BioCentury)
  • FDA's Broad-Based Effort To "Modernize" Combination Product Regulatory Process In Full Swing (IPQ)
  • Alternative treatment cures rare blood disease for first time (Pharmafile)
  • Real-world data shows that nearly all hepatitis C patients cured with Harvoni (PharmaLetter-$)
  • Pain Therapeutics finally sees a way forward for abuse-deterrent opioid (PharmaLetter-$) (Pink Sheet-$)
  • Pharma's rep with patient groups was on the rise, but not anymore: PatientView (Fierce)
  • A New Business Model For Deprioritized Clinical Trials (SCRIP-$)
  • Copying Valeant's Xifaxan just got 'a lot easier,' thanks to new FDA guidance: analyst (Fierce)
  • Big Pharma finds a hit with disease awareness social media posts in 2016 (Fierce)
  • Contraceptive pill reduces cancer risk long-term, study finds (PharmaTimes)
  • PDUFA date for novel glaucoma candidate latanoprostene bunod (PharmaLetter-$)

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

  • Minoryx Preps For Tough Pricing Regime As CNS Orphan Drug Enters Phase II/III (SCRIP-$)
  • Phase III Data Boost Prospects For Jazz's Sleep Apnea Drug (SCRIP-$)
  • Neurocrine posts full phase 3 Ingrezza data as PDUFA date, showdown with Teva in tardive dyskinesia near (Fierce)
  • Tarrex Biopharma Announces FDA Acceptance of IND Application for TX803 to Commence Phase I Clinical Trials in Colorectal Cancer Patients (Press)
  • Aegis Medical Innovations Announces FDA Approval of Clinical Trial (Press)
  • AVEO Announces First Patient Dosed in Phase 1/2 TiNivo Trial of Tivozanib and Opdivo (nivolumab) in Advanced RCC (Press)

US: Medical Devices

  • Smaller, Faster, Cheaper: Chip Technology for Medical Devices (MDDI)
  • Congressional Committee Members Publicly Release Discussion Bill on Lab Test Regulation (GenomeWeb)
  • Common Medical Device QMS Audit Problems: Little or No Audit Preparation (Emergo)
  • Cybersecurity expert calls out healthcare for 'lackadaisical' approach to growing threat (MassDevice)
  • InVivo submits 1st HDE module for neuro-spinal scaffold (MassDevice)
  • Fibrosis: How to prevent it in medical device implants (MassDevice)

US: Assorted & Government

  • Maryland House Passes Bill on Price Gouging of Generic Drugs (Focus)
  • We Fact-Checked Lawmakers' Letters to Constituents on Health Care (ProPublica)
  • Health Insurance Lobby Backs Key Trumpcare Revisions (Forbes)
  • What's at Stake in a Health Bill That Slashes the Safety Net (NYTimes)
  • A Young Man With Parkinson's Frets Over The Affordability Of GOP Health Plan (KHN)
  • Trump, Koch brothers at odds over 'Trumpcare' vote (Reuters)
  • The Rate Of PGR Petitions Hitting Orange Book Patents (Law360-$)
  • China Medical Technologies execs indicted for fraud (MassDevice)
  • Warning: Lawyers May Be Hazardous To Your Health (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • UK group expanding campaign to curb antibiotics in meat production (Reuters)
  • ABPI Wales responds to Welsh Government Statement: Response to The Independent Review of the Individual Patient Funding Request (IPFR) process (ABPI)
  • Pierre Fabre and H-Immune partner on MAb cancer immunotherapies (PharmaLetter-$)
  • German Merck taps up cell-based pyrogen detection kit (InPharmaTechnologist)
  • BOPA guidelines for biosimilars: a new era in biological therapy (PharmaLetter-$)
  • Russia's FAS to ease access of foreign drugmakers to state tenders (PharmaLetter-$)
  • NuVasive wins UK NICE support for XLIF procedure (MassDevice)

Asia

  • Japan clears Novocure's 2nd gen Optune device (MassDevice)
  • Launch of LINZESS Tablets 0.25mg in Japan (Press)

India

  • Sun Pharma gets positive verdict from DoP on revision of ceiling price of nitrofurantoin capsule (PharmaBiz)
  • Wockhardt gets USFDA nod for generic anti-bacterial drug (Economic Times)

Canada

  • ZOLL Receives Health Canada Approval for Two New Models Of AEDS (Press)

Australia

  • TGA completes review of home-use kits (TGA)

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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