Regulatory Focus™ > News Articles > 2 > Recon: Novo's Once Weekly Diabetes Drug Ozempic Gets EU Approval

Recon: Novo's Once Weekly Diabetes Drug Ozempic Gets EU Approval

Posted 12 February 2018 | By Michael Mezher

Recon: Novo's Once Weekly Diabetes Drug Ozempic Gets EU Approval

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

In Focus: US

  • FDA Chief Goes Against the Administration Stereotype (NYTimes)
  • Trump's big promises on drug costs followed by modest steps (AP) (NYTimes)
  • McCain and Baldwin to Trump: Hold pharma's feet to the fire on drug prices (STAT)
  • Pharma furious after being "blindsided" in budget deal (Axios)
  • White House Calls to Expedite Review of 2nd or 3rd Classes of New Molecular Entities (Focus) (STAT)
  • Regulatory Reform: Companies and Industry Groups Offer up a Wish List of CDER, CDRH Changes (Focus)
  • States look to lower drug costs, consider Canadian imports (STAT)
  • Former Aetna Medical Director Admits To Never Reviewing Medical Records Before Denying Care (Forbes)
  • How Much Profit Should Novartis Earn By Curing A Childhood Leukemia? (Forbes)
  • Amgen 'looking hard' at striking deals using $27bn cash pile (Financial Times)
  • OxyContin maker stops promoting opioids, cuts sales staff (Reuters) (NCB)
  • David Hung makes a quick, abrupt exit at Axovant after humiliating setbacks (Endpoints)
  • Once rejected, FDA now rolls out a short red carpet for Amicus' migalastat (Endpoints)
  • Ex-FDA commish Califf joins Cytokinetics' board just months after big ALS flop (Endpoints)
  • Heart Stents Are Useless for Most Stable Patients. They're Still Widely Used.   (NYTimes)
  • A Better Way to Provide a 'Right to Try' (Bloomberg) (The Nation)

In Focus: International

  • EU approves Novo's once-weekly diabetes therapy (PharmaTimes) (BioCentury) (Fierce)
  • Norway to buy Biogen's Spinraza medicine: broadcaster NRK (Reuters)
  • Greek prime minister vows to recover billions 'stolen' by Novartis in bribery scandal (STAT) (Financial Times)
  • Roche bispecific antibody tops Lucentis in diabetic eye disease (Fierce)
  • Regeneron's Eylea still sitting pretty even after new data from would-be rivals Roche, Novartis: analyst (Fierce)
  • US, EU and Japan Regulators Accept Submissions for Pfizer's 3rd-Gen ALK Inhibitor Lorlatinib (Press)
  • Sanofi in $155m influenza vaccine deal (Pharmafile)
  • Roche's Gazyvaro gets NICE nod for high-risk lymphoma patients (PharmaTimes)
  • NICE backs EUSA's kidney cancer drug Fotivda (PharmaTimes)
  • Shield Therapeutics shows nothing is iron clad in biopharma (Financial Times)
  • Europe's Common Data Conundrum (BioCentury)
  • Even Australia's Medical Marijuana Poster Boy Can't Get the Drug (NYTimes)
  • Sanofi Pasteur posts 8.3% growth despite 2017 vaccine setbacks (Fierce)

Pharmaceuticals & Biotechnology

  • Two's Company, Three's Diversity (LifeSciVC)
  • Use of placebos on children in study draws researcher's ire (STAT)
  • What's he thinking about? Vivek Ramaswamy lines up a heavyweight title fight for a late-stage diabetes drug (Endpoints)
  • Training Program for Regulatory Project Managers; Information Available to Industry (FDA)
  • What's the trouble with pain? Analysis shows scarce investments, high failure rate for new drugs (Endpoints)
  • ContraVir Pharmaceuticals Reaches Agreement with the FDA on the NDA Package for TXL™ Leveraging the 505(b)(2) Regulatory Pathway (Press)
  • Lilly, Livongo team up for real-world diabetes research, aiming for better results in an outcomes-oriented market (Fierce)
  • Houston district becomes unlikely battleground for vaccine policy fight (Politico)
  • Why so many medicines are in short supply months after Hurricane Maria (CBS)
  • How CFF's $25m Award Provides Validation For Corbus' Approach To CF (BioCentury)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • New data for aflibercept show prolonged injection intervals (FirstWorldPharma)
  • Roche posts positive PhII results for bispecific antibody eye drug, joining Novartis in rivalry with Eylea (Endpoints)
  • Icon Bioscience Receives FDA Approval for DEXYCU, a Potentially Transformational Drug Therapy for Treating Inflammation Associated with Cataract Surgery (Press)
  • Advaxis Announces Publication of Phase 2 Results Evaluating Axalimogene Filolisbac for the Treatment of Recurrent Metastatic Cervical Cancer in the International Journal of Gynecological Cancer (Press)
  • Applied Therapeutics Initiates Phase 1 Trial for AT-001 In Diabetic Complications (Press)
  • Santen Presents Phase I/II Data on DE-122 (Carotuximab) in Patients with Refractory Wet Age-Related Macular Degeneration (Press)
  • MabVax Therapeutics Announces Positive Interim Data from Expanded Cohort in Phase 1 Trial Evaluating MVT-5873 in Combination with First-Line Chemotherapy in Pancreatic Cancer (Press)
  • Concert Pharmaceuticals Announces Initiation of Enrollment in Second Cohort of CTP-543 Phase 2a Trial for Alopecia Areata (Press)
  • Ra Pharmaceuticals Announces Completion of Dosing in Phase 2 Program of RA101495 SC in Paroxysmal Nocturnal Hemoglobinuria (Press)
  • Phase II Data Support Potential for Novel Anti-VEGF/Anti-Angiopoietin-2 Bispecific Antibody, RG7716, for People With Diabetic Macular Edema (Press)

Medical Devices

  • 17 black innovators who made medtech better (Medical Design & Outsourcing)
  • Veryan's helical stent meets safety, efficacy endpoints after 12 months (MassDevice)
  • Shift to R&D prompts Philips Healthcare to shutter manufacturing at Cleveland imaging plant (MassDevice)
  • Source-Ray wins $100m Pentagon contract (MassDevice)
  • Are You Talking? Because CDRH Says It's Listening (At Least If You Are In the Digital Health Space): Notes from A Two Day Workshop (FDA Law Blog)
  • Canon Medical Systems' Vantage Galan 3T XGO Edition with All-New Saturn X Gradient Receives FDA Clearance (Press)
  • MagForce AG Receives FDA Investigational Device Exemption Approval to Conduct a Clinical Trial with NanoTherm Therapy as Focal Ablation Treatment for Intermediate Risk Prostate Cancer (Press)
  • AVITA Medical Announces FDA Approval of Expansion of RECELL Compassionate Use Program in Life Threatening Injuries (Press)

US: Assorted & Government

  • Alexander, Murray Statement on Senate Health Committee's FDA Agenda for the Spring (Senate HELP)
  • Administration Imposes Sweeping Limits on Federal Actions Against Companies (NYTimes)
  • Actelion Pharmaceuticals, Ltd. v. Matal (Fed. Cir. 2018) (Patent Docs)
  • Only You Can Prevent…. (Drug & Device Law)
  • Cherokee AG Wants Federal Opioid Jurisdiction Case Dropped (Law360-$)
  • Indivior Sues Teva, Others Over Opioid Addiction Generics (Law360-$)
  • Merck Loses Fed. Circ. Bid To Enforce Nasonex Patent (Law360-$)
  • AbbVie Investor Demands AndroGel Records In Chancery (Law360-$)

Upcoming Meetings & Events

Europe

  • Tobacco firms in France cheated nicotine tests: anti-smoking body (Reuters)
  • Swissmedic warns on rise in illegally imported medicines in 2017 (PharmaLetter-$)
  • Regulatory information – adjusted fees for pharmacovigilance applications to EMA from 12 February 2018 (EMA)
  • EU serialisation: Challenges facing pharma one year out (InPharmaTechnologist)

Asia

  • CFDA Releases Submission Guidelines For Anti-PD-1, PD-L1 mAbs (BioCentury)
  • Abbisko Aims To Be First To Market In China With 'Me Better' Cancer Compounds (BioCentury)

India

  • Lupin launches generic influenza treatment capsules in the US (Economic Times)
  • GST to hit GSK Consumer's global growth, says CFO Simon Dingemans (Economic Times)

Canada

  • Device Or Drug? Canada Updates Classification Guidance For Difficult To Distinguish Products (Pink Sheet-$)

General Health & Other Interesting Articles

  • Migraine tied to higher risk of cardiovascular diseases (Reuters)
  • NIH scientists adapt new brain disease test for Parkinson's, dementia with Lewy bodies (NIH)
  • Herpes Is Slowly Retreating, but the Infection Remains Common (NYTimes)

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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