Regulatory Recon: NICE Rejects Pfizer's Besponsa for ALL; Sanofi to Increase Investment in Biologics Production (14 June 2017)

Posted 14 June 2017 By Michael Mezher

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

In Focus: US

  • Johnson & Johnson's flu drug succeeds in mid-stage trial (Reuters) (Press)
  • Follow The Money: The Flow Of Funds In The Pharmaceutical Distribution System (Health Affairs Blog)
  • Big Pharma gives your doctor gifts. Then your doctor gives you Big Pharma's drugs. (Washington Post)
  • Will AstraZeneca's SGLT2-favoring data win the class a shot at front-line diabetes use? (Fierce)
  • Senate, White House Working On Drug Pricing (BioCentury)
  • Wyden Introduces Price Transparency Bill (BioCentury) (Wyden)
  • CFO Clancy Leaves Biogen For Alexion (BioCentury) (Pharmafile) (Press)
  • J&J, Pfizer, Merck sit atop Fortune's 500 for pharma (BioPharmaDive)
  • Trump, in Zigzag, Calls House Republicans' Health Bill 'Mean' (NYTimes)
  • Trump hosts lunch with Republican senators, Obamacare repeal on menu (Reuters)
  • The Smartphone Psychiatrist (The Atlantic)
  • After Learning of Faulty Equipment That Could Endanger Babies, Clinical Trial Leaders Continued Experiment, Apparently Didn't Alert Key Officials (Public Citizen)
  • Orphan Biosimilars: Developers See Big Prospects In Small Markets; Soliris Is One Target (Pink Sheet-$)

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In Focus: International

  • NICE rejects Pfizer's ALL drug Besponsa (PharmaTimes)
  • Multiple myeloma patients to get NHS access to Amgen's Kyprolis (PharmaTimes)
  • GSK cues up regulatory filings for relapsing malaria drug (PMLive)
  • Bhutan and Maldives successfully eliminate measles (Pharmafile)
  • Do doctors have a duty to take part in pragmatic randomised trials? (BMJ)
  • Snakebite finally makes a WHO list of top global health priorities (STAT)
  • Sanofi to invest further in biologics (Reuters)
  • WHO confirms Congo polio outbreaks in new eradication setback (Reuters)
  • Interview: Celltrion's Journey To The Top (SCRIP-$)
  • Celltrion biosimilar proves effectiveness in lymphoma and rheumatoid arthritis (Pharmafile)
  • Pharma Opposes 'Harmful' Changes To EMA's Access To Documents Policy (Pink Sheet-$)
  • EU, U.S. and Japanese regulators join forces on antibiotic trials (Fierce) (EMA)

Pharmaceuticals & Biotechnology

  • Struggling Regulus promotes former Lilly executive as new CMO (Fierce)
  • New Data Show the Gross-to-Net Rebate Bubble Growing Even Bigger (Drug Channels)
  • Sandoz US President Peter Goldschmidt Talks Generic Policy Improvements (Pink Sheet-$)
  • Want to earn more, pharma reps? Go large, get on the road or jump to biotech (Fierce)
  • FiercePharma investigates the who, why and how of pharma marketing at Lions Health (Fierce)
  • Drug Price Inflation and a Patent Cliff Could Trigger a Wave of Deals in Generic Drugs Space (The Street)
  • PhRMA: Health Spending on Non-Prescription Drugs to Out-Pace Drug Spending (PhRMA)
  • Bristol-Myers Squibb Voluntarily Recalls One Lot of Eliquis (apixaban) 5 mg Tablets (FDA)
  • Dr Reddy's recalls 3.25 lakh cartons Cipla-made acne drug from US (Economic Times)
  • Aspirin linked to higher risk of serious bleeding in the elderly (Reuters)
  • Reversal of type 1 diabetes possible through century-old vaccine (Pharmafile)
  • Brain Cell Transplants Are Being Tested Once Again For Parkinson's (NPR)
  • ICER Revising Assessment Of Repatha's Cost-Effectiveness (BioCentury)
  • Taking Biosimilars Down A PEG: Why Copying Neulasta Isn't So Easy (Pink Sheet-$)
  • Researchers aim to repurpose former experimental cancer therapy to treat muscular dystrophy (NIH)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • BioTime's Renevia succeeds in pivotal European facial wasting trial (Reuters)
  • Centrexion's chili-based painkiller offers relief for 6 months – study (Reuters)
  • Bioverativ announces FDA acceptance of Investigational New Drug Application for BIVV001, a novel, long-acting FVIII hemophilia therapeutic utilizing Amunix XTEN® half-life extension tech (Press)
  • Lilly's CGRP inhibitor galcanezumab hits the mark in migraines as race to market kicks off (Press)
  • Tiny Aldeyra's eye drug misses primary endpoint in phase 2 (Fierce)
  • Phase 2a Safety and Efficacy Data Support Further Development of Oral CC-220 in Patients with Lupus (Press)
  • Boehringer Ingelheim presents phase III results demonstrating clinical equivalence of adalimumab biosimilar candidate to HUMIRA (Press)
  • FDA Approves Humalog Junior KwikPen for the Treatment of Diabetes (Press)
  • FDA Grants Breakthrough Therapy Designation to Omeros' MASP-2 Inhibitor OMS721 for the Treatment of IgA Nephropathy (Press)
  • Jardiance® (empagliflozin) analysis reinforces established safety profile (Press)
  • Bristol-Myers Squibb To Present New Research Related to the Treatment of Rheumatoid Arthritis Patients With Highly Active, Progressive Disease at EULAR 2017 (Press)
  • Lilly to Present New Data on Olumiant® (baricitinib) in Rheumatoid Arthritis and Taltz (ixekizumab) in Psoriatic Arthritis at EULAR 2017 (Press)
  • Modra Pharmaceuticals Announces Start of Phase II Study for its Lead Oral Chemotherapy in Patients with Metastatic Prostate Cancer (Press)
  • ACEA Biosciences Announces Successful Completion of Phase I Clinical Study of Novel Autoimmune Disease Drug (Press)
  • GenSight Biologics Reports Long-Term Positive Safety and Visual Acuity Results at Week 96 in Phase I/II Study of GS010 for the Treatment of Leber's Hereditary Optic Neuropathy (LHON) (Press)
  • Phase 1 Clinical Study Results of REMD Biotherapeutics' Lead Product Candidate, REMD-477, Demonstrate Reduced Need for Insulin and Improved Blood Glucose Levels for Patients with Type 1 Diabetes (Press)

Medical Devices

  • 2017 Medical Design Excellence Awards Winners (MDDI)
  • Cash for clunkers: Could it work for legacy medical devices? (Fierce)
  • Are drones a fast way to deliver emergency defibrillators? (Reuters)
  • Fresenius Medical targets $27B in sales by 2020 (MassDevice)
  • 3D printing: FDA clears Si-Bone's iFuse-3D sacroiliac device (MassDevice)
  • Invuity recalls PhotonBlade (MassDevice)
  • Cleveland Clinic spinout Infuseon wins FDA nod for CNS drug delivery device (MassDevice)

US: Assorted & Government

  • Major groups announce anti-AHCA push (Politico)
  • G.O.P. Senators Might Not Realize It, but Not One State Supports the A.H.C.A. (NYTimes)
  • Trump Says Market Is Failing, but One Insurer Bets Big on Obamacare (NYTimes)
  • Court Decides It Lacks Jurisdiction Before FDA Approval Occurs (Press)
  • How About This Health Care Act That Both Democrats And Republicans Support (Forbes)
  • Ninth Circuit Reverses Daubert Exclusion (Drug & Device Law)
  • What To Expect When You Are Managing A Population Health Coalition (Health Affairs Blog)
  • As US looks to modernize NAFTA, strong enforcement of existing obligations should be a top priority (PhRMA)
  • Olympus settles power morcellator suit (MassDevice)
  • FDA delays rolling out new nutrition facts label (Reuters) (FDA Law Blog)
  • Drug patents do better in IPR proceeding than other technologies, report (PharmaLetter-$)

Upcoming Meetings & Events

Europe

  • Value of CCG pound shrinking, commissioners warn (PharmaTimes)
  • Marketing authorisations granted in May 2017 (MHRA)
  • Parallel import licences granted in May 2017 (MHRA)
  • Biocartis Gets CE Mark for EGFR Mutation Test (GenomeWeb)
  • Biotronik wins CE Mark for 3T scans with ProMRI pacers (MassDevice)
  • Mologic Receives CE Mark Approval for PERiPLEX Diagnostic for Infection in Patients on Peritoneal Dialysis (Press)
  • Russian pharma industry doubts transparency of government spending (PharmaLetter-$)

Asia

  • China Investment Roundup: Strategic Overseas Moves Target Product Acquisitions (SCRIP-$)

India

  • Lupin gets USFDA nod for opioid analgesic tablets (Economic Times)
  • Glenmark gets USFDA's tentative nod for Saxagliptin tablets (Economic Times)
  • DCGI asks FDC manufacturers with no approval to submit phase IV trial protocols to prove safety of drugs (PharmaBiz)
  • New writ petition to be filed in Delhi High Court lists 38 private hospitals for stent price violation (PharmaBiz)

Canada

  • Braeburn, Knight seek Health Canada nod for opioid dependence implant (MassDevice)

Australia

  • New MedSearch app is now available for download (TGA)
  • Targeted project: Macular degeneration (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.

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