Regulatory Recon: FDA Delays Decision on Sarepta DMD Drug Novo Diabetes Combo Gets Unanimous Support at AdComm (25 May 2016)

Posted 25 May 2016 | By Michael Mezher 

Regulatory Recon: FDA Delays Decision on Sarepta DMD Drug Novo Diabetes Combo Gets Unanimous Support at AdComm (25 May 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA panel recommends approval of Novo Nordisk diabetes drug (Reuters) (Fierce) (SCRIP-$) (Tarius)
  • FDA delays decision on Sarepta's muscle-wasting disorder drug (Reuters) (Fierce) (The Street) (Press)
  • BIO Report Claims Fewer Than 1 in 10 Drugs That Enter Clinical Trials Get Approved (BIO) (Boston Business Journal)
  • Big Ideas, Big Conflicts in Plan to Synthesize a Human Genome (MIT Technology Review)
  • Billions at Stake in University Patent Fights (Bloomberg)
  • California sues Johnson & Johnson over marketing for pelvic mesh (Reuters)
  • Groups Protest Senate Bill's Provision to Exempt Biologics From USP Standards (Focus)
  • FDA Warns German Contract Manufacturer Over API Stability Concerns (Focus)
  • Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device (Focus)
  • Exclusive: Sanofi to unveil challenge to Medivation's board – sources (Reuters)
  • Celgene, Gilead Said to Join Suitors Mulling Medivation Bids (Bloomberg)

In Focus: International

  • Monsanto rejects Bayer's $62bn takeover bid (The Guardian) (WSJ-$) (Press)
  • What we must do to avert antibiotic catastrophe (The Guardian)
  • WHO Releases Draft Medical Device Regulatory Framework (Focus)
  • Novartis willing to sell Roche stake without demanding premium – CEO (Reuters)
  • Asia Regulatory Roundup: CFDA Releases New Guidance on Device Trial Inspections (Focus)
  • Chinese Regulators Expand List of Medical Devices Exempt from Clinical Trial Requirements (Emergo)
  • Colombia appeals to World Health Organization in fight for cheaper cancer drug (Colombia Reports)
  • Pharmaceutical Manufacturing in LMICs: Where Things Go Wrong? (USP)
  • WHO Plans To Reshape Itself To Better Handle International Outbreaks (NPR)
  • Canadians facing delayed access to new, innovative medicines: Report (PharmaLetter-$)

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US: Pharmaceuticals & Biotechnology

  • Combination therapies key to curing cancer, says Pfizer (In-PharmaTechnologist)
  • Lilly says new type of pain drug could lessen need for opioids (Reuters)
  • Our Experience With First-Time Biotech CEOs: Five Behaviors That Matter (LifeSciVC)
  • How shortcut clinical trials may be misleading oncologists (Oregon Health & Science University)
  • Flu Vaccine May Benefit Heart Failure Patients (CardioBrief)
  • Annual Healthcare Cost For Family Of Four Now At $25,826 (Forbes)
  • Catalent launches new kit labeling system to reduce 'risk of human error' (Outsourcing-Pharma)
  • Recipharm will serialize customers' drugs for free until US and EU rules come into force (In-PharmaTechnologist)
  • Janssen's Stelara Maintained Clinical Remission After Year Of Treatment (DD&D)
  • Gilead names Kevin Young new chief operating officer (Pharmafile)
  • Repligen raising $100m may signal more M&A activity to come (BioPharma-Reporter)
  • Flatiron Health and the FDA Embark on Cancer Research Collaboration (Press)
  • Epidemiology and Reporting Characteristics of Systematic Reviews of Biomedical Research: A Cross-Sectional Study (PLOS)
  • Looking for a FDA Breakthrough Therapy Designation (BTD)? Utilizing the Preliminary BTD Advice System Might be USEFUL – or NOT (CATO)

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

  • Portage Announces Orphan Drug Designation Request Granted to Biohaven for BHV-4157 (Press)
  • Viamet Receives Orphan Drug Designation from the FDA for VT-1598 for the Treatment of Coccidioidomycosis (Press)
  • First HIV mAb ibalizumab hits PhIII target (Fierce) (Press)
  • Independent Phase II and III Clinical Studies on 22nd Century's Smoking Cessation Technology Highlighted on New Heracles Website (Press)
  • IL-23 inhibitor risankizumab induces remission in Phase II study in patients with moderate-to-severe Crohn's disease (Press)
  • ImmusanT Reports Nexvax2 Phase 1 Data in Patients with Celiac Disease (Press)
  • Ignyta Announces RXDX-105 Phase 1 Data Presentation at the 2016 ASCO Annual Meeting (Press)
  • Baxalta Reports Positive Phase 1 Results for BAX 930, Investigational Recombinant ADAMTS13 to Treat Hereditary Thrombotic Thrombocytopenic Purpura (hTTP) (Press)
  • Cytori Fully Enrolls Pivotal U.S. Phase III Scleroderma Trial (Press)
  • Alkermes Announces Initiation of Phase 1 Clinical Study of Immuno-Oncology Drug Candidate ALKS 4230 (Press)
  • Seattle Genetics Initiates Pivotal Phase 3 Trial of Vadastuximab Talirine (SGN-CD33A) for Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) (Press)

US: Medical Devices

  • A first for medical wearables (PHG Foundation)
  • Accelerate Time-to-Market by Improving Process Validation (GxP Lifeline)
  • Biotronik introduces new CardioMessenger Smart portable monitoring device in US (Cardiovascular Devices)
  • Roche announces the first FDA-approved CMV test for use in hematopoietic stem cell transplant recipients (Press)
  • FDA clears next-gen tattoo removal laser from Cynosure (MassDevice)

US: Assorted & Government

  • SEC Reviewed Valeant's Use of 'Non-GAAP' Financial Measures (WSJ-$)
  • Roche tells Supreme Court no need to revisit Sequenom patent invalidation (Reuters)
  • Arizona Becomes 21st State to Pass a Law Restricting Biosimilar Substitution at Pharmacies (Focus)
  • Medicare Program: Continued Action Required to Address Weaknesses in Provider and Supplier Enrollment Controls (GAO)
  • Medtronic Can't Shake FCA Kickback Claims (Law360-$)
  • Sanofi Wants Jury Verdict Axed In Amgen Drug Patent Row (Law360-$)
  • Anthem CEO Says Cigna Deal Moving Forward (WSJ-$)
  • Takeda loses again to Hikma in gout drug patent battle (Fierce)
  • FDA Announces Final Regulations on Nutrition and Supplement Facts Labels and on Serving Sizes (FDA Law Blog)

Upcoming Meetings & Events


  • Sandoz' rituximab biosimilar coming to the EU (Biosimilar News)
  • NICE recommends three drugs to treat diabetes (Pharmafile) (EPR) (PharmaTimes)
  • Rare disease treatment advocates criticise NHS delays in commissioning (Pharmafile)
  • May 25 Is Here: Will The EU Reach Agreement On Its New Medtech Regs Today? (Clinica-$)
  • Bayer remains top of most reputable pharma list; report (PharmaLetter-$)
  • Experts call on NHS England to commission lomitapide (PharmaTimes)
  • A new day for 'me-too' meds? EU officials say they're tools for holding prices down (Fierce)
  • GSK announces positive headline results from Salford Lung study (PharmaLetter-$)
  • Notified Bodies Withdraw More EU Device Certificates As Oversight Gets Tougher (Gray Sheet-$)
  • EFPIA welcomes TTIP progress on regulatory convergence but more ambitious outcomes are expected (EFPIA)
  • Mainstay Medical wins CE Mark for ReActiv8 neurostim (MassDevice)
  • Biotrial Rejects French Phase I Inquiry Findings, Says Action Plan Already In Place (SCRIP-$)
  • Black Triangle Warning Dropped From Pfizer's Smoking Cessation Drug Label (SCRIP-$)
  • Wales has highest number of prescriptions per head of population among UK countries (Pharmaceutical Journal-$)


  • Turkey Regulatory Update: First Local Biosimilar, Counterfeits, Reimbursement Issues (PharmasiaNews-$)
  • Eisai To Launch In-House Developed Antiepileptic Drug Fycompa (Perampanel Hydrate) As Adjunctive Therapy For Partial-Onset And Generalized Tonic-Clonic Seizures In Japan (Press)
  • Japan approves Teijin Pharma's Feburic (BioSpectrum)
  • Thunderbolt Pharma, Inc., a Vitesse Biologics Company, Acquires Rights to BAFF/APRIL Dual Antagonist Program from Astellas Pharma Inc. (Press)


  • Delhi High Court asks Roche to explain lawsuit over Avastin copy (Economic Times)
  • India Deliberates Orphan Rules (SCRIP-$)
  • Dr Reddy's buys 6 OTC brands from US-based Ducere Pharma (Economic Times)
  • Maha FDA cancels 8 licenses, suspends 30 during surprise raids for non-compliance to D&C Act (PharmaBiz)
  • DTAB again turns down health ministry's proposal to amend Rule 3-A of D&C Rules to notify NIB as CDL for testing vaccines (PharmaBiz)
  • Drugs Technical Advisory Board Recommends Against Generic Substitution in India (24 Insight)
  • Ajanta Pharma's ANDA For Zomig Receives USFDA Final Approval (24 Insight)
  • Zydus Cadila gets USFDA's final nod for fungal treatment drug (Economic Times)


  • Medtronic RestoreSensor implantable neurostimulators (TGA)
  • TGA presentation given at ISPE Conference Sydney, 4-5 May 2016 (TGA)


  • ECDC: Rapid Risk Assessment – Zika (ECDC)
  • Mosquito Hunters Set Traps Across Houston, Search For Signs Of Zika (KHN)
  • Faced with strict laws, Brazilian women keep abortions secret (Reuters)
  • Former White House Ebola Czar Urges Congress To Act Faster On Zika (NPR)

Other International

  • World Health Assembly highlights importance of multisectoral action on health (WHO)
  • Israeli firms develop high-speed 3D printer for stem cells (Reuters)

General Health & Other Interesting Articles

  • Has a Hungarian physics lab found a fifth force of nature? (Nature)
  • Call for gastric surgery to be standard diabetes treatment (Reuters)
  • Massage may be option for pain relief (Reuters)
  • Liver donors may suffer long-term effects after donation (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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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