Regulatory Focus™ > News Articles > Regulatory Recon: FDA Names Industry Insider to Run OPQ (28 September 2015)

Regulatory Recon: FDA Names Industry Insider to Run OPQ (28 September 2015)

Posted 28 September 2015 | By Michael Mezher 

Regulatory Recon: FDA Names Industry Insider to Run OPQ (28 September 2015)

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 approves two new drug treatments for diabetes mellitus (FDA)
  • FDA’s Patient Preference Initiative: The Need for Evolving Tools and Policies (FDA Voice)
  • Roche drug succeeds in hard-to-treat form of multiple sclerosis (Reuters)
  • FDA Taps Former Novartis, J&J Employee To Head Pharmaceutical Quality Shop (InsideHealthPolicy-$) (DrugWonks) (BioCentury) (Pink Sheet-$) (FDANews-$)

In Focus: International

  • FDA revokes approval for Sun Pharma's seizure drug over compliance issues (Reuters)
  • French Court Denies Roche Action Over Avastin In AMD  (SCRIP-$)
  • Dutch regulatory expresses concern that narrow-spectrum penicillin is no longer available (PharmaLetter-$)
  • NHS England rules on biosimilar interchangeability (BioPharma-Reporter)
  • Sanofi wins EU approval for Praluent anti-cholesterol drug (Reuters)

Sponsored Content

  • 10 Essential Tips for Mastering UDI – Regulatory and Quality Solutions (R&Q) has created the ultimate UDI resource to help your UDI process run efficiently. From establishing your core team to implementing systems that are flexible, our white paper contains everything you need to know in order to optimize your process – from beginning to end. Download and share the guide today.

US: Pharmaceuticals and Biotechnology

  • NEJM: FDA's proposed risk-disclosure guidelines still aren't enough (FiercePharmaMarketing)
  • Improving The Biosimilars Review Process: What's Needed? (SCRIP-$)
  • New Antifungals Sprout In Warmer Regulatory Climate (Pink Sheet-$)
  • The Long Road To The First Antifungal Vaccine (Pink Sheet-$)
  • FDA approves Novo Nordisk's long-awaited diabetes drug (Reuters) (FierceBiotech)
  • M7(R1) Addendum to ICH M7; International Conference on Harmonisation; Draft Guidance for Industry (FDA)
  • Labeling Lower-Dose Estrogen-Alone Products for Symptoms of Vulvar and Vaginal Atrophy (FDA)
  • Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016 (FDA)
  • Biosimilar Application Reviews May Be Growing More Challenging (Pink Sheet-$)
  • Biosimilar Statistical Guidance Will Stress Flexibility, Woodcock Says (Pink Sheet-$)
  • Duck And Cover: PhRMA, BIO And GPhA Respond To Turing Pricing Debacle  (Pink Sheet-$)
  • FDA Patient Meeting On Huntington’s, Parkinson’s: No News Is Good News (Pink Sheet-$)
  • Patient Engagement Early In Drug Development Requires Cultural Shift (Pink Sheet-$)
  • FDA Science Board's Report: Legislative Negotiating Tactic, Or Just Whining For Money? (Pink Sheet-$)
  • TF Supplements Issues Voluntary Nationwide Recall of Dietary Supplements with Undeclared Active Pharmaceutical Ingredients (FDA)

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

  • Cell Cure Neurosciences Ltd. Receives FDA Fast-Track Designation for OpRegen® for the Treatment of the Dry Form of Age-Related Macular Degeneration (Press)
  • pSivida Announces NDA for Medidur™ Now Planned Using Six-Month Efficacy Data from Both Phase III Trials (Press)
  • Novo Nordisk Receives FDA Approval for Tresiba® (insulin degludec injection) for Adults with Type 1 and Type 2 Diabetes (Press)
  • Bristol's Opdivo boosts kidney cancer survival beyond two years (Reuters)
  • Roche says new drug shows benefits in lung, bladder cancer tests (Reuters)
  • Lilly's CYRAMZA® (ramucirumab) Significantly Improves Progression-Free Survival in Phase II Bladder Cancer Trial (Press)
  • Roche’s ocrelizumab first investigational medicine to show efficacy in people with primary progressive multiple sclerosis in large Phase III study (Press)
  • Opdivo (nivolumab) Demonstrates Long Term Survival Benefit in Patients with Previously Treated Non-Squamous Non-Small Cell Lung Cancer in CheckMate -057 (Press)
  • Opdivo (nivolumab) Demonstrates Superior Overall Survival in a Phase 3 Trial Compared to Standard of Care in Patients with Previously Treated Advanced Renal Cell Carcinoma (Press)
  • Bristol-Myers Squibb Announces U.S. Food and Drug Administration Regulatory Filing Update for the Opdivo+Yervoy Regimen in Patients with Previously Untreated Advanced Melanoma (Press)
  • New Findings Show Anti-Tumor Activity of KEYTRUDA® (pembrolizumab) in Patients with Advanced Nasopharyngeal Carcinoma (Press)
  • VARGATEF® plus docetaxel significantly reduced tumour burden in lung cancer patients with advanced adenocarcinoma compared to docetaxel alone (Press)

US: Medical Devices

  • FDA approves Bayer's electronic autoinjector for MS therapy (Reuters) (Press)
  • FDA Panel Urges New Label, More Guidance on Female Sterilization Device (MedpageToday)
  • Pew Charitable Trusts: UDI use must be supported by private, government sectors (FierceHealthIT)
  • Hip implant maker claims surgical funder inflated patients’ bills (Reuters)
  • New Device Coating Protects Against Bacteria, Fungus, and Yeast Infections (MedDeviceOnline)
  • Implanet wins expanded FDA 510(k) for Jazz band device (MassDevice)
  • Industry Challenges FDA's User Fee Markup (Gray Sheet-$)
  • Getting IDE Approval Is Now Quicker than Ever (MDDI)

US: Assorted and Government

  • How Patent Law Can Block Even Lifesaving Drugs (NYTimes)
  • How Effective is a “Depomed Threat” at Resolving an Orphan Drug Clinical Superiority Dispute? (FDA Law Blog)
  • Amid Competing LDT Regulatory Proposals, Common Ground but Key Disagreements for Congress to Consider (GenomeWeb)
  • The Campaign Against Drug Pricing: Candidates Can Only Hope Voters React As Strongly As Wall Street (RPM Report)
  • What Does FDA Have To Do With Drug Pricing? Quite A Lot, It Seems (RPM Report)
  • No Patent Board Sanctions For Bass; Celgene Denied (SCRIP-$)

Upcoming Meetings and Events              

Europe

  • French Court Denies Roche Action Over Avastin In AMD  (SCRIP-$)
  • Dutch regulatory expresses concern that narrow-spectrum penicillin is no longer available (PharmaLetter-$)
  • NHS England rules on biosimilar interchangeability (BioPharma-Reporter)
  • Sanofi wins EU approval for Praluent anti-cholesterol drug (Reuters)
  • Roche, Boehringer and Gilead line up for EU drug approvals (FierceBiotech)
  • Nineteen new medicines backed for EU approval (PharmaTimes)
  • Amgen Bispecific Antibody Blincyto Gets Green Light From Europe’s CHMP (Pink Sheet-$)
  • Novartis' new heart drug on track for approval in Europe (Reuters)
  • EFPIA, Siffa and Latvian Government Meet to Forge Stability Pact and Boost Patient Access to Medicines (EFPIA)

Canada

  • Alexion sues Canada over Soliris price cut attempt as drug cost debate explodes on center stage (FiercePharma)

India

  • FDA revokes approval for Sun Pharma's seizure drug over compliance issues (Reuters)
  • Should the Indian Government Limit the Katoch Committee Recommendations on API Sector to the Sick Psus? (24 Insight) (PharmaBiz)
  • Delhi drug control dept to replicate Gujarat's e-governance model for better governance (PharmaBiz)
  • CIPMMA to fight against govt decision to amend D&C Act to make pharmacy graduates only eligible for wholesale licences (PharmaBiz)
  • IPC inducts 29 new ADR centres under PvPI programme bringing total number of ADRs to 179 (PharmaBiz)

China

  • As China Reforms Drug Regulations, FDA Official Looks To Boost Collaboration (Tan Sheet-$)

Japan

  • MARIZEV® (Omarigliptin), Merck’s Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes, Approved in Japan (Press)
  • AbbVie’s Viekirax approved as HCV treatment in Japan (EuropeanPharmaceuticalReview)
  • Japan approves Daiichi Sankyo’s Cravit Injections (BioSpectrum)
  • Bayer’s thrombosis drug approved in Japan (BioSpectrum)

Australia

  • Speed Up Access To Cancer Drugs, Australian Senate Tells Govt (PharmAsiaNews)

Other International

  • WHO Removes Nigeria from Polio-Endemic List (WHO)
  • Peru Amends, Formalizes Medical Device Regulations (Emergo)
  • Podcast: Mexico’s medical device registration process (Emergo)

General Health and Other Interesting Articles

  • IOM: Most Patients Experience Diagnostic Error at Some Point (Medpage Today)

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe