This Week in Pharmaceutical Regulation (3-7 November 2014)

Posted 07 November 2014 | By Alexander Gaffney, RAC 

This Week in Pharmaceutical Regulation (3-7 November 2014)

Welcome to This Week in Pharmaceutical Regulation, your weekly review of regulatory news and intelligence.

Regulatory Focus:

  • Is FDA Listening Enough to Patients? Agency Wants Feedback (Regulatory Focus)
  • Report Finds FDA Slow to Approve CNS Drugs, But Getting Faster (Regulatory Focus)
  • FDA's Regulation of Generic Manufacturers, Clinical Trials Comes Under Scrutiny (Regulatory Focus)
  • In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims (Regulatory Focus)
  • FDA System to Keep Track of Drug Manufacturers Nears Completion (Regulatory Focus)
  • Enough Horsing Around: FDA Warns Four Companies Over Equine Ulcer Drugs (Regulatory Focus)

US: Pharmaceuticals and Biotechnology: FDA

  • FDA unlikely to pull conventional opioids (BioCentury)
  • Groups Sue FDA Over Livestock-Feed Additive (WSJ-$) (Press) (Reuters) (Food Safety News)
  • CSPI Wants to See FDA’s Findings on Drugs in Milk (Food Safety News)
  • IPCA Labs' USFDA woes raise huge concern (Business Standard) (DNAindia)
  • GOP Poised To Slow Down FDA Product Safety Measures (Law 360-$)
  • FDA Working With Patients on Multiple Myeloma Master Protocol (Press)
  • FDA warning cites Hikma plant for repeatedly failing to investigate issues (Fierce)
  • OGD Puts the Pedal to the Metal the Last 4 Days of October to Reach 31 Approvals (Lachman)
  • FDA Urged To Ban Drug Coating Chemical (Law 360-$)
  • FDA Appeals Depomed Orphan Drug Case (FDA Law Blog)
  • Statistical Analysis of FDA's Inspection Findings (GMP Compliance)
  • Pfizer Director: Need for regulatory commitments clarity in NDAs, and US FDA concurs (In-Pharma)
  • Courtroom Drama Over NEUPOGEN Biosimilar Spills Over to FDA With the First Petition Accompanied by a 505(q) Certification (FDA Law Blog)
  • MMRF, FDA, NCI to develop multiple myeloma master protocol (BioCentury) (Press)
  • Mind the Gap: Strengthening relations with the European Medicines Agency to the benefit of public health (FDA)
  • Getting Potentially Life-Saving Drugs to High-Risk Breast Cancer Patients Faster (FDA)
  • Exclusivity, Labeling Are Sticking Points In FDA-Industry Abuse-Deterrence Talks (IHP-$)
  • J&J Wins Dismissal Of Listerine False Labeling Suit (Law 360-$)
  • Generic Manufacturing Reviews Getting Speedier Communication Program (Pink Sheet-$)
  • Sarepta silent on FDA's riposte (BioCentury)
  • Abuse-Deterrent Opioids: FDA Regulatory Options Aired At Meeting (Pink Sheet-$)
  • Annual Testing Of Drugs For Quality By The FDA (Two-Four Insight)
  • FDA vs. EU Inspections: Similarities & Differences (GxP Lifeline)
  • Edoxaban Review Spurs FDA Call For Changes In Anticoagulant Trials (Pink Sheet-$)
  • Sanofi's Duty To Detail FDA Concerns Key To Lemtrada Cases (Law 360-$)
  • FDA Asks Generics Makers to Help Fill in Gaps in Bioequivalence Testing Guidance (FDA News-$)
  • Power to the people: Patients' influence over FDA (SCRIP-$)
  • FDA Export Bans Plunge Wockhardt Profits (Reuters)
  • FDA Partially Grants Public Citizen Petition, Ads Warnings to Proton Pump Inhibitors (FDA)
  • US FDA offers more perspective on real-time release testing (Outsourcing Pharma)
  • Responding to FDA 483 Observations, Part 1 (Quality Digest)
  • FDA Official: Agency Could Soon Reach 'Tipping Point' On Breakthrough Drugs (IHP-$)
  • Wockhardt says U.S. export ban unlikely to be lifted until next year (Reuters)
  • FDA Post-Marketing Study Compliance Efforts To Get HHS OIG Review (Pink Sheet-$)
  • Experts To Industry: Start Implementing Social Media Guidelines Now (Pink Sheet-$)
  • Pharmaxis's NSW Australia Plant Taken off of Import Alert (FDA)
  • FDA Clears ISCO's Stem Cell Line for Clinical Uses (Press)
  • Forest recalls another 90,000-plus bottles of Bystolic (Fierce)
  • New labeling sought for longtime cancer drug tamoxifen (USA Today)
  • Lannett Announces Positive FDA Inspection Results (Press)
  • Recall for Buffered Formalin Due to Incorrect Concentration (FDA)
  • FDA Medicare study in 134,000 atrial fibrillation patients confirms positive safety profile and effectiveness of BI's Pradaxa in general practice (Press)
  • ANDA Litigation: Patents Are Being Challenged Sooner, OxyContin Draws Most Fire (Pink Sheet-$) (Pharmalot) (FDA News-$) (Report) (Patent Docs)
  • FDA AdComm to Review Cerexa's NDA for Ceftazidime-acibactam (FDA)
  • FDA Helps Shut Down Steroid Distribution Network (WDTV)
  • Doctor Pleads Guilty to FD&C Act Misdemeanor Charges (DemingHeadlight)
  • Takeda Litigation Against FDA Over Colcrys Moves Forward (Press)
  • Veloxis respectfully begs to differ with FDA (BioCentury)
  • CDER: Management of the Regulatory Science and Review Enhancement Program (FDA MAPP)
  • MAPP: Critical Path Innovation Meetings Policy and Procedures (FDA)
  • Industry Doesn’t Wait for FDA to Meet Track-and-Trace Pedigree Requirement (FDA News-$)
  • ICON Selected by the FDA to Develop New Patient-Reported Outcome Measure for Hospital-Acquired Bacterial Pneumonia Trials (Press)

US: Pharmaceuticals and Biotechnology: Advisory Committees

US: Pharmaceuticals and Biotechnology: Approvals

  • FDA Rescinds Tentative Approval for Ranbaxy’s Generic Nexium (Bloomberg) (Reuters) (FDA Law Blog)
  • J&J Wins U.S. Approval for Hepatitis C Combo With Gilead (Bloomberg) (Press) (PharmaTimes) (SCRIP-$) (BioCentury)
  • Dr Reddy's gets FDA approval for generic of Roche's Valcyte (Reuters)
  • Ranbaxy Exclusivity Implosion on Nexium Remains ‘Very Hazy’ (Pink Sheet-$) (SCRIP-$) (FDA Law Blog)
  • Lilly wins expanded use of Cyramza in gastric cancer (SCRIP-$) (Press)
  • Aeterna shares halve after FDA rejects growth hormone test (Reuters)
  • FDA Issues Complete Response Letter for Aeterna Zentaris' Macrilen NDA in Adult Growth Hormone Deficiency (Press) (Fierce)
  • Merck announces approval of secondary feeding label for Zilmax (Drovers) (Press)
  • Merck takes steps to return Zilmax to U.S. cattle market (Reuters) (Fierce)
  • Ranbaxy gets USFDA nod to market Fenofibrate capsules (Press)
  • Glenmark Generics Receives Final ANDA Approval for Omeprazole DR Capsules (Press)

US: Pharmaceuticals and Biotechnology: Filings

  • Vertex Submits NDA In U.S. And Europe For Lumacaftor Combined With Ivacaftor (Press)
  • GSK submits asthma biologic in US, EU (PharmaTimes)
  • Dr Reddy's Laboratories may file new drug applications with FDA within year (India Times)
  • Avanir says FDA approval in November for migraine treatment unlikely (Reuters) (Press)
  • Danish Lundbeck’s Brexpiprazole Could Reach U.S. Market In 2015 (Pink Sheet-$)
  • Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen for HIV (Press)
  • GSK submits mepolizumab NDA, MAA in eosinophilic asthma (SCRIP-$) (Fierce)
  • First dengue vaccine likely to be available in Second Half of 2015: Sanofi ​Pasteur (India Times) (Reuters) (Press)
  • Boehringer's Spiriva Respimat under FDA review in asthma (SCRIP-$) (Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results

  • Amgen's Trebananib Fails to Improve Survival in Phase 3 Ovarian Cancer Study (Press) (BioCentury)
  • Lundbeck's schizophrenia drug wollops competition in novel head-to-head trial (BioPharmaDive) (Press)
  • Intercept Liver Drug Needs Safety Review, Researchers Say (Bloomberg)
  • 'BelPhen' Passes Early Safety Test (MedPage Today)
  • BI Subgroup Analysis Shows Giotrif More Effective in Asian Patients (BI)
  • Changes to late-stage breast cancer trial sends shares of Celldex plunging (BioFlash) (The Street)
  • Novo Nordisk's first foray into obesity comes through in Phase III (Fierce) (Press)
  • Eisai and Arena Pharmaceuticals Report Results of an Investigational Phase 2 Trial of Lorcaserin HCl as an Aid for Smoking Cessation (Press)
  • Unusual Clinical Trial for Nanoparticles Clears Safety Testing (DD&D)
  • Nymox blasted as lead drug flops in twin PhIII enlarged prostate studies (Fierce) (PharmaTimes)
  • US: Pharmaceuticals and Biotechnology: Designations
  • Auspex Pharmaceuticals Receives FDA Orphan Drug Designation of SD-809 for Treatment of Huntington's Disease (Press)
  • Spark Therapeutics Receives FDA Breakthrough Therapy Designation for Its Lead Product Candidate, SPK-RPE65 (Press)
  • Basilea reports granting of U.S. orphan drug designation to isavuconazole for the treatment of invasive candidiasis (Press)
  • Promedior Receives Fast Track Designation for PRM-151 for the Treatment of Myelofibrosis (Press)
  • FDA Grants Orphan Drug Designation To Merrimack Pharmaceuticals' MM-141 For The Treatment of Pancreatic Cancer (Bezinga)
  • FDA Grants Orphan Drug Designation To Basilea's Isavuconazole (RTT) (Press)

US: Pharmaceuticals and Biotechnology: General

  • Thermo Fisher pledges to fix glitch in drug analysis software (Reuters) (Outsourcing Pharma)
  • Phoenix Man Gets Probation for Selling Fake Viagra (AP)
  • Combination Products Challenge Biopharma Manufacturers (PharmTechTalk)
  • Pediatric summit explores growing issue of risk vs. benefits of rare disease drugs (BioFlash)
  • Who Is A DSCSA Repackager? (RxTrace)
  • If Generic Injectable Shortages are Nearing an End, What can Hospira do? (Pharmalot)
  • Patient groups, PhRMA to huddle on expanded access (BioCentury)
  • Antibiotics Coalition Wants Drug Companies to Stop Growth Promotion Marketing (Food Safety News)
  • Meat Companies Go Antibiotics-Free as More Consumers Demand It (WSJ-$)
  • Pfizer Nixes Pharmacists' Claims In Lipitor Pay-To-Delay Row (Law 360-$)
  • 'Low-T' Class Action Filed (Press)
  • J&J Bit Off More Than McNeil Could Chew In 2006 Pfizer OTC Acquisition (Pink Sheet-$)
  • Bio-Rad settles bribery violations in Thailand, Russia and Vietnam for $55m (Outsourcing Pharma)
  • Arizona Voters Pass New "Right to Try" Referendum Into Law (Newsweek) (10th Amendment Center) (KPHO) (Governing)
  • For the dying, state laws offer hope that critics call hollow (Modern Healthcare)
  • On the Trail of Drug Risks: May problems with therapies show up post-FDA approval. Could mining electronic data and online chatter head off trouble? (ProtoMag)
  • Orphan Drug Costs Double in Four Years (EP Vantage)
  • Viagra's Come-Hither Ad Campaign (Bloomberg)
  • Addressing The Threat Of Antibiotic Resistance: Policy Solutions To Fix A Broken Pipeline (HealthAffairs)
  • Flu Season Brings Stronger Vaccines And Revised Advice (NPR)
  • Two Plead Guilty In Enfield Drug Warehouse Heist (Hartford Courant)
  • Donuts, drugs and December: How are They Related? (Healthcare Economist)
  • WHO recommends naloxone to prevent 20,000 overdose deaths in U.S. (Reuters)
  • The world's most effective HIV prevention drug hasn't lived up to its potential (WaPo)
  • Biosimilar Medications Could Create Billions in Savings (DD&D)
  • SCRIP's New Mini-Site on Antimicrobial Resistance (SCRIP)
  • PATH Malaria Vaccines Initiative nets $156M from Gates Foundation (Fierce)
  • GSK, Sanofi see setbacks in flu vaccine production for US market (In-Pharma)

Ebola Outbreak

  • US officials unveil plan to test Ebola drugs (AP) (BioCentury-$) (Bloomberg) (Bloomberg) (LATimes) (SCRIP-$) (MedPage Today)
  • Experimental Ebola drugs should not be withheld, WHO says (Guardian)
  • WHO welcomes approval of a second Ebola vaccine trial in Switzerland (WHO)
  • Tekmira to produce Ebola treatment for U.S. Dept of Defense (Reuters)
  • GSK hepatitis C shot shows promise, bodes well for Ebola vaccines (Reuters)
  • German doctors use experimental heart drug in treating Ebola patient (Reuters)
  • WHO's Chan Blames Big Pharma for Lack of Ebola Vaccine (NYTimes) (SCRIP-$)
  • Nose Spray Ebola Vaccine Protects Monkeys (NBC)


  • Sir Michael Rawlins appointed chair of MHRA (Pharmafile) (MHRA) (BioCentury) (PharmaTimes) (SCRIP-$)
  • France asks Roche for data on use of cancer drug Avastin in eye (Reuters) (SCRIP-$)
  • UK Gov't urged to support Off-Patent Drugs Bill (PharmaTimes)
  • EU plans risk reduction steps for Servier, Amgen heart drug (Reuters) (EMA)
  • EGA and EBG see EMA latest biosimilars guidance as “important step forward” (PharmaLetter-$)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 November 2014 (EMA)
  • EMA releases another update of the Pre-Authorisation Procedural Advice for CP users (Exalon)
  • EMA’s Release of Regulatory Data: Possible Fall out for Journals and Research Synthesis (PLoS)
  • The Medical Innovation Bill: helping patients and innovation, or a prescription for negligence? (PharmaPhorum)
  • UK's NICE recommends GSK's Arzerra for untreated chronic lymphocytic leukemia (PharmaLetter-$)
  • Eisai "speechless" as G-BA denies price premium for Fycompa (PMLive)
  • IQWIG confirms an additional benefit of Eisai's Halaven (PharmaLetter-$)
  • Added benefit of Takeda’s Entyvio is not proven, says IQWiG (PharmaLetter-$)
  • Inventiva Receives Approval for Orphan Drug Designation (Press)
  • EMA starts review of Biogen Idec's haemophilia A therapy (PMLive) (Press)
  • Netherlands Kiadis gets EMA orphan drug status for ATIR to treat acute myeloid leukemia (Press)
  • Public consultation of the HTA Core Model version 2.1 (EUnetHTA)


  • India: Developing Biosimilars In India: Prescriptions And Problems (Mondaq)
  • India to set up new drugs regulator for traditional medicines (Reuters)
  • Dr BR Jagashetty to take over as National Advisor of drugs control & project-in charge CDSCO in mid-November (PharmaBiz)
  • NPPA extends date to register under IPDMS for companies by one month (PharmaBiz)
  • Peeved Bayer to USTR: Indian govt picking winners (SCRIP-$)
  • Indian firms: Don't judge IP regime by 'isolated' cases (SCRIP-$)
  • Indian Doctors give drugs without knowing side-effects: Study (India Times)
  • Patent office issues final Guidelines for examination of patent applications in pharmaceuticals (PharmaBiz)
  • Indian panel outlines principles for review of essential drugs list (SCRIP-$)
  • India Wants to Cut Down on API Imports (LiveMint)
  • Health Ministry to grant clinical trial waiver for cancer drugs Aflibercept, Trastuzumab emtansine (PharmaBiz)
  • Insight On India – Highlights For The Week Of Oct 26-Nov 1, 2014 (Two-Four Insight)


  • China Solicits Comments on Biosimilars Guideline (JDsupra)
  • Beijing Wants APEC to Push Chinese Trade Pact (AP)
  • Golden spear: a thorn in Big Pharma’s ED business in China? (In-Pharma)


  • A new bill will make Health Canada’s drug approvals more transparent. In theory, anyway (NationalPost)
  • Canadian firms fear release of "confidential" info under new law (SCRIP-$)
  • Lawsuit Filed Challenging Genetic Patents in Canada (Globe and Mail)
  • Canadian drug companies violating the law (The Star)


  • One in 10 drug companies fail TGA quality audit (The Australian)
  • Australia thrashes out patient access deals for Soliris/Kalydeco (SCRIP-$)
  • Australia's Pharmceuticals Industry Council to cease operation (PharmaLetter-$)

Other International

  • ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments (IPQ-$)
  • New USP Chapters on Storage and Distribution under Way - but what is the Relevance? (GMP Compliance)
  • ISPE Issues Detailed Quality Metrics Definitions (FDA News)
  • About the International Coalition of Medicines Regulatory Authorities (ICMRA) (TGA)
  • Agenda Papers for Upcoming ICH Meeting Posted (ICH)

Clinical Trials

  • Paving the critical path of drug development: the CDER perspective (Nature)
  • The Clinical Trials Transformation Initiative: innovation through collaboration (Nature)
  • Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations. (PubMed)
  • Pregnant women must be studied too (The Conversation)
  • Biotechs can increase valuation by implementing adaptive design. (GEN)

General Regulatory And Interesting Articles

  • Global Spending on Pharmaceuticals to Soon Surpass $1 Trillion (BBC)
  • BBC Puts Spotlight on High Pharma Profit Margins (BBC) (Fierce)
  • Can the Time a Drug is Administered Affect its Effectiveness? (PNAS)
  • Formaldehyde and Chicken Eggs: What’s Inside a Flu Shot (Wired)
  • Amazing Photographs Of Drugs Englarged (IFL Science)
  • Anti-Vaxxers in a Nutshell… (Imgur)
  • Giant Study Clear Contraceptices of Any Major Risks (EMPR) (BMJ)
  • Gardedam Therapeutics could name its drug after you! (If you donate enough to its crowdfunding effort) (MedCityNews)

This Week in Pharmaceutical Regulation is our weekly intelligence briefing for the regulatory affairs space, bringing you the top pharmaceutical regulatory news stories from around the globe. Each week, 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 pharmaceutical industry.

Need to contact the editor? Find him on Twitter at @AlecGaffney or send him an email at

A story's inclusion in This Week in Pharmaceutical Regulation does not imply endorsement by Regulatory Focus or RAPS.

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