This Week in Pharmaceutical Regulation (10-14 November 2014)

Posted 16 November 2014 | By Alexander Gaffney, RAC 

This Week in Pharmaceutical Regulation (10-14 November 2014)

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

Regulatory Focus

  • EMA's Top Drug Regulator, Guido Rasi, Forced to Step Down ( Regulatory Focus)
  • Bill to Speed up Approvals for Sunscreen Ingredients, Other Drugs Awaits Obama's Signature ( Regulatory Focus)
  • US Senate Unveils Major Changes to FDA Program in Hopes of Fighting Ebola ( Regulatory Focus)
  • FDA Says it Discovered Problems With Generic Version of ADHD Drug Concerta ( Regulatory Focus)
  • Second Generic Version of ADHD Drug Concerta Found to Have Problems ( Regulatory Focus)
  • How Many Drug Companies Manage to Get Two New Drugs Approved by FDA? Not Many ( Regulatory Focus)
  • Is a Drug Unsafe or Just Unprofitable? How a Lack of Data Clouds Regulatory Classifications ( Regulatory Focus)
  • Barraged by Drug Ads? FDA Wants to Know How That Makes You Feel—About the Drug ( Regulatory Focus)
  • FDA Warns Indian Generics Manufacturer Cadila Over Data Integrity Issues ( Regulatory Focus)
  • FDA in Wider Crackdown Against Marketers of Drugs Meant for Horses ( Regulatory Focus)
  • Does Your Spouse Affect How you Perceive Drug Safety? An FDA Study Aims to Find out ( Regulatory Focus)
  • FDA Announces a Secretive Meeting to Discuss an Unknown Drug for Unknown Reasons ( Regulatory Focus)

US: Pharmaceuticals and Biotechnology: FDA

  • Blood Donations by Gay Men Seen Winning U.S. Panel’s Backing ( Bloomberg)
  • FDA Withdraws Appeal in the Depomed Case ( FDA Law Blog) ( What That Means)
  • FDA's Janet Woodcock Explains Agency's Stance on Abuse-Resistant Opioids ( BioCenturyTV)
  • FDA's Hamburg on Balancing the Risks, Benefits for 310M Patients ( Medscape)
  • FDA's post-approval studies continue to suffer delays and setbacks ( Nature)
  • Without Enforcement Discretion, Track And Trace Deadlines Could Mean Rx Shortages ( Pink Sheet-$)
  • Michigan Bill Looks to Ban Sale of Most Products Containing Triclosan ( Bill)
  • Vancomycin Shortage Listing Raises Question On FDA’s Prevention Strategy ( Pink Sheet-$)
  • Justice Department Probes Generic Competition After Price Hike Reports ( Pharmalot)
  • Plaintiffs Renew Bid to See Diabetes Drug Adverse Event Reports ( Law)
  • Do Depression Drugs Still Need Suicide Warnings? ( TIME)
  • How pharmacology may be driving FDA decision on Daiichi’s new anticoagulant ( BioCentury-$)
  • Therapeutic focus – Survival benefit still eludes ovarian cancer trials ( EP Vantage)
  • Doubling Down On Antibiotic Incentives: Congress, Obama Administration Drafting Proposals ( RPM Report-$)
  • FDA Issues Warning Letters for Unapproved Omeprazole Drugs Marketed for Use in Horses ( FDA)
  • Safety Concerns Slow Sales of Testosterone Therapy ( Bloomberg)
  • FDA Aspergillosis Biomarker Qualification Highlights New Drug Development Tool Process ( RPM Report-$)
  • Team-Based Quality Assessment Approach Among Key Changes Underway as CDER’s Office of Pharmaceutical Quality Comes to Life ( IPQ-$)
  • Indian Drugmakers see US sales hit by delay in new approvals ( Reuters)
  • Ipca clarifies 'gravity' of FDA inspection at Indore site ( SCRIP-$)
  • FDA Funding Goes to Research Consortium Working to Improve Locally Acting Drugs ( DD&D)
  • DMD: Why a ‘miracle’ drug exists but you can’t have it yet ( Mosaic Science)
  • New USP Requirements on Plastic Packaging Systems ( ECA)
  • The History of FDA's Shirley Amendment ( Pharma Letter-$)
  • Court approves $325 million settlement against Pfizer ( Boston herald)
  • NYT: Pfizer lobbied Missouri AG to win favorable off-label deal ( Fierce)
  • Entyvio REMS Decision Explained ( RPM Report-$)
  • Drug Cos. Seek Judgment In Nexium Pay-For-Delay Case ( Law 360-$)
  • Del. Court Is 1st To Apply Daimler To Hatch-Waxman Case ( Law 360-$)
  • Health Affairs Policy Brief on Biosimilars ( Health Affairs)
  • FDA Streamlines Critical Path Innovation Meetings Process ( FDA News-$)
  • FDA Sends RPG Lifesciences A Warning Letter Last Year. ( Link) Now Indian Authorities Say its Generic Lipitor Isn't Meeting Quality Standards ( PharmaBiz)
  • Global Traceability Data Exchange: Troubled Waters Ahead ( RxTrace)
  • Internet Changes Medication Sales Regulations ( NJ Law Journal-$)
  • C-Path, IMI to benchmark PPP performance ( BioCentury)
  • District Court sets accelerated date to resolve Takeda suit against FDA over Colcrys ( PharmaLetter-$)
  • Should FDA Permit the Importation of Drugs by Individuals? ( The Hill)
  • FDA Mini Sentinel Evaluation of Buprenorphine Products ( Mini-Sentinel)
  • U.S. FDA Approves Supplemental New Drug Applications for Once-Monthly Long-Acting Therapy INVEGA SUSTENNA (paliperidone palmitate) for the Treatment of Schizoaffective Disorder ( Press)
  • Biothera Names Carey Anderson VP of Regulatory Affairs ( Press)

US: Pharmaceuticals and Biotechnology: Advisory Committees

  • Edoxaban Review ‘Not About Comparative Efficacy,’ FDA Says ( Pink Sheet-$)
  • FDA Advisory Committee to Review Three Investigational Cancer Drugs For Pediatric Written Requests ( Tarius)
  • FDA Advisory Committee to Review Cerexa’s Ceftazidime-avibactam for Complicated Infections ( Tarius)
  • US FDA Advisory Committee to Discuss Clinical Trial Development for Antibacterial Products ( Tarius)

US: Pharmaceuticals and Biotechnology: Approvals

  • Par Pharmaceutical Announces First FDA Approval of Vasostrict (vasopressin injection, USP) ( Press)

US: Pharmaceuticals and Biotechnology: Filings and Designations

  • FDA Accepts Amgen's Biologics License Application For LDL Cholesterol-Lowering Medication Evolocumab ( Press)
  • Skipping Past Congress: Limited Use For AZ/Actavis Antibiotic Gets FDA Review ( Pink Sheet-$)
  • FDA and EMA Grant Orphan Designation to Xeris Pharmaceuticals' Soluble Glucagon for Prevention of Hypoglycemia in Congenital Hyperinsulinism Patients ( Press)
  • Threshold Pharmaceuticals Receives FDA Fast Track Designation for TH-302 for the Treatment of Previously Untreated Patients With Metastatic or Locally Advanced Unresectable Soft Tissue Sarcoma ( Press)
  • Acadia: Don't expect Nuplazid NDA until 1Q 2015 ( SCRIP-$) ( Press)
  • Navidea Receives $1.1Million PDUFA Filing Fee Refund for Award of Orphan Drug Status ( Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results

  • Humira is in the Crosshairs as Amgen gets its First Phase III Biosimilars Win ( Reuters)
  • Merck Braces for Study on Medicines Worth $4 Billion a Year ( Bloomberg) ( Reuters)
  • Sanofi/Regeneron's dupilumab shines in asthma trial ( PharmaTimes) ( SCRIP-$) ( Reuters) ( Fierce)
  • U.S. gene study raises hope for Merck cholesterol drug Zetia ( Reuters)
  • Harvoni achieves 81-98% cure rates in hardest-to-treat patients ( SCRIP-$)
  • Gilead Announces Harvoni Study Results in Chronic Hepatitis C Patients with Advanced Liver Disease and Those Who Failed Prior Treatment ( Press)
  • BMS claims advance with hepatitis C regimen ( Pharmafile) ( Press) ( SCRIP-$)
  • Merck's Shortened Hep C Regimens Fall Short of Cure-Rate Goal ( The Street) ( Press) ( Reuters) ( Fierce)
  • Amgen psoriasis drug tops J&J's Stelara in Phase III study ( Reuters) ( Press) ( BioCentury)
  • AbbVie Hepatitis C Drug Cures 97% in Transplant Patients Study ( Bloomberg) ( Fierce) ( BioCentury) ( PharmaPhorum)
  • Merck's head-to-head Vytorin trial might be surprisingly flattering  ( Fierce) ( MM&M) ( Pharmalot)
  • Polyphor’s POL7080 receives QIDP designation from the FDA ( PharmaLetter-$)
  • Merck Looking To Phase III Trials As Pivotal Proving Ground For HCV Combo ( Pink Sheet-$)
  • No SAEs in dialysis study of Akebia's AKB-6548 ( BioCentury)
  • Teva reports positive Phase III trials behind Qnasl, a nasal allergy treatment ( DSN)
  • Repros’ Androxal Primed For NDA Submission, But Outcomes Study Looms ( Pink Sheet-$)
  • Amgen takes another stride in frenzied race toward the PCSK9 finish line ( Fierce) ( SCRIP-$)
  • Synageva BioPharma Presents New Data From Phase 3 Study Of Sebelipase Alfa In Children And Adults With LAL Deficiency At The AASLD Meeting ( Press)
  • Severe Epileptic Patients in Coma Respond to Sage Therapeutics Experimental Drug ( The Street) ( Xconomy) ( Fierce)
  • FLINTy reception for Intercept ( BioCentury)
  • ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients ( Press)
  • Results of Civacir (Hepatitis C Immune Globulin) US Phase III clinical trial ( Press)
  • Battered ArQule shares bump up on badly needed positive data for tivantinib ( Fierce)

US: Pharmaceuticals and Biotechnology: General

  • Why Are There So Few New Drugs Invented Today? ( NYTimes)
  • Whatever Happened to Pharmaceutical Swag? ( The Atlantic)
  • Pharma Trade Group Head Causes a Stir With a Remark About Patents ( Pharmalot)
  • The Short-Term And Long-Term Outlook Of Drug Coupons ( Health Affairs)
  • DOJ's Investigation Into Generic Pharma Pricing Is Unusual ( Law 360-$)
  • Why some generic drug prices are skyrocketing ( CBS) ( NEJM)
  • Missouri lawmakers form panel to investigate AG Ties to Pfizer ( KMBC)
  • The NFL's Anti-Weed Policy Even Extends to Drugs That Could Prevent Brain Damage ( VICE)
  • How NORD is putting patients in control of rare disease natural history studies ( BioCentury-$)
  • After hepatitis C cure, companies target next big liver disease market ( Reuters)
  • Cigna Agrees to Reduce H.I.V. Drug Costs for Some Florida Patients ( NYTimes)
  • Calculating cost to treat all hepatitis C patients in USA ( PharmaTimes)
  • Despite campaign talk, contraception plan not on GOP agenda ( Washington Times)
  • US Capitol Capsule: US seeks to get TPP, 'Asia pivot' back on track ( SCRIP-$)
  • Strategies to reduce the use of antibiotics in animals ( Pharm Journal)
  • One In A Million: Aegerion Looks To Raise The Price Of Myalept ( Pink Sheet-$)
  • Major Medical Centers ask Congress to Probe Genentech Distribution Shift ( Pharmalot)
  • Study Shows T-Dap Vaccine Not Linked With Higher Risk of Pre-Term Birth ( CBS)

Ebola Outbreak

  • Ebola drug testing sparks ethics debate ( AP)
  • Ebola shows drug development can be accelerated, says Piot ( PharmaPhorum)
  • MSF unveils plans for three Ebola trials in west Africa ( Pharma Times) ( Reuters) ( Fierce) ( Bloomberg)
  • Fauci: GSK/NIAID Ebola vaccine safety 'looks good'  ( SCRIP-$)
  • Ebola nasal vaccine under threat as funding runs dry ( In-Pharma)
  • Regeneron Speeding Development Of mAb To Treat Ebola ( Pink Sheet-$) ( SCRIP-$)
  • The Rationale For Using Brincidofovir (BCV) In Ebola Patients ( Forbes)
  • Cepheid receives grant to develop Ebola diagnostic test ( Reuters)
  • The Inaccurate And Unfair WHO Attack On Pharma Ebola Efforts ( Forbes)
  • European responses to the Ebola crisis- Initiatives at the European Medicines Agency ( Harvard BOH)
  • Scientists tell U.S. - find recipe for Ebola cure in survivors' blood ( Reuters)
  • Medical Experts Look For New Ways To Test Ebola Drugs ( NPR)
  • Ebola Contracts Worth $2 Billion Could Benefit Drugmakers ( Bloomberg)
  • GSK ‘moves best people’ to keep Ebola vaccine manufacture in-house ( Outsourcing Pharma)
  • Fujifilm says tests results on Avigan as Ebola drug by end-2014 ( Reuters)


  • EMA quizzed over Humira trial data redactions ( SCRIP-$) ( EMA) ( AllTrials) ( Pharmalot) ( PharmTech) ( Pharma Times) ( In Pharma) ( BioCentury)
  • Cancer drugs to be re-evaluated in UK ( OnMedica)
  • EMA celebrates ten years of harmonised herbal medicines standards across EU ( EMA)
  • UK agrees “Patent Box” compromise with Germany ( PharmaLetter-$)
  • SMC accepts Eylea and Onglyza for use in NHS Scotland ( PharmaLetter-$)
  • Patient Reported Outcomes in Orphan Drug Submissions: Do They Make a Difference? ( Context Matters)
  • CVMP Outcomes From 4-6 November Meeting ( EMA)
  • What's in store at MHRA under NICE man Rawlins? ( SCRIP-$)
  • Searching the EU Regulatory Agencies ( Regulatory-Intelligence)
  • Germany Post AMNOG: Insights for BioPharma ( BioPharm International)
  • France's ANSM Says Contraceptive Warnings May Have Helped Hundreds ( ANSM)
  • NICE rejects arguments against wider statin use ( OnMedica)
  • Helping Patients in Patient-Centered Approaches to Health ( Applied Clinical Trials)
  • Italy cracks whip on health claim abusers - fines could reach €5m ( Nutra-Ingredients)
  • New tool for companies to facilitate maintenance of information on authorised medicines ( EMA)
  • Five new drugs for NHS Scotland ( PharmaTimes)
  • SMC Rejects Perjeta ( Herald Scotland)
  • Orexigen Rises as Weight Loss Drug Review Proceeds ( AP) ( BioCentury)
  • EU/U.S. Trade Pact Talks May Stumble Over Drug Regulation, Affordability ( Pink Sheet-$)
  • MHRA Opens One Stop Shop for Regenerative Medicine Information ( Master Control)
  • Stakeholder engagement in Value Based Pricing and Value Based Assessment ( PharmaPhorum)
  • GlaxoSmithKline Announces EU Regulatory Submission for Severe Aplastic Anemia Indication for Revolade (eltrombopag) ( Press)
  • UK's world-leading genome project goes live ( PharmaPhorum)


  • Tainted drugs suspected in Indian sterilization surgery deaths ( Reuters)
  • Apex Committee turns down DCGI's proposal on trial approval for FDCs, subsequent new drugs, vaccines ( PharmaBiz)
  • Insight On India – Highlights From The Week Of Nov 2-8, 2014 ( 24 Insight)
  • Karnataka drug control officers raid 6 quack clinics stocking drugs, pick samples of NSQ drugs from pharmacy outlets ( PharmaBiz)
  • NGOs, experts express concern over Indo-US ‘bilateralism’ on Intellectual Property ( PharmaBiz)
  • Setting Standards for Biotech Therapeutics in India ( Biopharm International)
  • Industry opposes PET ban, may challenge if govt refuses to withdraw same ( PharmaBiz)
  • Apex committee on clinical trials gives approval to 33 proposals of clinical trials ( PharmaBiz)
  • Indian IPR think tank ticks all the wrong boxes? ( SCRIP-$)
  • Maha FDA cracks down inter state abortion drug racket, stocks worth Rs.3 lakh seized ( PharmaBiz)
  • Centre to roll out training plan for stakeholders soon for nationwide survey of spurious, NSQ drugs ( PharmaBiz)
  • Kerala plan to have own clinical trial registry not taken off as DC Dept yet to commence work ( PharmaBiz)
  • India gets minister for traditional medicine ( Reuters)


  • China launches its biosimilars process ( BioCentury) ( Translated Regulation)
  • Pork Belies: Will traceability regs see China lose dominance of global heparin market? ( In-Pharma)
  • China sets new requirements for hospitals running clinical trials ( In-Pharma)


  • Japan unveils sunshine data of its own, raising eyebrows after Diovan scandal ( Fierce) ( Pharmalot)


  • Canada Passes a Drug Safety Law, but Criticism Persists ( Pharmalot)
  • Octapharma's Nuwiq gets Health Canada approval to treat hemophilia A ( PBR)


  • Consultations on adoption of European Union guidelines in Australia: Outcome of previous consultation ( TGA)
  • All EMA Standards Adopted by TGA ( TGA)

Other International

  • WHO's Clinical Trial Data Disclosure Statement Still Open for Comment ( WHO)
  • Ukraine plans to ban drug imports from Russia ( PharmaLetter-$)
  • Ghana: ‘Good governance of pharma sector critical to sustain health insurance scheme’ ( PharmAfrica)
  • 5 years on from the Brazilian Generics Drugs Act, is there still an opportunity for branded originator drugs? ( EyeforPharma)

Clinical Trials

  • Therapeutic focus – Survival benefit still eludes ovarian cancer trials ( EP Vantage)
  • Medical Science Has a Data Problem ( Newsweek)
  • OHRP and Standard-of-Care Research ( NEJM)
  • Check Up: Cardiac clinical trials short on diversity in age, race, gender ( Inquirer)
  • Clinical trials insight: cardiovascular disease ( PharmaPhorum)

General Regulatory And Interesting Articles

  • Near-Animal, Near-Human: The Future of Drug Testing? ( In The Pipeline)
  • QT Prolongation Risk Assessed for Non-SSRI Antidepressants ( MPR)
  • Allergic to Penicillin? You're Probably Not ( NBC)
  • Combining The DNA Of Three People Raises Ethical Questions ( NPR)
  • Here’s How You Milk Snakes to Make Antivenom ( Wired)
  • Microbiome Studies Contaminated By Sequencing Supplies ( Scientific American)

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