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)

Europe

• 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)

India

• 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

• 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

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

Canada

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

Australia

• 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)