This Week in Pharmaceutical Regulation (17-21 November 2014)

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

Regulatory Focus

• FDA Explains How its New Incentive Program for Rare Pediatric Disease Treatments Works ( Regulatory Focus)
• Proposed Rule Calls for Clinical Trial Results to be Reported, Even When Product Isn't Approved ( Regulatory Focus)
• How Should FDA Prioritize the Review of Important New Generic Drugs? Agency Wants to Know ( Regulatory Focus)
• New FDA Guidance Explains Approval Process for HIV Prevention Products ( Regulatory Focus)
• FDA Plans Huge Study on How Public Understands Drug Risk ( Regulatory Focus)
• Gilead Makes Record-Setting Purchase of Special FDA Voucher ( Regulatory Focus)
• US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program ( Regulatory Focus)
• FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show ( Regulatory Focus)
• Company's Compassion Leads to Clinical Hold on Experimental Drug ( Regulatory Focus)
• Laws Spreading That Allow Terminal Patients Access to Experimental Drugs ( Regulatory Focus)
• Oceania Regulator ANZTPA Shut Down by Australia and New Zealand ( Regulatory Focus)
• When FDA Comes Calling, Do US Companies Fare Better Than Others? ( Regulatory Focus)
• European Medicines Regulators Put New Conflict-of-Interest Policy in Place ( Regulatory Focus)
• FDA, CDC Put $18M Behind Adverse Event System for Vaccines ( Regulatory Focus)
• Canada Launches Ebola Vaccine Trial ( Regulatory Focus)

US: Pharmaceuticals and Biotechnology: FDA

• FDA Delays Final Rule on Allowing Generic Drug Makers to Update Labels ( Pharmalot) ( Focus Explainer)
• Ranbaxy Sues FDA Over Nixed Approvals Of Generics ( Law 360-$)
• FDA Mulls Over Results of NEJM Antiplatelet Tx Study ( MPR) ( FDA) ( Pink Sheet-$)
• FDA eases up on overall survival requirement with Avastin approval ( EP Vantage-$)
• “Breakthrough” Means Breaking Down Bureaucracy ( RPM Report-$)
• Colorado Health Department to Recommend ‘Premarket Approval’ for Edible Marijuana ( NYTimes)
• AIDS Group Wages Lonely Fight Against Pill to Prevent H.I.V. ( The Upshot)
• FDA Revises Internal Policy on Allowing Emergency IND Applications ( FDA)
• Will The DSCSA Cause Drug Shortages After January 1? ( RxTrace)
• Mallinckrodt Sues FDA After Agency Downgrades Therapeutic Equivalence Rating for Generic CONCERTA ( FDA Law Blog)
• Painkiller marketing secrets? Check Chicago's unredacted suit against Endo, Purdue, Cephalon, et al. ( Fierce) ( Bloomberg)
• New FDA MAPP on Chemistry Review of Question-based Review (QbR) Submissions ( FDA)
• Senators Call on FDA to Require More Women in Trials of Heart Disease Treatments ( Senate) ( Letter)
• Hamburg Signs Regulatory Agreement With Chinese Officials ( SFDA)
• Group: Pfizer Colluded With FDA to Hide Animal Feed Risk ( Press)
• FDA, Industry Metrics Initiatives Confront Challenge of Tracking Quality Culture ( Gold Sheet-$)
• Questions Linger as Industry Rushes to Meet Jan. 1 Traceability Deadline ( Gold Sheet-$)
• Primer On FDA’s "Breakthrough Therapy" Program ( In Vivo-$) ( In Vivo-$) ( In Vivo-$) ( In Vivo-$)
• Eli Lilly's VP of Global RA: "FDA should develop a multi-year pilot program to explore the science of patient input in benefit/risk assessment" ( PhRMA)
• Sun Pharma recalls 68,194 bottles of anti-depression drug in US ( India Times) ( FDA) ( LiveMint)
• Pliva Asks High Court To Review Generic Drug Ruling ( Law 360-$)
• House of Representatives to Hear FDA Testimony on Ebola Product Development ( House)
• Should Adverse Drug Event Reporting by Healthcare Providers be Mandatory? ( Adverse Events)
• FDA to Revoke NDAs for 13 Products, Citing Failure to Submit Annual Reports ( FDA News-$) ( FDA)
• Toxicity Database Collaboration Between EPA, FDA Could Be Boon for Computational Toxicology Efforts ( Genome Web-$)
• Express Preemption for OTC Drugs ( D&D Law)
• Spain's Grifols' U.S. plasma installation cleared by FDA ( Reuters)
• Solgar, Inc. Issues Voluntary Class I Recall of Powder ( FDA) ( FDA)
• What Price Could the Public be Paying for the Slow Down in Generic Drug Approvals? ( Lachman)
• House Takes up Bill to Reform Tropical Disease Priority Review Voucher System ( House)
• Rx vs OTC- the Debate Continues ( Lachman)
• U.S. FDA Slams Ranbaxy’s Claims In Nexium, Valcyte Lawsuit ( PharmAsia-$)
• W.Va. Jury Finds Takeda Destroyed Key Actos Documents ( Law 360-$)
• Ibuprofen ‘Regulatory History’ Pre-empts Failure-To-Warn Claims In State Court – CHPA ( Tan Sheet-$)
• Right-to-Try Bill Moves Forward in California County ( BH Courier)
• PhRMA's Castellani on the Need for More Off-Label Communication ( Morning Consult)
• FDA Webinar on 60-Day NF Qualifying (A)NADA Labeling Supplements ( FDA)
• US court overturns Ranbaxy bid to block launch of rival generic drugs ( Reuters) ( PharmAsia-$)
• FDA Launches Surprise Inspection of Dr Reddy's Visakhapatnam Unit ( Indian Express)
• Sunscreen Innovation Act Awaits Obama's Signature ( LoC)
• Generic Firms Say Impurity Limits Should Not Factor in ANDA Filings ( FDA News-$)
• FDA Practices Discourage Biologic Market Competition, Says PCMA White Paper ( PharmExec)
• Naproxen Recall After Packager Mixes up Tablets With Softgels ( FDA)
• New Web Tool Launches to Allow Consumers to Personalize Tracking of FDA Drug Recalls ( Press)
• GPhA Says Slow FDA Approvals Contribute to Generic Drug Price Hikes ( IHP-$)
• GDUFA Fee Waivers Floated During Generic Drug Pricing Senate Hearing ( IHP-$)
• New FDA MAPP on Developing Indication-Specific Guidances ( FDA)
• 2014: The Social Media Guidance Year ( DTC Perspectives)
• Letter in Support of FDA Enforcement of Compounding Law ( Pew)
• Future bleak for Novartis' myeloma drug ( Pharmafile)
• Allergan Hit With $6.5M Verdict In Off-Label Botox Suit ( Law 360-$)
• Judge Scolds Kirkland & Ellis Attys In Ranbaxy-FDA Row ( Law 360-$)

US: Pharmaceuticals and Biotechnology: Approvals

• FDA Approves Purdue's Hard-to-Abuse Hydrocodone Pill Hysingla ( Fierce) ( AP) ( Fierce) ( SCRIP-$) ( BioCentury) ( Press) ( Reuters) ( WaPo) ( NYTimes) ( FDA)
• FDA Explains Hysingla Approval ( FDA) ( Pink Sheet-$)
• Genzyme’s MS Drug Lemtrada Approved by the FDA ( Press) ( Boston Herald) ( BioFlash) ( Reuters) ( Fierce) ( WSJ-$) (MS Discovery) ( Pharma Times)
• Roche's Avastin wins FDA green light in ovarian cancer ( Fierce) ( MPR) ( Press) ( MedPage Today) ( SCRIP-$) ( BioCentury) ( Reuters)

US: Pharmaceuticals and Biotechnology: Advisory Committees

• FDA Advisory Committee Supports Minor Changes to the Risk Evaluation and Mitigation Strategy of Alexion’s Soliris ( Tarius) ( Pink Sheet-$) ( Pink Sheet-$) ( Tarius)
• FDA Posts Advisory Committee Materials for Science Board Meeting ( Tarius)
• FDA Posts Advisory Committee Materials for Meeting to Review the Use of Anesthetic and Sedation Drugs in Pediatrics ( FDA)
• FDA Posts Advisory Committee Materials for Discussion About How to Streamline Clinical Trial Development for Antibacterial Products ( Tarius)
• Anti-Infective Drugs Advisory Committee; Notice of Meeting ( FDA) ( Tarius)
• FDA Advisory Committee Reviews the Use of Anesthetic and Sedation Drugs in Pediatrics ( Tarius)
• Why ODAC didn't buy Novartis' explanation of panobinostat tox in MM Phase III ( BioCentury)
• Diabetes Endpoints, CV Requirements Get Special Handling At FDA-Patient Meeting ( Pink Sheet-$)
• Basilea reports that U.S. FDA sets date of Advisory Committee meeting on isavuconazole NDA for the treatment of invasive aspergillosis and mucormycosis ( Press)

US: Pharmaceuticals and Biotechnology: Submissions, Filings and Designations

• Janssen Submits New Drug Application to U.S. FDA for Three-Month Paliperidone Palmitate ( Press)
• FDA Accepts Actavis' Bipolar Drug sNDA ( Press)
• FDA acceptance of sNDA for SAPHRIS (asenapine) for the treatment of bipolar I disorder in pediatric patients announced ( Press)
• Pernix Submits sNDA for TREXIMET Use in Adolescent Patients ( Press)
• US FDA seeks additional data from Kremers Urban Pharmaceuticals' methylphenidate ER tablets ( PharmaBiz)
• ChemoCentryx's CCX168, an Orally Administered Complement C5a Receptor Inhibitor, Granted Orphan-Drug Designation in Atypical Hemolytic Uremic Syndrome Treatment by the FDA ( Press)
• Sanofi and Regeneron’s dupilumab gets Breakthrough designation from FDA ( Pharma Letter-$) ( Reuters) ( Press)
• U.S. FDA Grants Fast Track Designation to Novavax' RSV F-Protein Nanoparticle Vaccine for Protection of Infants Via Maternal Immunization ( Press)
• Merrimack Pharmaceuticals Receives FDA Fast Track Designation for MM-398 in Post-Gemcitabine Metastatic Pancreatic Cancer ( Press)
• BerGenBio Receives Orphan-drug Designation from FDA for BGB324 in the Treatment of Acute Myeloid Leukaemia ( Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results

• Surprise: Merck's cholesterol combo Vytorin hits goal in long-awaited outcomes trial ( Fierce) ( Press) ( Forbes) ( Bloomberg) ( Forbes)
• Novartis Arthritis Drug Generates Positive Late-Stage Trial Results ( WSJ-$) ( PharmaPhorum)
• Novartis heart failure drug provides host of benefits: study ( Reuters) ( Fierce)
• FDA orders CytRx to halt patient enrollment after death of a cancer patient ( Fierce) ( Reuters)
• Novartis adds to its case for secukinumab for ankylosing spondylitis ( Fierce)
• Amicus Drug Improves Marker of Heart Health in Fabry Patients ( The Street)
• Bristol-Myers immunotherapy shows promise to replace chemo for melanoma ( Reuters) ( Press) ( Fierce) ( SCRIP-$) ( WSJ-$)
• MSD Announces Positive Study Investigating the Use of Pembrolizumab Compared to Chemotherapy in Patients with Ipilimumab-Refractory Advanced Melanoma ( Press)
• AstraZeneca's PhIII gout data for lesinurad includes a hit, a strikeout and a missing player ( Fierce) ( Press)
• Keryx announces results from ferric citrate phase 3 long-term safety extension study ( Press)
• AstraZeneca lupus drug produces positive results in trial ( Reuters)
• HIV drugs show promise in treating common eye disease ( Reuters)
• Gene therapy found effective in hemophilia B ( Reuters)
• ZS Pharma's PhIII ZS-9 results positive, but raise safety concerns ( SCRIP-$)
• Analyses support Pradaxa safety profile ( MM&M) ( Press)
• Synergy Pharma constipation drug succeeds mid-stage trial ( Reuters)
• Taking NSAIDs with fibrillation meds boosts risk of bleeding ( Reuters)
• Heart Drug, Losartan, Falls Short of Promise in a Study ( NYTimes)
• Study Ties Dental Drugs, Heart Infection Risk ( PharmPro)
• Positive News for Pradaxa Antidote ( Press)
• Merck's Zetia cuts heart attack, stroke risk in long-awaited study ( Reuters)
• Regeneron drug highly effective for those who can't take statins: study ( Reuters)
• PCSK9s Get Boost From IMPROVE-IT; Outcomes Data Restores Faith In LDL Surrogate ( Pink Sheet-$)
• Large Japanese Trial Casts Further Doubt On Aspirin To Prevent A First Heart Attack ( Forbes)
• Celgene's Oral OTEZLA (Apremilast) Showed Sustained Clinical Response over Two Years in Patients with Active Psoriatic Arthritis ( Press)
• NIH-sponsored study identifies superior drug regimen for preventing mother-to-child HIV transmission ( NIH)

US: Pharmaceuticals and Biotechnology: General

• Tufts: Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion ( Tufts CSDD) ( Bloomberg) ( Fierce) ( Pink Sheet-$)
• Tufts Study Gets Pushback from MSF, KEI ( KEI) ( Pharmalot) ( Pharma Times) ( The Upshot) ( SCRIP-$) ( Outsourcing Pharma)
• Upton: 21st Century Cures Act Will "Speed Up Approval for All Drugs and Devices" ( E&C) (1:00 in)
• Alarming rise in pregnant women on narcotic painkillers, heroin ( CBS)
• Most Illinois Medicaid Patients Denied New Hepatitis C Drugs ( KHN)
• Quantitative drug benefit-risk assessment: utility of modeling and simulation to optimize drug safety in older adults ( PubMed)
• Payers' hep C delay tactics work: Coverage hurdles are dampening Harvoni script growth ( Fierce)
• Do laws hindering umbrella-wielding assassins also hurt Pharma? ( In-Pharma)
• Counterfeit Avastin Leads to $2M Fine for Doctor ( Fierce)
• Payers' hep C delay tactics work: Coverage hurdles may be dampening Harvoni script growth ( Fierce)
• Soaring Generic Drug Prices Draw Senate Scrutiny ( AP)
• Generic Drug Medicaid Rebate Bill Aims To Counter Large Price Increases ( Pink Sheet-$) ( Senate-PDF)
• Why are some generic drugs skyrocketing in price? ( AEI)
• GPhA Issues Statement on Generic Drug Costs ( BioPharm International)
• Ohio House Votes to Shield Execution Drugmaker ( AP)
• Medicare, Medicaid, And Pharmaceuticals: The Price Of Innovation ( Health Affairs)
• Public Citizen Calls on HHS to Transfer Common Rule Re-Write Authority to OHRP ( Public Citizen)
• Pallone Picked as Top Democratic Member on the House Energy and Commerce Committee ( The Hill) ( CQ) ( BioCentury)
• Burgess to Serve as House Energy and Commerce Subcommittee Chairman in the 114th Congress ( Press)
• FDA Advisory Committee Hears FDA Reports and Votes to Establish Two New Subcommittees ( Tarius)
• Number of Indians turning whistle-blowers in US on the rise ( India Times)
• $6B Record Haul For DOJ As FCA Reaches New Heights ( Law 360-$)
• FDA says expects China to OK staff visas after two-year delay ( Reuters) ( ECN) ( Bloomberg)
• How Far Does FDA’s Say-So Travel? ( FDA Law Blog)
• FDA Weekly Enforcement Report ( FDA)
• Federal Investigation Into Painkillers Targets N.F.L. Teams’ Medical Staffs ( NYTimes)
• Kentucky Drops Two-Drug Execution Method ( AP)
• Patent Trolls Eye Biotech Firms; New PTO Proceedings Are ‘Game Changer’ ( Pink Sheet-$)
• The "Vaccine Court" Keeps Claimants Waiting ( AP)
• What Effect Will the Sunshine Act Have on the Practice of Medicine? ( BioCentury)
• Generics makers, execs face potential criminal charges in U.S. pricing probe ( Fierce)

Ebola Outbreak

• EMA: New pathways and Ebola vaccines can help expedite approvals ( In-Pharma)
• Pharma giant Merck, smaller U.S. firm in talks on Canadian Ebola vaccine production ( Canada.com)
• Ebola mAb Therapies Get BARDA Backing; FDA, NIH Get Grilling At House Hearing ( Pink Sheet-$)
• Clinical Trials on Zmapp Beginning in January ( House)
• Examining Medical Product Development in the Wake of the Ebola Epidemic ( House)
• Ebola drugs, vaccines scale-up in jeopardy without funds ( SCRIP-$)
• Study Will Test Survivors' Blood to Treat Ebola ( AP) ( Bloomberg)
• Bloodmobiles To Collect Plasma From West Africa's Ebola Survivors ( NPR)
• WHO panel: Prioritize drugs for Ebola efficacy trials ( SCRIP-$)
• WHO starts survey of Ebola treatments, says none proven so far ( Reuters) ( AP)
• No safety concerns yet in trials of GSK's Ebola vaccine ( Reuters)
• Canada begins domestic trial of experimental Ebola vaccine ( Reuters)
• Ebola Vaccine Challenge: Motorbikes and Kerosene Fridges ( Bloomberg)
• Improved Ebola Situation in Liberia May Complicate Vaccine Trials ( Scientific American)
• Ebola Outbreak Draws Investor Attention; Real Impact May Be Clinical Trial Models ( RPM Report-$)
• How Fear of Ebola Is Paving the Way for Poor-Quality Medicines ( USP)
• Nebraska Hospital: Surgeon with Ebola Has Died ( AP) ( NYTimes) ( SCRIP-$)
• Death of second Ebola patient in U.S. shows need for early, accurate tests, experts say ( WaPo)

Europe

• Thalidomide: how men who blighted lives of thousands evaded justice ( Guardian)
• More Information About EMA's New Leader, Andreas Pott ( EMA)
• European Commission Grants Marketing Authorization for Gilead’s Harvoni ( Press) ( Fierce) ( BioCentury) ( Pharma Times)
• EMA, FDA Officials Meeting to Further GMP Inspection Cooperation ( EMA)
• EMA Recommends Making Emergency Contraceptive ellaOne Available OTC in Europe ( EMA)
• EMA Clears Testosterone Drugs of Elevated Heart Risks ( EMA)
• Two new medicines recommended for the treatment of chronic hepatitis C ( EMA) ( Reuters)
• Novartis gets CHMP backing for psoriasis drug Cosentyx ( Pharma Times) ( Fierce)
• Cerdelga recommended for approval in type 1 Gaucher disease ( EMA) ( Press)
• Boehringer's Nintedanib receives positive CHMP opinion in European Union for the treatment of IPF ( Press) ( Fierce)
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 November 2014 ( EMA)
• European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine) ( EMA)
• CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls ( EMA)
• France Negotiates a Steep Discount for Sovaldi From Gilead ( Pharmalot)
• MHRA's Top 10 GMP Deficiencies ( ECA) ( MHRA)
• Europe Edges Toward New HTA Understanding ( PharmExec)
• NICE wants more Xolair data ( Pharmafile) ( Pharma Times) ( PMLive)
• Most European hospitals face medicines shortages ( PMLive)
• Internationally health economic evaluations are a fixed component of reimbursement decisions, says IQWiG ( PharmaLetter-$)
• Public consultation of the draft methodological guideline “Methods for health economic evaluations” ( EUnetHTA)
• Discussion paper on the clinical investigation of medicines for the treatment of Alzheimer´s disease and other dementias ( EMA)
• ALK Abello files for European approval for its dust mite allergy sublingual tablets ( Pharma Letter-$)
• Britain begins review to speed access to new drugs ( Reuters)
• Is the UK’s NICE Becoming More Restrictive? ( Context Matters)
• Launch of the EDQM's new Standard Terms database ( EDQM)
• European Commission Approves Navidea’s Sentinel Lymph Node Detection Agent Lymphoseek ( Press)
• Drug Makers Relieved As Europe's Unitary Patent Gets Predictable Boost ( Pink Sheet-$)
• An untimely end for the UK Patent Box? ( SCRIP-$)
• U.K. health secretary: Novartis holding government to 'ransom' with Bexsero pricing ( Fierce)
• Janssen Seeks European Approval of Chronic Inflammatory Disease Drug ( Press)
• Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with OIE recommendations ( EMA)
• Concept paper for the revision of the guidelines on data requirements for veterinary medicinal products for minor use minor species ( EMA)
• Concept paper for a guideline on data requirements regarding veterinary medicinal products for the prevention of transmission of canine and feline vector-borne diseases ( EMA)
• VICH GL23: Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing ( EMA)
• Fragile X Syndrome: orphan designation for CNRS molecule ( MNT)
• Crisis at the EMA - but might Rasi return? ( SCRIP-$)
• France's ANSM Releases Data Showing Restrictions on Celgene's Thalidomide Working ( ANSM)
• EMA Budget Recommended for Discharge in Parliament ( EUroParl)
• Celgene Announces Swissmedic Approval of REVLIMID (lenalidomide) for Treatment of Patients with Relapsed or Refractory ( Press)
• pSivida Reports ILUVIEN Granted Marketing Authorization in Ireland ( Press)

India

• Only 14% of NMEs launched between 2008-12 are available in India ( Twitter)
• Special marks on packs proposed to identify essential drugs ( India Times) ( India Times)
• Sterilisation deaths: drug company had faced action earlier ( Business Standard)
• Sterilization deaths expose India's struggle with faulty drugs ( Reuters)
• Indian State Recalls Pills Linked to Sterilization Deaths ( NYTimes)
• Drug Maker Arrested in India Sterilization Deaths ( AP)
• Rat poison linked to India sterilisation deaths, with death toll expected to rise ( Guardian) ( Reuters)
• Top-selling 100 drugs to get cheaper soon ( India Times)
• India's fixed-dose combo problem: Too much of a good thing? ( BioPharma Dive)
• Insight On India – Highlights From The Week Of Nov 9-15, 2014 ( TwoFour Insight)
• Indian Government to rollout bulk drug pharma policy within 15 days ( India Times)
• India’s dangerous medicine industry ( The Hill)
• Advocates Protest Meetings Between Pharma Lawyers and Indian Officials ( Pharmalot)
• Inside Indian pharma's push to reform and modernize ( BioPharma Dive)
• CDSCO & IPC discuss taking regulatory action following analysis of PvPI data ( CDSCO)
• Aurobindo Pharma executive shot at in Hyderabad in failed kidnapping attempt ( The Hindu) ( Times of India) ( India Times)
• 300 Doctors Accused of Being Bribed by Pharmaceutical Company ( India Times)
• Foreign drug makers urge Indian government to review IPR think tank ( India Times)

China

• Stronger punishments for production and sale of fake drugs in China ( Pharma Letter-$)

Japan

• Regeneron Announces EYLEA (aflibercept) Injection Approved for the Treatment of Diabetic Macular Edema (DME) in Japan ( Press)

Canada

• Canadians to Save $3.8-Billion Through Unprecedented Three-Year Pan-Canadian Agreement on Generic Prescription Medicines ( Press)
• Apotex claims Health Canada’s ban on its drugs made in India is ‘unlawful’ ( Toronto Star)
• Health Canada approves IMBRUVICA for chronic lymphocytic leukemia ( MNT)
• Health Canada Joins FDA in Investigating Antiplatelet Therapies ( Press)
• Celgene's OTEZLA (apremilast tablets), First in a New Class of Oral Treatment, Receives Health Canada Approval for Plaque Psoriasis ( Press)

Australia

• Contraceptive pills available without a prescription under a proposal considered by the Therapeutic Goods Administration ( NewsAU)
• Australian to Unveil New Software for eCTD submissions in 2015 ( TGA)

Other International

• ICH Reforming in Ways that Could Strengthen Harmonization Process ( Gold Sheet-$)
• Interpol: Organized crime, aware of weak points, targets counterfeit drugs ( Fierce)
• WHO joins drive to make all clinical trial data publically available ( PharmJournal)
• MedDRA Subscription Rates Staying the Same for 2015 ( ICH)
• Advertising Proposals Kick Off Singapore Drug Rule Revisions ( PharmAsia-$)
• Corruption tars drug industry drive to improve access for poor ( Reuters) ( Guardian) ( FT-$) ( PMLive)
• Implementation Challenges for ICH’s New M7 Guideline on Mutagenic Impurities Will Present Themselves at Both the Development and Post-Approval Levels ( IPQ-$)
• South Africa to Spend $2.2 billion on HIV Drugs in Next 2 Years ( Scientific American)
• Presbia Flexivue Microlens Receives Approval from Korean Ministry of Food and Drug Safety (MFDS) ( Press)

Clinical Trials

• NIH Explains its New Data Sharing Policy ( NIH) ( NIH)
• Public Citizen Calls on HHS to Transfer Common Rule Re-Write Authority to OHRP ( Public Citizen)
• Analysis finds 100% SDV has minimal impact on overall data quality ( Outsourcing Pharma)
• Continued Complexity Of A High Profile CRO Data Integrity Case ( Lachman)
• Collaboration can fix ‘broken’ clinical trials model TransCelerate CEO tells CROs ( BioPharma Reporter)
• Medidata and TransCelerate BioPharma Inc. Announce Findings of Joint Research Initiative on Clinical Trial Site Monitoring Methods ( Press)

General Regulatory And Interesting Articles

• Global medicines spend to reach $1.3trn by 2018 ( PMLive) ( Pharmalot) ( Fierce)
• The Genotype-Drug Connection ( MedPage Today)
• Likelihood approach for evaluating bioequivalence of highly variable drugs ( PubMed)
• Only half of patients take their medications as prescribed ( Press)
• Needles no more: say hello to a tube of squeezable biologics ( Biopharma Reporter)
• Quiz: The Name of a Drug, or the Name of a Pokemon? ( Boston Business Journal)
• How the biologics landscape is evolving ( PharmJournal)
• Can psychedelic trips cure PTSD and other maladies? ( WaPo)
• Taking More Than One Vaccine at a Time Doesn't Hurt ( NYTimes)
• Payout From Drug Raises Questions for Cystic Fibrosis Group ( NYTimes)
• ‘Tweens’ most likely to misuse over-the-counter meds ( Reuters)
• Don’t Slow Your EQMS Adoption Roll ( Pharma Manufacturing)
• When Treating ADHD, Should Children be Given One Drug or Two? ( NYTimes)
• Semen Protects HIV From Microbicide Attack ( Scientific American)
• How Bacteria In The Gut Help Fight Off Viruses ( NPR)
• What kills us, in one chart ( Vox)
• Some Humor on the Use of Control Groups ( PharmaGossip)