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)

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