Regulatory Focus™ > News Articles > Regulatory Recon: $2.6 Billion to Get a Drug Approved, Study Finds (19 November 2014)

Regulatory Recon: $2.6 Billion to Get a Drug Approved, Study Finds (19 November 2014)

Posted 19 November 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: $2.6 Billion to Get a Drug Approved, Study Finds (19 November 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • 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)
  • Mallinckrodt Sues FDA After Agency Downgrades Therapeutic Equivalence Rating for Generic CONCERTA (FDA Law Blog)
  • 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)
  • What Price Could the Public be Paying for the Slow Down in Generic Drug Approvals? (Lachman)
  • CDRH: Legacy 510(k) Devices Need Cybersecurity Risk Assessments (MDDI)
  • Texas judge tosses out 76 suits in J&J's ongoing vaginal mesh litigation (Fierce)
  • EPA advisory panel's ruling could disrupt medtech (Mass Device)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • Mallinckrodt Sues FDA After Agency Downgrades Therapeutic Equivalence Rating for Generic CONCERTA (FDA Law Blog)
  • FDA Advisory Committee Supports Minor Changes to the Risk Evaluation and Mitigation Strategy of Alexion’s Soliris (Tarius) (Pink Sheet-$)
  • 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)
  • 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)

U.S. FDA Slams Ranbaxy’s Claims In Nexium, Valcyte Lawsuit (PharmAsia-$)

  • 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)
  • 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: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Janssen Submits New Drug Application to U.S. FDA for Three-Month Paliperidone Palmitate (Press)
  • Merrimack Pharmaceuticals Receives FDA Fast Track Designation for MM-398 in Post-Gemcitabine Metastatic Pancreatic Cancer (Press)
  • 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)
  • BerGenBio Receives Orphan-drug Designation from FDA for BGB324 in the Treatment of Acute Myeloid Leukaemia (Press)
  • Positive News for Pradaxa Antidote (Press)

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)
  • 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)

US: Medical Devices

  • CDRH: Legacy 510(k) Devices Need Cybersecurity Risk Assessments (MDDI)
  • Texas judge tosses out 76 suits in J&J's ongoing vaginal mesh litigation (Fierce)
  • EPA advisory panel's ruling could disrupt medtech (Mass Device)
  • BrainScope Announces FDA Clearance of Ahead 100 Device for Adjunctive Assessment of Traumatic Brain Injury (Press)
  • September 2014 PMA Approvals (FDA)
  • Roche nabs FDA clearance for quick strep test (Fierce)
  • Data Shows the CardioMEMS HF System Significantly Reduced 30-Day Hospital Readmission Rates (Press)
  • Argon Medical's CLEANER XT and CLEANER 15 Rotational Thrombectomy Systems Receive FDA Clearance for Mechanical Declotting and Infusion in the Peripheral Vasculature (Press)

US: Dietary Supplements

  • Children's Probiotic Supplement Contaminated With Disease-Causing Fungus (Forbes)
  • NPA Expectations for New NDI Guidance (NPI)
  • FDA Urged to Require Better Labeling of Sesame, an Allergen (CSPI)

Upcoming Meetings

Ebola Outbreak

  • WHO seeks swifter Ebola test to help stamp out epidemic (Reuters)
  • Study Will Test Survivors' Blood to Treat Ebola (AP) (Bloomberg)
  • Bloodmobiles To Collect Plasma From West Africa's Ebola Survivors (NPR)

Europe

  • European Commission Grants Marketing Authorization for Gilead’s Harvoni (Press) (Fierce) (BioCentury) (Pharma Times)
  • MHRA's Top 10 GMP Deficiencies (ECA) (MHRA)
  • Europe Edges Toward New HTA Understanding (PharmExec)
  • NICE wants more Xolair data (Pharmafile) (Pharma Times) (PMLive)
  • 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)

India

China

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

Canada

  • Health Canada Joins FDA in Investigating Antiplatelet Therapies (Press)

Other International

  • MedDRA Subscription Rates Staying the Same for 2015 (ICH)
  • Advertising Proposals Kick Off Singapore Drug Rule Revisions (PharmAsia-$)
  • For endorsement at the 19th AHWP Meeting-PROPOSED FINAL document on "Role of Standards in the Assessment of Medical Devices" (AHWP)

Clinical Trials

  • 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

Regulatory Reconnaissance #444 – 19 November 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, 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 industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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