Regulatory Focus™ > News Articles > Regulatory Recon: UK Regulator MHRA Appoints A New—and Familiar—Chair (4 November 2014)

Regulatory Recon: UK Regulator MHRA Appoints A New—and Familiar—Chair (4 November 2014)

Posted 04 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: UK Regulator MHRA Appoints A New—and Familiar—Chair (4 November 2014)

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

In Focus: US

  • Thermo Fisher pledges to fix glitch in drug analysis software (Reuters) (Outsourcing Pharma)
  • FDA Partially Grants Public Citizen Petition, Ads Warnings to Proton Pump Inhibitors (FDA)
  • US FDA offers more perspective on real-time release testing (Outsourcing Pharma)
  • FDA Official: Agency Could Soon Reach 'Tipping Point' On Breakthrough Drugs (IHP-$)
  • Novo Nordisk's first foray into obesity comes through in Phase III (Fierce) (Press)
  • Medical firm profited on pain with knockoff spine surgery hardware (CIR)
  • Stryker Settles Suits by Hip Implant Patients for $1 Billion (NYTimes) (Reuters) (Mass Device) (Press) (Bloomberg)
  • Boston Scientific rushed faulty transvaginal mesh to market: lawyer (Reuters)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • Thermo Fisher pledges to fix glitch in drug analysis software (Reuters) (Outsourcing Pharma)
  • FDA Partially Grants Public Citizen Petition, Ads Warnings to Proton Pump Inhibitors (FDA)
  • US FDA offers more perspective on real-time release testing (Outsourcing Pharma)
  • Responding to FDA 483 Observations, Part 1 (Quality Digest)
  • FDA Official: Agency Could Soon Reach 'Tipping Point' On Breakthrough Drugs (IHP-$)
  • Antibiotics Coalition Wants Drug Companies to Stop Growth Promotion Marketing (Food Safety News)
  • Meat Companies Go Antibiotics-Free as More Consumers Demand It (WSJ-$)
  • Wockhardt says U.S. export ban unlikely to be lifted until next year (Reuters)
  • FDA Post-Marketing Study Compliance Efforts To Get HHS OIG Review (Pink Sheet-$)
  • Experts To Industry: Start Implementing Social Media Guidelines Now (Pink Sheet-$)
  • Patient groups, PhRMA to huddle on expanded access (BioCentury)
  • If Generic Injectable Shortages are Nearing an End, What can Hospira do? (Pharmalot)
  • Pharmaxis's NSW Australia Plant Taken off of Import Alert (FDA)
  • FDA Clears ISCO's Stem Cell Line for Clinical Uses (Press)
  • Forest recalls another 90,000-plus bottles of Bystolic (Fierce)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Novo Nordisk's first foray into obesity comes through in Phase III (Fierce) (Press)
  • First dengue vaccine likely to be available in Second Half of 2015: Sanofi ​Pasteur (India Times) (Reuters) (Press)
  • Eisai and Arena Pharmaceuticals Report Results of an Investigational Phase 2 Trial of Lorcaserin HCl as an Aid for Smoking Cessation (Press)
  • Boehringer's Spiriva Respimat under FDA review in asthma (SCRIP-$) (Press)
  • Basilea reports granting of U.S. orphan drug designation to isavuconazole for the treatment of invasive candidiasis (Press)

US: Pharmaceuticals and Biotechnology: General

  • Donuts, drugs and December: How are They Related? (Healthcare Economist)
  • WHO recommends naloxone to prevent 20,000 overdose deaths in U.S. (Reuters)
  • The world's most effective HIV prevention drug hasn't lived up to its potential (WaPo)
  • Biosimilar Medications Could Create Billions in Savings (DD&D)

US: Medical Devices

  • Medical firm profited on pain with knockoff spine surgery hardware (CIR)
  • Stryker Settles Suits by Hip Implant Patients for $1 Billion (NYTimes) (Reuters) (Mass Device) (Press) (Bloomberg)
  • Boston Scientific rushed faulty transvaginal mesh to market: lawyer (Reuters)
  • How to Classify a Mobile Medical App and Submit It For FDA Approval or Clearance (MDDI)
  • Tomorrow: FDA Webinar on Distinguishing Device Recalls from Enhancements (FDA)
  • ReShape finally reveals pivotal obesity data ahead of FDA review (Fierce)
  • AtriCure Receives FDA Approval For Pivotal Study to Enroll Non-Paroxysmal Afib Patients (Press)
  • Notices About Lack of UDIs Now Showing Up in FDA Recall Notices (FDA)
  • Covidien’s HawkOne Directional Atherectomy System Receives FDA 510(K) Clearance for the Treatment of Peripheral Arterial Disease (Press) (Mass Device)

US: Dietary Supplements

  • One in Six Consumers Have Doubts About Safety, Efficacy, Quality of Supplements (NI-USA)

US: Assorted And Government

Upcoming Meetings

Ebola Outbreak

  • WHO's Chan Blames Big Pharma for Lack of Ebola Vaccine (NYTimes) (SCRIP-$)
  • Bill Gates Expresses Support for Clinical Trials Without Placebo Controls (WSJ-$)
  • Ebola: We need to forget randomised trials where half the participants receive a placebo (Guardian)
  • Nose Spray Ebola Vaccine Protects Monkeys (NBC)
  • Canada commits funding for Ebola vaccine research, stockpile (Reuters)

Europe

  • Sir Michael Rawlins appointed chair of MHRA (Pharmafile) (MHRA) (BioCentury) (PharmaTimes) (SCRIP-$)
  • EMA’s Release of Regulatory Data: Possible Fall out for Journals and Research Synthesis (PLoS)
  • Agenda for EMA's Upcoming PRAC Posted (EMA)
  • UK's NICE recommends GSK's Arzerra for untreated chronic lymphocytic leukemia (PharmaLetter-$)
  • IQWIG confirms an additional benefit of Eisai's Halaven (PharmaLetter-$)
  • Added benefit of Takeda’s Entyvio is not proven, says IQWiG (PharmaLetter-$)
  • Inventiva Receives Approval for Orphan Drug Designation (Press)

India

  • Peeved Bayer to USTR: Indian govt picking winners (SCRIP-$)
  • Indian firms: Don't judge IP regime by 'isolated' cases (SCRIP-$)

China

  • Golden spear: a thorn in Big Pharma’s ED business in China? (In-Pharma)

Canada

Australia

Other International

  • Agenda Papers for Upcoming ICH Meeting Posted (ICH)
  • Bio-Rad settles bribery violations in Thailand, Russia and Vietnam for $55m (Outsourcing Pharma)

Clinical Trials

General Regulatory And Interesting Articles

  • Formaldehyde and Chicken Eggs: What’s Inside a Flu Shot (Wired)
  • It's 10 PM, Do You Know Where Your Meds Are? (Forbes)
  • Amazing Photographs Of Drugs Englarged (IFL Science)
  • Anti-Vaxxers in a Nutshell… (Imgur)
  • Giant Study Clear Contraceptices of Any Major Risks (EMPR) (BMJ)
  • Rare disease patients in EU and US share policy priorities (The Parliament)
  • Gardedam Therapeutics could name its drug after you! (If you donate enough to its crowdfunding effort) (MedCityNews)

Regulatory Reconnaissance #433 – 4 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.


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