Regulatory Focus™ > News Articles > Regulatory Recon: UK Looking at How to Speed up Drug Reimbursement Decisions (20 November 2014)

Regulatory Recon: UK Looking at How to Speed up Drug Reimbursement Decisions (20 November 2014)

Posted 20 November 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: UK Looking at How to Speed up Drug Reimbursement Decisions (20 November 2014)

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

In Focus: US

  • 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)
  • FDA Advisory Committee Reviews the Use of Anesthetic and Sedation Drugs in Pediatrics (Tarius)
  • Sunscreen Innovation Act Awaits Obama's Signature (LoC)
  • Do laws hindering umbrella-wielding assassins also hurt Pharma? (In-Pharma)
  • Registration Deadline for Devices Coming up Soon (FDA)
  • FDA’s Supplement Division Still Without Permanent Leader (NPI)

In Focus: International

  • Britain begins review to speed access to new drugs (Reuters)
  • Is the UK’s NICE Becoming More Restrictive? (Context Matters)
  • NICE aims for earlier cancer diagnosis (Pharmafile) (Pharma Times)
  • In, on and near body networks EU regulation (MDL)
  • Indian Government to rollout bulk drug pharma policy within 15 days (India Times)
  • Apotex claims Health Canada’s ban on its drugs made in India is ‘unlawful’ (Toronto Star)
  • WHO joins drive to make all clinical trial data publically available (PharmJournal)

US: Pharmaceuticals and Biotechnology

  • US court overturns Ranbaxy bid to block launch of rival generic drugs (Reuters) (PharmAsia-$)
  • FDA Launches Surprise Inspection of Dr Reddy's Visakhapatnam Unit (Indian Express)
  • FDA Advisory Committee Reviews the Use of Anesthetic and Sedation Drugs in Pediatrics (Tarius)
  • Sunscreen Innovation Act Awaits Obama's Signature (LoC)
  • Generic Firms Say Impurity Limits Should Not Factor in ANDA Filings (FDA News-$)
  • 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)

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

  • 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)
  • Gene therapy found effective in hemophilia B (Reuters)
  • PharmaEngine Announces the Receipt of US FDA Fast Track Designation for MM-398 in Post-Gemcitabine Metastatic Pancreatic Cancer by Merrimack (Press)

US: Pharmaceuticals and Biotechnology: General

  • 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)

US: Medical Devices

  • Registration Deadline for Devices Coming up Soon (FDA)
  • Boston Scientific Touts Synergy Bioabsorbable Polymer Stent Trial Data (Gray Sheet-$)
  • DOD-backed BrainScope wins FDA clearance for traumatic brain injury diagnostic (Fierce)
  • Ventilator Recalled Over Potential Power Failure (FDA)
  • IlluminOss wins FDA nod for bone fracture device trial (Mass Device)
  • Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51 MIS Interspinous Fixation Implant (Press)

US: Dietary Supplements

  • FDA’s Supplement Division Still Without Permanent Leader (NPI)
  • 7th Circ. Slams 'Selfish' $6.5M Deal In Supplement Suit (Law 360-$)
  • DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer (FDA Law Blog)
  • Adulterated Supplement Recalled Over Sibutramine, Phenolphthalein (FDA)

US: Assorted And Government

  • 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)
  • 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)

Upcoming Meetings

Ebola Outbreak

  • Ebola mAb Therapies Get BARDA Backing; FDA, NIH Get Grilling At House Hearing (Pink Sheet-$)
  • Clinical Trials on Zmapp Beginning in January (House)
  • Examining Medical Product Development in the Wake of the Ebola Epidemic (House)
  • Ebola drugs, vaccines scale-up in jeopardy without funds (SCRIP-$)

Europe

  • Britain begins review to speed access to new drugs (Reuters)
  • Is the UK’s NICE Becoming More Restrictive? (Context Matters)
  • NICE aims for earlier cancer diagnosis (Pharmafile) (Pharma Times)
  • In, on and near body networks EU regulation (MDL)
  • 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)
  • Covidien Achieves CE Mark for the Nellcor Bedside SpO2 Patient Monitoring System, PM100N (Press)

India

  • Indian Government to rollout bulk drug pharma policy within 15 days (India Times)
  • DoP sets up Task Force to identify issues relating to promotion of local production of high end medical devices (PharmaBiz)
  • India’s dangerous medicine industry (The Hill)
  • Advocates Protest Meetings Between Pharma Lawyers and Indian Officials (Pharmalot)

Japan

  • Deregulation at heart of Japan's new robotics revolution (Reuters)

Canada

  • 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)

Other International

  • Interpol: Organized crime, aware of weak points, targets counterfeit drugs (Fierce)
  • WHO joins drive to make all clinical trial data publically available (PharmJournal)

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)

General Regulatory And Interesting Articles

  • Likelihood approach for evaluating bioequivalence of highly variable drugs (PubMed)
  • The Band-Aid Of The Future Stops Bleeding Instantly (Digg)
  • Only half of patients take their medications as prescribed (Press)

Regulatory Reconnaissance #445 – 20 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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