Regulatory Focus™ > News Articles > Regulatory Reconnaissance: High Costs of Ultra Orphan Drug Concern UK Regulators (4 March 2014)

Regulatory Reconnaissance: High Costs of Ultra Orphan Drug Concern UK Regulators (4 March 2014)

Posted 04 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • Lung Cancer Trials Soften Endpoint (MedPage Today)
  • Who Stands To Gain With FDA Approval Of OTC Lipitor? (Forbes)
  • REMS Decision, Evaluation Guidances In Process, FDA Says (Pink Sheet-$)
  • Actavis Defects from GPhA Over Regulation of Biosimilars (IHP-$)
  • How the FDA can improve regulation of mobile health, according to FDASIA workgroup (MobiHealthNews)
  • State AGs subpoena Endo Health over pelvic mesh products (Mass Device)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • Lung Cancer Trials Soften Endpoint (MedPage Today)
  • Who Stands To Gain With FDA Approval Of OTC Lipitor? (Forbes)
  • REMS Decision, Evaluation Guidances In Process, FDA Says (Pink Sheet-$)
  • FDA-backed study provides path forward for Probuphine (SCRIP-$)
  • GSK's Pandemrix problems rumble on (SCRIP-$)
  • Powerful senator seeks Zohydro ban; Zogenix reinforces its defense (SCRIP-$) (MedPage Today)
  • Quick RedHill/IntelGenx FDA response fails to impress investors (SCRIP-$)
  • Jubilant says the FDA has cleared its Canada plant of earlier warning (Fierce)
  • Nexium Buyers Urge Judge To Rethink Ranbaxy Win In MDL (Law 360-$)

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

  • Forest Laboratories and Adamas Pharmaceuticals Announce Forest's Submission of New Drug Application for Memantine Extended Release and Donepezil Fixed-Dose Combination for Alzheimer's Disease (Press)
  • AAA Receives Orphan Drug Designation from FDA and EMA for Gallium-68 DOTATATE for Use in Patients with Gastro-Entero-Pancreatic Neuroendocrine Tumors (Press)
  • Why doctors both heartened, underwhelmed by InterMune's Esbriet data in IPF (BioCentury-$)
  • GSK stops Phase-II lupus trial (MM&M)
  • FDA Gives MEI's Leukemia Drug Orphan Status (Press)
  • AbbVie hepatitis C treatment does well in late-stage study (Crain's) (Press)
  • Jaguar Files INADAs for Diarrhea in Companion Animals and Horses (Press)
  • Oxygen Biotherapeutics Inc. Provides an Update on Communication with the FDA Regarding Oxycyte Development Program (Press)

US: Pharmaceuticals and Biotechnology: General

  • Actavis Defects from GPhA (IHP-$)
  • Drugmakers Slash Spending On Doctors' Sales Talks (NPR) (ProPublica)
  • Medicare's Drug Program Needs Stronger Protections Against Fraud, Watchdog Says (ProPublica)
  • Freed of Disclosure Requirement, Drug Maker Pulls Doctor Payments Offline (ProPublica)
  • Track-and-Trace Not Enough to Halt Drug Counterfeiters (PharmExec)
  • CDC reports switch to two-dose regimen of Merck's chickenpox vaccine a success (Fierce)
  • Consumers should be wary when a doctor prescribes a drug for 'off-label' treatment (Consumer Reports)

US: Medical Devices

  • How the FDA can improve regulation of mobile health, according to FDASIA workgroup (MobiHealthNews)
  • Medline's ACME Monaco guidewire recall is Class I (Mass Device)
  • State AGs subpoena Endo Health over pelvic mesh products (Mass Device)
  • Retiring Rep. Dingell's Health Policy Legacy Includes Fierce Oversight Of Device Center (Pink Sheet-$)
  • Ear-Cleaning Product Marketer Accused Of False Advertising (Law 360-$)
  • Opinion: Government Should Better Regulate Quality Control For Device Implants (MDDI)

US: Dietary Supplements

  • Proposed changes to supplement labels could cause many products to be reformulated (NI-USA)
  • FDA Issues Import Alert on Dietary Ingredient, Kratom (NPI)

US: Assorted And Government

  • FDA's Proposed Budget Due out Later Today
  • FDA ICCR focuses in on nanomaterials and test alternatives (Cosmetics Design)

Europe

  • NICE tells Alexion: "explain high costs of Soliris" (Pharma Times) (Pharmafile) (PMLive) (Pharma Letter-$) (Alexion) (BioCentury) (Bloomberg)
  • CHMP considering changing indication for diabetes drugs (BioCentury)
  • Unresolved questions surround France's new biosimilars substitution law (BioCentury)
  • EU votes to let customs stop and destroy fake drugs shipped through Europe (In-Pharma)
  • U-turn could see Pfizer's Inlyta on NHS (Pharma Times)
  • EMA: Draft guideline on core SmPC for human fibrinogen products (EMA)
  • Oops: England's entire healthcare data set uploaded to Google servers (MedCity News)
  • Europe: Whatever Happened to Faster Reimbursement for Generics? (PharmExec)
  • France tightens acitretin prescribing rules over pregnancy concerns (SCRIP-$)

Japan & China

  • Japan Regenerative-Medicine Research Stirs Scientific Controversy (PharmAsia-$)
  • China Cracks Down on DNA Testing (Forbes)
  • Off-patent Originator Drugs Could Disappear In China Over Next Decade: BCG Report (PharmAsia-$)

General Regulatory And Interesting Articles

  • Clinical studies still not being published (Pharmafile)
  • The Push for Transparency: Risks, Costs, and Concerns (PharmExec)
  • Stopping criminal access to APIs must not block generics, says expert (In-Pharma)
  • The top 10 pharma companies by 2013 revenue (Fierce)
  • 'High use' pain killer addicts get fix from doctors, dealers: study (Reuters)
  • Giant virus revived from deep freeze in Siberian tundra (LA Times)

Regulatory Reconnaissance #268 - 4 March 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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


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