Regulatory Focus™ > News Articles > Regulatory Recon: Gilead's Big Bid to Wipe out HepC in Georgia (23 April 2015)

Regulatory Recon: Gilead's Big Bid to Wipe out HepC in Georgia (23 April 2015)

Posted 23 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Gilead's Big Bid to Wipe out HepC in Georgia (23 April 2015)

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

In Focus: US

  • Scrutinizing Substantial Equivalence: 510(k) Predicate Standard Questioned (Gray Sheet-$)
  • Who’s Liable for 3D Printed Medical Devices? (MedicalDeviceSummit)
  • Shuren: FDA Open To Better LDT Oversight, Possibly Through Legislation (IHP-$)
  • Labeling foul-up involving acetaminophen leads RB to recall 135 lots of Mucinex (Fierce) (Law 360-$) (FDA) (FDA)
  • FDA to award $1M EHR mining grant for drug-safety surveillance (MedCityNews)
  • FDA's Regulation of Search (EyeonFDA)
  • States Trying to Take on Drug Pricing (Policy and Medicine)
  • What 21st Century Cures Will Mean For Clinical Trial Sponsors (ClinicalLeader)

In Focus: International

  • Gilead uses Georgia as free-drug testbed for hepatitis C elimination (Reuters)
  • Chinese Team Reports Gene Editing Human Embryos (MIT TR)
  • Novartis heart drug enters UK's early access scheme (PharmaTimes) (Pharmafile)
  • WHO consults on new annual fee for pre-qualification of drugs, devices (SCRIP-$)
  • South America mulls centralized price negotiations for hep C drugs (SCRIP-$)

Take Your Regulatory Career to the Next Level With Executive Training

  • Now more than ever, senior regulatory professionals must bridge science, regulation, business and strategy. RAPS’ Executive Development Program at the Kellogg School of Management is the only program of its kind that caters exclusively to experienced regulatory professionals. It is an exceptional opportunity to strengthen your management and leadership skills over four intensive days in an intimate learning environment. Register for the Executive Development Program here.

US: Pharmaceuticals and Biotechnology

  • Labeling foul-up involving acetaminophen leads RB to recall 135 lots of Mucinex (Fierce) (Law 360-$) (FDA) (FDA)
  • FDA to award $1M EHR mining grant for drug-safety surveillance (MedCityNews)
  • FDA's Regulation of Search (EyeonFDA)
  • ISPE Targets Five Quality Metrics for Round Two of Pilot Program (FDAnews-$)
  • FDA Announces Bystolic Shortage (EndocrinologyAdvisor)

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

  • FDA grants priority review to Boehringer's blood clotting agent (Reuters) (Press)
  • FDA accepts for filing Bayer's sBLA for Betaconnect to treat RRMS (PBR) (Press)
  • Enanta Announces U.S. FDA Grants Priority Review for AbbVie’s Investigational, All-Oral, Interferon-Free Treatment Regimen for Genotype 4 Chronic Hepatitis C Infection (Press)
  • Gilead presents new Sovaldi data (Pharmafile) (Press) (Press)
  • Medivir: Data from OPTIMIST trials show SVR12 rates of 97 percent in HCV patients without cirrhosis and 84 percent in HCV patients with cirrhosis (Press)
  • Ultragenyx gains on De Vivo results (BioCentury)
  • Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease (Press)
  • CymaBay gets FDA orphan drug status for MBX-8025 to treat hypertriglyceridemia (PBR)
  • Capricor Granted FDA Orphan Drug Designation For Allogeneic Cardiosphere-Derived Cells (Press)

US: Pharmaceuticals and Biotechnology: General

  • Massachusetts Introduces Drug Cost Transparency Bill That Would Cap Prices For Certain Products; North Carolina and Pennsylvania Also Introduce Bills Requiring Drug Cost Reports (Policy and Medicine)
  • Generic Drug Prices Keep Rising, but is a Slowdown Coming? (Pharmalot)
  • Saxenda debuts in US with $1,000-a-month price tag (PMLive)
  • California Senate Committee Approves Bill Removing Vaccine Exemptions (NPR)

US: Medical Devices

  • Scrutinizing Substantial Equivalence: 510(k) Predicate Standard Questioned (Gray Sheet-$)
  • Who’s Liable for 3D Printed Medical Devices? (MedicalDeviceSummit)
  • Shuren: FDA Open To Better LDT Oversight, Possibly Through Legislation (IHP-$)
  • Appeals court upholds preemption ruling in Medtronic InFuse lawsuit (Mass Device)
  • Agilent Technologies Announces Resolution to U.S. FDA Warning Letter for Dako Denmark (Press)
  • Coloplast Titan Inflatable Penile Prosthesis Approved for Ectopic Placement (Press)
  • Circumcision Clamp Makers Sued Over Amputated Penis (Law 360-$)
  • VuCOMP Files Industry’s First PMA for Computer-Aided Detection for Digital Breast Tomosynthesis (Press)
  • FDA Approves Breast Tomosynthesis Option for Siemens Mammography Platform (Press)

US: Dietary Supplements

  • Diet pill death from DNP: Could it happen here? (CBS)
  • Pharma Critic Skewers Homeopathy At FDA Hearing (Forbes)

US: Assorted And Government

  • Senate committee approves bill to help Obama pass the Trans-Pacific Partnership (Vox) (SCRIP-$)
  • FDA's Weekly Enforcement Report (FDA)

Upcoming Meetings and Events

Ebola Outbreak

Europe

  • Novartis heart drug enters UK's early access scheme (PharmaTimes) (Pharmafile)
  • Gilead uses Georgia as free-drug testbed for hepatitis C elimination (Reuters)
  • ellaOne emergency contraception available for sale through UK pharmacies (PharmJournal)
  • ESCMID warns that Europe may surpass one million deaths due to ineffective antibiotics by 2025 (MNT)
  • Primary Immunodeficiencies Diseases (PI): adoption of a European Consensus aimed at providing enhanced access to Immunoglobulins Therapies (Ig) (EDQM)

India

China

  • Chinese Team Reports Gene Editing Human Embryos (MIT TR)
  • Drumbeat grows for better access to medicines, hospital reforms in China (Fierce)

Canada

  • Health Canada proposes tighter controls over veterinary drug imports (BetterFarming)

Other International

  • WHO consults on new annual fee for pre-qualification of drugs, devices (SCRIP-$)
  • South America mulls centralized price negotiations for hep C drugs (SCRIP-$

Clinical Trials

  • What 21st Century Cures Will Mean For Clinical Trial Sponsors (ClinicalLeader)
  • A shake-up of the way clinical trials are conducted is on the horizon, with the aim of improving access to medicines. (PharmJournal)
  • All about that base: Risk-based monitoring takes center stage (Outsourcing Pharma)
  • Remote SDV/SDR: Alternatives to Redact/Fax (Polaris)

Regulatory Reconnaissance #542 – 23 April 2015

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe