Regulatory Recon: Amarin Beats FDA in Off-Label Vascepa Case (7 August 2015)
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In Focus: US
- Amarin Wins Injunction Against FDA Over Off-Label Marketing (Law360-$) (Reuters)
- How Aprecia Unlocked 3D Printing's Potential for Drug R&D (SCRIP-$)
- FDA focuses on informatics platform as part of precision medicine work (FierceHealthIT) (Focus)
- 31 Drugs, Including Viagra, Will Be Cut From CVS’s Formulary (NYTimes)
- FDA Left Companies' Trade Secrets, Data Open To Hackers (SCRIP-$)
- Need a Guidance Document? We’ve Got You Covered (FDA Voice)
- Representatives Seek Protections for Hatch-Waxman and BPCIA in Innovation Act (Patent Docs)
- Fetal Tissue Firm Supplies NIH, FDA (Politico)
- Combination Products Reform Bill is a Good Start, but its Provisions Need Strengthening (FDA Law Blog)
In Focus: International
- Novo Nordisk May Withhold Xultophy From Germany If Price Talks Fail (Pink Sheet-$)
- MHRA reviews liquid ranitidine packaging after audit of dispensing incidents (Pharmaceutical Journal)
- NICE to allow companies to hide information? Our response (AllTrials)
- Canada Implements New Recall/Disclosure Policy (Pink Sheet-$)
- Global tech org reveals new standards for blood glucose monitoring devices (FierceMedicalDevices)
- ANVISA to allow Production Sharing of Drugs and Medical Devices (Emergo)
- New TPP Leaks Show Conflict but Little Clarity (PharmAsiaNews)
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US: Pharmaceuticals and Biotechnology
- Amarin Wins Injunction Against FDA Over Off-Label Marketing (Law360-$)
- How Aprecia Unlocked 3D Printing's Potential for Drug R&D (SCRIP-$)
- FDA focuses on informatics platform as part of precision medicine work (FierceHealthIT) (Focus)
- 31 Drugs, Including Viagra, Will Be Cut From CVS’s Formulary (NYTimes)
- Hepatitis C Treatments Are Cost Effective (Policy and Medicine)
- Process Patents Are Vital To Biotech — Why Not Extend Them? (Law360-$)
- Here's How Ineffective Sunscreens Get Past the FDA (Forbes)
- Public Notification: Achieving Zero Contains Hidden Drug Ingredient (FDA)
- 5 Big FDA Decisions Expected in August (24/7 Wall St)
- Clinical Trial Reporting Requirements Could Inhibit Data Access (Pharmaceutical Processing)
- Judge to Rule on Use of Pentobarbital for Death Penalty (Pharmaceutical Processing)
- Proposals to lessen the shortage of essential cancer drugs, generics and biosimilars in the US and the world (GaBI)
US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
- Pfizer, Bristol revive cancer drugs that rev up immune system (Reuters)
- Aurobindo gains FDA approval for alprazolam tablets (DSN)
- Glaucoma treatment may counter the virulence of tuberculosis (Pharmaceutical Journal)
- GW Pharmaceuticals granted Fast Track designation by FDA and orphan designation by EMA (PharmaLetter-$)
- Flowonix Medical Inc. Announces FDA Approval of New Product (Press)
- Valor Biotherapeutics to Begin Phase 1 Clinical Study of Novel Lymphoma Therapy (Press)
US: Pharmaceuticals and Biotechnology: General
- FDA Left Companies' Trade Secrets, Data Open To Hackers (SCRIP-$)
- Need a Guidance Document? We’ve Got You Covered (FDA Voice)
- Patient-funded trials may do more harm than good, ethicists warn (MNT)
- Mark your calendars: A new release coming soon from openFDA (FDA)
- Campaign Against Fake Drugs Gains Momentum (PharmTech)
- Preclinical randomised controlled trials could tackle high attrition rates in drug development (Pharmaceutical Journal)
- Study Tracks Clinical Trials Outcomes to Preregistration Requirement (FDANews)
US: Medical Devices
- FDA clears Stryker’s total knee for Mako robot-assisted surgery device (MassDevice)
- The security of medical devices (MassDevice)
- Medtronic Recalls Part Of Newly Approved Heart Device (Law360-$)
- 2015 Medical Devices: PMAs, Supplements, De Novo and 510(k)s (Gray Sheet 1, 2, 3, 4)
- Medtech Approvals: May 2015 PMAs (MassDevice) (FDA)
- FCC vote allows unlicensed devices to operate on same frequency as medical monitors (FierceHealthIT)
- Apollo Endosurgery wins FDA nod for gastric weightloss balloon (MassDevice) (FierceMedicalDevices)
- Doctors use 3D printed cerebrovascular models to prep for procedures (MassDevice)
- A cheaper, high-performance prosthetic knee (MIT)
US: Assorted and Government
- Representatives Seek Protections for Hatch-Waxman and BPCIA in Innovation Act (Patent Docs)
- Fetal tissue firm supplies NIH, FDA (Politico)
- Combination Products Reform Bill Is A Good Start, But Its Provisions Need Strengthening (FDA Law Blog)
Upcoming Meetings and Events
Europe
- Fatal Explosion at GSK Belgium Plant (Pharmaceutical Manufacturing) (Brussels Times)
- Novo Nordisk May Withhold Xultophy From Germany If Price Talks Fail (Pink Sheet-$) (SCRIP-$)
- MHRA reviews liquid ranitidine packaging after audit of dispensing incidents (Pharmaceutical Journal)
- NICE draft guidance recommends Daiichi's Lixiana (BioCentury)
- Pfizer Warns 'Troublesome' Price Hike Investigation Means Legal Uncertainty for Industry (SCRIP-$)
- NICE to allow companies to hide information? Our response (AllTrials)
- Clinical trial lawyer welcomes action by EMA on alleged data manipulation of trials (Lexology)
- Synflorix gains positive opinion from European agency (Vaccine News)
- India suspends trade talks with the EU over generic drugs ban (EurActiv)
- Cost reductions due to biosimilars in Europe (GaBI)
- EMA Grants Orphan Drug Designation to DCR-PH1, Dicerna's Investigational Therapy for the Treatment of Primary Hyperoxaluria Type 1 (Pharmiweb)
Canada
- Canada Implements New Recall/Disclosure Policy (Pink Sheet-$)
- Health Canada approves Varithena for patients with varicose veins (MNT)
- GlaxoSmithKline’s adult asthma medication gets regulatory nod in Canada (PharmaLetter-$)
Australia
- Australian government to tackle dementia research (PharmaLetter-$)
India
- Commerce ministry sets up sub-committee to simplify pharma export permits with single inspection at first point (PharmaBiz)
- Indian bio-pharma views US FDA’s dissolution test norms to a more simple process, ensuring higher efficiency (PharmaBiz)
China
- China’s FDA calls for verification data on clinical trials (Outsourcing-Pharma)
- AstraZeneca Sues Chinese Co. To Block Generic Nexium (Law360-$)
Other International
- Global tech org reveals new standards for blood glucose monitoring devices (FierceMedicalDevices)
- ANVISA to allow Production Sharing of Drugs and Medical Devices (Emergo)
- New TPP Leaks Show Conflict but Little Clarity (PharmAsiaNews)
- New Meningitis Strain in Africa Brings Call for More Vaccines (NYTimes)
General Health and Other Interesting Articles
- Public do not understand concept of antibiotic resistance (Pharmaceutical Journal)
- CDC's Approach to Legionnaire's Disease Causes Preventable Outbreaks (Forbes)
- Steven Pinker is right about biotech and wrong about bioethics (The Incidental Economist)
- For Vaccines Needed in an Epidemic, Timing is Everything (NYTimes)
- Which Drugs Are Most Commonly Prescribed to Pregnant Women? (MPR)
Regulatory Reconnaissance #613– 7 August 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 @Michael_Mezher or send him an email at [email protected].
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.