Regulatory Focus™ > News Articles > Regulatory Recon: FDA Reviewers Positive on Sanofi, Regeneron's New Cholesterol Drug (8 June 2015)

Regulatory Recon: FDA Reviewers Positive on Sanofi, Regeneron's New Cholesterol Drug (8 June 2015)

Posted 08 June 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Reviewers Positive on Sanofi, Regeneron's New Cholesterol Drug (8 June 2015)

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

In Focus: US

  • FDA says Sanofi and Regeneron's cardio contender looks approvable (Fierce) (Tarius) (Pink Sheet-$) (SCRIP-$) (MedPage Today) (WSJ-$)
  • Ferring Lets Loose with the Latest Lawsuit Challenging Denial of NCE Exclusivity for Colon Cleansing Drug (FDA Law Blog)
  • Amgen's Repatha lowers LDL, no marked safety events: FDA staff (Reuters)
  • FDA's GDUFA War Chest Grows, And Industry May Look For Lower Fees (Pink Sheet-$)
  • At the FDA, drugs and tweets don't mix (Politico)
  • US, Canada expect Medical Device Single Audit Program draft guidelines this month (Clinica-$)
  • ‘Medjack:’ Hackers threaten hospitals using medical devices as back doors (MassDevice)
  • Congress may soon mandate that UDIs appear on Medicare claims forms (Fierce)

In Focus: International

  • New devices chief at EU commission as prospect of trialogue gets closer (Clinica-$)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 2-4 June 2015 (EMA)
  • EMA says no on designating alternative to qualified person for pharmacovigilance database (Clinica-$)
  • EC Authorization for Eisai's Lenvatinib (EC) (Press)
  • EC Authorization for Boehringer's Empagliflozin (EC)
  • Trade body urges India to prevent online sale of prescription drugs (PharmaBiz)
  • Health Canada's use of its priority review process for new drugs: a cohort study (PubMed)

US: Pharmaceuticals and Biotechnology

  • FDA says Sanofi and Regeneron's cardio contender looks approvable (Fierce) (Tarius) (Pink Sheet-$) (SCRIP-$) (MedPage Today) (WSJ-$)
  • Ferring Lets Loose with the Latest Lawsuit Challenging Denial of NCE Exclusivity for Colon Cleansing Drug (FDA Law Blog)
  • Amgen's Repatha lowers LDL, no marked safety events: FDA staff (Reuters)
  • FDA's GDUFA War Chest Grows, And Industry May Look For Lower Fees (Pink Sheet-$)
  • At the FDA, drugs and tweets don't mix (Politico)
  • Generic Facility Fees Are Smaller Part Of Funding Picture Than Expected (Pink Sheet-$)
  • Is The 21st Century Cures Act Good Or Bad For The Biopharmaceutical Industry? (Forbes)
  • 'Female Viagra' May Be More Marketing Than Science (Bloomberg) (Forbes)
  • California to Make Access to Hormonal Birth Control OTC (Vox) (NPR)
  • FDA Approval Summary: Ramucirumab for Gastric Cancer (PubMed)
  • Painkillers Resist Abuse, but Experts Still Worry (NYTimes)
  • FDA Talks Drug Quality During China Trip (FDA)
  • US preference for ANSI 363 excipient standards will change, says EXCiPACT (In-Pharma)
  • Regulatory challenges in developing long-acting antiretrovirals for treatment and prevention of HIV infection. (PubMed)
  • Association rule mining in the US Vaccine Adverse Event Reporting System (VAERS). (PubMed)
  • Orexigen, Takeda sue Actavis over generic Contrave (BioCentury) (Fierce) (Reuters)
  • InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA (RxTrace)
  • Two drugs manufactured by Wockhardt recalled in the US (India Times)
  • Mapping the Evolution of Pharmaceutical Quality (PCM)
  • California Right to Try Bill Clears Senate (Press)

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

  • Janssen Initiates Rolling Submission of Biologic License Application (BLA) for daratumumab with U.S. FDA for the Treatment of Multiple Myeloma (Press)
  • Lilly's Basal Insulin Peglispro Shows Superiority to Insulin Glargine in Type 2, Type 1 Diabetes (Press) (Press)
  • AstraZeneca presents new positive phase III data on triple therapy approach with dapagliflozin, saxagliptin and metformin for the treatment of type 2 diabetes (Press)
  • Titan Pharma Opioid Addiction Implant Passes Key Study Hurdle (The Street)
  • Boehringer: Empagliflozin/metformin demonstrates reductions in blood glucose in data presented at ADA  (Press)
  • Lilly: Once-Weekly Trulicity (dulaglutide) Provides Greater Blood Sugar Reduction Compared to Once-Daily Victoza® (liraglutide) in Japanese Patients after 52 weeks (Press)
  • Sanofi's Lyxumia (Lixisenatide) Statistically Superior To Rapid Acting Insulin For Body Weight Change With Similar Blood Sugar Control When Both Are Added To Basal Insulin (Press)

US: Pharmaceuticals and Biotechnology: General

  • Growing Hope: The Fight for Medical Marijuana for Epileptic Kids (NBC)
  • AMA: No More Non-Medical Vaccine Exemptions (MedPage Today)
  • Where Pay-For-Delay Stands 2 Years After Actavis (Law 360-$)
  • SCRIP's US Capitol Capsule (SCRIP-$)

US: Medical Devices

  • US, Canada expect Medical Device Single Audit Program draft guidelines this month (Clinica-$)
  • ‘Medjack:’ Hackers threaten hospitals using medical devices as back doors (MassDevice)
  • Congress may soon mandate that UDIs appear on Medicare claims forms (Fierce)
  • American Medical Association Leading Charge for CLIA Modernization (IHP-$)
  • Cook Group Scores Win In Pelvic Mesh Suit (Law 360-$)
  • FDA Posts Some Pretty Interesting 3-D Printed Device Models (FDA)
  • Proven Process client Flowonix Medical Inc. achieves FDA PMA Approval of Prometra II infusion device (Mass Device)

US: Dietary Supplements

  • Dietary supplement amendments introduced to must-pass defense spending bill (AHPA)
  • New Jersey Bill Urges Greater Federal Oversight Over Dietary Supplements (Scout)

US: Assorted And Government

  • Congress' Bipartisan Revival Opens Health Policy Doors (Law 360-$)
  • Confidential USTR Emails Show Close Industry Involvement In TPP Negotiations (IP Watch)
  • PwC's Weekly Regulatory Newsletter (PwC)
  • IRS Informally Rules that Disgorgement Payments Made Pursuant to FDA Consent Decree May Be Deductible (FDA Life)

Upcoming Meetings and Events

Europe

  • New devices chief at EU commission as prospect of trialogue gets closer (Clinica-$)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 2-4 June 2015 (EMA)
  • EMA says no on designating alternative to qualified person for pharmacovigilance database (Clinica-$)
  • Speculation intensifies as EU awaits Council of EU amendments (Clinica-$)
  • EC Authorization for Eisai's Lenvatinib (EC) (Press)
  • EC Authorization for Boehringer's Empagliflozin (EC)
  • BioMarin Submits Drisapersen MAA to EMA for the Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping (Press)
  • NICE issues guidance for two prostate cancer drugs (Pharmafile) (BioCentury) (Fierce) (SCRIP-$)
  • NICE says Novartis' Certican costs too much for NHS (PharmaTimes)
  • Ulcerative colitis patients get NHS access to Takeda's Entyvio (PharmaTimes)
  • Pharma R&D exodus on the Horizon? EU industry bemoans funding cuts (In-Pharma)
  • Italian competition body probes pricing in the vaccines market (SCRIP-$)

India

  • CDSCO And Dept Of Pharma Encroach On Each Other’s Medical Device Turf (24 Insight)
  • Industry flaws India's approach on ADR-related action (SCRIP-$)
  • Trade body urges Centre to prevent online sale of prescription drugs (PharmaBiz)

Japan

  • PhRMA: Need For Long-Term Japan Pharma Policies (Pink Sheet-$)

China

  • Collaboration Key For China Regulatory Reforms, RDPAC Says (Pink Sheet-$)

Canada

  • Health Canada's use of its priority review process for new drugs: a cohort study (PubMed)
  • Canada Signs Onto ICH Q3A(R2) and Q2(R1) (HC) (HC)

Clinical Trials

  • Imiquimod story highlights the danger of hidden trials (AllTrials)

General Regulatory And Interesting Articles

  • Call Centers: New Battle Front for Fake Drugs (WSJ-$)

Regulatory Reconnaissance #571 – 8 June 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