Regulatory Focus™ > News Articles > Regulatory Recon: Woodcock: Sponsors Need Evidence FDA Can Trust, Brexit Could Move EMA to Sweden (2

Regulatory Recon: Woodcock: Sponsors Need Evidence FDA Can Trust, Brexit Could Move EMA to Sweden (26 February 2016)

Posted 26 February 2016 | By Michael Mezher 

Regulatory Recon: Woodcock: Sponsors Need Evidence FDA Can Trust, Brexit Could Move EMA to Sweden (26 February 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • On precision medicine, Obama is playing the long game (STAT) (SCRIP-$) (NYTimes) (WSJ) (YouTube) (White House)
  • Tragic Patient Stories Don't Trump Weak Data, FDA Official Says (Bloomberg)
  • OGD Director Uhl Provides the Lowdown on GDUFA Implementation (FDA Law Blog) (Slides)
  • FDA Taps Siemens Quality VP To Finally Fill CDRH Compliance Director Job (Gray Sheet-$)
  • Pharmaceutical Policy Reform — Balancing Affordability with Incentives for Innovation (NEJM) (Interview)
  • Report: Pfizer dodging $35B in taxes (USA Today) (The Hill) (Report)
  • NIH vowed to move its research chimps from labs, but only 7 got safe haven in 2015 (Washington Post)

In Focus: International

  • Swedish industry wants European medicines agency if UK quits EU (Reuters)
  • Bial cannot rule out link between BIA 10-2474 and lung lesions in study dogs (In-PharmaTechnologist)
  • More Notified Bodies Bite The Dust - But Are Products Any Safer? (Clinica-$)
  • New NHS cancer drugs fund approved (BBC) (BioCentury)
  • Malaysia's Medical Device Authority Clarifies Declaration of Conformity Rules (Emergo)
  • CFDA's Order On Chinese Pharmacopoeia Could Lead To Greater Testing Of Imported Medicines (SCRIP-$)

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Precision Medicine

  • President Urges Breaking Down Of Drug, Device Distinctions, Regulatory Barriers (Gray Sheet-$)
  • Obama Is Using The Bully Pulpit To Set Patient Data Free (Forbes)
  • Obama's Precision Medicine Initiative Is The Ultimate Big-Data Project (Fast Company)
  • Personalized Medicine Considers Which Would-Be Stem Cells to Cultivate, and When (GEN)
  • Economics Of Precision Medicine: Will It Lower Drug Costs? (SCRIP-$)
  • IBM and New York Genome Center's new cancer tumor repository aims to revolutionize treatment (Washington Post)
  • Verily, Vanderbilt to test enrollment in U.S. Precision Medicine pilot (Reuters)
  • Intel hops on the precision medicine bandwagon with new projects for 2016 (Fierce)
  • Inova unveils $100 million venture fund focused on precision medicine (Washington Business Journal)

US: Pharmaceuticals & Biotechnology

  • 'Seriously flawed' study linking behavioral problems to Gardasil retracted (Washington Post)
  • CardioBrief: New FDA Chief Will Champion Clinical Trials (MedpageToday)
  • FDA Budget Request Reminds Congress: OTC Rulemakings Take Time (Tan Sheet-$)
  • Despite Globalization, Three Quarters of Serious Issues FDA Found Were in US (Gold Sheet-$)
  • USFDA Denies Citizen Petition For Amedra's Albenza – Generic Entry On Horizon (24 Insight)
  • Soon-Shiong Makes Case for "Cancer MoonShot" at Biocom Conference (Xconomy)
  • Going Germline: Mitochondrial Replacement as a Guide to Genome Editing (Cell)
  • Targeted Therapy Works in Triple-negative Breast Cancer Models (Thomson Reuters)
  • FDA Feels Heat On Drug Pricing And Generic Labeling Rule (Pink Sheet-$)
  • Curing Document Control Conundrums: A Checklist for Sustained Efficiency and Audit Readiness (GxP Lifeline)
  • Clinical Trials for Childhood Cancer Drugs are Critical, But Parents Don't Always Understand Them (DD&D)

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

  • Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris (Press)
  • Heat Biologics stops enrolment in trial arm testing HS-410 as a bladder cancer monotherapy (BioPharma-Reporter)
  • Cara Therapeutics Provides Update on CLIN3001 Postoperative Pain Trial for I.V. CR845 (Press)

US: Medical Devices

  • Alfred E. Mann, entrepreneur behind the rechargeable pacemaker and an artificial retina, dies at 90 (LA Times) (MassDevice)
  • Cook Medical expands beacon tip cath recall (MassDevice) (FDA)
  • Class 1 Device Recall Draeger Critical Care Ventilator (FDA)
  • FDA Highlights Human Factors In Three Recently Issued Guidance Documents (National Law Review)
  • APN Health Receives FDA Clearance for Innovative Cardiac Mapping System (Press)

US: Assorted & Government

  • Congressional Hearings Focus on Compassionate Use, FDA Issues (Focus)
  • Why America pays so much more for drugs (Washington Post)
  • Finally letting FDA be FDA (The Hill)
  • Big verdict doesn't assure more wins for plaintiffs in talc-cancer cases (Reuters)
  • More Overdose Deaths from Anxiety Drugs (NYTimes)
  • To require the Secretary of Health and Human Service to develop a voluntary patient registry to collect data on cancer incidence among firefighters (Congress)
  • More than 200 patients at NJ hospital possibly exposed to HIV, hepatitis (Reuters)
  • The Multibillion-Dollar Epidemic: 5 Takeaways From PBS' 'Chasing Heroin' (Forbes)
  • Solid Affirmances: Avandia Summary Judgment, and Westminster (Drug and Device Law)
  • Kannalife eyes share float to fund cannabis-based medicine (Reuters)

Upcoming Meetings & Events

Europe

  • Gilead's HIV drug gets closer to getting Europe approval (Reuters)
  • European Regulatory Roundup: Brexit Could Lead to New Regulatory Burdens (Focus)
  • Google's UK AI subsidiary DeepMind partners with NHS to develop medical apps (MobiHealthNews)
  • Shining a light on drug company payments to healthcare professionals (PharmaceuticalJournal-$)
  • Expert: Prepping Suppliers For Surprise Audits Imperative For Device Firms Under EU Unannounced Inspection Scheme (Gray Sheet-$)
  • Medicines marketing authorisation: Change of ownership application (MHRA)
  • Genomics England partners with ICON for 100,000 Genome Project (BioSpectrum)
  • BSG guidance recommends switching to biosimilar infliximab (GaBI)
  • Clinical trials – a rigorous framework for trial authorisation and patient safety monitoring (EPR)
  • Sobi and Biogen Receive Positive Opinion from CHMP for Alprolix (rFIXFc) for the Treatment of Hemophilia B (Pharmiweb)
  • AbbVie Receives EMA Orphan Drug Designation for Investigational Compound Venetoclax for the Treatment of Acute Myeloid Leukemia (AML) (Press)
  • Bio-Rad Gets CE IVD Mark for Droplet Digital PCR System (Genomeweb)
  • Gilead's MAA for TAF in hepatitis B now under assessment by the EMA (EPR)
  • Lilly Receives Positive CHMP Opinion for Ixekizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis (Press)
  • Bristol-Myers Squibb Receives Two Positive CHMP Opinions for Opdivo® (nivolumab) for Patients with Previously Treated Advanced Non-Squamous Non-Small Cell Lung Cancer and Renal Cell Carcinoma (Press)
  • Orphan Drug Designation in the European Union for TNT009 for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (MNT)

Asia

  • South Korea approved more clinical trials in 2015 (Fierce)
  • Japan's Daiichi Sankyo doses first patient in Duchenne trial (Fierce)
  • Novartis cooperating with South Korean authorities after raid (In-PharmaTechnologist)

India

  • Government approves scheme to strengthen drug regulatory system (Economic Times)
  • India Quality Forum: What Regulators Really Want (SCRIP-$)
  • Drug price regulator finds 4,700 medicines illegally over-priced (Economic Times)
  • Sunovion Overcomes Section 3(d) Objections To Obtain Patent In India For Novel Tetralone-Based Amines (24 Insight)
  • Government in talks with manufacturers to lower prices of stents (Economic Times)
  • Duty exemption withdrawal on drugs to boost Make in India: Government (Economic Times)
  • Sun Pharma medical representative on two day strike (Economic Times)
  • CDSCO to bring in uniformity inspections of Sch M units across country (PharmaBiz)

Australia

  • ConceivePlease one step hCG urine pregnancy test (TGA)

Zika Virus

  • Zika Virus Vector (Aedes aegypti): Genomic Sequence (Patent Docs)
  • Disease Detectives In Brazil Go Door-To-Door To Solve Zika Mystery (NPR)
  • Zika infection may cause stillbirth, loss of brain tissue: report (Reuters)
  • There is 'promising pathway' for vaccine against Zika: Obama (Reuters)
  • 3 pregnant women diagnosed with Zika in Florida (CBS News)
  • Bacteria-Laden Mosquitoes May Be the Cheapest Way to Stop Dengue and Zika
  • Some Latin American cities could so (MIT Technology Review)
  • Why Scientists Hope To Inject Some People With Zika Virus (NPR)

Other International

  • One in five African children denied access to vaccines: report (AFP)
  • Health experts press for urgent, integrated approach to tackle dengue (Reuters)

General Health & Other Interesting Articles

  • Flu Vaccine Nearly 60 Percent Effective According to Preliminary CDC Data (ICH)
  • First Uterus Transplant in U.S. Bolsters Pregnancy Hopes of Many (NYTimes)

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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