Regulatory Focus™ > News Articles > Regulatory Recon: Califf Calls for Stronger FDA Workforce, NICE Reverses Course on Zytiga After Pric

Regulatory Recon: Califf Calls for Stronger FDA Workforce, NICE Reverses Course on Zytiga After Price Drop (21 March 2016)

Posted 21 March 2016 | By Michael Mezher 

Regulatory Recon: Califf Calls for Stronger FDA Workforce, NICE Reverses Course on Zytiga After Price Drop (21 March 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

  • Califf: FDA Workforce Needs Strengthening (MedpageToday)
  • Artificial Hearts Ticking Along Decades After Jarvik-7 Debate (NYTimes)
  • FDA Approves New Treatment for Inhalation Anthrax (FDA)
  • Johnson & Johnson Settling Cases Tied to Device That can Spread Uterine Cancer (WSJ-$) (MassDevice)
  • Texas Woman is the First Person to Undergo Optogenetic Therapy (MIT Technology Review)
  • Generic User Fee Negotiations may be Falling Behind Schedule (Pink Sheet-$)
  • Avoiding 'Teapot Tempest,' Clinton Campaign Distances Itself From Theranos (STAT)
  • Should Congress Pass the Cures Act? (ProtoMag)
  • Runs in the Family (The New Yorker)

In Focus: International

  • U-Turn Over Prostate Cancer Drug Zytiga After Price Change (BBC) (PharmaTimes) (Reuters)
  • Fourth Person Dies of Ebola in Latest Flare Up in Guinea (Reuters)
  • China Vows Crackdown on Fake Vaccines Amid Scandal (Reuters) (Shanghai Daily)
  • Valeant CEO Pearson Will Step Down, Ackman Added to Board (Bloomberg) (WSJ-$)

US: Pharmaceuticals & Biotechnology

  • Real-world study results back switch to Remsima (PharmaLetter-$) (Pharmafile)
  • A window into one of the most baffling things about drug prices (Washington Post)
  • NEJM Responds to Allegations Its Correspondent Reported Confidential, Inaccurate Patient Information (Forbes)
  • Health policy: Strategies to optimize expedited investigational new drug safety reports (Nature-$)
  • Insulin Exclusivity: How Big Will The Fight Be? (Pink Sheet-$)
  • Tech Megatransfer: Merck Pays Harvard $20M For "Accelerated" Cancer Drugs (Xconomy)
  • Keeping Track: FDA Following Through On Opioid Promises (Pink Sheet-$)
  • Contraindications, Warnings Updated for Tudorza Pressair (MPR)
  • FDA Rules Favorably On Major Depressive Disorder Drug (DD&D)

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

  • Pfizer's Xeljanz meets goals in ulcerative colitis trials (Reuters) (Press)
  • BioMarin drug for genetic disorder succeeds in late-stage study (Reuters)
  • XTL Biopharmaceuticals Completes Phase 2 Trial Design for Lead Compound hCDR1 in the Treatment of Lupus (Press)
  • J&J psoriasis drug Stelara eases Crohn's disease in second trial (Reuters)
  • Oral Ozanimod Showed Histologic Improvements in Patients with Ulcerative Colitis in the Phase 2 TOUCHSTONE Trial (Press)
  • Cerulean Presents CRLX301 Phase 1 Data at the 14th International Congress on Targeted Anticancer Therapies (Press)
  • Chi-Med Initiates Sulfatinib Phase III Registration Study in Pancreatic Neuroendocrine Tumor Patients (Press)

US: Medical Devices

  • FDA Weighs Danger Tied to Blood-Monitoring Devices (WSJ-$)
  • Final Guidance: Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance Environment for Multi-Configuration Passive Medical Devices (FDA)
  • FDA: Verathon recall of video laryngoscope is Class I (MassDevice) (FDA)
  • New Whitepaper: In Vitro Diagnostics – The Basics (imarc)
  • Study finds CMS competitive bidding program restricts access to diabetes testing supplies (Fierce)
  • FDA approves expanded use of Roche hepatitis C virus RNA test as aid in diagnosis (Press)
  • Vermillion Announces FDA Clearance of Overa, Second Generation OVA1 Test (Press)
  • Olea Medical Receives FDA Clearance for Olea Sphere 3.0 (Press)

US: Assorted & Government

  • FTC Sends Refund Checks Totaling Nearly $210,000 to Consumers Who Bought Nano-UV "Disinfectant" Devices from Zadro Health Solutions, Inc. (FTC)
  • Why is Washington Turning its Back on Waste in Medicare Spending? (Forbes)
  • Zubik v. Burwell, Part 3: Birth Control Is Not Abortion (Harvard Bill of Health)
  • Research Institution Pays $3.9 million HIPAA Settlement for Breach (FDA Law Blog)
  • Breaking News – No Circuit Split (Yet) Over Post-Bauman General Jurisdiction by Consent (Drug and Device Law)
  • Federal Circuit Holds That Specific Personal Jurisdiction Exists Anywhere an ANDA Applicant Intends to Market its ANDA Product (Orange Book Blog) (SCRIP-$)
  • He won his own battle against cancer. Biden just picked him to lead a war (Washington Post)
  • Sen. Alexander Introduces Bill to Continue Implementation of Precision Medicine Initiative (GenomeWeb)

Upcoming Meetings & Events

Europe

  • Germany's IQWiG views Tafinlar, Stivarga and Cotellic (PharmaLetter-$) (BioCentury)
  • NICE confirms support for Novartis' heart drug Entresto (PharmaTimes)
  • 'No More Questions' On Scrutiny As EU Talks Set To Give Notified Bodies Yet More Responsibility (Clinica-$)

India

  • Indian court extends relief to pharma firms in drug ban case (Reuters)
  • Health ministry cancels repeat animal testing for new drugs already tested abroad (PharmaBiz) (SCRIP-$)
  • Over 33,000 applications cleared for drug mfg through FDA online system in 2 years (PharmaBiz)
  • 'Miracle drug' for resistant Tuberculosis to be rolled out for trial today (Economic Times)
  • Medical devices market likely to grow to $8.6 billion by 2020: Report (Economic Times)
  • Drug makers body says government's ban 'arbitrary and unfair' (Economic Times)
  • HC to resume hearing on pharma cos' pleas against Centre's order (Economic Times)
  • Exploring all options to deal with drug ban: Merck (Economic Times)
  • Aurobindo Pharma gets USFDA nod for osteoporosis drug (Economic Times)

Zika

  • Puerto Rico Braces for Its Own Zika Epidemic (NYTimes)
  • WHO backs trials of bacteria, genetic modification to fight Zika mosquitoes (Reuters)
  • New Zika lab test gets emergency approval from FDA (Washington Post) (CDC)
  • WHO sends team to Cape Verde after microcephaly case found (Reuters)
  • Still uninsured for your Latin American event? Then expect a Zika exclusion (Reuters)
  • Brazil says confirmed and suspected microcephaly cases rise to 5,131 (Reuters)
  • This lab is ground zero in the U.S. fight against Zika (Washington Post)
  • CDC issues a Cuba travel warning over the Zika virus (Washington Post)

Other International

  • Trans-Pacific Trade Pact Not A Good Deal For Small-Molecule Generics? (Pink Sheet-$)
  • Health workers rush to contain fresh Ebola outbreak in Guinea (Reuters)

General Health & Other Interesting Articles

  • With cancer in one breast, no survival advantage in removing second one (Reuters)
  • Here's Everything You Need To Know About The Patient's Bill of Rights (Forbes)

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.


Categories: Recon, Regulatory News

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