Regulatory Focus™ > News Articles > Regulatory Recon: FDA Warns Pfizer's Kansas Site; AstraZeneca Sells Zoladex Rights for $250M (20 Feb

Regulatory Recon: FDA Warns Pfizer's Kansas Site AstraZeneca Sells Zoladex Rights for $250M (20 February 2017)

Posted 20 February 2017 | By Michael Mezher 

Regulatory Recon: FDA Warns Pfizer's Kansas Site AstraZeneca Sells Zoladex Rights for $250M (20 February 2017)

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

In Focus: US

  • Hurry Up And Wait At FDA (BioCentury)
  • FDA Hunts For Big Consolidation, Lab Space In Atlanta (Forbes)
  • Pfizer Hit With Warning at Kansas Generic Copaxone Fill/Finish Site (InPharmaTechnologist) (Momenta)
  • Biosimilar Inflectra matches Remicade efficacy in trial (PharmaTimes) (PMLive) (Press)
  • CDC temporarily halts work at biosafety labs because of air hose concerns (Washington Post) (NYTimes) (Reuters)
  • Cotton Eyes Orphan Drug Program Tweaks; Highlights Price Hikes, Import Limits (InsideHealthPolicy)
  • Dear Vice President Pence: Stop peddling false hopes to dying patients (STAT)
  • Why the CRISPR patent verdict isn't the end of the story (Nature)
  • Can Employers Take A Bigger Role In Controlling Drug Costs? (Health Affairs Blog)
  • The high price of progress (Nature)
  • Approvals in 2016: cost–benefit challenges of new anticancer agents (Nature)
  • Approvals in 2016: questioning the clinical benefit of anticancer therapies (Nature)
  • Cardiovascular disease expected to place $1 trillion cost burden on US (Pharmafile)
  • Three reports show slowdown in US medicines growth spending (PharmaLetter-$) (PhRMA)
  • FDA Explains Why Newly Approved Biologic's Name Lacks a Suffix (Focus)
  • The Problem of the "Intended Use" Regulations Continues to Fester (FDA Law Blog)
  • Merck Settles Long-Running Pay-For-Delay Suit (Law360-$)
  • Top Senate Republican: Will move on healthcare when support coalesces (Reuters)
  • With Coverage in Peril and Obama Gone, Health Law's Critics Go Quiet (NYTimes)
  • Conservatives See Obamacare Repeal Slipping Away (Forbes)
  • How Mike Pence used Obamacare to halt Indiana's HIV outbreak (Politico)
  • Some genetic tests are worthwhile, some are not (Washington Post)

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In Focus: International

  • China to slash drug distribution groups in price drive (Financial Times)
  • Joint Declaration for an Ambitious EU Industrial Strategy (EFPIA)
  • What pharma can and must do to improve access in lower and middle-income countries, with Takeda's Isabel Torres (PharmaLetter-$)
  • Legal Change Beckons After EU Active Substance Master File Pilot Success (Pink Sheet-$)
  • Mereo's brittle bone drug joins EU's adaptive pathways scheme (PharmaTimes)
  • AstraZeneca sells off cancer drug to TerSera for $250 million (Pharmafile) (PMLive)
  • CETA: An Opportunity to Create Jobs in the Generic, Biosimilar Industries (Medicines for Europe)
  • Argentina and science: Stuck in a bad romance? (Nature)
  • South Korea to establish foot-and-mouth vaccine plant by 2020 (Reuters)
  • Transparency Push: EMA to Revise Policy on Document Access (Focus)
  • EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research (Focus)
  • Nordic Nanovector sees interest in its Non-Hodgkin Lymphoma treatment (Reuters)
  • Sought-after Stada confirms unnamed third suitor (Fierce) (Press)
  • Health Canada approves Rexulti (PharmaLetter-$) (Press)
  • Generic version of top-selling lung cancer drug hits Chinese market (Pharmafile)
  • Novo Sees Brighter China Outlook As Volumes Rise (SCRIP-$)

US: Pharmaceuticals & Biotechnology

  • MD Anderson Benches IBM Watson In Setback For Artificial Intelligence In Medicine (Forbes)
  • ICON Selected by the FDA to Validate Patient-Reported Outcome Endpoints for Antibacterial Drug Trials (Press)
  • BlackThorn Therapeutics bring in new CEO (Phamafile)
  • Prescription-drug monitoring cuts doctor-shopping for painkillers (Reuters)
  • CRISPR/CAS9 Method Reduces DMD Pathology (BioCentury)
  • Synergy Rx Pharmacy Issues a Voluntary Nationwide Recall of the Products Listed Below due to a Lack of Quality Assurance (FDA)
  • Trial shows ArmaGen biologic improves cognition in Hurler syndrome patients (Fierce)
  • Strategic CRO takes $100m hit from Pfizer's shelved PCSK9 candidate (BioPharmaReporter)

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

  • Celgene's potential blockbuster gets positive Phase 3 results in multiple sclerosis (Pharmafile) (SCRIP-$)
  • Phase II Study Supports Potential for Genentech's Tecentriq® (Atezolizumab) Plus Avastin® (Bevacizumab) for People With Locally Advanced or Metastatic Renal Cell Carcinoma (Press)
  • Chi-Med Initiates a Phase II Study of Savolitinib in Pulmonary Sarcomatoid Carcinoma (Press)
  • Exelixis Announces Phase 1 Trial Results for Cabozantinib in Combination with Nivolumab with or without Ipilimumab in Refractory Metastatic Urothelial Carcinoma and Other Genitourinary Tumors (Press)

US: Medical Devices

  • J&J's Ethicon to buy Torax Medical (MassDevice)
  • How Detailed Are Your Design Inputs? (MDDI)
  • Insulet touts Omnipod Horizon hybrid closed-loop system in patients with T1D (MassDevice)

US: Assorted & Government

  • To Fund Health Plan, GOP Considers Limiting Popular Tax Break (NYTimes)
  • Congress Goes Home, and Constituents Fired Up Over Health Care Are Waiting (NYTimes)
  • 9th Circ. Doubts Timeliness Of Amgen Off-Label Sales Suit (Law360-$)
  • Non-Physician Learned Intermediaries (Drug & Device Law)
  • Scheme Tied to UnitedHealth Overbilled Medicare for Years, Suit Says (NYTimes)

Upcoming Meetings & Events

Europe

  • Falsified packs of cancer drug Votrient found in Germany (Securing Industry)
  • Managing the move to paperless communication (MHRA)
  • Novartis, NHS joint working pact delivers new eye service (PharmaTimes)
  • Janssen Strives For Simplicity In HIV R&D, While Hunting For A Cure (SCRIP-$)
  • Spain's pharma industry committed to Big Data to optimize the use of healthcare information (PharmaLetter-$)
  • New Managing Director of UK & Ireland for Novartis (Pharmafile)
  • First monoclonal antibody in veterinary medicine recommended for a marketing authorisation (EMA)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 February 2017 (EMA)
  • Custom to build £20 million Pharmaceutical Innovation Centre in Brighton (EPR)
  • Masimo MightySat Rx Oximeter Cleared in Europe to Measure Breathing Rate (MedGadget)

Asia

  • NDA filed for immune checkpoint inhibitor, atezolizumab, in Japan (PharmaLetter-$)
  • Takeda Pharmaceutical to transfer Japan consumer healthcare business to subsidiary (Business Times)
  • In China, consumers seem to shrug off deadly bird flu outbreak (Reuters) (NYTimes)

India

  • New Medical Devices Rules make Central Licensing Authority competent authority to license Class C & D devices (PharmaBiz)
  • Marksans Pharma's facility in Goa inspected by UK regulator (Economic Times)
  • Private hospitals reuse disposables, make you pay for them (Economic Times)
  • Price cap on stents opens the floodgates for new realities (Economic Times)
  • Stent companies fight to stay afloat, but patients wary after cap (Economic Times)
  • Indian pharma companies still wary of US drug market (Economic Times)

Canada

  • Regulatory decision summary for Oraquick HCV Rapid Antibody Test Kit (Health Canada)

Other International

  • ANVISA Reveals Draft Serialization Regulation and Asks For Comments (RxTrace)
  • WHO teams assist people in hard-to-reach areas of Nigeria (WHO)
  • Adoption of western lifestyles in sub-Saharan Africa leading to increased demand for chronic Rx drugs (PharmaLetter-$)

General Health & Other Interesting Articles

  • CRISPR pioneer muses about long journey from China to pinnacle of American science (Washington Post)
  • An Unexpected Takeaway From The Early Autism Diagnosis Study (Forbes)
  • Wearable Fitness Devices Don't Seem to Make You More Fit (NYTimes)
  • Blood Pressure? 120 May Be a Good Target (NYTimes)
  • Hunched Over a Microscope, He Sketched the Secrets of How the Brain Works (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.


Categories: Recon, Regulatory News

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