Regulatory Focus™ > News Articles > Regulatory Recon: Brexit Could Threaten UK Supply of New Drugs; Valeant Said to be in Talks to Sell

Regulatory Recon: Brexit Could Threaten UK Supply of New Drugs Valeant Said to be in Talks to Sell Salix Unit to Takeda (2 November 2016)

Posted 02 November 2016 | By Michael Mezher 

Regulatory Recon: Brexit Could Threaten UK Supply of New Drugs Valeant Said to be in Talks to Sell Salix Unit to Takeda (2 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • FDA Updates Guidance on Collecting Race, Ethnicity Data in Clinical Trials (Focus)
  • Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers (Focus)
  • Despite ramped-up hiring, FDA continues to grapple with hundreds of vacancies (Washington Post) (Chicago Tribune)
  • FDA Warns Chinese Drug Manufacturer for Limiting Inspection, Systemic Data Manipulation (Focus)
  • FDA highlights liver safety issues in Cempra drug review (Reuters)
  • Dealmakers Behind Soaring Drug Prices Hit the Jackpot (Bloomberg)
  • Financial toxicity: a potentially devastating side effect of treating cancer (STAT)
  • Fearing Democratic tidal wave, the drug industry is pouring money into GOP coffers (STAT)
  • Get ready for more drug ads: Facebook is making a bid for pharma dollars (STAT)
  • Palatin Female Libido-Boosting Shot Fails Crucial Sex Frequency Test (The Street) (Reuters)
  • Biosimilar Interchangeability: NOR-SWITCH-Type Study Not Enough For US FDA (Pink Sheet-$)
  • Consumer expenditure on FDA regulated products: 20 cents of every dollar (FDAVoice)
  • FDA, Industry Focus on Abuse-Deterrent Opioids (Medpage)
  • Celldex, Aiming For More Cancer Drug Combos, Pays $62.5M For Kolltan (Xconomy)
  • Seattle cancer center bets big on experimental T-cell immunotherapy (Washington Post)
  • Avacta joins major US cancer centre for CAR-T immunotherapy development (Pharmafile)
  • Vantage Point – Medtech needs to up its cybersecurity game (EP Vantage)
  • Improving the Pipeline for Developing and Testing Pharmacological Treatments in Pregnancy (PLOS)

In Focus: International

  • Industry Concerned Over EMA Plan To Make More PIP Information Public (Pink Sheet-$)
  • Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016) (Focus)
  • China approves Pfizer vaccine Prevenar (Reuters)
  • Brexit threatens supply of new drugs, report warns (Reuters) (The Times)
  • More deaths tied to Medtronic's SynchroMed II drug pump (MassDevice)
  • South Korea Celltrion to expand R&D investment for original drugs (Reuters)
  • Valeant Said to Be in Talks for Sale of Salix to Takeda (Bloomberg) (Reuters)
  • Lundbeck, Takeda drug fails to best placebo in ADHD PhII (Fierce)
  • Investing in Cuban Health Care Biotech Industries (National Law Review)
  • Cheap cancer measures could save hundreds of thousands of lives in poor countries (Reuters)
  • Brazil's Limited Legal Framework On Biosimilar Interchangeability Could Actually Help Sponsors (Pink Sheet-$)
  • Pharma in Indonesia: competing for higher margins (PharmaLetter-$)
  • Shire shares fall after reporting drop in sales of haemophilia drugs (The Guardian) (Financial Times) (Fierce)
  • Shire Exits Biosimilars, Streamlines Oncology Business (SCRIP-$)
  • NICE backs Lilly's Taltz for psoriasis (PharmaTimes)
  • First med tech/app innovations picked for new NHS payment scheme (PharmaTimes)
  • Vtesse's Niemann-Pick C therapy awarded PIM status (PharmaTimes)

US: Pharmaceuticals & Biotechnology

  • Scientists Grow 'Organoids' To Study Breast Cancer In 3D (Forbes)
  • Death Of Pfizer Heart Drug Shows The Challenges Of CV R&D And Why Companies Are Bowing Out (Forbes)
  • Indistinguishable From Magic? (In the Pipeline)
  • Simplifying HIV Treatment: A Surprising New Lead (NIH)
  • Costs keep women from taking drugs to prevent cancer's return (Reuters)
  • New USP Drug Classification System Proposed—Comment Now (USP)
  • Orphan drugs: Leading the way in patient-centricity (PMLive)
  • Patient Advocate Leads Drive to Add Rare Diseases to CIRM's Stem Cell Bank (CIRM)
  • Celgene and IBM Watson Health Forge Collaboration Designed to Transform Patient Safety Monitoring (Press)
  • Takeda launches drug discovery biotech (PMLive)

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

  • Baxter Initiates Clinical Trial for Citrate Anticoagulant for Use During Continuous Renal Replacement Therapy (Press)
  • Omeros Announces Positive Data from Phase 2 Clinical Trial Evaluating PPAR-Gamma Agonist in Heroin Users Treated with Buprenorphine/Naloxone (Press)
  • Roche to present new data on medicines for autoimmune diseases and severe inflammatory disorders at the 2016 ACR/ARHP Annual Meeting (Press)

US: Medical Devices

  • TCT 2016: TAVR to the fore on Day 2 (MassDevice)
  • TCT 2016: Early clinical data back Medtronic's inside-out stent (EP Vantage)
  • Edwards' ECHO Data: The Latest in the TAVR Durability Debate (MDDI)
  • Abiomed launches quality assurance program for Impella heart pump (MassDevice)
  • Fresenius acquires Xenios (MassDevice)
  • Lucid M1 Ultrasound Brain Damage Assessment System Cleared by FDA (Medgadget)
  • Largest Observational Study to Date of the St. Jude Medical AMPLATZER Amulet Left Atrial Appendage Occluder Demonstrates High Implant Success and Strong Safety Profile (Press)
  • FDA Granted E-QURE Approval to Initiate Its US Clinical Trial (Press)
  • Admera Health Receives New York State Approval for Pharmacogenomics Test (GenomeWeb)
  • TytoCare gets FDA clearance for digital stethoscope (mobihealthnews)

US: Assorted & Government

  • Marketplace Open Enrollment Begins (Health Affairs Blog)
  • Anthem CEO Won't Commit To Obamacare Beyond 2017 (Forbes)
  • M.D. Tenn. Bids Adieu to Out-of-State Class Reps (Drug and Device Law)
  • Bayer, Pfizer Agree To Judge's Deal In Bovine Drug IP Row (Law360-$)
  • Blue Shield Again Owes Californians Millions In Health Care Rebates (KHN)
  • How much Nutella do you eat? The FDA wants to know (STAT)

Upcoming Meetings & Events

Europe

  • Launch of a public consultation during the EC-EUnetHTA Forum (ETnetHTA)
  • Medivir Abandons Separate Listing, Sells Off Commercial Unit (SCRIP-$)
  • Hemophilia And Rare Diseases Drive European Mid-Pharmas Sobi And Recordati (SCRIP-$)
  • Mundipharma submits MAA for opioid overdose reversal treatment (PharmaLetter-$)

Asia

  • CALL FOR COMMENTS on the PROPOSED document "Guidance on Regulatory Practices for Combination Products" (AHWP)
  • CALL FOR COMMENTS on the PROPOSED document "Guidance for Minor Change Reporting" (AHWP)

India

Australia

  • TGA Presentation: Prescription Medicines MMDR Reforms, Targeted Stakeholder information Meeting, 14 October 2016 (TGA)
  • TGA presentation: Nanoparticle Therapeutics 2016, 20 October 2016 (TGA)

Canada

  • Health Canada approves Edwards Intuity heart valve (MassDevice)

Zika

  • Sanofi-Walter Reed Zika alliance brings in Brazilian vaccine institute Fiocruz (Fierce)
  • Zika infections double in Vietnam as cases increase in south (Reuters)

Other International

  • Smith & Nephew opens $55m plant in Costa Rica (MassDevice)

General Health & Other Interesting Articles

  • 'Going Flat' After Breast Cancer (NYTimes)
  • Washington state investigating possible cluster of rare condition (Reuters)

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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