Regulatory Focus™ > News Articles > Regulatory Recon: Sen. Markey Blocks Califf Nomination Over Pediatric OxyContin Decision (25 January

Regulatory Recon: Sen. Markey Blocks Califf Nomination Over Pediatric OxyContin Decision (25 January 2016)

Posted 25 January 2016 | By Michael Mezher 

Regulatory Recon: Sen. Markey Blocks Califf Nomination Over Pediatric OxyContin Decision (25 January 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

  • Ed Markey Blocks Vote on FDA Chief Over Opiate Approvals (BostonGlobe)
  • Webcast - Moving Forward: Collaborative Approaches to Medical Device Cybersecurity (FDA) (Focus I, II)
  • US Adds More Countries to Zika Travel Alert (Reuters) (CDC)
  • Fight to Lower Drug Prices Forces Some to Switch Medication (NPR)
  • Deficiencies Found at Theranos Lab (WSJ)
  • To Fight Growing Threat From Germs, Scientists try Old-Fashioned Killer (WSJ)
  • Feds Tell judge Martin Shkreli can go to Washington to Testify Before Congress (STAT)
  • Data Sharing and the Journal (NEJM)

In Focus: International

  • WHO Issues Interim Guidance on Clinical Care for Survivors of Ebola Virus Disease (ICT) (WHO)
  • Vietnam Invites Indian Pharma Companies to set up Units (Economic Times)
  • WHO sees Zika outbreak spreading through the Americas (Reuters)
  • Researchers question design of fatal French clinical trial (Nature)
  • Drugmaker in fatal trial received EU funds (Financial Times-$)
  • Roche begins probe into Avastin use for eye ailments (Economic Times)

US: Pharmaceuticals and Biotechnology

  • Biosimilars Among 100+ Guidances FDA Plans For 2016 (SCRIP-$) (Focus)
  • Pharma Contract Manufacturers Pursue Quantity And Quality (C&EN)
  • Is There Hope For Sarepta Therapeutics? Yes, A Bit (Forbes)
  • NEJM Calls Data Scientists "Parasites." Can Joe Biden Change This? (Forbes)
  • Do We Really Want To Separate Clinical Data Gathering and Data Analysis? (Forbes, Part I, Part II)
  • Drug shortages in American ERs — mostly of lifesaving medicines to treat infectious diseases or poisonings — have increased more than 400 percent (Washington Post)
  • A Drug to Cure Fear (NYTimes)
  • Current market model doesn't work for antibiotics. Here's why. (Modern Healthcare)
  • The effects of the Trans-Pacific Partnership on pharmaceutical innovation (MNT)
  • Opinion: Biosimilar Naming Conventions Ain't Broke, So Don't Fix Them (Pharmaceutical Compliance Monitor)
  • LDL Hypothesis Brings Out Skeptics, Supporters At FDA Panel (Pink Sheet-$)
  • Will 2016 Be The Year of the Biosimilar? (Pink Sheet-$)
  • Biosimilar Name Debate Heats Up As USP Says Zarxio Doesn't Need Suffix (Pink Sheet-$)
  • Biosimilar Advisory Committees Will Focus Less On Clinical Data (Pink Sheet-$)
  • PCSK9 Inhibitors May Feel Effects Of FDA Judgment On IMPROVE-IT (Pink Sheet-$)
  • PD-1/L1 Checkpoint Inhibitors Move Into New Fields At ASCO GI (Pink Sheet-$)
  • Independent experts say OncoMed cancer drug unlikely to succeed in study (Reuters)

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

  • Duchenne drug by Cambridge's Catabasis looks safe in early trial (Boston Business Journal)
  • Immunocore's IMCgp100 Granted Orphan Drug Designation by US FDA for the Treatment of Uveal Melanoma (Press)
  • FDA Accepts Eli Lilly & Co. (LLY) sNDA for Jardiance Cardiovascular Outcomes Data (StreetInsider)
  • Valeant Announces FDA Acceptance of BLA Submission for Brodalumab in Moderate-to-Severe Plaque Psoriasis (Press)
  • FDA approves new uses for BMS' Opdivo/Yervoy cancer combo (Pharmafile) (Press)
  • Tracon Announces FDA Orphan Drug Designation for TRC105 in Soft Tissue Sarcoma (Press)
  • XTL Biopharmaceuticals Announces Encouraging Feedback from FDA on its Upcoming IND Filing for Lupus Drug hCDR1 (Press)

US: Medical Devices

  • Medical Device Cybersecurity: FDA's New Draft Guidance (Drug and Device Law) (Focus)
  • 10 Hotly Anticipated Devices of 2016 (MDDI)
  • New test could detect elusive pathogens in patients at high infection risk (MNT)
  • FDA Guidance for ISO 10993-1: What to Expect (MDDI)
  • FDA proposes to require PMAs for cranial electrotherapy stimulators for depression (MassDevice)
  • FDA clears next-gen Pelvalon incontinence device (MassDevice)
  • Magnetom Amira MRI, a 1.5T Scanner with Nifty Features, FDA Cleared (medGadget)
  • Dako Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma (Press)
  • Rosetta Genomics Granted Patent Allowance for Use of Gene Expression Signature for Classification of Kidney Tumors (Press)
  • Sysmex CS-5100 Coagulation Analyzer from Siemens FDA Cleared (medGadget)
  • ChloraDerm™ Antimicrobial Transparent Film Dressing receives FDA Clearance for 7-Day Catheter Site Protection Against MRSA and other Infection-Related Organisms (Press)

US: Assorted and Government

  • Why Have We Watched "Cures" So Closely? (Alliance for a Stronger FDA)
  • West Palm Beach doc, daughter expose drug price hikes up to 1,700% (Palm Beach Post)
  • Improving Regulatory Transparency for New Medical Therapies Act (Policy and Medicine)
  • Patient groups funded by drugmakers are largely mum on high drug prices (USA Today)
  • Biosimilar Substitution: 'Devil' Is In Barriers To Switch In State Laws (Pink Sheet-$)
  • Cuomo proposes drug price caps (BioCentury)
  • California Shelves Drug Transparency Bill (MedpageToday)
  • Energy And Commerce Members Want FDA Overseas Operations Update (Tan Sheet-$)
  • Fed. Circ. Denies Longer Patent Term For Pfizer Cancer Drug (Law360-$)
  • Who's To Blame For 'Superbug' Outbreak And What's Next (Law360-$)

Upcoming Meetings and Events              

Europe

  • Interview with Filmmaker on Thalidomide Documentary (The Guardian)
  • EU MAHs Will See Relief on Some Pharmacovigilance Updates (Focus) (EMA) (Guidance)
  • Become a pharmaceutical assessor at MHRA (MHRA)
  • GSK, Astra, J&J link with universities in new drug research fund (Reuters)
  • Britain and Bill Gates pledge 3 billion pounds to fight malaria (Reuters)
  • British Pharmacological Society calls for transparency early in clinical research (AllTrials) (BPS Statement)
  • Germany's G-BA recognizes added benefit of Lixiana in stroke and SE prevention (PharmaLetter-$)
  • NHS England fast-tracks access to prostate cancer drug (PharmaTimes)
  • NHS launches a series of med tech trials with Google's Verily, IBM, Philips (FierceMedicalDevices) (The Telegraph)
  • Benefit-risk profile of ambroxol and bromhexine medicines confirmed by EC (EPR)
  • EC approves Type II variation for Takeda's Adcetris (EPR)
  • K2M wins CE Mark for Rhine cervical disc (MassDevice)

India

  • Indian Start-up Vyome Wins Milestone FDA Nod For Acne Studies (PharmAsiaNews-$)
  • Prescription drugs sold in Maharashtra without renewal of licenses in violation of Schedule H compliance (PharmaBiz)
  • Task Force asks govt to review policies which restrict distribution & availability of drugs for communicable diseases (PharmaBiz)
  • Trust needed to bring back clinical trials to India, says ISCR president (Outsourcing-Pharma)
  • Country's first bone marrow registry MDRI registers nearly 30,000 voluntary stem cell donors (Pharmabiz)
  • FDA approves Aurobindo's generic Zemplar (DSN)

Other International

  • Celltrion to use cloud-based technology to boost biosimilar trials (PharmaLetter-$)
  • Breakthrough in Cambodia malaria row (IRIN)
  • Zika Virus Vaccine Hunt Begins Following 4,000 Brazilian Birth Defects (SCRIP-$)
  • Thailand quarantines 32 people after second MERS case confirmed (Reuters)

General Health and Other Interesting Articles

  • Don't Get Trapped By The Myth Of The 'Good Death' (Forbes)
  • Rapid early weight gain tied to higher childhood blood pressure (Reuters)
  • More evidence HIV/AIDS fight requires multiple approaches (Rueters)

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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