Regulatory Focus™ > News Articles > Regulatory Recon: Califf Removes Name From Papers Following Nomination (7 October 2015)

Regulatory Recon: Califf Removes Name From Papers Following Nomination (7 October 2015)

Posted 07 October 2015 | By Michael Mezher 

Regulatory Recon: Califf Removes Name From Papers Following Nomination (7 October 2015)

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

In Focus: International

  • Negotiators look to be only ones happy about TPP pharma deal (FiercePharmaAsia)
  • Delhi high court restrains Glenmark from selling anti-diabetes drug (LiveMint) (Economic Times)
  • Cannabis Oils Are Legal And Ready In Canada, Still Need Health Canada Approval (Huffington Post)
  • Scottish Gov’t to limit pelvic mesh implants (MassDevice)
  • AHWP Seeks Feedback On Device, IVD Clinical Evidence Guidelines (Clinica-$) (AHWP 1, 2)

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US: Pharmaceuticals and Biotechnology

  • FDA says it's fighting drug shortages (Modern Healthcare)
  • New Inspection Program to Consist of Three Groups Under CDER/ORA (FDANews-$)
  • More drugs qualifying for FDA accelerated review, driven by non-innovative medicines (Pharmaceutical Journal-$)
  • ANDA Renaissance: FDA Aims To Reduce Refuse-To-Receive Actions (Pink Sheet-$)
  • Next Biosimilars Hurdle: Winning Over Physicians (Pink Sheet-$)
  • Pharma's Trade Scorecard Looks Good – Except For That Big Biologics Blemish (Pink Sheet-$)
  • US FDA issues alert for sterile products made by Californian compounder (In-Pharma Technologist)
  • Conventional wisdom yields conventional outcomes, says 'Brilliant' drug delivery professor (In-Pharma Technologist)

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

  • Axovant rolls into Phase III with a risky Alzheimer's gambit (FierceBiotech) (Press)
  • FDA Approves Olysio Use in HIV Co-Infection, HCV Genotype 4 (MPR)
  • Seattle Genetics Announces Initiation of Phase 1/2 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Opdivo® (Nivolumab) in Second-line Hodgkin Lymphoma (Press)

US: Medical Devices

  • FDA Quietly Proposes Change to Intended Use Rule (MDDI)
  • TransMedics wins FDA panel date for organ preservation device (MassDevice)
  • Voices From AdvaMed 2015: Michael Mussallem On Gains, Challenges In Medtech Policy (Gray Sheet-$)
  • Voices From AdvaMed 2015: Nadim Yared On What Emerging Device Firms Need (Gray Sheet-$)
  • Focus Diagnostics Flu, RSV Test Kit Cleared with Additional Strains (GenomeWeb) (Press)
  • Luminex Corporation Receives FDA Clearance for ARIES® System and ARIES® HSV 1&2 Assay (Press)
  • FDA Approves INSIGHTEC's Next Generation Exablate Fibroid Treatment System and Removes Requirement for Patients to be Family Complete (Press)
  • Corindus wins FDA nod for radial access stenting with CorPath (MassDevice)
  • FDA Approves Alcon's Pre-loaded Intraocular Lens Delivery System (DD&D)
  • Groundbreaking computer program diagnoses cancer in two days (MNT)

US: Assorted and Government

  • Express Scripts Says It Will Save America Money On New Cholesterol Drugs, But Its Math Doesn't Check Out (Forbes)
  • GSK, Teva To Take Lamictal Pay-For-Delay Case To High Court (Law360-$)
  • Cymbalta Judge Severs Claims and Smacks Down Plaintiff Lawyers’ Self-Created "Quagmire" (Drug and Device Law)

Upcoming Meetings and Events

Europe

  • NHS rejects suggestion a lack of guidance has slowed biosimilar uptake (BioPharma-Reporter)
  • French To Test Future EU Clinical Trial Procedures For Drugs (SCRIP-$)
  • IQWiG finds no hint of added benefit for Novartis’ Zykadia in NSCLC (PharmaLetter-$)
  • Aimmune Therapeutics Receives EMA Decision Agreeing With PIP for AR101 for the Treatment of Peanut Allergy (Press)
  • British docs weigh in on pharma, and it's no better than most U.S. opinions (FiercePharmaMarketing)

India

  • Pharma contract manufacturing on the rise in India (PharmaLetter-$)
  • Jubilant Life gets USFDA nod for Indomethacin capsules (Economic Times)
  • Current D&C Rules adequate to ensure sale of drugs online in legal & ethical manner (PharmaBiz)
  • DoP directs NPPA to revise retail prices of metronidazole injection, & tablets (PharmaBiz)

Australia

  • High Court Rules Nucleic Acid Used to Predict Breast and Ovarian Cancer is Not Patentable (High Court of Australia)
  • Recall - Apohealth children’s paracetamol for 1 to 5 years, children’s paracetamol for 6 to 12 years, and children’s ibuprofen for 6 months to 12 years (TGA)
  • Recall - Terry White Chemists branded children’s paracetamol syrup for 1 to 5 years and children’s paracetamol syrup for 6 to 12 years (TGA)

Other International

  • Saudi FDA lowers fee for issuing and renewing licenses of device establishments (Clinica-$)
  • Shanghai-based biotech Ark Biosciences successfully completes PhI on RSV candidate (FiercePharmaAsia)
  • UNESCO Calls for More Regulations on Genome Editing, DTC Genetic Testing (GenomeWeb) (UNESCO)

General Health and Other Interesting Articles

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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