Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Ranbaxy Hit With New FDA Import Alert (24 January 2014)

Regulatory Reconnaissance: Ranbaxy Hit With New FDA Import Alert (24 January 2014)

Posted 24 January 2014 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

In Focus: International

US: Pharmaceuticals/Biotechnology

  • U.S. FDA Strikes Again, Now Bans Ranbaxy's Toansa API Facility (PharmAsia-$) (India Times) (Pharma Times) (Reuters) (SCRIP-$) (WSJ-$) (Law 360-$) (FDA) (Bloomberg)
  • As Superbugs Spread, Regulators Begin to Remove Roadblocks for New Treatments (WSJ-$)
  • Tenth Circuit Affirms False Statement Conviction: Lesson Learned (FDA Law Blog)
  • Tufts: Breakthrough Therapy progress TBD (MM&M)
  • CNS Products Primed For "Breakthrough" Benefits (Pink Sheet-$)
  • Generic Drug Firms Voice Support For State Substitution Bill With Notification Reqs (Inside Health Policy)
  • Indiana: Biological drug bill advances to full Senate (IBJ)
  • Eli Lilly Sues Glenmark Over Cancer Drug ANDA (Law 360-$)
  • Teva asks Supreme Court to review Copaxone ruling (BizJournal)
  • Perrigo Receives FDA Final Approval For Generic Equivalent To Prandin (Press)

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

  • Amgen cholesterol antibody scores in another phase III trial (PMLive) (Pharma Times) (BioCentury) (SCRIP-$) (Reuters) (MM&M) (Fierce)
  • More positive Phase III data for Pfizer pain drug (Pharma Times) (BioCentury) (SCRIP-$) (Pharma Letter-$) (Fierce)
  • BEMA Buprenorphine meets in Phase III pain trial (BioCentury)
  • Lundbeck and Otsuka's brexpiprazole shows efficacy in Phase III trial (Pharma Letter-$)
  • BioLineRx gains orphan status for novel stem cell mobilization treatment (Pharma Letter-$) (Press)
  • Radiation Protection Treatment Named Orphan Drug (Press)
  • GSK announces headline results for Phase III study of the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) in metastatic melanoma (Press)
  • e-Therapeutics Announces Temporary Halt of Recruitment into ETS2101 Cancer Trials Because of Drug Supply Issue (Press)

US: Pharmaceuticals and Biotechnology: General

  • J&J carves out a new group to develop drugs for poor countries (Fierce)
  • Growing IV saline shortage has providers scrambling during bad flu season (Modern Healthcare)
  • Cleveland BioLabs dives after BARDA ends negotiations to back radiation drug (SCRIP-$)

US: Medical Devices

  • Stent Remains Available Despite Trial Showing Dangers (Forbes)
  • Surgeons point to Sorin's heart valve in a child's death (Fierce)
  • CardioBuzz: Rinaldi on Cardiac Device Approvals (MedPage Today)
  • Miltenyi Biotec Receives FDA Approval for CliniMACS CD34 Reagent System for Prevention of Graft-Versus-Host Disease in the Treatment of Acute Myeloid Leukemia (Press)
  • SafeSept Needle Free Transseptal Guidewire Receives FDA Market Clearance (Press)

US: Dietary Supplements

  • Nutrition labels to undergo changes for first time in 20 years (AP) (Bloomberg)
  • Slim science, disciplined doctor behind Craze study (USA Today)

US: Assorted And Government

  • Enforcement Report - Week of January 22, 2014 (FDA)
  • Mini Sentinel Paper on Signal Refinement in Postmarketing Studies (MS)

Upcoming Meetings And Events

  • 28 January 2014: Allergenic Products Advisory Committee Meeting (FDA)
  • 28 January 2013: US State of the Union Address (White House)
  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • CHMP Recommends Six Medicines for Approvalm Rejects Four (EMA)
  • CHMP positive on GSK diabetes drug Eperzan (Pharma Times) (Press) (Reuters) (Bloomberg)
  • CHMP adopts positive opinion for biosimilar Bemfola for infertility (Biosimilar News)
  • Novartis to request re-examination of serelaxin (RLX030) in acute heart failure (AHF) (PharmaNewsEU) (Fierce) (Bloomberg) (SCRIP-$)
  • CHMP backs Xolair for severe hives (PMLive)
  • Bayer's Riociguat Recommended for Approval in the EU in Two Forms of Pulmonary Hypertension (Press) (Bloomberg)
  • Teva's Laquinimod MS Pill Fails to Win EU Agency Backing (Bloomberg)
  • CHMP Rejects PTC's Ataluren for Nonsense Mutation Duchenne Muscular Dystrophy (Press) (Reuters)
  • UK's NICE gives green light to Roche's MabThera for GPA and MPA (Pharma Letter-$) (PMLive)
  • Endocyte Provides Update on CHMP Review of Pending EU Conditional Marketing Authorization Applications for Vintafolide and Etarfolatide (Press)
  • Newspaper backs down over NICE 'champagne perks' attack (Pharmafile)
  • Biotronik wins CE Mark for drug releasing balloon (Mass Device)
  • EC Names Scioderm's Rare Skin Disease Treatment as Orphan Drug (Press)
  • Teva and Active Biotech Remain Committed to the Development of NERVENTRA (laquinimod) for Multiple Sclerosis Following the Negative Opinion from the EMA's CHMP (Press)

India

  • India Clinical-Trial Approvals Dropped to 23 Last Year From 270 In 2008 (PharmAsia-$)
  • Biocon Chief Complains Of India Trial Delays Forcing Moves Abroad (PharmAsia-$)
  • Sun Pharma gets DGCI nod for breast cancer drug (India Times)

Japan & China

  • Japan's MHLW Off-Label Drugs Committee Validates Levonorgestrel For Menorrhagia (PharmAsia-$)
  • MHLW Says No Causal Relationship Between HPV Vaccine And Immune/Nerve Adverse Events (PharmAsia-$)

Other International

  • Novo Nordisk quits South African pharma group amidst drug row (PharmAfrica) (Fierce)
  • Regulatory pathway for biosimilar products in Nigeria (PharmAfrica)
  • Russian medical device fees hike could damage local industry (Clinica-$)
  • Major Drug Trial Fails To Control TB In South African Gold Mines (Kaiser)

General Regulatory And Interesting Articles

  • Harvard Scientists Say Research Subjects Should See Data (Bloomberg)
  • Steve Davis Describes How One Blue Dot Managed To Save Millions Of Lives (Huffington Post)
  • Real-time insight into how fast a living body metabolizes drugs, opening the door to highly personalized medicine (MNT)
  • Should the Sun Set on Further Vitamin D Trials? (JAMA)

Regulatory Reconnaissance #242 - 24 January 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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