Regulatory Focus™ > News Articles > Regulatory Recon: FDA Gives Expedited OK to Spectrum's Beleodaq (7 July 2014)

Regulatory Recon: FDA Gives Expedited OK to Spectrum's Beleodaq (7 July 2014)

Posted 07 July 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Gives Expedited OK to Spectrum's Beleodaq (7 July 2014)

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

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In Focus: US

  • FDA Grants Spectrum Pharmaceuticals Accelerated Approval of Beleodaq (belinostat) for Injection (Press) (FDA) (PMLive) (Pharmafile) (Pharma Times) (Fierce) (BioCentury) (MedPage Today)
  • FDA's Looming Decision On A Generic To Teva's Copaxone Reveals Drug Approval Woes (Forbes)
  • After drug deaths, Massachusetts lawmakers seek to curb compounding pharmacies (Reuters)
  • FDA to Hold Social Media Q&A Webinar on 10 July 2014 (FDA)
  • Regulators Need to Catch Up with 3-D Printing Technology (MDDI)

In Focus: International

  • Indian Regulators Given $291 Million to Upgrade Regulatory Capacity (PharmaBiz)
  • Japan first to approve Roche lung cancer drug alectinib (Pharma Times)(SCRIP-$) (Press) (Pharma Times)
  • Positive WHO assessment of China’s vaccines regulatory authority (Pharma Letter-$) (WHO)
  • GlaxoSmithKline risks being thrown out of China – or it may quit in disgust (Guardian) (FT-$) (SCRIP-$)
  • New opioid standards to tackle widespread, serious abuse in Canada (Globe and Mail)
  • Canada Releases Final Guidance on Review of Drug Brand Names (HC)
  • EC sets out its pharma priorities (PMLive)

US: Pharmaceuticals and Biotechnology

  • FDA Grants Spectrum Pharmaceuticals Accelerated Approval of Beleodaq (belinostat) for Injection (Press) (FDA) (PMLive) (Pharmafile) (Pharma Times) (Fierce) (BioCentury) (MedPage Today)
  • FDA's Looming Decision On A Generic To Teva's Copaxone Reveals Drug Approval Woes (Forbes)
  • After drug deaths, Massachusetts lawmakers seek to curb compounding pharmacies (Reuters)
  • FDA to Hold Social Media Q&A Webinar on 10 July 2014 (FDA)
  • Zykadia Expedited Timeline Challenged By Late-Breaking GMP Concern (Pink Sheet-$)
  • Boehringer’s Tiotropium Spray May Be Ready To Shed Mortality Issues (Pink Sheet-$)
  • Right Drug, Right Patient: Streamlining Clinical Trials to Speed Drug Development (Brookings)
  • House E&C Committee to hold 21st Century Cures meetings (BioCentury) (E&C)
  • Beyond Pregnancy Registries: Complementary Post-Marketing Approaches (Pink Sheet-$)
  • Afrezza Approval Comes With Post-Marketing Trial On Lung Cancer, CV Risk (Pink Sheet-$)
  • After REMS: An Interview With Amgen’s Paul Seligman (Pink Sheet-$)
  • Michigan Considering "Right to Try" Law (Detroit FP)
  • Research Firm Asks FDA To Clear Path For Generic Fosamax (Law 360-$)
  • Merck Sues To Block Teva’s Generic Nasonex (Law 360-$)

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

  • FDA accepts NDA for InterMune's pirfenidone (BioCentury)
  • Endo and BioDelivery Sciences Announce Phase III Results for BEMA buprenorphine in Opioid-Experienced Patients with Chronic Pain (Press)
  • CASI Pharmaceuticals Receives U.S. Orphan Drug Designation For The Use Of ENMD-2076 To Treat Hepatocellular Carcinoma (Press)
  • Hyperammonemia drug gets FDA orphan drug status for other genetic metabolic disorders (MedCity News)
  • Regado sinks on Phase III enrollment halt (SCRIP-$) (BioCentury)
  • In midst of Ebola crisis, Tekmira program halted (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Vaccine Refusal Myths Drive Up Development Costs, Prices (Forbes)
  • 2020 Antibiotic Goal in Jeopardy? HHS Analysis Shows Need For Earlier, Larger Incentives (Pink Sheet-$)
  • Bill Would Expand Definition of Synthetic Drugs to Ban Based on Marketing Content (House)
  • Pill to Prevent H.I.V. Gets a Prominent Backer: Andrew Cuomo (NYTimes)
  • Canadian painkillers allegedly showing up on market in southern U.S. (Globe and Mail)
  • Prescription roulette: Are discount drug sellers safe? (CNBC)
  • US Capitol Capsule: When sincerity trumps science: Implications for FDA (SCRIP-$)

US: Medical Devices

  • Regulators Need to Catch Up with 3-D Printing Technology (MDDI)
  • FDA Looking at Morcellation This Week (FDA)
  • Class 1 Recall for Langston Dual Lumen Catheters (FDA)
  • Class 1 Recall for Ventlab Manual Resuscitators (FDA)

US: Dietary Supplements

  • FD&C: How DSHEA Complemented Food-Safety Standards, Enforcement Authority (NPI)

US: Assorted And Government

  • Improving the quality of disseminated research, without violating the First Amendment (TIE)
  • Obamacare doesn't cover contraception for men (Vox)

Europe

  • Mekinist shown EU green light (Pharmafile) (Pharma Times) (Press)
  • EC sets out its pharma priorities (PMLive)
  • Expanded EU approval sets Halaven on course (SCRIP-$)
  • Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In Italy (Forbes)
  • GSK and Genmab receive EU authorisation for Arzerra (ofatumumab) as first-line treatment for CLL (Press) (BioCentury)
  • Teva Receives CHMP Positive Opinion for Seasonique Extended-Regimen Contraceptive for Marketing Authorization in Several European Countries (Press)
  • The Medicines Company Receives Market Authorization Renewal for Angiox (Bivalirudin) from the European Medicines Agency and the European Commission (Press)
  • EU Seeking Director of IMI (EU)

India

  • Indian Regulators Given $291 Million to Upgrade Regulatory Capacity (PharmaBiz)
  • India's draft patent guidelines could lead to unnecessary bias against pharma patent applications: USIBC (PharmaBiz)
  • India heavily dependent on drug imports from China: Study (India Times)

Japan & China

  • Japan first to approve Roche lung cancer drug alectinib (Pharma Times)(SCRIP-$) (Press) (Pharma Times)
  • Positive WHO assessment of China’s vaccines regulatory authority (Pharma Letter-$) (WHO)
  • GlaxoSmithKline risks being thrown out of China – or it may quit in disgust (Guardian) (FT-$) (SCRIP-$)
  • China to Try Private Eye Who Worked for GSK in Secret (Pharmalot) (AP) (Bloomberg)
  • Chinese Dream: From Big Drug Market to Strong Pharma Player (Reuters)
  • New China FDA Rules Allow Resumption Of Clinical Genome Sequencing (PharmAsia-$)
  • NIFTY Becomes First CFDA Approved Non-Invasive Prenatal Genetic Test (Press)
  • Anoro Ellipta (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD (Press)
  • Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza (daclatasvir) and Sunvepra (asunaprevir) Dual Regimen (Press)

Canada

  • Canada Releases Final Guidance on Review of Drug Brand Names (HC)
  • Health Canada inspection raises concerns about Quebec vaccine plant (Canadian Manufacturing)
  • New opioid standards to tackle widespread, serious abuse in Canada (Globe and Mail)
  • BioMarin Announces Health Canada Approval of VIMIZIM(TM) (elosulfase alfa) for the Treatment of Morquio A Syndrome (Press)
  • Nexavar (sorafenib tablets) now Approved in Canada for the Treatment of Differentiated Thyroid Cancer (Press)

Other International

  • Australia: New pharmaceutical conduct code under fire for not going far enough (Guardian)
  • Drugmakers warn on South Korea pricing policy (FT-$)
  • Russia’s new device regulatory system not always a smooth ride for medtech industry (Clinica-$)
  • Building the AllTrials campaign in Spain and Latin America (AllTrials)
  • Brazil’s ANVISA opens public consultation on bioavailability/bioequivalence of medicines (Pharma Letter-$)

Clinical Trials

  • Pharma-backed TransCelerate makes progress on clinical trial efficiency (SCRIP-$)
  • Alzheimer's R&D suffers as trial failure rate hits an 'astounding' 99.6% (Fierce)

General Regulatory And Interesting Articles

  • How to fix a broken market in antibiotics (Reuters)
  • Companies ignore whistleblowers at their peril (FT-$)
  • Testosterone Use Doesn't Increase Heart Risk, Study Finds (WSJ-$)
  • New Pfizer Breakthrough Miraculously Extends Lifespan Of Near-Death Patents (The Onion-Satire)
  • A Contraceptive Implant with Remote Control (MIT)
  • The Lancet: New trial suggests cheaper drugs for common heart attack procedure could improve outcomes and save health budgets millions (Press)
  • Bone marrow transplant safe, effective for adult sickle cell patients: study (Reuters)
  • ADHD drugs may up risk of heart problems in kids (CBS)

Regulatory Reconnaissance #351 – 7 July 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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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