Regulatory Focus™ > News Articles > Regulatory Recon: FDA Gives Lightning-Quick Approval to Amgen Drug (4 December 2014)

Regulatory Recon: FDA Gives Lightning-Quick Approval to Amgen Drug (4 December 2014)

Posted 04 December 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Gives Lightning-Quick Approval to Amgen Drug (4 December 2014)

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

In Focus: US

In Focus: International

  • EU bans imports from Ranbaxy's injectable antibotics unit (Reuters)
  • EMA/WHO hatch plan to speed approvals in developing countries (SCRIP-$)
  • EMA Clears Novartis' Flu Vaccine Fluad Over Fatality Concerns (EMA) (AP) (In-Pharma) (Reuters) (SCRIP-$)
  • European Biosimilars Makers Weigh in on Latest Draft Guidelines (FDAnews-$) (EMA)
  • Govt shelves D&C (Amendment) Bill 2013, to resubmit fresh Bill 2014 in Parliament (PharmaBiz)
  • Task force for simplifying regulatory forms & formats forms four sub-committees (PharmaBiz)
  • Indian manufacturing problems spur growth... for testing companies (Outsourcing Pharma)

US: Pharmaceuticals and Biotechnology

  • Amgen snags a lightning-fast approval for its leukemia immunotherapy Blincy (Fierce) (FDA) (Pink Sheet-$) (Pharma Times) (Reuters) (Press) (SCRIP-$) (BioCentury) (Bloomberg)
  • FDA Makes the Case that "Placebo"-Controlled Ebola Trials are Necessary (NEJM) (Forbes) (Forbes)
  • New Analysis Says FDA Farm Antibiotic Reduction Won’t Work As Planned (Wired) (Pew) (FSN)
  • Patients make their voices heard in drug approval process (Boston Globe)
  • BIO's FDA/Sponsor Interaction Survey Results Coming Soon (BIO)
  • Compounders Say DQSA Creates Hurdles to Delivery of Products (FDAnews-$)
  • FDA Approves PulmoFlow's Tobramycin & Nebulizer Combination for Cystic Fibrosis (Press) (CF Today)
  • Overview of the 2 December 2014 Blood Products AdComm Meeting (Tarius)
  • FDA panel to wrangle with Actavis/AstraZeneca antibiotic combo (SCRIP-$) (Tarius) (Pink Sheet-$)
  • Wyoming Legislators Propose 'Right-to-Try' Bill (Laramie Boomerang) (Wyoming News)
  • Schumer, doctors praise FDA pregnancy labeling requirements (The Hill)
  • CDC says flu shots may not be good match for 2014-15 virus (Reuters) (SCRIP-$)
  • NECC trustee files compensation plan for 2012 meningitis outbreak victims (Reuters)
  • Tomorrow: PDUFA Date for Incyte's Jakafi (Motley Fool)
  • An exploration of counterfeit medicine surveillance strategies guided by geospatial analysis: lessons learned from counterfeit Avastin detection in the US drug supply chain (PubMed)
  • Bob West to Retire from FDA on December 26, 2014 (Lachman)
  • AstraZeneca pay-to-delay could cost it and the industry billions of dollars (Fierce) (Bloomberg)
  • FDA enlists Vanderbilt to help with drug and device monitoring (Lebanon Democrat)
  • There Will be Blood (Shield Laws) (D&D Law)

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

  • Bayer tees up its new hemophilia drug for an FDA submission (Fierce)
  • ADMA’s lead product meets primary endpoint in Phase III trial (PharmaLetter-$)
  • Phase 3 Results Published in The NEJM Show Superiority of Pfizer’s XALKORI (crizotinib) Compared to Platinum-Based Chemotherapy in Previously Untreated Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (Press)
  • CorMedix Inc. Files Request with FDA for QIDP Designation for Neutrolin (Press)
  • Seres Health targets microbiome, gets $48M to push fecal transplant pill into Phase 3 (MedCityNews)

US: Pharmaceuticals and Biotechnology: General

  • Prescription Painkiller Deaths in the U.S. Finally Drop (Bloomberg) (WonkBlog)
  • Prescription Drugs are 9% of Total US Healthcare Expenditures (WonkBlog)

US: Medical Devices

  • UDI: What You Need to Know About Timelines, Compliance and Submissions (MDS)
  • Heart Sync Inc. Issues a Voluntary Device Correction for Multi-function Defibrillation Electrodes (FDA) (FDA)
  • CONMED Corporation, PadPro and R2 Multi-Function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs (FDA)

US: Dietary Supplements

  • Supplement Facilities Must Renew FDA Registration by Dec. 31, 2014 (NPI)

US: Assorted And Government

  • Next Congress Poised to Push Regulatory Reforms (Hatch)

Upcoming Meetings

Ebola Outbreak

  • FDA Makes the Case that "Placebo"-Controlled Ebola Trials are Necessary (NEJM) (Forbes) (Forbes)
  • Ebola booster vaccine starts first trials in Oxford (Reuters)

Europe

  • EU bans imports from Ranbaxy's injectable antibotics unit (Reuters)
  • EMA/WHO hatch plan to speed approvals in developing countries (SCRIP-$)
  • EMA Clears Novartis' Flu Vaccine Fluad Over Fatality Concerns (EMA) (AP) (In-Pharma) (Reuters) (SCRIP-$)
  • European Biosimilars Makers Weigh in on Latest Draft Guidelines (FDAnews-$) (EMA)
  • EMA seeking drugmaker feedback on cyclodextrin and propylene glycol labelling plan (In-Pharma)
  • French parliament OKs hep C drug rebate scheme (SCRIP-$)
  • Added benefit of Lundbeck’s Selincro not proven, says IQWiG (PharmaLetter-$)
  • 15 proposals to improve EU device policy, governance structure (Clinica-$)
  • Bayer Submits Marketing Authorization Application in Europe for Recombinant Factor VIII Product (BAY 81-8973) for the Treatment of Hemophilia A in Adults and Children (Press)
  • Neutrolin Label Expansion Approved in Germany (Press)

India

  • Govt shelves D&C (Amendment) Bill 2013, to resubmit fresh Bill 2014 in Parliament (PharmaBiz)
  • Task force for simplifying regulatory forms & formats forms four sub-committees (PharmaBiz)
  • Indian manufacturing problems spur growth... for testing companies (Outsourcing Pharma)
  • India needs to conduct more clinical trials for discovering new drugs: KIMS experts (PharmaBiz)
  • Antibiotics Cause Adverse Reactions in Indian Hospital (DNAindia)
  • ‘Superbugs’ Kill India’s Babies and Pose an Overseas Threat (NYTimes)

China

  • Regulatory Guidelines and Drug Applications for Pharmaceuticals in China (Pacific Bridge)

Canada

  • Canadian Regulators Find HES Solutions Increase Risk of Kidney Injury and Death  (Health Canada)
  • Homeopaths Threaten Public Health Selling Sugar Pills as Vaccine Alternatives (SBM)

Other International

  • Pakistani children test positive for HIV after blood transfusions (Reuters)

Clinical Trials

  • Geography may limit access to cancer clinical trials (Reuters)

General Regulatory And Interesting Articles

  • ​A Drug Might Heal Spinal Injuries By Sparking Nerve Growth (NPR)
  • How Effective Are OTC Cough Medicines? (MPR)

Regulatory Reconnaissance #452 – 4 December 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.

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.


Categories: Recon, Regulatory News

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