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Agency Actions

Regulatory Approval Sought for LDL Cholesterol-Lowering Drug Evolocumab

First BLA submission for PCSK9 inhibitor

FDA Removes Clinical Hold on Early Trials of Cancer Drug Vantictumab

Treatment targets lung, breast, and pancreatic tumors

FDA Grants ‘Priority Review’ Designation for Ivabradine for Treatment of Chronic Heart Failure

Drug approved in Europe in 2012

FDA Recommends Not Using Lidocaine to Treat Teething Pain

Agency requires new boxed warning

Cancer Immunotherapy Pembrolizumab Expected to Be Approved Soon

Companies race to develop similar treatments

Regulatory Approval Sought for Long-Acting Schizophrenia Treatment Aripiprazole Lauroxil

Injectable agent is administered once a month

Hydrocodone Combination Products Move to Schedule II

After a 15-year process, the change occurs October 6

FDA Approval Sought for Thyroid Cancer Drug Lenvatinib

Treatment improves progression-free survival versus placebo

FDA Advisors Back Tiotropium Respimat for Maintenance Treatment of COPD

Positive decision based on data from eight efficacy trials

FDA Questions Abuse-Deterrent Hydrocodone/Acetaminophen Combo Tablet

Agency asks for additional clinical trial

CDC Advisors Recommend Prevnar 13 Vaccine for Older Adults

Medicare coverage may be a problem

First Biosimilar Monoclonal Antibody (Remsima) Submitted for FDA Review

Approval decision due next year

WHO Backs Use of Experimental Ebola Drugs as Death Toll Tops 1,000

ZMapp is on its way to Liberia

WHO Declares Ebola Virus Epidemic an International Emergency

Outbreak in Africa is largest ever recorded

CDC Mounts ‘Surge Response’ to Ebola Virus Outbreak

U.S. hospitals can safely manage Ebola patients, agency says

FDA Grants Priority Review for Ruxolitinib (Jakafi) for Treatment of Polycythemia Vera

Approval decision set for December

FDA Advisors Give ‘Thumbs Up’ to Immune Therapy HyQvia

Approval decision expected in third quarter of 2014

FDA Panel Reviews Long-Term Safety of Immune Therapy HyQvia

Agency questions risk of inflammation and fertility problems

NIH Launches New Program to Find Potential Drug Targets

Researchers will explore poorly understood genes

Surgeon General Issues ‘Call to Action’ to Prevent Skin Cancer

Skin cancer rates rising; most cases are preventable

CDC Warning: Ebola Virus Disease Confirmed in Traveler to Nigeria

Agency advises U.S. health care providers to be on the alert

FDA Rejects Sublingual Sufentanil for Pain Relief

Delivery device questioned

FDA Grants Priority Review to Bevacizumab (Avastin) for Ovarian Cancer

Approval decision expected in November

Vaccine Combo Gains ‘Breakthrough Therapy’ Status for Treatment of Pancreatic Cancer

Immunotherapy prolongs survival in mid-stage trial

FDA Warns Consumers About Powdered Pure Caffeine

One death reported

FDA Committees to Address Safety of Testosterone Products

Meeting scheduled for September

Mosquito-Borne Chikungunya Virus Hits U.S.

Florida has first reported case in a non-traveler

FDA Grants ‘Breakthrough Therapy’ Designation to Pirfenidone for Treatment of Pulmonary Fibrosis

Approval decision expected by November

Nintedanib Receives FDA ‘Breakthrough Therapy’ Designation

Treatment under review for patients with pulmonary fibrosis

Simeprevir/Sofosbuvir Combo Wins Priority Review for Chronic Hepatitis C Infection

Treatment achieves 93% virologic response

Avastin (Bevacizumab) Granted Priority Review for Treatment of Cervical Cancer

FDA approval decision expected in October 2014

Psychotropic Drug Brexpiprazole Submitted to FDA

Serotonin–dopamine activity modulator treats schizophrenia and major depression

Antifungal Agent Isavuconazole Submitted for FDA Review

Treatment targets aspergillosis and mucormycosis

FDA Accepts New Drug Application for Basal Insulin Toujeo

Treatment provides 300 U/mL of insulin glargine

Personalized Cell Therapy CTL019 Receives FDA ‘Breakthrough Therapy’ Designation

Treatment targets ALL cancer cells

FDA Grants Priority Review to Pulmonary Fibrosis Drug Nintedanib

Tyrosine kinase inhibitor targets growth factors

Leukemia Drug Blinatumomab Receives ‘Breakthrough Therapy’ Designation

Antibody targets cancer proteins

Breakthrough Therapy Status for Pradaxa Antidote

Idarucizumab being evaluated to specifically reverse the anticoagulant effect of Pradaxa

FDA Advisors Seek More Data on Ovarian Cancer Drug Olaparib

Committee votes against accelerated approval

FDA Review Finds No Clear CV Risks for Diabetic Patients Taking Olmesartan

An earlier study prompted the agency’s review

FDA Accepts New Drug Application for Raltegravir/Lamivudine Combo for HIV Patients

Drug would be used with other antiretroviral agents

FDA Advisors Question Benefit of Ovarian Cancer Drug Olaparib

Efficacy data obtained from small subgroup

Cancer Drug Docetaxel May Cause Symptoms of Alcohol Intoxication, FDA Warns

Agency to revise labels of all docetaxel products

FDA Adds Warning to Testosterone Products About Potential for Blood Clots

Agency sees risk of VTE

Mocetinostat Receives ‘Orphan Drug’ Designation for Treatment of Myelodysplastic Syndrome

Mid-stage trials are under way

Meningitis B Vaccine Bexsero Submitted for FDA Review

Vaccine was used for meningitis outbreaks at U.S. universities

FDA Advisors Say No Cardiovascular Outcomes Studies Needed for Opioid Receptor Antagonists

Movantik (naloxegol oxalate) set for September review

FDA Requests Clinical Trials to Investigate Use of Lisdexamfetamine (Vyvanse) in Preschool-Age Children With ADHD

Studies to begin in first half of 2015

Weight Loss Drug Gets New Review Date From FDA

Approval decision expected in September 2014

FDA Removes Clinical Hold on Study of Pancreatic Cancer Drug

Investigators evaluate recombinant hyaluronidase in patients with advanced disease

Muscular Dystrophy Drug Drisapersen on Path to Accelerated Approval

FDA outlines confirmatory trials

Parkinson’s Drug Safinamide Submitted for Regulatory Review

Treatment has both dopaminergic and non-dopaminergic activities

New Drug Application Submitted for Epinephrine Pre-Filled Syringe

Product would offer low-cost alternative to epinephrine auto injectors

New Drug Application for Hydrocodone/Acetaminophen Combo Accepted for Review

Phase III trial provides positive efficacy results

FDA Rejects Oxycodone/Morphine Combo (Moxduo) for Treatment of Acute Pain

Efficacy and safety data are insufficient

Investigational Compound CO-1686 Named ‘Breakthrough Therapy’ for NSCLC

FDA submission expected in 2015

Elotuzumab Receives ‘Breakthrough Therapy’ Designation for Multiple Myeloma

Monoclonal antibody is used in combination with lenalidomide and dexamethasone

Breast Cancer Drug Palbociclib Readied for FDA Submission

CDK inhibitor blocks tumor-cell proliferation

FDA Rejects Heart Failure Drug Serelaxin

Agency requests further efficacy data

FDA Reduces Starting Dose of Sleep Drug Lunesta (Eszopiclone)

Treatment carries risk of next-morning impairment

CDC Urges Use of Anti-HIV Pill

Targeted groups include people with infected partners or those who don’t practice safe sex

Nivolumab Receives FDA ‘Breakthrough Therapy’ Designation for Hodgkin Lymphoma

Early trial evaluates PD-1 immune checkpoint inhibitor

Regulatory Approval Sought for Invega Sustenna (Paliperidone Palmitate) for Treatment of Schizoaffective Disorder

New FDA submission based on positive data from 15-month relapse-prevention study

Supplemental New Drug Application Submitted to FDA for Simeprevir/Sofosbuvir Combo

Treatment targets genotype-1 HCV infection

FDA Agrees to Review Antibody Therapy MK-3475 for Advanced Melanoma

Approval decision expected in October

Health and Financial Analysis Supports NIH’s Decision to Fund Women’s Health Initiative

Program saves $35.2 billion in direct medical expenditures

FDA Rejects Plumiaz (Diazepam) Nasal Spray for Epilepsy Seizures

Agency approval doubtful this year

CDC Announces First Case of MERS Infection in U.S.

Infected traveler hospitalized in Indiana

Company Seeks Approval of Extended-Release Hydrocodone With Abuse-Deterrent Properties

Trial data presented at pain society meeting

FDA Proposes Stricter Safety Rules for Pelvic Mesh

Adverse events cause concern

FDA Reminds Health Care Professionals to Stop Prescribing More Than 325 mg of Acetaminophen

High dose linked to severe liver toxicity

FDA Rejects Delayed-Release Aspirin/Omeprazole Tablets

Agency cites deficiencies at manufacturing facility

FDA to Review Psychiatric Side Effects of Smoking-Cessation Drug Chantix (Varenicline)

Public meeting scheduled for October

FDA Advisors Reject Combination Pain Pill Moxduo

Oxycodone/morphine offers no advantages over individual treatments

AbbVie Submits New Drug Application for All-Oral, Interferon-Free Regimen for Hepatitis C

Investigational treatment designated as ‘breakthrough therapy’

Antibiotic Combo Ceftolozane/Tazobactam Seeks Regulatory Approval

Treatment targets urinary tract and intra-abdominal infections

FDA Agrees to Review Cobicistat and Elvitegravir for HIV Therapy

Approval decisions expected in October

Volasertib Granted ‘Orphan Drug’ Designation for Acute Myeloid Leukemia

Late-stage trial evaluates Polo-like kinase inhibitor

Empagliflozin/Linagliptin Tablet Submitted for FDA Review for Treatment of Type-2 Diabetes in Adults

Filing follows completion of phase III trial

New Drug Application Submitted to FDA for Fixed-Dose Atazanavir/Cobicistat Combo for HIV-1 Patients

Treatment eliminates need for boosting agent in separate tablet

Parkinson’s Drug Rytary (Carbidopa/Levodopa) Resubmitted for FDA Review

Company provides updated safety and stability data

Mydicar Receives ‘Breakthrough Therapy’ Designation as Heart Failure Treatment

Cardiac catheter delivers gene therapy directly to heart

FDA Halts Mid-Stage Study of Recombinant Hyaluronidase in Pancreatic Cancer

Thromboembolic events raise concerns

Supplemental New Drug Application Filed for Ibrutinib (Imbruvica) for Treatment of Leukemia and Lymphoma

Treatment improves survival versus ofatumumab

FDA Delays Decision on Inhaled Insulin Product Afrezza

Advisory panel recommended approval

Meningitis B Vaccine Bexsero Receives ‘Breakthrough Therapy’ Designation

FDA submission expected in second quarter of 2014

Regulatory Approval Sought for HCV Combo Treatment

Daclatasvir + asunaprevir targets genotype 1b infection

FDA Advisors Back Two Antibiotics for ABSSSIs

Anti-Infective Drugs Advisory Committee votes unanimously for Dalvance and Sivextro

Janssen Seeks Approval for Combination HIV Therapy

Darunavir and cobicistat tablet would eliminate need for separate boosting agent

FDA Advisors Question Safety and Effectiveness of Diabetes Device, Afrezza

Deficiencies include potential effects on lung function

FDA Panel Recommends Approval of DNA-Based Colon Cancer Test

Testing demonstrates 92% sensitivity

Eye Treatment Iluvien (Fluocinolone Intravitreal Implant) Tries Again for FDA Approval

Drug–device combo rejected in October 2013

FDA Agrees to Review Drug–Device Combo for Migraine

Approval decision expected in November

FDA Committee Gives ‘Thumbs Down’ to Serelaxin for Acute Heart Failure

Advisors question efficacy data

FDA Halts Patient Enrollment in Myelofibrosis Trial

Agency cites potential for hepatotoxicity with imetelstat

Xtandi (Enzalutamide) Submitted to FDA for Expanded Labeling

Approval sought for use in chemo-naïve patients with advanced prostate cancer

FDA Postpones Decision on MS Drug Plegridy

Agency needs more time to review application

FDA Halts Testing of Cancer Drug Imetelstat

Agency cites risk of liver toxicity

FDA Gives Green Light to Studies of Extended-Release Metadoxine in Adults With ADHD

Phase III trial to begin enrollment in first quarter of 2014