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Agency Actions
FDA Agrees to Review Rizatriptan Oral Film Formulation for Acute Migraine
Approval decision expected in February 2014 (June 18)
NIH Launches Dietary Supplement Label Database
Searchable collection contains label information from supplements sold in U.S. (June 17)
FDA’s Cyber Security Team Issues Warning on Medical Devices
Report urges health care facilities to take proactive measures (June 13)
FDA Rejects Kidney Cancer Drug Tivozanib
Pivotal data deemed ‘uninterpretable’ (June 10)
FDA Panel Votes to Relax Safety Restrictions on Rosiglitazone (Avandia)
New analysis suggests drug may not increase heart attacks (June 6)
FDA Advisors Reconsider Safety of Diabetes Drug Rosiglitazone (Avandia)
Cardiovascular risk is longstanding concern (June 5)
NIH Compares Diabetes Drugs in Head-to-Head Trial
Metformin will be combined with other therapies in 5-year study (June 3)
FDA Rejects Testosterone Drug for Third Time
Risks and complications cause concern (May 30)
FDA Accepts New Drug Application for Omeprazole/Aspirin Tablets
Agency decision expected in January 2014 (May 29)
FDA Rejects Nail Infection Drug Efinaconazole
Agency faults product container (May 28)
FDA Advisors Back New Sleep Drug, Suvorexant
Daytime somnolence is a concern (May 22)
NIH Funds Studies to Improve Prediabetes and Type 2 Diabetes Treatment
Trials for adults and youth compare treatments in newly diagnosed subjects (May 22)
Multiple Sclerosis Drug Plegridy (Peginterferon) Submitted for FDA Review
Treatment significantly reduces disease activity in phase III trial (May 21)
FDA Alert: Lack of Sterility Assurance for Drug Products From ‘The Compounding Shop’
Agency tells Florida firm to withdraw products from the market (May 8)
FDA Warning: Nonproprietary Name for Breast Cancer Drug Could Cause Medication Errors
Possible confusion between Kadcyla and Herceptin (May 6)
FDA Advisors Give ‘Thumbs Down’ to Renal Cancer Drug, Tivozanib
Additional safety data needed (May 2)
FDA Rejects Opioid-Dependence Drug Probuphine (Buprenorphine)
Agency asks for more efficacy data (Apr. 30)
Labeling Updates for Anticoagulant Drug Pradaxa (Dabigatran)
Label now includes boxed warning and new phase III data (Apr. 30)
All patients should have eye exams (Apr. 26)
FDA Says ‘No’ to Two HIV Drugs
Agency cites deficiencies in quality testing (Apr. 29)
NIH Discontinues HIV Vaccine Study
Vaccine regimen fails to prevent infection or reduce viral load (Apr. 25)
Lambrolizumab Receives ‘Breakthrough Therapy’ Designation for Melanoma
Antibody therapy prevents cancer cells from ‘hiding in plain sight’ (Apr. 24)
FDA Announces Nationwide Recall by Compounding Pharmacy
All sterile non-expired products recalled due to lack of sterility assurance (Apr. 21)
FDA Advisors Recommend Approval of Breo Ellipta (Fluticasone Furoate/Vilanterol) for COPD
Agency decision expected in May (Apr. 17)
FDA Rejects Migraine Drug Levadex (Dihydroergotamine)
Agency cites manufacturing issues (Apr. 16)
Reformulated tablets have abuse-deterrent properties (Apr. 16)
FDA Issues Alert About Lack of Sterility of Drug Products
Two manufacturers cited (Apr. 15)
FDA Accepts New Drug Application for Kidney Disease Therapy Tolvaptan
Review set for September (Apr. 12)
Breast Cancer Drug Palbociclib Receives FDA ‘Breakthrough Therapy’ Designation
Combo treatment with letrozole enters phase III trial (Apr. 10)
FDA to Review Tablet Formulation of Antifungal Drug Posaconazole (Noxafil)
Approval sought for once-daily administration (Apr. 10)
CDC Finds Increase in Self-Reported Hypertension
Use of antihypertensive medications also on rise (Apr. 5)
FDA Eases Restrictions on Tobacco-Replacement Products
Action comes in response to complaints from health care stakeholders (Apr. 1)
Hepatitis C Drug Simeprevir Submitted for FDA Review
More than 3 million people have HCV infection in U.S. (Mar. 28)
FDA Rejects Chemotherapy Nausea Drug
Agency requests new analysis of phase III data (Mar. 28)
New Cardiovascular Drugs for Patients at Risk of Aspirin-Induced Ulcers
NDA submitted for omeprazole/aspirin combo tablets (Mar. 27)
Temporary Tattoos Are Risky, FDA Says
Dangers include blisters and permanent scarring (Mar. 25)
NDA Submitted for Investigational Diabetes Drug, Empagliflozin
Marketing application follows completion of phase III registration trials (Mar. 25)
FDA Says ‘No’ to Hypertension Drug Treprostinil for Second Time
Approval sought for treatment of PAH (Mar. 25)
FDA Issues Safety Warnings on ‘Male Enhancement’ Products
Agency notes growing trend of dietary supplements with hidden chemicals (Mar. 21)
FDA Advisors Recommend Approval of Subdermal Opioid-Dependence Drug Probuphine (Buprenorphine)
Final review set for April (Mar. 21)
FDA Alert: Sterile Drug Products Recalled by N.J. Specialty Pharmacy
IV solution contained fungus particles (Mar. 18)
Docs and Health Experts Urge FDA to Limit Caffeine in Energy Drinks
Beverages linked to increased emergency visits and deaths (Mar. 19)
Kinase Inhibitor Compound (LDK378) Receives FDA ‘Breakthrough Therapy’ Designation for NSCLC
Phase II trials are under way (Mar. 15)
FDA Eyes Possible Precancerous Changes With Diabetes Drugs
Incretin mimetics come under scrutiny (Mar. 14)
NIH Highlights Lifelong Effect of Acute Kidney Injury
Research and education initiatives are under way (Mar. 13)
FDA Grants Fast Track Designation for CMX001 for Prevention of Cytomegalovirus Infection
Drug blocks replication of DNA viruses (Mar. 12)
CDC Warns Health Officials About Deadly New Virus
Fourteen cases reported outside U.S. (Mar. 7)
CDC: Immediate Action Needed to Halt Spread of Deadly Bacteria
More inpatients infected with carbapenem-resistant bugs (Mar. 5)
FDA Advisors Say ‘No’ to Menopause Drug Sefelsa (Gabapentin)
Agency review scheduled for May (Mar. 4)
FDA Denies Approval for Expanded Use of Xarelto (Rivaroxaban) in ACS
Second rejection for blood thinner (Mar. 4)
FDA Grants ‘Fast Track’ Designations for Antibiotic Candidates
Drugs target gram-negative infections and C. difficile diarrhea (Feb. 28)
Morphine/Oxycodone Combo Drug, Moxduo, Resubmitted for FDA Review
Company anticipates launch before end of the year (Feb. 28)
FDA Halts Clinical Trials of Thyroid Drug Sensipar (Cinecalcet) in Children
Agency cites death of 14-year-old patient (Feb. 26)
Cancer, Epilepsy, and Opioid-Dependence Drugs Set for FDA Review
New treatments include buprenorphine implant (Feb. 27)
FDA Recalls Anemia Drug, Omontys (Peginesatide)
Recall due to anaphylaxis and some deaths (Feb. 24)
FDA Gives ‘Thumbs Down’ to Hepatitis B Vaccine, Heplisav
Agency asks for more safety data (Feb. 25)
FDA Sets Review Date for New COPD Drug, Anoro Ellipta
Approval decision expected in December (Feb. 19)
FDA Agrees to Review Diabetes Drug Lixisenatide
Agency submission follows drug’s approval in Europe (Feb. 19)
FDA Grants ‘Breakthrough Therapy’ Designations for Ibrutinib
Investigational oncology agent aimed at B-cell malignancies (Feb. 12)
Hospitals See Reductions in Some Health Care-Associated Infections
CDC highlights areas for improvement (Feb. 11)
FDA Rejects Two Insulin Products, Requests New Cardiovascular Trial
Previous warning letter cited (Feb. 10)
Pulmonary Hypertension Drug Riociguat Submitted for Agency Approval
Walking distance improved in two phase III trials (Feb. 11)
FDA Offers Guidance on Developing Drugs for Alzheimer’s Disease
Draft proposal focuses on treatments for early-stage disease (Feb. 7)
FDA Rejects Application for Chronic Fatigue Drug Ampligen (Rintatolimod)
Drug’s developer plans to appeal the decision (Feb. 4)
FDA Committee Recommends Approval of Olodaterol for Maintenance Treatment of COPD
Inhaled drug designed for use in combination with tiotropium (Jan. 30)
FDA Advisors Question Effectiveness of CF Drug, Bronchitol (Mannitol Powder)
High drop-out rates cited (Jan. 29)
FDA Accepts IND for Optina (Danazol) for Treatment of Diabetic Macular Edema
Clinical trial expected in first quarter, 2013 (Jan. 22)
FDA Accepts Supplemental NDA for Tarceva (Erlotinib) for Advanced Lung Cancer
Agency decision expected in second quarter of 2013 (Jan. 16)
Application Submitted to FDA for First-Line Use of Tysabri (Natalizumab) in MS
Approval would expand drug’s indication (Jan. 16)
FDA Grants Priority Review to Afatinib for NSCLC
Investigational compound aimed at disease with EGFR mutation (Jan. 15)
Current Flu Vaccine About 60% Effective
H3N2 influenza A is predominant circulating strain (Jan. 11)
New Lung Cancer Screening Guidelines for Heavy Smokers
ACS recommends screening every year between ages 55 and 74 (Jan. 11)
Twitter Can Help People Lose Weight
Method offers low-cost alternative to traditional behavioral weight-loss interventions (Jan. 14)
Quillivant XR (Methylphenidate) Launched in U.S. for Treatment of ADHD
First once-daily, extended-release liquid option (Jan. 14)
Diabetes Drug Albiglutide Submitted for FDA Review
Treatment replenishes GI peptide involved in insulin release (Jan. 14)
Report: Americans Live Sicker, Die Younger
Health disadvantage is pervasive across age and socio-economic groups (Jan. 9)
Foundation Criticizes Price Hikes on AIDS Drugs
Increases average 6% for key medications (Jan. 10)
Flu Vaccine Rates Remain Low in Children Despite Recommendations
Researchers call for evidence-based guidelines for lab testing and treatment (Jan. 10)
FDA Panel Recommends Approval of Canagliflozin for Diabetes
If approved, drug would be first SGLT2 inhibitor available in U.S. (Jan. 10)
Colorectal Cancer Drug Tivantinib Fails Mid-Stage Trial
No additional benefit when added to irinotecan and cetuximab (Jan. 11)
‘PapGene’ Test Detects Ovarian, Endometrial Cancers
New method could pioneer genomic-based cancer screening (Jan. 9)
Spin and Bias in Breast Cancer Studies
Authors call for guidelines for reporting efficacy and toxicity in published trials (Jan. 9)
Genetic Form of Anemia Offers New Approach to Treating Drug-Resistant Tumors
Sickle-shaped red blood cells target and destroy tumor cells (Jan. 9)
Insulin ‘Handshake’ Could Lead to Better Diabetes Treatments
Injections may become a thing of the past (Jan. 10)
FDA Lowers Recommended Ambien Dose
Agency cites risk of impaired activities morning after use for all insomnia drugs (Jan. 10)
Vaccine Triggers Immune Response to Early Signs of Colon Cancer
First test in humans of vaccine based on tumor proteins (Jan. 7)
NCI Report: Cancer Death Rates Continue to Drop in U.S.
But HPV-related cancers are on the rise (Jan. 7)
Cardiovascular Researchers Investigate New Interventional Technology for CAD
Drug-eluting, bioresorbable scaffold provides support to heart vessels (Jan. 8)
New strategy adopts best practices as alternative to cutting benefits or provider payments (Jan. 9)
Nobel Laureate Publishes Novel Hypothesis on Curing Late-Stage Cancers
James D. Watson sees antioxidants as key to future research (Jan. 9)
Epilepsy and Migraine Genetically Linked
Migraine rates found to be increased in people with close relatives with epilepsy (Jan. 7)
Targeting the Use of Acid Suppressants in Hospital Patients
Study identifies those at greatest risk for GI bleeds (Jan. 7)
Costly Breast Cancer Screenings Don’t Guarantee Better Outcomes for Older Women
Researchers find no relation between screening costs and detection of advanced cancers (Jan. 7)
Mixed Results With Aeroquin (Inhaled Levofloxacin) in Cystic Fibrosis Trials
Antibiotic delivered with investigational nebulizer (Jan. 7)
Pivotal Phase III Data Reported for Psoriasis Drug Apremilast
PDE4 inhibitor targets inflammation (Jan. 7)
Report: How Prostate Cancer Therapies Compare by Cost and Effectiveness
Surgery ranks as most cost-effective treatment (Jan. 4)
Shifting the Balance Between Good Fat and Bad Fat
Protein p62 regulates metabolism in fat tissue, may offer therapeutic target for obesity (Jan. 4)
Skin-Infection Antibiotic Dalbavancin Meets Primary Endpoint in Phase III Trial
Drug non-inferior to vancomycin (Jan. 4)
FDA Accepts Resubmission of NDA for Muscle Relaxant-Binding Drug, Sugammadex
Agency had requested more data on hypersensitivity and bleeding (Jan. 7)
Positive Phase III Results for Empagliflozin in Diabetes
FDA filing expected this year (Jan. 7)
However, entry of generics will hinder growth beginning in 2015 (Jan. 3)
CDC Studies Find More Women Getting Pap Tests as Recommended
Some women are tested without need (Jan. 3)
Researchers Establish Link Between Pesticides and Parkinson’s Disease
Study suggests potential new target for therapeutic drugs (Jan. 3)
FDA Approves Rebif Rebidose (Interferon Beta-1a) Auto-Injector for MS
Decision based on ease-of-use data (Jan. 3)
Launch Date Set for Eye Drug, Jetrea (Ocriplasmin)
First pharmacological treatment for vitreomacular adhesion (Jan. 4)
Electrical Brain Stimulation Releases Opiate-Like Painkiller
Researchers use new approach to treat severe facial pain (Jan. 2)
Experimental Vaccine Temporarily Halts HIV
Investigators see hope for functional cure (Jan. 2)
Researchers Identify Cause of Muscle Pain Associated With Statin Therapy
Drugs affect energy production in muscles (Jan. 3)
Dexpramipexole Fails Phase III Study in ALS Patients
Development efforts halted (Jan. 3)
Nexavar (Sorafenib) Meets Efficacy Endpoint in Phase III Thyroid Cancer Trial
Treatment improves progression-free survival versus placebo (Jan. 3)
Hydrogen Peroxide Vapor Helps Eradicate Hospital ‘Superbugs’
Johns Hopkins decontaminates isolation rooms with robotic, vapor-dispersing devices (Dec. 31)
Researchers Identify Early Predictor for Glaucoma
Study results suggest new detection tool (Jan. 2)
FDA Approves First Anti-diarrheal Drug for HIV/AIDS Patients
Fulyzaq (crofelemer) available in early 2013 (Jan. 2)
Obesity Associated With Increased Risk of Death
But being overweight has significantly lower risk, CDC study finds (Jan. 2)
NIH Report: Coordinated Care Can Address High Rates of Emergency Department Use by Disabled Adults
Authors recommend tailored prevention and primary care programs (Jan. 2)
Researchers Find Molecular Mechanism Responsible for OA Pain
Discovery may lead to new approaches to pain control (Dec. 27)
Cancer Screening Rates Decline in U.S.
Study shows differences between white-collar and blue-collar workers (Dec. 27)
Mixed Results in Phase III Trial of Pain Drug for Knee Surgery
No effect on symptoms endpoint, but postoperative pain reduced (Dec. 27)
FDA Approves Eliquis (Apixaban) to Reduce Stroke, Blood Clots in Patients With Atrial Fibrillation
Agency cites risk of potentially fatal bleeding (Dec. 28)
Drug inhibits enzyme essential for energy generation in TB bacterium (Dec. 31)
FDA Approves IV Immune Globulin, Bivigam, for Immunodeficiency
Safety and efficacy demonstrated in phase III study (Dec. 20)
