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Agency Actions
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)
FDA Says ‘No’ to Two HIV Drugs
Agency cites deficiencies in quality testing (Apr. 29)
All patients should have eye exams (Apr. 26)
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)
Reformulated tablets have abuse-deterrent properties (Apr. 16)
FDA Rejects Migraine Drug Levadex (Dihydroergotamine)
Agency cites manufacturing issues (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)
Docs and Health Experts Urge FDA to Limit Caffeine in Energy Drinks
Beverages linked to increased emergency visits and deaths (Mar. 19)
FDA Alert: Sterile Drug Products Recalled by N.J. Specialty Pharmacy
IV solution contained fungus particles (Mar. 18)
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)
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)
Twitter Can Help People Lose Weight
Method offers low-cost alternative to traditional behavioral weight-loss interventions (Jan. 14)
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)
Colorectal Cancer Drug Tivantinib Fails Mid-Stage Trial
No additional benefit when added to irinotecan and cetuximab (Jan. 11)
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)
Genetic Form of Anemia Offers New Approach to Treating Drug-Resistant Tumors
Sickle-shaped red blood cells target and destroy tumor cells (Jan. 9)
Spin and Bias in Breast Cancer Studies
Authors call for guidelines for reporting efficacy and toxicity in published trials (Jan. 9)
‘PapGene’ Test Detects Ovarian, Endometrial Cancers
New method could pioneer genomic-based cancer screening (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)
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)
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)
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)
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)
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)
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)
Electrical Brain Stimulation Releases Opiate-Like Painkiller
Researchers use new approach to treat severe facial pain (Jan. 2)
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)
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)
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)
FDA Approves IV Immune Globulin, Bivigam, for Immunodeficiency
Safety and efficacy demonstrated in phase III study (Dec. 20)
Report: Ulcerative Colitis Drug Market Will Double Over Next Decade
Uptake of Humira, Simponi, vedolizumab, and tofacitinib drives market growth (Dec. 19)
Link Between Diabetes, High Blood Pressure, and Colon Cancer Recurrence
Statins may lower cancer risk (Dec. 19)
New Compound Reverses Fatty Liver Disease
Treatment targets proteins responsible for fat production (Dec. 19)
CDC Analysis: HIV Cases Decline for Black Women, Increase for Gay Men
New report finds stable disease incidence in U.S. since 1990s (Dec. 19)
Positive Phase III Results for Skin-Infection Drug Oritavancin
Single dose non-inferior to twice-daily vancomycin (Dec. 20)
Positive Safety Results for IV Stem-Cell Therapy in Rheumatoid Arthritis
Few serious adverse events after 3 months of treatment (Dec. 19)
Lung Cancer Drug Fails Phase III Trial
No improvement in survival with antigen-specific immunotherapy (Dec. 19)
New Type of Antibiotic May Defeat Drug-Resistant Bugs
Researchers target growth-promoting thioredoxin system in bacterial cells (Dec. 18)
Blood Test Predicts Lymphedema
Circulating proteins accurately ‘flag’ disorder’s presence (Dec. 18)
Researchers Find Way to Make One-Time Flu Vaccine
Recombinant genetic engineering uses virus fragment (Dec. 18)
Mobile App Helps Providers Better Document Conditions and Care
Reimbursement coding revisions demand improved record-keeping, researcher says (Dec. 17)
Report: Sales of Antiretroviral Agents for HIV Will Decline Slightly Over Next Decade
Generic drugs expected to limit market growth (Dec. 17)
New Guidelines for Treating Severe Heart Attack
Coronary intervention with balloon angioplasty and stents is preferred therapy (Dec. 17)
Positive Phase II Results for Psoriasis Drug Ponesimod
Disease severity significantly reduced versus placebo (Dec. 18)
Experts advise starting with non-opioid medication (Dec. 18)
Scientists Discover Gene Linked to Breast and Ovarian Cancer
Finding could have implications for genetic testing and targeted prevention (Dec. 17)
FDA Approves Four-Strain Seasonal Influenza Vaccine
Vaccine will be available for 2013—2014 flu season (Dec. 17)
FDA Approves Signifor (Pasireotide Diaspartate) for Cushing’s Disease
New drug lowers cortisol levels (Dec. 14)
CMS Announces Continued Progress in Setting Up Health Insurance Marketplaces
But a lot remains to be done (Dec. 15)
Pediatricians Say Thimerosal Should Stay in Global Vaccine Supply
Ethyl mercury isn’t methyl mercury (Dec. 17)
Dogs Can Sniff Out ‘Superbug’ Infections
Researchers see potential for screening hospital wards (Dec. 13)
Brain Chemical Linked to Suicidal Behavior
Blocking effects of glutamate could prevent suicides (Dec. 13)
Approval decision scheduled for October 2013 (Dec. 13)
Hypercholesterolemia Drug Kynamro (Mipomersen) Gets ‘Thumbs Down’ in Europe
Drug is currently under FDA review in U.S. (Dec. 14)
FDA Okays Iclusig (Ponatinib) for Leukemia
Agency approval comes 3 months ahead of schedule (Dec. 14)
FDA Accepts NDA Submission for New Antidepressant Drug, Vortioxetine
Approval decision expected in October 2013 (Dec. 13)
New Hormone Therapy Shows Promise for Menopausal Symptoms
Novel approach combines estrogen with SERM-like drug (Dec. 13)
Positive Phase III Results for Oncolytic Virus, Reolysin, in Head-and-Neck Cancers
Tumors stabilized in 86% of patients (Dec. 13)
Report: Medical Advances Reshape Health Landscape Worldwide — But Not Always for the Better
Fewer people dying, but more live with disability (Dec. 13)
Investigational Kinase Inhibitor Fostamatinib Inferior to Humira in Phase II Trial
Additional studies are ongoing (Dec. 13)
Phase III Studies: Ruxolitinib (Jakavi) Reduces Disease Burden in Patients With Myelofibrosis
Results sustained over 2 years (Dec. 11)
Report: Health Insurance Costs Rose Faster Than Income in All States From 2003 to 2011
Average family premiums increased by 62% (Dec. 12)
Pancreas Size Linked to Increased Risk for Type 1 Diabetes
Finding provides new insight into disease pathogenesis (Dec. 12)
Next Steps for Solanezumab, Potential Alzheimer’s Drug
Company decides to withhold FDA application (Dec. 12)
Industry Sponsorship Influences Clinical Trial Findings, Researchers Claim
Study calls for new look at how bias is handled in guidelines and reviews (Dec. 12)
Popular Weight-Loss Drug May Be Toxic
Orlistat affects therapeutic potential of some anticancer drugs (Dec. 10)
FDA Expands Use of Abiraterone (Zytiga) for Late-Stage Prostate Cancer
Drug can now be used before treatment with chemotherapy (Dec. 10)
Report: Third-Generation Antiepileptic Drugs Expected to Fuel Growth of Epilepsy Market Through 2021
But second-generation agents will remain sales leaders (Dec. 11)
Positive Phase III Results for Revlimid Plus Low-Dose Dexamethasone in Refractory Multiple Myeloma
FDA review set for February 2013 (Dec. 11)
NIH-Funded Trial Will Assess New TB Drug
Investigators plan to compare oxazolidinone antibiotic with standard TB therapy (Dec. 11)
Pertuzumab (Perjeta) Extends Survival in Patients With Metastatic Breast Cancer
Combo therapy reduces mortality risk by 34% (Dec. 8)
Apixaban (Eliquis) Reduces Recurrence of Blood Clots in Phase III Trial
Drug awaits FDA approval (Dec. 8)
Investigational Drug Ponatinib Curbs Chronic Leukemia
Treatment achieves 56% major cytogenetic response (Dec. 9)
Metformin Improves BMI and Blood Glucose Levels in Obese Children
First evidence that front-line diabetes drug delays onset of type 2 diabetes in children (Dec. 10)
Researchers Find New Way to Attack Stomach-Ulcer Bug
X-rays identify drug target for bacteria that affect millions of people worldwide (Dec. 10)
Report Foresees Declining Sales for Bisphosphonates in Osteoporosis Market
Experts think sclerostin inhibitors will be key players over next decade (Dec. 6)
Severe Acute Kidney Injuries Rise Nationwide
Researchers find kidney injuries and deaths doubled in last decade (Dec. 6)
Antidepressant Drug Targets Brain Receptors in New Way
Novel compound modulates receptors responsible for learning and memory (Dec. 6)
Thalidomide Derivative Studied in Cutaneous Lupus Erythematosus
Patients show clinical improvement within 2 weeks (Dec. 7)
Data show trend toward improved overall survival with eribulin (Dec. 7)
Adult Antiviral Drug Suppresses Hepatitis B in Teens
Virologic response was 89% with tenofovir (Dec. 5)
New Blood Test for Children With Autism
Researchers identify gene ‘signature’ that verifies the disorder (Dec. 6)
Discovery of Molecular Pathway for Depression Reveals New Drug Targets
Finding may shape future of antidepressant medications (Dec. 6)
Galantamine (Razadyne) Lowers Mortality in Alzheimer’s Patients
Smaller cognitive decline also seen versus placebo (Dec. 5)
Children With HIV Have Increased Risk of Atherosclerosis
Risk is 2.5-fold greater in infected children (Dec. 5)
Surgeons Implant Brain ‘Pacemaker’ for Alzheimer’s Disease
Procedure performed for first time in U.S. (Dec. 5)
Updated Phase III Survival Data for Faslodex (Fulvestrant) in Breast Cancer
Overall survival not significantly different between 500-mg and 250-mg doses (Dec. 5)
Report: Substantial Growth Expected in Gout Drug Market
Sales of drugs for chronic gout will double by 2021 (Dec. 5)
Breath Test May Help Diagnose Colorectal Cancer
Researchers use simple breath sampling as screening tool (Dec. 5)
Cabozantinib (Cometriq) Shows Promise in Prostate Cancer Spread to Bone
Tumors reduced on bone scans (Dec. 4)
New Study: Copper May Prevent Spread of Drug-Resistant Infections
Copper surfaces rapidly kill bacteria on contact, researchers find (Dec. 4)
Report: NSCLC Drug Market Expected to Grow Over Next Decade
Co-development of lung-cancer drugs and companion diagnostics looks promising (Dec. 4)
FDA Announces Partnership to Speed Patient Access to New Medical Devices
Public–private consortium promotes regulatory science (Dec. 3)
Rayos (Delayed-Release Prednisone) Launched in U.S.
Drug is approved for rheumatologic diseases and other indications (Dec. 3)
‘Nanobubbles’ Kill Diseased Cells While Leaving Healthy Cells Untouched
New discovery could replace cell processing in cancer treatment and other disease therapies (Dec. 3)
FDA Accepts Pediatric NDA for Proton Pump Inhibitor AcipHex (Rabeprazole)
Priority review set for March 2013 (Nov. 30)
FDA Panel Has Mixed Opinion of Vibativ (Telavancin) for Nosocomial Pneumonia
Committee thinks drug should be used only if other alternatives are unsuitable (Nov. 29)
FDA Panel Recommends Accelerated Approval of Bedaquiline for Multidrug-Resistant Tuberculosis
NDA was filed in June (Nov. 28)
Drug considered generally equivalent to abiraterone (Nov. 29)
FDA Approves Cometriq (Cabozantinib) for Metastatic Thyroid Cancer
Kinase inhibitor blocks abnormal proteins involved in cancer cell growth (Nov. 29)
Autism Treatment May Do More Harm Than Good
Clinical evidence does not support use of chelation therapy, researchers find (Nov. 29)
Study Supports Safety of Whooping Cough Vaccine in Older Adults
Kaiser Permanente researchers recommend Tdap for all adults aged 65 and older (Nov. 29)
FDA Agrees to Review Tivozanib for Advanced Renal Cell Carcinoma
Agency decision expected in July 2013 (Nov. 28)
New Data for Liraglutide (Victoza) in Diabetic Patients
Hemoglobin target reached more often versus comparators (Nov. 27)
Measles Vaccination With Microneedle Patch
New delivery technique could revolutionize immunization programs, researchers say (Nov. 27)
Positive Results for Regorafenib (Stivarga) in Colorectal Cancer and GIST
Findings reported from two phase III trials (Nov. 27)
FDA Accepts NDA Filing for Cariprazine for Treatment of Schizophrenia and Bipolar I Disorder
Drug is dopamine receptor partial agonist (Nov. 28)
Report: Errors and Infections Still Serious Problem in American Hospitals
Massachusetts and Maine get best ratings (Nov. 28)
Computer Model Predicts Regional Peaks in Flu Outbreaks
Researchers adapt techniques used in weather prediction (Nov. 26)
Amarin Announces U.S. Patent Issuance for Vascepa (Icosapent Ethyl)
Omega 3 fatty acid reduces triglyceride levels (Nov. 27)
Report: Angiogenesis Inhibitors Will Dominate Kidney Cancer Treatment Through 2021
Immunotherapy agent nivolumab expected to become sales leader (Nov. 26)
Sustained Virologic Response With Sofosbuvir in Hepatitis C Patients
Phase III trial evaluates drug in patients unwilling or unable to take interferon (Nov. 27)
Pimavanserin Meets Primary Endpoint in Phase III Parkinson’s Psychosis Trial
Antipsychotic efficacy significantly greater versus placebo (Nov. 27)
