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All News - Page 91
Patient groups bothered over diminished safety standards for biosimilars
June 10, 2015
Patients for Biologics Safety & Access (PBSA) sent a letter to FDA addressing safety concerns about final FDA guidance documents issued for biosimilars.
Sleep study: Suvorexant effective in people with insomnia
June 10, 2015
Suvorexant (BELSOMRA) was an effective and well-tolerated treatment of insomnia, according to a new study presented at SLEEP 2015 in Seattle, Washington.
Heartburn drugs linked to heart attacks
June 10, 2015
Certain Protein-pump inhibitors (PPIs) such as omeprazole (Prilosec) are associated with a short-term risk of heart attacks and other cardiac events, according to a new study.
FDA's Sentinel Initiative identifies drug safety problems
June 9, 2015
The FDA's Sentinel Initiative uses big data and broad networks to detect and respond to risks associated with prescription drugs. In the June 4th Health Affairs' Health Policy Brief, the FDA describes how the Sentinel Initiative improves on the FDA's Adverse Event Reporting System (FAERS) database.
FDA panel recommends approving Repatha, Praluent to lower cholesterol
June 9, 2015
FDA’ s Endocrinologic and Metabolic Drugs Advisory Committee recommended this week to approve cholesterol-lowering drug evolocumab (Repatha) from Amgen in a 15-0 vote. It also voted 13-3 in favor of FDA approving Sanofi and Regeneron's Praluent (alirocumab), but most panel members called for a restricted label in high-risk patients with genetic conditions causing elevated cholesterol, rather than wider use in the general elevated cholesterol population.
HSCA to FDA: Address backlog of generic drug applications
June 9, 2015
The Healthcare Supply Chain Association (HSCA) recently sent a letter to FDA urging timely implementation of the remaining provisions of the Generic Drug User Fee Amendment (GDUFA).
7 proven elements of a successful antibiotic stewardship program
June 9, 2015
Earlier this year, the Obama Administration announced a 5-year plan to combat antibiotic resistance. The Forum on Antibiotic Stewardship was created to meet this "growing public health threat" and to reduce the misuse of antibiotics.
Antiepileptic drug can now be used in pediatric patients
June 5, 2015
FDA has expanded the indication for topiramate (Qudexy XR, Upsher-Smith Laboratories) extended-release capsules within the pediatric population.
Combo therapy yields intriguing results in melanoma progression
June 5, 2015
Results of a new study on combination drugs used to treat melanoma were presented at the 2015 American Society of Clinical Oncology meeting in Chicago. Researchers showed that a combination of ipilimumab and nivolumab stopped the advancement of melanoma for nearly a year in 58% of cases.
Continued advances in cancer outcomes unveiled at ASCO
June 4, 2015
Leading cancer drugs reduced the risk of death by half for people with lung cancer and assisted patients with HER2-positive breast cancer live longer without the disease recurring. The findings were just two of the numerous important study results presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago, Ill., this week.
FDA grants priority review to expand use of Brilinta
June 3, 2015
The FDA has granted Priority Review for ticagrelor (Brilinta, AstraZeneca) for patients with a history of heart attack.
[BLOG]: Use and abuse of opioids: FDA responds
June 3, 2015
In this blog post, David Calabrese RPh, MHP and Andrea Marks, MS discuss Catamaran's research on opioid abuse. Catamaran is concerned about opioid misuse and is moving forward with plans to combat opioid abuse.
Two TKIs go head-to-head in squamous cell carcinoma of the lung study
June 3, 2015
In patients with advanced squamous cell carcinoma (SCC), afatinib significantly improved overall survival (OS) compared to erlotinib, according to data presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
PCORI awards prison system $2M to study naltrexone benefit in opioid abuse
June 2, 2015
The Patient-Centered Outcomes Research Institute (PCORI) recently awarded more than $2 million to the University of Pennsylvania for research on opioid addiction treatment and relapsing in the Philadelphia Prison System. The study assesses the effectiveness of naltrexone to prevent relapse.
Dosage breakthrough for schizophrenia drug, plus 5 more FDA approvals
June 2, 2015
FDA approvals for the first week of June 2015.
Drug approved for rare, lung disease that strikes younger women
June 1, 2015
Lymphangioleiomyomatosis (LAM) is a rare, progressive lung disease that primarily affects women of childbearing age. The FDA has approved sirolimus (Rapamune, Pfizer) as the first drug to treat LAM. Rapamune was originally approved to prevent organ rejection.
Once-daily maintenance combo drug approved for COPD
June 1, 2015
FDA approved once-daily tiotropium bromide and olodaterol (Stiolto Respimat, Boehringer Ingelheim) Inhalation Spray as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
IL-6 inhibitor shows positive clinical benefit in RA patients
June 1, 2015
Sarilumab may be an effective option for patients with moderately-to-severely active rheumatoid arthritis (RA) according to topline results from a new study.
COPD fixed-dose combo enhances lung function
June 1, 2015
Because lung function can be substantially reduced by the time most chronic obstructive pulmonary disease (COPD) patients first see a physician, maintenance treatment should be considered at the time of diagnosis, according to new data analyses presented at the American Thoracic Society (ATS) 2015 International Conference.
Investigational dual bronchodilator improves lung function over single bronchodilators in COPD
May 29, 2015
In patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), investigational indacaterol/glycopyrronium (QVA149) bromide significantly improved lung function compared to the single bronchodilators, according to data presented at the American Thoracic Society (ATS) International Conference in Denver, May 15 to 20.
Grassroots FDA partnership aims to reduce heart disease deaths
May 28, 2015
FDA has joined nonprofit National Forum for Heart Disease and Stroke Prevention to advance the cause of a heart-healthy and stroke-free society in a first-of-its-kind cooperative public education program to reduce the burdens of heart disease and stroke.
The 5 most over-prescribed antibiotics
May 28, 2015
Because of overuse and misuse, some antibiotics are losing effectiveness against highly resistant bacteria.
First concentrated mealtime insulin analog approved
May 28, 2015
The FDA approved Eli Lilly’s Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), the company announced on May 27.
Breast cancer drug research roundup from ASCO
May 28, 2015
Among the many poster sessions being presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL, are several on the latest trials that are planned to evaluate potential treatment options for breast cancer. These trials include 1 phase 2 study and 3 phase 3 studies.
FDA approves 2 new IBS-D treatments
May 28, 2015
The FDA approved two new treatments to treat irritable bowel syndrome with diarrhea (IBS-D), Viberzi (eluxadoline) and Xifaxan (rifaximin), this week.
FDA drug approvals-May 2015
May 26, 2015
FDA actions in brief, complete response, breakthrough therapy designation, fast-track designations, orphan drug designations
High healthcare costs driven by spike in Rx costs
May 26, 2015
A significant spike in prescription drug costs helped drive healthcare costs for families covered under an average employer's health insurance plan up an estimated 6.3% in 2015, according to the Milliman Medical Index (MMI) report.
