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Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen receives FDA priority review designation for Kyprolis to treat relapsed multiple myeloma

Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. [More]
Many teens still ignorant of significant physical danger posed by legal drugs

Many teens still ignorant of significant physical danger posed by legal drugs

Legal drugs such as OxyContin now kill more people than heroin and cocaine combined. While awareness of the dangers of illegal drugs has increased, many teens are still ignorant of the significant physical danger posed by legally prescribed drugs, according to a new study in Journal of Public Policy & Marketing. [More]
Study explains why generic insulin remains out of reach for diabetes patients

Study explains why generic insulin remains out of reach for diabetes patients

A generic version of insulin, the lifesaving diabetes drug used by 6 million people in the United States, has never been available in this country because drug companies have made incremental improvements that kept insulin under patent from 1923 to 2014. [More]
Amgen seeks marketing approval of Repatha (evolocumab) in Japan for treatment of high cholesterol

Amgen seeks marketing approval of Repatha (evolocumab) in Japan for treatment of high cholesterol

Amgen today announced that an application seeking marketing approval of Repatha (evolocumab) for the treatment of high cholesterol has been submitted for review to the Ministry of Health, Labour and Welfare in Japan. [More]
Selten Pharma's SPI-026 granted FDA Orphan Drug Designation for treatment of PAH

Selten Pharma's SPI-026 granted FDA Orphan Drug Designation for treatment of PAH

Selten Pharma, Inc., a privatively held biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare diseases, announced today that its lead compound tacrolimus (SPI-026) has been granted Orphan Drug Designation by the U.S. Food & Drug Administration for the treatment of pulmonary arterial hypertension (PAH). [More]
New hepatitis C drugs to place economic burden on health care system, predicts MD Anderson study

New hepatitis C drugs to place economic burden on health care system, predicts MD Anderson study

The cost of treating people infected with the hepatitis C virus (HCV) with newly approved therapies will likely place a tremendous economic burden on the country's health care system. The prediction comes from a cost-effectiveness analysis led by researchers at The University of Texas MD Anderson Cancer Center. [More]
Study finds that reformulated OxyContin forces some drug abusers to switch to heroin

Study finds that reformulated OxyContin forces some drug abusers to switch to heroin

A reformulation of OxyContin that makes it harder to abuse has curtailed the drug's illicit use. But some 25 percent of drug abusers entering rehab said they still abused the prescription painkiller despite package labeling that emphasizes its abuse-deterrent properties, new research indicates. [More]
Survey: Only 53% of primary care physicians use state's prescription drug monitoring programs

Survey: Only 53% of primary care physicians use state's prescription drug monitoring programs

In a new survey, researchers at the Johns Hopkins Bloomberg School of Public Health found that physicians report relatively high awareness of state databases that track drug prescriptions but more than one-fifth indicated they were not aware of their state's program at all. [More]
Physicians urge households to add 'clean my medicine cabinet' to Spring cleaning chores list

Physicians urge households to add 'clean my medicine cabinet' to Spring cleaning chores list

After marijuana and alcohol, the most commonly abused drugs by those over the age of 14 are prescription and over-the-counter medications. [More]
Ranibizumab drug reverses diabetes-related blindness

Ranibizumab drug reverses diabetes-related blindness

Ranibizumab, a prescription drug commonly used to treat age-related vision loss, also reverses vision loss caused by diabetes among Hispanic and non-Hispanic whites, according to a new study led by investigators from the University of Southern California Eye Institute. [More]
Breckenridge files Paragraph IV ANDA litigation with Sanofi for generic version of Jevtana

Breckenridge files Paragraph IV ANDA litigation with Sanofi for generic version of Jevtana

Breckenridge Pharmaceutical, Inc. announced today that it has filed an ANDA with a Paragraph IV certification for cabazitaxel solution; IV (infusion) in 60 mg/1.5 mL (40 mg/mL) strength, a generic version of Jevtana® by Sanofi. [More]
FDA advisory committees to review Amgen's talimogene laherparepvec for metastatic melanoma treatment

FDA advisory committees to review Amgen's talimogene laherparepvec for metastatic melanoma treatment

Amgen announced today that the Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration will jointly review the Company's Biologics License Application (BLA) for talimogene laherparepvec. [More]

FDA accepts NDA filing for Inspirion Delivery Technologies' investigational drug, MorphaBond ER

Inspirion Delivery Technologies, LLC, a specialty pharmaceutical company focused solely on the development of Abuse-Deterrent Formulations (ADFs) of opioid products, together with its financial partner Trygg Pharma Group, announced that the U.S. Food & Drug Administration has accepted for filing the New Drug Application ("NDA") submitted on November 21, 2014 for its investigational drug, MorphaBond ER, an extended-release (ER), abuse-deterrent formulation of morphine. [More]
Policymakers need to look beyond painkiller abuse to reduce opioid overdose deaths, say researchers

Policymakers need to look beyond painkiller abuse to reduce opioid overdose deaths, say researchers

According to researchers at Brandeis University, the University of North Florida and Johns Hopkins University, policymakers must look beyond painkiller abuse, also called non-medical use, in their efforts to reduce opioid overdose deaths. [More]
One in four nonsmokers still exposed to secondhand smoke, shows CDC report

One in four nonsmokers still exposed to secondhand smoke, shows CDC report

Although secondhand smoke (SHS) exposure in the United States dropped by half between 1999 to 2000 and 2011 to 2012, one in four nonsmokers -- 58 million people -- are still exposed to SHS, according to a new Vital Signs report from the Centers for Disease Control and Prevention. [More]
Trust for America's Health supports President's proposal to end sequestration

Trust for America's Health supports President's proposal to end sequestration

The following is a statement from Jeffrey Levi, PhD, executive director of the Trust for America's Health (TFAH) and chair of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health. [More]
TOS announces FDA approval of new prescription drug for treating binge eating disorder

TOS announces FDA approval of new prescription drug for treating binge eating disorder

The United States Food and Drug Administration recently approved lisdexamfetamine dimesylate, under the brand name Vyvanse, to treat moderate to severe binge eating disorder (BED) in adults, a first of its kind prescription drug specifically indicated for BED. [More]
Study: Common pesticide may alter the development of brain's dopamine system

Study: Common pesticide may alter the development of brain's dopamine system

A commonly used pesticide may alter the development of the brain's dopamine system -- responsible for emotional expression and cognitive function - and increase the risk of attention deficit hyperactivity disorder in children, according to a new Rutgers study. [More]
HHS sets goals to shift Medicare payments to reward quality of care rather than volume

HHS sets goals to shift Medicare payments to reward quality of care rather than volume

New plans announced by the Department of Health and Human Services (HHS) mean that hospitals will need to accelerate changes to patient care if they are to avoid receiving lower payments. [More]
Kaleo, CHMI partner to reduce prescription drug-related deaths

Kaleo, CHMI partner to reduce prescription drug-related deaths

Kaleo, a privately-held pharmaceutical company, today announced a national strategic partnership with the Clinton Health Matters Initiative, an initiative of the Clinton Foundation, that will help support its goal of cutting prescription drug-related deaths in half, saving approximately 10,000 lives over five years. [More]
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