Posted today in New Drug Applications

FDA Accepts Sanofi NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide

Sanofi announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. Following the redemption of a Priority Review Voucher with...

Posted today in Clinical Trials

Data Presented at APASL from First Completed Phase 3 Trial of All-oral Chronic Hepatitis C Regimen in Chinese Patient Population Shows Daclatasvir and Asunaprevir DUAL Therapy Demonstrated High Cure Rates Among HCV Genotype 1b Patients

(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced data from the first completed all-oral chronic hepatitis C (HCV) regimen Phase 3 trial that includes a Chinese patient population. The results of the registrational trial, which studied daclatasvir in combination with asunaprevir for 24 weeks in Asian (non-Japanese) patients with...

Posted today in Medical

Study Shows Just How Big a Role Cellphones Play in Car Crashes

In a finding that demonstrates how crucial it is to pay attention when behind the wheel, researchers report that video taken inside cars showed drivers were distracted seconds before an accident in more than two-thirds of crashes. Not surprisingly, the findings link cellphone use to many crashes. But the investigators said they also discovered something...

Posted 3 days ago in New Drug Approvals

FDA Approves Briviact (brivaracetam) to Treat Partial Onset Seizures

The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy. Epilepsy is a brain disorder that causes people to have recurring seizures. A seizure is an episode, usually of relatively short duration, of...

Posted 3 days ago in New Drug Approvals

Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR+, HER2- Metastatic Breast Cancer

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of Ibrance (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. Now Ibrance also is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative...

Posted today in Medical

More American Women Opting for Mastectomy, Study Finds

More women in the United States are undergoing mastectomies, even though the overall rate of breast cancer has remained stable, a new federal government report reveals. The rate at which American women opted for mastectomy jumped by more than a third (36 percent) from 2005 to 2013, according to data from the U.S. Agency for Healthcare Research and...

Posted today in Medical

Vaginal Ring Offers Some Protection Against HIV, Study Says

An insertable vaginal ring containing a month's supply of a continuous-release HIV prevention drug reduced the risk of HIV in African women by at least 27 percent, a new study found. The ring works by slowly and continuously delivering a highly localized and controlled amount of the antiretroviral medication dapivirine. This drug aims to halt the ability...

Posted today in Medical

Lung Cancer Survivors May Be Getting Too Many PET Scans

Many lung and esophageal cancer survivors have PET imaging scans as part of ongoing monitoring for the possible return of cancer, but a new study suggests that many of those scans may be unnecessary. In addition, the researchers found that having the pricey scans as the first line of imaging detection might not improve survival rates. PET scans can...

Posted today in Medical

Racial Gap in U.S. Cancer Deaths Is Narrowing: Report

The gap in cancer deaths among blacks and whites in the United States has narrowed for most cancers, but disparities remain for two common cancers, a new report from the American Cancer Society says. For deaths from breast cancer in women, the gulf between blacks and whites has widened, the report noted. For deaths attributed to colon cancer in men,...

Posted today in Medical

Heart Irregularities May Be Linked to Pregnancy Complication

Heart abnormalities between pregnancies may help spot which women with a history of pregnancy-related high blood pressure (preeclampsia) might have an increased risk for the condition in future pregnancies, researchers report. Preeclampsia is a serious condition that occurs in 3 percent to 8 percent of pregnancies, according to the Italian authors...

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Posted in Blog

Can the U.S. Win the War On Opioids?

Remember the “War on Drugs”? This may conjure images of Mexican drug lords, packages of smuggled cocaine, or clandestine DEA agents. But now we all know that the real bandit is found right in our own home — in our bathroom medicine cabinets. According to the Centers for Disease Control (CDC), 44 people in the […]

Posted in Blog

FDA Flashback: The Top Five New Drug Approvals From 2015

This past year close to 100 new drugs were FDA-approved, so it’s encouraging to look back and see the progress that’s been made as 2015 ends. In fact, more than 40 novel drugs, including a new drug class for patients with high cholesterol, a first-time biosimilar, a life-saving heart failure drug, and a controversial agent to […]

Posted in Blog

The Search for an Affordable Drug: 3 Practices To Outlaw

It may come as a surprise that as a pharmacist I am as mad as anyone about the ongoing trend of prescription drug price gouging. The real tragedy is that this gouging is often occurring with older prescription drugs for rare diseases that have limited manufacturer availability. It’s not that they can’t be made inexpensively; […]