FDA Approval: Viibryd
Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD). Viibryd is a new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist. Clinical Data plans to make Viibryd available in U.S. pharmacies in the second quarter of this year.
“It is also the first drug that the Company has developed, and to have received marketing approval from the FDA on its first review is a significant milestone for Clinical Data.”
"When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient," said Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego. "Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile."
The mechanism of the antidepressant effect of Viibryd is not fully understood but is thought to be related to its enhancement of serotonergic activity in the central nervous system (CNS) through selective inhibition of serotonin reuptake. Viibryd is also a partial agonist at serotonergic 5HT1A receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd's antidepressant effect are unknown.
For more information about recent drug approvals or pharmaceutical branding, please contact Vince Budd at [email protected]
Be a Light to the Village
For our December Helping Hands event, AW chose to sponsor the Christmas Village Toy Store at the request of one of our visual designers. It is a suggestion that many AW employees embraced, as the excitement of children at Christmas far outweighs our own as adults.
The inspiration came in 2006 for The Christmas Village Toy Store, a collaborative effort among several area churches that is designed to empower and develop at-risk urban communities in Charlotte. The store itself preserves and promotes joy and dignity at Christmas by engaging a free market system, allowing shoppers to pay a discounted price for desired items rather than be forced to accept “charity.”
Both those who donate toys or volunteer their time and shoppers who purchase toys contribute to store profits that are reinvested into the local community through educational grants and scholarships. Because of this, even the shoppers at the Toy Store are “paying it forward” into their own communities.
Addison Whitney was able to donate several boxes and bags full of toys for children ranging in age from infant to teenager. There were dolls, mp3 players, blocks, books, bath accessories and much more. In addition to donating toys, several employees, along with their friends or spouses, volunteered their time to helping the Toy Store prepare and run the shopping events. We were represented as toy pricers and parking lot attendants.
We would like to say thank you to Warehouse 242 and the other Charlotte-area churches who are part of the Christmas Village Toy Store for allowing us the opportunity to give to such an amazing organization. We look forward to being part of the initiative in the future, whether as individuals or as a company.
A Fresh Start
Sarah is a Charlotte-area junior who has been a Girl Scout for ten years.
She is now in the final stage of earning her Gold Award.
Much like the Eagle Award is to the Boy Scouts of America, the Gold Award is the highest achievement within the Girl Scouts of the USA. Only about 5% of eligible Scouts successfully earn the prestigious award. The Scout must complete 30 hours of leadership work, 40 hours of career exploration, and the 4Bs Challenge during which the scout identifies key needs in her community. After those steps have been taken, she must complete a service project. This service project must extend beyond GSUSA and provide a lasting benefit. It requires a minimum of 65 hours of work.
Sarah says that the homelessness crisis in Charlotte has been a passion of hers for many years, primarily due to her mother’s involvement with the Urban Ministry Center for almost half of Sarah’s life. Because of this, it was an easy decision for Sarah to determine her Gold Award project, as she has grown up working with homeless people.
For her project, called “A Fresh Start,” she is compiling 85 laundry baskets full of basic household items, including dish detergent, washcloths, hangers and sponges, to be donated to the upcoming residents of Charlotte’s newly constructed Moore Place, a housing facility built by the Urban Ministry Center. Moore Place will be Charlotte’s first permanent supportive home built to give a roof to chronically homeless men and women. Sarah’s aim is to provide these baskets as a house warming gift and starter pack.
As a Helping Hands event for November, Addison Whitney collected enough goods to fill two laundry baskets with the household items. These items will benefit two new residents of Moore Place and will make a dramatic impact in getting these new residents settled in their new homes.
Sarah plans to help the residents move in and hopes to continue working with them long after their first bottle of laundry detergent runs out.
If you’d like to put together a basket for Sarah’s project, please visit her website.
You can read more about Moore Place here.
FDA Approval: Halaven
FDA Approves Eisai Inc. (ESALF.PK)'s Halaven For Late-Stage Breast Cancer
11/15/2010
SILVER SPRING, Md., Nov. 15, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.
Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.
Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.
Halaven's safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.
The study was designed to measure the length of time from when this treatment started until a patient's death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.
"There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Halaven shows a clear survival benefit and is an important new option for women."
The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.
Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late- stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.
Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.
For more information:
FDA: Office of Oncology Drug Products
NCI: Breast Cancer
Media Inquiries: Erica Jefferson, 301-796-4988, [email protected]
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
FDA Approval: Ofirmev
PRNewswire via COMTEX News Network/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced last week that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV(TM) (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
"The approval of OFIRMEV is a significant milestone for Cadence as we advance our mission to improve the lives of hospitalized adults and children," said Ted Schroeder, President and CEO of Cadence. "IV acetaminophen is the unit market share leader among all injectable pain medications in Europe. With our planned launch early in the first quarter of 2011, we believe that OFIRMEV will fill a significant gap in the United States for the treatment of pain and fever in the hospital setting."
Acute pain, particularly postoperative pain, often requires a multi-modal approach in which two or more analgesics are used with the goal of providing better analgesic efficacy. U.S. physicians already prescribe acetaminophen frequently in combination with opioids for oral management of pain, where it is the most widely used non-opioid in fixed combination therapies. In clinical studies, OFIRMEV improved pain relief, reduced opioid consumption, and improved patient satisfaction when used as part of a multi-modal regimen.
"OFIRMEV is a long-awaited and much needed addition to postoperative pain management," said Eugene R. Viscusi, M.D., Director of Acute Pain Management at Thomas Jefferson University in Philadelphia. "With the approval of OFIRMEV, clinicians will now be better able to use a multi-modal approach to pain management in the hospital setting, when oral medication can't be used."
Paint AW Pink
Part of Addison Whitney culture includes active support of philanthropic endeavors. Breast cancer is an illness that has affected all of us in some way, and we are part of a much larger initiative dedicated to finding a cure.
In honor of Breast Cancer Awareness Month, we here at AW made donations to BCC Rally and Susan G. Komen for the Cure. As a gift, in return for our donations, we each received a 7-inch hot pink ribbon to be displayed on our desks, cubes or doors. Excitingly, we collected enough money to receive 35 bows. They went up on Friday, October 1, the first day of Breast Cancer Awareness Month.
To coincide with day one, we encouraged everyone to wear pink to the office and help to Paint AW Pink. Friday was definitely a pink day as the bows glowed brightly throughout the office, and many of us showed off our pink shirts and dresses.
The bows stayed up through October, but we will always be part of the fight for a cure.
National Name a Day Day
We all know Labor Day, April Fool's Day, Groundhog Day and Earth Day. These holidays are nationally known and often make headlines. In our lifetime, we've all probably celebrated one or all of these (one way or another). There are federal, national, religious, secular and lastly, weird and unusually named holidays. If you're taking entries, how do I get my holidays on the list? How do I make it official? I guess my first step is to research if any of my days are already taken.
Not surprisingly, I found that there is a "day" for nearly every day of the year. Some days have multiple celebrations. Most of the strangely named and unusual celebrations are not officially recorded by presidential proclamation or congressional records. Go figure. I did find a few I could get on board with: Book Lovers Day, Eat Outside Day & Don't Cry Over Spilled Milk Day. Some I would not be a supporter of: National Chocolate Covered Insect Day & No Pants Day which is celebrated on the 1st Friday in May, thankfully not at AW. When polled, a few associates came up with celebrations they'd like to add to the list.Read more
FDA Pharmaceutical Approval: Zuplenz
FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.
"The FDA approval of Zuplenz marks an important milestone for Strativa as it reinforces our commitment to enhancing prescription products to meet the different needs of patients," said John A. MacPhee, President, Strativa Pharmaceuticals. "Zuplenz offers an innovative and convenient, easy-to-take formulation for patients who have trouble swallowing tablets, while providing the trusted efficacy expected from ondansetron."
For more information regarding Pharmaceutical Naming or Brand Development, contact Vince Budd at [email protected]
24 Hours of Booty
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This weekend, more than 1,200 cyclists converged on Charlotte for 24 Hours of Booty. For 24 hours, cyclists rode a nearly three mile loop around the Myers Park neighborhood in a sign of unity against all types of cancer. This annual event raises money for cancer research and survivorship. This year, participants raised more than $1 million!
Addison Whitney’s own Verbal Branding Coordinator Jenna Wise took part in the ride as part of Team Gita. Volunteerism is a large part of the Addison Whitney culture so seven members of our team, along with a few spouses, signed up to help out.
Some people may think of volunteering as something you’re giving an organization, but I’m always amazed at how much I get back from volunteering a few hours of my time. This event was incredibly inspiring. The race began as cancer survivors rode off after an emotional send-off. And then an army of cyclists, some riding in memory of those they’d lost to cancer, and others simply devoted to helping others took off – all 1,200 of them.
This event isn’t about how many laps you’ll ride, it’s about why you ride. The best part of my night was then a father and daughter came over to chat. The young girl proudly told me she was riding for her mom who was a survivor. That’s why you ride.
The Rebranding of the Y
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Any given day, you’re sure to find an Addison Whitney employee at the Y running on a tredmill or perfecting Zumba moves. As a member of the YMCA of Greater Charlotte, I received an email last week from the President & CEO and Metropolitan Board Chair that blew my mind – in a good way.
By the time I’d received the email, I’d heard the news of the YMCA’s rebranding to the Y. I had seen the new logo and color palette. And I had read quite a few articles and blog entries cheering and jeering the change.
But this email was different because it was from my Y. The email, entitled “Still Your YMCA,” communicated the changes members can expect including a new brand strategy defining its cause of strengthening the foundations of community and a refreshed logo. But it also told members what would not change: the mission, core values and services members enjoy.
A key to successfully introducing a rebranding effort to your target audience is communication. As a member of the brand strategy team, we tell our clients going through rebranding efforts to do just what the Y did so well. Tell your target audience why you did it, how you did it and what they can expect. Change can be scary, so calm any fears by clearly stating what will not change.
The email from the YMCA of Greater Charlotte says it best: “As you can see, the Y isn't changing any of the great programs and services that we've always provided; we're just trying to do a better job of explaining why they matter.”
And you’re off to a great start.