EMA Approval: Jonexa
Jonexa (hylastan) is a bacterially fermented product derived from hyaluronan that is indicated for the treatment of pain associated with OA of the knee and administered in one or two injections. Genzyme expects to launch Jonexa in select European Union markets and Hong Kong in 2010 because they believe opportunity exists in those markets for a lower cost, more convenient OA treatment option than locally available multiple injection products.
For more information about recent drug approvals or pharmaceutical branding, please contact Vince Budd at [email protected]
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]
FDA Approval: Brilique
LONDON, Dec 6 (Reuters) - AstraZeneca's new heart medicine Brilique -- or Brilinta -- won final clearance from EU regulators on Monday, putting it on track to compete with Plavix, the world's second biggest-selling drug, next year.
AstraZeneca is relying on revenues from the new product to offset expiring patents on some of its best-selling medicines, such as heartburn treatment Nexium and Seroquel for schizophrenia.
The approval by the European Commission had been expected following a positive recommendation from experts at the European Medicines Agency in September.
AstraZeneca said that of the European markets that would start selling Brilique in 2011, the majority of launches would occur in the second half of the year due to pricing and reimbursement negotiations.
The drug is recommended for preventing dangerous blood clots in patients with serious chest pain or previous heart attacks.
It is a competitor for Sanofi-Aventis and Bristol-Myers Squibb's top-seller Plavix, which had sales last year of more than $9.5 billion, and AstraZeneca will face a tough competitive marketplace, since Plavix is off patent in parts of Europe and loses U.S. patent protection in 2012.
In the United States, where the medicine will be sold as Brilinta, the Food and Drug Administration is due to decide on whether to approve it by Dec. 16. It was endorsed by a U.S. advisory panel in July, despite a perplexing lack of benefit seen among a North American sub-group of patients in a clinical trial that found it was superior to Plavix overall. (Reporting by Ben Hirschler, editing by Kate Kelland)
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."
FDA Pharmaceutical Approval: Suboxone
According to ClinicaSpace, MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, today announced that its partner, Reckitt Benckiser Pharmaceuticals Inc., a wholly-owned subsidiary of Reckitt Benckiser Group plc (LSE: RB), has received approval from the U.S. Food and Drug Administration (FDA) to market Suboxone® (buprenorphine HCl/naloxone HCl dihydrate) sublingual film for the treatment of opioid dependence.
This is the second U.S. marketing authorization for a prescription product based on MonoSol Rx's PharmFilm® technology, closely following the July 2010 FDA approval of the anti-emetic Zuplenz® (ondansetron) oral soluble film.
Suboxone® sublingual film delivers a convenient, quick-dissolving therapeutic dose of buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. The drugs rapidly absorb under the tongue to ensure compliance.
A. Mark Schobel, President and CEO of MonoSol Rx, stated, "We are very pleased to announce the approval of Suboxone® sublingual film and disclose our important relationship with Reckitt Benckiser. Following the FDA approvals of Suboxone® sublingual film and Zuplenz® oral soluble film, both within the past two months, the agency has clearly accepted our proprietary PharmFilm® technology as a viable prescription drug dosage form.
FDA Pharmaceutical Approval: Glassia
Kamada Ltd. (KMDA.TA) received FDA Approval for AATD Drug Glassia.
According to the Alpha-1 Association, Alpha-1 Antitrypsin Deficiency (Alpha-1) is a condition that is passed on from parents to their children through genes. This condition may result in serious lung and/or liver disease at various ages in life.
Alpha-1 antitrypsin is a protein that is produced mostly in the liver. Its primary function is to protect the lungs from neutrophil elastase. Neutrophil elastase is an enzyme that normally serves a useful purpose in lung tissue-it digests damaged or aging cells and bacteria to promote healing. However, if left unchecked, it will also attack healthy lung tissue. Alpha-1 antitrypsin, in sufficient amounts, will trap and destroy neutrophil elastase before it has a chance to begin damaging the delicate lung tissue. Consequently, if an individual doesn't have enough alpha-1 antitrypsin, the enzyme goes unchecked and attacks the lung.
According to MarketWatch, David Tsur, Chief Executive Officer of Kamada said, "We are very proud with this achievement. This success belongs to each one of the company's employees. With this unique product, Kamada is able to offer the US Alpha-1 patients a new liquid, ready- to- use drug that may ease their therapy routine and provide an additional high quality product in the US market for the benefit of this community.
We are committed to the Alpha-1 patient community and take great pride in further developments of our second generation product, an inhaled Alpha- 1-Proteinase Inhibitor currently in stage 2-3 clinical development."
Visit MyGlassia.com for more information about this treatment.
For more information regarding Pharmaceutical Naming or Brand Development, contact Vince Budd at [email protected]
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]
Happy 50th Anniversary!!
The pill. No, not a pill, but THE pill. The pill that sexually revolutionized women and the control over their bodies. The pill that wrapped itself in religious dilemma and political controversy. The pill that to this day still raises concerns over morality and safety.
This year marks the 50th anniversary of this medicinal wonder. Often misunderstood, this hormonal remedy has walked a littered road of controversial backtalk and revolutionary movements. Therefore, like most things taboo, interesting, or just pretty, it has earned itself a Time magazine cover, adequately accessorized with a very detailed and fascinating article. I mean, I read the entire thing.
Whether you’re for it, against it, on it, or a boy, this article gives an intriguing outlook about the history of birth control as a concept, how it transformed into a drug, and ultimately how it became a way of life for many women...and, of course, the chaos that shadowed it.
Check out the Time article here, and leave your thoughts/feelings below.
FYI, today roughly 100 million women around the world use the pill.
Contributed by: Keri Lynch
Happy Birthday BOTOX!
While the results are temporary, I have a feeling BOTOX® is here to stay.
Did you know BOTOX is the most popular non-surgical beauty treatment in the world? It is also one of the world's most versatile and most widely researched medicines in the world.
Botulinum toxin, a purified protein derived from the bacterium Clostridium botulinum has been researched for over 100 years. Since it was identified in 1895, researchers have been intrigued by its potential therapeutic uses.
In 1987, Jean Carruthers discovered that injections of botulinum type A could erase lines and wrinkles. Botox was first approved on March 14th, 1990 for the treatment of misaligned eyes, uncontrollable blinking and nerve disorder. Soon to follow would be approvals to reduce the symptoms of muscle contractions in the neck and foot deformity. Most recently, in July 2004, BOTOX was granted approval in the United States to treat the symptoms of severe underarm sweating. A similar product is BOTOX Cosmetic®, which is approved for the treatment of frown lines between the eyebrows, forehead wrinkles and crow's feet.
Today, BOTOX is one of the most popular physician-administered aesthetic prescription procedures and researchers are exploring many medical uses for BOTOX. It is currently seeking approval from the FDA for migraine headaches.
Why is the product so popular? Many believe this is because of its ability to achieve predictable and measurable results through a relatively simple treatment that requires no surgery.
Happy Birthday, BOTOX! Make a wish!
Contributed by: Ashley Popham