FDA: Page
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Deep Dive
Innovative antidepressant developments depend on unlocking new targets
For the last 50 years, the treatment of depression with drugs has hinged mainly on targeting serotonin, dopamine or norepinephrine. There is still an unmet need for more treatment options, and the development pipeline does not seem promising for now.
By Nicole Gray • May 30, 2014 -
Deep Dive
Months after launch, Hepatitis C drug pricing debate remains
Everyone is discussing the price tag for Gilead's new hepatitis C treatment, while the company counters that using Sovaldi to cure hepatitis C will offset long-term disease-related costs.
By Nicole Gray • May 30, 2014 -
Novo Nordisk ready to venture into Germany with Tresiba for diabetes
Many pharma companies have found it difficult to eitehr launch into or stay in the German market because of tough pricing policies. After choosing not to launch Tresiba in Germany after EU approval, Novo Nordisk is rethinking their position and moving into the German market--which happens to be the largest pharma market in the EU.
By Nicole Gray • May 30, 2014 -
FDA allows first test into market to determine cause of kidney disease
Antibody-based testing will make it possible to determine whether a specific type of chronic kidney disease is autoimmune in nature. The implications have the potential to keep many patients off of the kidney transplant waiting list.
By Nicole Gray • May 30, 2014 -
Essentialis receives orphan drug designation for Prader-Willi syndrome treatment
Researchers are recruiting subjects for a clinical trial that may confirm a breakthrough treatment for this orphan disease.
By Nicole Gray • May 30, 2014 -
FDA accepts NDA from Mallinckrodt for combo pain medication
The NDA has been issued for Xartemis, a new oxycodone/acetaminophen formulation for the treatment of moderate to moderately severe pain.
By Nicole Gray • May 29, 2014 -
FDA approves Aloxi for treatment of chemotherapy-related nausea/vomiting in children
FDA has approved Esai's Aloxi for the treatment of CINV in children, including infants as young as one month old. This is the first time a treatment for CINV has been approved for children six months and under. The majority of cases of cancer in children occur in those one year and under.
By Nicole Gray • May 29, 2014 -
Report analyzes pros, cons of clinical research in 'BRIC' countries
The countries -- Brazil, Russia, India and China -- represent an opportunity for conducting clinical trials, Thomson Reuters reports. There are 30 million potential subjects, access to lab settings and well-educated healthcare professionals and manufacturing capabilities. But there are also challenges.
By Nicole Gray • May 29, 2014 -
Pfizer expands OTC portfolio with launch of OTC Nexium 24HR
The launch marks the fourth therapeutic area in which the company has an OTC presence. Pfizer acquired rights to Nexium from AstraZeneca in 2012.
By Nicole Gray • May 29, 2014 -
NICE approves coverage of Genzyme's Lemtrada for MS
In a reversal from last year, NICE has approved coverage of Genzyme's Lemtrada (alemtuzumab) for the treatment of multiple sclerosis. After receiving additional cost-effectiveness data as requested, the company decided that the treatment is worth covering.
By Nicole Gray • May 28, 2014 -
GlaxoSmithKline focus of UK fraud inquiry
News of this investigation comes shortly after initiation of an investigation of the company in China for alleged illegal activities related to bribing doctors.
By Nicole Gray • May 28, 2014 -
Deep Dive
The end of an era: E-cigarette manufacturers face regulatory oversight
New regulations introduced by FDA in April promise to be a game-changer for this rapidly growing industry.
By Nicole Gray • May 28, 2014 -
Top analyst ranks 22 pharma firms based on R&D prowess
Bristol-Myers Squibb tops the list, compiled by analyst Richard Evans.
By Nicole Gray • May 27, 2014 -
FDA approves Vectibix for colorectal cancer
The drug will be used in combination therapy for treatment of a specific type of the cancer.
By Nicole Gray • May 27, 2014 -
CMHP says no to Avastin for brain cancer
Although Avastin (bevacizumab) is widely used on the U.S. to treat various types of cancer, including glioblastoma, European advisors have recommended that EMA not approve it for treatment of glioblastoma.
By Nicole Gray • May 27, 2014 -
CMHP recommends against serelaxin for heart failure use
The Committee for Medicinal Products for Human Use (CMHP) has advised the European Medicines Agency (EMA) not to approve the drug for the treatment of heart failure. This rejection comes several days after a similar rejection by the FDA.
By Nicole Gray • May 27, 2014 -
Deep Dive
AstraZeneca rethinks its drug R&D process
The cost of drug development is much higher than often cited, which means that research and development failure is even more costly. What factors influence success, and how are companies, like AstraZeneca attempting to improve research and development productivity?
By Nicole Gray • May 27, 2014 -
Acura Pharmaceuticals settles patent litigation with Sandoz
Acura has settled a patent-infringement suit with Sandoz for generic AVERSION oxycodone.
By Nicole Gray • May 23, 2014 -
Inhibikase receives orphan drug designation for PML treatment
Imatanib is used to treat various cancers, and has been tested extensively by Inhibikase Therapeutics for the treatment of PML, a potentially fatal side effect associated with immunomodulatory therapy for patients with autoimmune diseases. It represents the only treament option for PML and has been granted orphan drug designation by FDA.
By Nicole Gray • May 23, 2014 -
FDA cracks down on online pharmacies selling illegal prescription drugs
Online pharmacies offer Americans a cheaper alternative for prescription drugs---and often provide the drugs without prescriptions. However, these drugs are illegal. FDA has collaborated with other agencies to crack down on these drugs at the point of entry, confiscating more than 20,000 packages.
By Nicole Gray • May 23, 2014 -
Growing fear of MERS virus increases urgency of researchers
MERS has killed 181 people worldwide, but its appearance in the U.S. this month surprised authorities. Researchers at NovaVax are using a new method to develop vaccines, which could decrease the decade-long timeline and $1 billion cost associated with vaccine development.
By Nicole Gray • May 22, 2014 -
Takeda's Entyvio approved by FDA for inflammatory bowel disease
Although FDA approved the drug for second-line treatment of IBD (moderate-to-severe ulcerative colitis and Crohn's disease), the drug's targeted action in the gastrointestinal tract may make it appealing to patients who experience extreme side effects with certain first-line treatments such as TNF blockers.
By Nicole Gray • May 22, 2014 -
FDA grants orphan drug status to AbbVie's Humira
AbbVie's Humira has been granted orphan drug status for the treatment of uveitis. It is currently a $2.6 billion drug used to treat various inflammatory conditions.
By Nicole Gray • May 21, 2014 -
Bristol-Myers Squibb gains 'breakthough therapy' designation for cancer drug
The pharmaceutical company gains the designation from the FDA for an oncology product being developed for the treatment of multiple myeloma.
By Nicole Gray • May 21, 2014 -
Teva delays introduction of generic copaxone while promoting new formulation
As it faces patent expiration of Copaxone, Teva has launched a new, more convenient formulation and increased its patient support program.
By Nicole Gray • May 19, 2014
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