Clinical Trials: Page 148
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ASCO takes long look at clinically meaningful outcomes for patients
Increasingly, payers and clinicians are focusing on CMOS to drive decision-making about patient care.
By Nicole Gray • June 2, 2014 -
At ASCO conference, doctors mull new models for payment
Thought leaders at the American Society of Clinical Oncology conference are proposing methods to replace fee-for-service payments---a model they consider unsustainable.
By Nicole Gray • June 2, 2014 -
Explore the Trendline➔
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TrendlineNeuroscience drug development
Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.
By BioPharma Dive staff -
Professor calls for more stringent guidelines to reduce adverse cardiovascular events
An editorial by Dr. Robert Blankenfield in the Journal of Cardiovascular Pharmacology and Theraputics cites evidence from large-scale trials in order to make the case.
By Nicole Gray • June 2, 2014 -
Bayer and ar-GEN-X to collaborate on drug discovery
Development of antibody-based therapeutics is highly valued and has contributed significantly to treatment for cancer and autoimmune dieases. By collaborating, Bayer and ar-GEN-X are planning to advance those goals.
By Nicole Gray • June 2, 2014 -
Sanofi resubmits multple sclerosis drug for regulatory review
Now that Sanofi has further analyzed phase II data, it's time for the FDA to reconsider approval of this multiple sclerosis drug.
By Nicole Gray • June 2, 2014 -
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 -
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 approves first implantable heart monitor
The device, implanted into the heart, can automatically transfer data that signals heart failure early on, resulting in fewer hospitalizations.
By Nicole Gray • May 29, 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 -
BMS dives into the immunooncology fray with CytomX collaboration
Other companies, including Merck, AstraZeneca and Pfizer are also heavily involved in immunooncology. Data highlights from this research will be reported at ASCO.
By Nicole Gray • May 28, 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 -
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 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 -
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 -
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 -
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 -
FDA: Fluzone not linked with febrile seizures
After a CDC warning that Fluzone may be linked to the increase in febrile seizures during the winter of 2010-11, researchers looked at epidemiologic data. Their analysis confirmed no significant association.
By Nicole Gray • May 16, 2014 -
Cetirix Orthopaedics obtains new financing, patents
Ceterix Orthopaedics, which makes surgical equipment for arthroscopic procedures, received two new patents and a new round of financing.
By Nicole Gray • May 16, 2014
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