FDA: Page 123
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Eli Lilly opens clinical data to medical researchers
The company joins a growing number of peers that are making their clinical trial data available to researchers via secured, Web-based portals.
By Nicole Gray • June 5, 2014 -
Bayer, Orion partnering to develop prostate cancer drug
Bayer is trying to build a strong portfolio in this therapeutic area--and is off to a good start with Xofigo, which was approved last year.
By Nicole Gray • June 5, 2014 -
UK companies want quicker EMA approval for certain drugs
Pharma companies in the United Kingdom like the European Medicines Association's plan to bring certain drugs to market more quickly. There's already a queue and admission of a larger workload for regulating agencies.
By Nicole Gray • June 4, 2014 -
Deep Dive
India battles quality issues as generic drug demand rises
Headlines announcing a recall of drugs manufactured in India are commonplace, but the FDA intends to change that -- with support from Indian authorities.
By Nicole Gray • June 4, 2014 -
Companies partner to develop immunology-based cancer therapies
GlaxoSmithKline's collaboration with Adaptimmune is part of a larger trend in which large companies partner with companies specializing in treatments that leverage immune function to treat cancer.
By Nicole Gray • June 4, 2014 -
Boehringer's Giotrif improves overall survival in clinical trials
Once again, research has shown that the molecular make-up of a cancer -- in this case, lung cancer -- influences outcomes.
By Nicole Gray • June 4, 2014 -
Century-old testing procedure about to change
Researchers increasingly use genomics to guide their research, but active pharmaceutical ingredient testing is based on technology developed 100 years ago. That will be overhauled in 2015.
By Nicole Gray • June 4, 2014 -
GSK's combo breast cancer treatent fails in phase III
Although the trial in women with HER2-positive breast cancer just failed, the data confirmed strong results for 4-year DFS for women treated with trastuzumab alone.
By Nicole Gray • June 2, 2014 -
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 -
FDA launches massive data portal
OpenFDA, launched Monday and currently in beta, eventually will provide masses of data, documentation and a community for developers.
By Nicole Gray • June 2, 2014 -
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 -
ASCO looking at value, price to create cancer scorecard
With ASCO's annual meeting taking place in Chicago, the issue of the price of cancer drugs is front and center. The society's decision to factor cost into a new algorithm has been well received by payers and clinicians.
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 -
Generic celecoxib approved in the US
Despite the black box warning on Celebrex (celecoxib), many patients find relief from arthritis and orthopedic pain with the drug. Recent FDA approval of generic celecoxib will now make that therapeutic relief less costly.
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 -
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
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