FDA: Page
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Pradaxa faces challenges in U.S., moves forward in EU with approval
Boehringer Ingelheim is developing a strategy to reverse excess bleeding in Pradaxa-treated patients . The company continues to pursue regulatory milestones.
By Nicole Gray • June 9, 2014 -
Deep Dive
AstraZeneca ties its future to a promising drug pipeline
The firm predicts a nearly $20 billion increase in revenues by 2023, as it continues to develop small-molecule and biologics-based therapies for the treatment of various cancers.
By Nicole Gray • June 8, 2014 -
FDA approves Biogen Idea's Eloctate for Hemophilia A
Patients with hemophilia are benefiting from the availability of better treatment options -- including Eloctate -- that require fewer injections than previous treatments.
By Nicole Gray • June 7, 2014 -
GW Pharma's orphan drug gains fast-track status
The drug, Epidiolex, is used to treat Dravet syndrome, a rare form of childhood epilepsy.
By Nicole Gray • June 6, 2014 -
GSK to pay $105 million to settle suit over illegal marketing claims
As part of the settlement, the company has pledged to take a series of steps designed to prevent future violations.
By Nicole Gray • June 6, 2014 -
Major advisory panel redefines multiple sclerosis
For almost 20 years, researchers and clinicians have relied on an understanding of multiple sclerosis outlined in 1996. Using a treasure trove of new data and technology, the International Advisory Committee on Clinical Trials is refining that paradigm.
By Nicole Gray • June 5, 2014 -
Zytiga shows benefit in men with non-metastatic prostate cancer
Men with non-metastatic cancer may benefit from treatments for more aggressive cancer, based on a series of studies. The latest from JNJ highlights Zytiga's efficacy in reducing PSA levels significantly.
By Nicole Gray • June 5, 2014 -
As oral hepatitis C market grows, will AbbVie use a radical pricing strategy?
AbbVie is waiting for approvals from US and EU regulators for its new triple-drug, fixed-dose, oral hepatitis C drug. It's not as easy to take as Gilead's Sovaldi, but experts predict that AbbVie's pricing may be easier to swallow.
By Nicole Gray • June 5, 2014 -
BMS and Indian CRO extend drug discovery contract
Eight years of collaboration between the two companies has produced six drug candidates.
By Nicole Gray • June 5, 2014 -
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
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