FDA: Page
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Sanofi, Medtronic team up to offer options for diabetes patients
The new partnership focuses on innovative drug-device breakthroughs.
By Nicole Gray • June 17, 2014 -
Lawsuits target Bayer's Xarelto
There seems to be a growing push in the malpractice community to find harmed patients, although few suits have been filed so far.
By Nicole Gray • June 17, 2014 -
OncoMed halts phase I studies of cancer drugs, but aims to reinitiate
Ths company, which is testing a novel approach to treating cancer at the stem-cell level, is determined to continue development.
By Nicole Gray • June 17, 2014 -
Insulin 300 performs well in phase III trials
Will it beat its competitors?
By Nicole Gray • June 17, 2014 -
Deep Dive
As diabetes soars, so do research and treatment options
Currently, about 180 drugs are in development to address the diabetes-related challenges that persist despite available treatments.
By Nicole Gray • June 16, 2014 -
FDA approves Lymphoseek to help doctors target head, neck cancer locations
The approval marks the latest gain for the diagnostic drug.
By Nicole Gray • June 16, 2014 -
Medtronic buying Ireland-based Covidien
The merger will make Medtronic a mega-medical-device company.
By Nicole Gray • June 16, 2014 -
NICE reverses stance on skin cancer treatment after reviewing new survival data
The panel changed its decision of four months ago based on positive survival data extending out three years.
By Nicole Gray • June 16, 2014 -
Parion, Santen bring dry eye drug to Asian markets
The drug has a novel mode of action and will help Parion build an Asian distribution network with a new partner.
By Nicole Gray • June 13, 2014 -
Deep Dive
Small companies may be key to big advances in malaria treatment
Malaria remains a major killer worldwide, and treatments quickly become ineffective because of resistance. On an industry level, smaller firms are taking on that challenge.
By Nicole Gray • June 13, 2014 -
X-Chem, Pfizer team up on orphan drug development
The collaboration pairs two companies that are powerful in different ways.
By Nicole Gray • June 13, 2014 -
Critics slam European Medicines Agency on transparency issues
BMJ, the Cochrane Collaboration and the AllTrials campaign are among several groups that have accused the EMA of trampling on the rights of researchers and the public.
By Nicole Gray • June 13, 2014 -
Lilly's Cyramza fails in phase III liver cancer trials, but sees a way forward
Although the drug failed to show statistical results for survival advantage in patients with advanced liver cancer, there were some meaningful results.
By Nicole Gray • June 13, 2014 -
AstraZeneca breathes new life into its respiratory portfolio
The company has acquired rights to a drug developed by Synairgen and is reporting positive phase II results on its psoriatric arthritis drug.
By Nicole Gray • June 13, 2014 -
New statins being developed to reduce side effects
The fact that using statins to significantly decrease the risk of CVD can increase the risk of diabetes is counterintuitive, but it is real.
By Nicole Gray • June 12, 2014 -
FDA delays review date for Orexigen's obesity drug
With almost 10,000 study subjects, Orexigen is responding to the federal agency's request for rigorous evidence to support their resubmitted NDA.
By Nicole Gray • June 12, 2014 -
Researchers uncover protein that drives resistance to cancer treatment
A drug that has been approved for the treatment of myelogenous leukemia may help block resistance in Tarceva-treated lung cancer patients and extend lifespan.
By Nicole Gray • June 12, 2014 -
New Italian law allowing reimbursement for off-label prescribing causes concern
Opponents are concerned the law raises significant safety issues.
By Nicole Gray • June 12, 2014 -
British agency, doctors spar over aggressive statin guidance
In a letter, the physicians question the draft guidance, which could add millions of people to the number taking the cholesterol treatment.
By Nicole Gray • June 12, 2014 -
Dendreon faces large debt payment as CEO departs
For the company, the combination of low Provenge sales and high debt has been challenging, leading to speculation about its future.
By Nicole Gray • June 11, 2014 -
MS advocates fight back against NICE access policies
Once again, the British agency has rejected a multiple sclerosis drug, citing a high cost-to-utility ratio. MS advocates are fighting back.
By Nicole Gray • June 11, 2014 -
Edison Pharma gets another orphan drug designation for vatiquinone
Same molecule, different indication, additional orphan drug designation: That is the strategy that Edison Pharma is pursuing.
By Nicole Gray • June 10, 2014 -
Teva wins expanded indication for Parkinson's drug
The approval of Azilect for one more treatment combination is a positive step forward for the company's position in the Parkinson's disease category.
By Nicole Gray • June 10, 2014 -
Momenta Pharma receives orphan drug status for novel pancreatic cancer drug
The advent of a new possible treatment option for pancreatic cancer has the potential to shift the standard of care and increase the extremely low five-year survival rate for patients.
By Nicole Gray • June 10, 2014 -
Pfenex uses R&D prowess to develop AMD alternative to Lucentis
The company has brought its AMD candidate into clinical trials in just two years---and based on its high-throughput screening technology, there are many more candidate-concepts ready to be hatched.
By Nicole Gray • June 9, 2014
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