FDA: Page 122
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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In a letter, the physicians question the draft guidance, which could add millions of people to the number taking the cholesterol treatment.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 -
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
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