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39 Total results for product and free and sample content found

Datamonitor Healthcare

After several setbacks, Xadago has received a less than ideal FDA approval in Parkinson’s disease

By Stephanie Yip 28 Mar 2017

On 21 March 2017, Newron Pharmaceuticals and its partners Zambon and US WorldMeds announced the approval of Xadago (safinamide) for the treatment of Parkinson’s disease (PD) as an add-on therapy to levodopa/carbidopa for patients experiencing “off” periods (BusinessWire, 2017; FDA press release, 2017). This approval was long-awaited by Newron and its US partner, US WorldMeds, as it followed numerous earlier US regulatory setbacks. Newron and its partner are now looking to successfully launch Xadago, but the US approved label fell short of ideal as it did not extend to early-stage PD patients receiving dopamine agonists  

Topic Diseases Parkinsons disease

Datamonitor Healthcare

Potential to be a disease modifier gives Cosentyx a competitive edge in the psoriasis market

By Ines Mihel 27 Mar 2017

At the 2017 annual meeting of the Maui Derm for Dermatologists, Novartis presented new data from the A2302E1 study which suggest that Cosentyx (secukinumab) could change the course of psoriasis, with approximately 20% of patients achieving maintenance of skin clearance after stopping treatment for one year. Datamonitor Healthcare believes that these data could allow Cosentyx to be positioned earlier in the treatment algorithm and become a market leader in psoriasis.

Topic Diseases Psoriatic arthritis

Datamonitor Healthcare

ACC 2017 – FOURIER CVOT data spur physician demand for Repatha, but reimbursement will remain a major barrier

By Jack Allen 27 Mar 2017

Results from the Phase III FOURIER trial in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) find that Repatha treatment results in significant reductions in rates of stroke and myocardial infarction. These positive results have excited physicians, although it is likely that reimbursement will remain strict since payers did not view the results as positively as physicians.

Topic Diseases

Datamonitor Healthcare

Systemic Lupus Erythematosus Marketed and Pipeline Profiles Research Wire

By Manoli Kavishwar 22 Feb 2017

Enthusiasm following Benlysta's approval has died down, and there remains a considerable need for effective biologic therapies.

Topic Drug review

Datamonitor Healthcare

EPOCH failure reveals more about clinical trial design

By Maha Elsayed 16 Feb 2017

In February 2017, Merck & Co announced the discontinuation of verubecestat’s Phase II/III study, EPOCH, in mild to moderate Alzheimer’s disease due to the high likelihood of missing the primary endpoint.

Topic Alzheimers

Datamonitor Healthcare

Chronic Lymphocytic Leukemia

By Dominique Fontanilla 15 Feb 2017

While Rituxan-based therapies remain dominant in the first-line treatment setting for early- and late-stage chronic lymphocytic leukemia (CLL), the majority of patients with relapsed or refractory disease receive Imbruvica. 

Topic Research wire

Datamonitor Healthcare

Positive Phase III data for CVT-301

By Ines Guerra 14 Feb 2017

Positive Phase III data for CVT-301 confirm its potential as a new rescue therapy for fluctuating Parkinson’s disease patients

Topic Parkinsons disease

Datamonitor Healthcare

Idalopirdine’s lack of efficacy in Alzheimer’s Phase III trials

By Maha Elsayed 13 Feb 2017

Datamonitor healthcare looks at Idalopirdine’s lack of efficacy in Alzheimer’s Phase III trials ends regulatory submission, casting doubt over the 5-HT6 class

Topic Alzheimers

Datamonitor Healthcare

Praluent US sales block gives advantage to Amgen's Repatha in dyslipidemia

By Kevin Shannon 06 Jan 2017

On 5 January, Amgen secured a court ruling blocking Praluent (alirocumab; Sanofi/Regeneron) from being sold in the US. This ruling clears the way for Amgen’s Repatha (evolocumab) to potentially become the sole proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in the US market.

Topic Research wire

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