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350 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

Scrip

Lost $700m Opportunity As PTC Bids Farewell to Translarna in CF

By Francesca Bruce 28 Mar 2017

In withdrawing its European marketing application for Translarna in cystic fibrosis, PTC Therapeutics has bid farewell to a market opportunity once pegged at $700m.  

Topic Research

Scrip

C4 And Google's Calico Enter Mysterious Alliance On 'Diseases Of Aging'

By Joseph Haas 28 Mar 2017

While details are scant, the five-year collaboration will pair C4's targeted protein degradation approach with Calico's focus on diseases of aging. Privately held C4 otherwise is aiming to bring its first Degronomid candidate into the clinic in 2018.

Meddevicetracker

Discover the top medtech stories from the last week below

By Edward Stopke 27 Mar 2017

Meddevicetracker Weekly News Write-Up, March 27, 2017.

Topic Medtech weekly roundup Medtech

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

Medtech Insight

Industry: Next-Gen Sequencing Draft Guidances Have Good Ideas But Need Tweaks

By Elizabeth Orr 24 Mar 2017

The 37 groups and individuals who submitted comments on FDA’s two draft guidances on next-generation sequencing issued in July expressed appreciation for the thinking behind the guidances, but found bones to pick with some details.

Sitetrove

How to Mitigate the Risk of Selecting a Non-Enrolling Site for your Clinical Trial

By Loni Branon 24 Mar 2017

Enrollment success...This is what we all strive for but unfortunately it does not always happen and there is no money-back guarantee.

Topic Clinical trials

Pink Sheet

Malta Bids For EMA, Citing Quality Of Life, Healthcare, And Small Pharma Industry

By Ian Schofield 24 Mar 2017

Malta has joined the ever-growing number of countries wanting to host the European Medicines Agency when it relocates from the UK post-Brexit. The European Commission has said new “technical issues” have been raised that will need to be addressed, and industry bodies have outlined the criteria they say need to be met by the future host country.

Topic Brexit

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