Adi Reske

Find me on:

Recent Posts

Filgotinib: Still Early to Pop the Champagne

Posted by Adi Reske on Dec 24, 2015 12:38:39 PM

Recently, Galapagos NV and Gilead entered a partnership, potentially worth more than $2 billion, to develop Galapagos’s oral JAK1 inhibitor, filgotinib, for inflammatory diseases.

Earlier in December 2015, Galapagos announced positive interim Phase II Crohn’s disease results for filgotinib. Based on the data presented, 48% of moderate to severe CD patient treated with filgotinib achieved clinical remission at 10 weeks compared to 23% placebo (p=0.0067); clinical response (CDAI decrease of 100 points or more) as well improvement in patients’ quality of life were also met in the study. According to the company’s CEO, results from the Phase II trial merit moving the drug into a Phase III Crohn's program “as soon as possible”.

Read More

Topics: Brand Insights, Pharma, Life Sciences, Product Positioning

Pfizer’s Xeljanz: An Uphill Battle

Posted by Adi Reske on Oct 28, 2015 9:32:16 AM

Approx. 6 million people in the US have plaque psoriasisOn October 14th, 2015, Pfizer announced receipt of a Complete Response Letter (CRL) from the FDA regarding its recent supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib) in moderate to severe plaque psoriasis.

The FDA accepted Pfizer’s filing in February 2015 based on data from the Phase III Oral treatment Psoriasis Trials (OPT) Program. A global, multi-study, clinical development program, OPT was designed to evaluate Xeljanz 5 mg and 10 mg twice daily in patients with the skin disorder.

Read More

Topics: Brand Insights, Market Analysis, Pharma, Life Sciences, Competitive Strategy

Biosimilar Infliximab - What's All the Excitement About?

Posted by Adi Reske on Aug 11, 2015 11:05:24 AM

When in April this year the FDA accepted Celltrion’s filing for Remsima, the biosimilar Infliximab, patients and healthcare professionals in the United States were excited by the potential of a cheaper alternative to the expensive Remicade, an FDA approved tumor necrosis factor (TNF)-alpha inhibitor for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriasis, Crohn's disease (CD), and ulcerative colitis (UC) . However, a couple of weeks before the anticipated advisory committee, the FDA postponed discussions for an unknown date, requesting more information from Celltrion. Meanwhile, the excitement died down.

Read More

Topics: Competitive Intelligence, Market Analysis, Medical Devices, Pharma, Healthcare, Life Cycle Management, Life Sciences, Product Positioning, Competitive Strategy

Fuld + Company Blog

The material on this page draws on the research and experience of Fuld + Company thought leaders, consultants and others. Learn more about our expertise here.

Recent Posts

Request for Information

If you'd like someone at Fuld to contact you regarding your strategic competitive challenges, fill out the form below.