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.

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

Jack Bauer and the Flu

Posted by Robert Flynn on Oct 23, 2015 6:49:12 AM

On February 5, 2015, Public Health England announced that the flu vaccine had demonstrated low effectiveness against the main strain of flu that had circulated this past winter. Dr. Michael Skinner of Imperial College London, said in response, “Trying to predict which seasonal flu vaccine to produce each year must be a bit like a Jack Bauer car chase in Los Angeles…bound to prove somewhat hit & miss.” 

A similar miss occurred in 2004, when the United States suspended The Chiron Corporation’s shipment of 48 million doses of vaccine, citing problems at the company’s Liverpool, England, manufacturing plant.

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Topics: Brand Insights, Market Analysis, Pharma, Scenario Analysis, Healthcare, Life Sciences, Merger and Acquisition

New Micro Case Studies, have a look!

Posted by Fuld + Company on Oct 12, 2015 11:00:00 AM

Case studies are a curious animal. Everyone thinks they're important, but no one wants to write them, and, apart from the headlines, people don't really read them. They just want to know what was the challenge, what was done, how successful it was.

So at Fuld, we're introducing something new: the microinfographic case study. It's like the quick summary from a 3-5 page case study, with illustrations.

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Topics: Competitive Intelligence, Brand Insights, Fuld + Company, Innovation, Pharma, Healthcare, Life Cycle Management, Life Sciences, Product Positioning, Competitive Strategy

The Tweet Heard ‘Round the Pharmaceutical World: A Perspective On Pharmaceutical Drug Pricing

Posted by Alexis Kuchins on Oct 5, 2015 3:22:18 PM

A week ago, presidential candidate Hillary Clinton tweeted her intentions, if elected, to try to curb the rising costs of pharmaceuticals. The plan would place a monthly cap on the out-of-pocket cost that chronic pain patients would have to pay for prescription medications, a greater emphasis on bringing biotechnology-style drugs to the market, and encourage increased use of generic and imported drugs.

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Topics: Competitive Intelligence, Innovation, Market Analysis, New Market Entry, Pharma, Scenario Analysis, Healthcare, Industry Convergence, Life Sciences, Product Positioning, Competitive Strategy

Companion Diagnostic Strategy: Who Bears Those Costs?

Posted by Alexis Kuchins on Sep 28, 2015 4:25:04 PM

The 2015 World CDx conference in Boston, Massachusetts brought together thought leaders from pharma, diagnostics, and companion diagnostic companies (CDx). This dynamic group of individuals engaged in a dialogue on areas such as next generation sequencing and companion diagnostics, precision medicine, and the regulatory landscape. In conversation with participants and presenters there was a consistent theme of seeking to understand companion diagnostic strategy and who will bear those costs.

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Topics: Competitive Intelligence, Brand Insights, Innovation, Manufacturing/Industrial, Market Analysis, Medical Devices, Pharma, Scenario Analysis, Healthcare, Life Sciences

How one CEO knows how to push the limits

Posted by Leonard Fuld on Sep 24, 2015 9:30:00 AM

Jim Mongiardo: Boundary Hunter

Jim Mongiardo has had a fascinating career to date. He has run a string of medical and biotech companies over the past 25 years. He is a quick study. More important – and the reason he has succeeded so often – he quickly learns the business boundaries for each company he has managed and how to push those boundaries as far as he reasonably can. It takes smarts to learn operational, investment and regulatory boundaries. It takes courage to understand when you have reached your limits.

Immediately following his graduation from Harvard Law School, Mongiardo started out as a litigator in the New Jersey state court system but soon grew restless. He wanted to try his hand at business. Finding a job at Schering-Plough (merging with Merck & Company in 2009) he entered a management training program and soon to become head of marketing for Schering’s Over the Counter and Prescription Drug business.

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Topics: Competitive Intelligence, Brand Insights, Fuld + Company, Pharma, Healthcare, Fuld, Leonard, Life Cycle Management, Life Sciences, Competitive Strategy

Healthcare Industry Investors see Value in Owning Consumer Relationship

Posted by Jacob Golbitz on Aug 28, 2015 2:18:00 PM

On Monday the New York Times published a piece speculating on the next set of Unicorns, i.e., venture-backed start ups valued at $1 billion or more. An independent research firm developed the list using a proprietary "algorithm" to forecast their valuation. Not surprisingly, the list is dominated by technology companies, but a health care provider — One Medical Group — made the cut.

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Topics: Competitive Intelligence, Brand Insights, Innovation, Market Analysis, New Market Entry, Pharma, Healthcare, Industry Convergence, Life Sciences, Competitive Strategy

Turning Managed Care Into Engaged Care Increases Value

Posted by Jacob Golbitz on Aug 20, 2015 2:46:00 PM

Within three weeks of Aetna’s agreement to acquire Humana for $37 billion, Anthem announced its agreement to purchase Cigna for $54.2 billion. If both of these deals go through, the number of major health insurance carriers in the U.S. will drop from five to three: Aetna, Anthem and UnitedHealth Group.

As Fuld + Co.’s SVP Diane Borska pointed out, “merger mania” is often driven by an innate sense among executives that larger companies with deeper resources will be better able to navigate a changing, dynamic market than smaller competitors; i.e., bigger is better.

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Topics: Competitive Intelligence, Brand Insights, Innovation, Market Analysis, New Market Entry, Pharma, Healthcare, Industry Convergence, Life Sciences, Competitive Strategy

Sell-Offs and Mergers and Trades, Oh My!

Posted by Bruce Chin on Aug 18, 2015 11:44:41 AM

Current Trends in Big Pharma and What It Says About the Market

After unprecedented M&A activity in the last 20 years in Big Pharma, the trend of devolution isn’t just a topic that became popularised in Scotland. The pharmaceutical industry seems to be experiencing a similar trend. From the spin-off of AbbVie from Abbott in 2012 to Baxter’s specialised medicines spin-off, Baxalta, last month, the trend seems to be continuing. It continues with the swap of Novartis’s non-influenza vaccines business for the bulk of GSK’s oncology portfolio.

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Topics: Competitive Intelligence, Market Analysis, Medical Devices, Pharma, Healthcare, Industry Convergence, Life Cycle Management, Life Sciences, Merger and Acquisition, Product Positioning, 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.

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

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