With Gilead Sciences’ hepatitis C sales revenues from Solvaldi and Harvoni fading and lower than expected Yescarta sales, the company has been looking for new products to bolster its pipeline. In mid-July, Gilead addressed some of this need by deepening ties to an existing partner, Galapagos. The two companies have formed a 10-year, $5.1 billion...
Chief Digital Officer (CDO) is the latest title to become a standard within the pharmaceutical company C-suite, with Takeda, Bayer, GlaxoSmithKline, Novartis, Merck, Sanofi and others all making such appointments in recent years. As we’ve written before, this addition to the pharma senior management team reflects the growing importance of digital to pharma, which encompasses...
In May of this year, the Trump White House issued its “Blueprint to Lower Drug Prices” in response to the Administration’s views that excessively high drug prices “burdening the American people” were in part caused by “foreign freeloading” and a system currently rigged “to reward list price increases.” The policy document, which was open...
The concept of patient-centric drug development has been a frequent topic of discussion in recent years. Increasingly, companies have moved to adopt practices that create more active, networked relationships and interactions between physicians, patients, advocates and drug developers. The aim of such practices is to better respond to patient and physician needs and concerns, while...
Recent months have seen a series of corporate actions aimed at reconfiguring healthcare in the United States, beginning with drug store giant CVS’s bid in December 2017 to purchase Aetna, one of the country’s biggest insurers, for about $69 billion. This was followed on January 24 by Apple’s push into electronic healthcare records through an...
Sometime mid-month, the first clinical trial employing CRISPR gene editing technology within the human body will initiate in China, at Sun-Yat Sen University. Scientists there will seek to use CRISPR and TALEN, another gene editing method, to treat persistent HPV infection and disable the tumor growth mechanism in infected cells. In a non-invasive approach, scientists...
We have written frequently about the growing importance of biomarkers and how diagnostics will increasingly play a dominant role in the way that therapeutics are prescribed and reimbursed. Immuno-oncology (IO) treatments in particular are expected to benefit from the availability of truly predictive biomarkers, based on the dramatic treatment gains they have achieved for a...
On March 29, the US Food and Drug Administration approved Roche’s Ocrevus (ocrelizumab) for the treatment of either relapsing multiple sclerosis (MS), or primary progressive MS (PPMS). The approval was particularly noteworthy as Ocrevus is the first therapeutic approved for the treatment of PPMS, a form of the disease that accounts for 10-15% of MS...
For many young biotech and pharma companies, the decision about how to take their first drug to Europe has been simple: just license the European marketing rights to a company that already is well established there, and collect milestone payments and a stream of royalties. For an inexperienced company, dealing with the European regulatory and...
We recently wrote about rare disease drug development and commercialization, and why such franchises succeed better within small companies or perhaps as stand-alone, independently operating units of larger firms. When the patient population targeted by a particular therapy is small, success depends on a highly patient-centric approach to both drug development and commercialization. One must...