Pharmaceutical supply-chain managers have yet another item to step up their control of: tractor-trailers. A critical part of the delivery of supply, these large trucks have been used by many pharmaceutical companies for years to transport raw materials, ingredients, and final drug products. Cargo theft has always been a concern, but that concern is now growing. Read more »

I have just returned from an event in France which, I have to say, really impressed me. Not because I had the perfect excuse to visit Paris for a couple of days (although that was undoubtedly a bonus), but because I was so impressed by the calibre of presentations and new innovations that were showcased from this relatively small meeting. Read more »

The announcement by the Bill and Melinda Gates Foundation late last week at the World Economic Forum in Davos, Switzerland, that the foundation will commit $10 billion during the next 10 years to help research, develop, and deliver vaccines in poor and developing countries is an important pledge for global public health, a commitment that the foundation is also hoping that governments and the private sector will participate in as well.

The 10-year, $10-billion funding is in addition to the $4.5 billion that the foundation has committed to vaccine research, development, and delivery since the inception of the foundation. “We must make this the decade of vaccines,” said Bill Gates, in a press release by his foundation. “Vaccines already save and improve millions of lives in developing countries. Innovation will make it possible to save more children than before.” The Gateses said that the increased investment in vaccines by governments and the private sector could help decrease child mortality by the end of the decade, and they called for these entities to fill funding gaps.

The large funding provided by the Gates Foundation to increase access to existing vaccines as well as to support development for new vaccines for diseases such as malaria and tuberculosis, public-private partnerships such as the Global Alliance for Vaccines and Immunization, which is developing vaccines for diarrhea and pneumonia, as well as high-profile government intervention into vaccine development such as in the case of pandemic flu have helped to transform the vaccine sector into what traditionally had been a low-margin sector in the pharmaceutical industry to a more value-added one. In fact, Gates acknowledged that public–private partnerships “are transforming the business of vaccines.”

Although vaccines still represent a relatively small part of the overall pharmaceutical market, they represent a part of the growth strategy of certain pharmaceutical majors such as sanofi-aventis, GlaxoSmithKline, Novartis, Pfizer (through its recent acquisition of Wyeth), and Merck & Co. In an investor-relations presentation on vaccines in December 2009, sanofi aventis estimated the vaccine market at EUR 15 billion ($21 billion) in 2008 and projected that the market would reach EUR 23 billion ($32 billion) by 2013. When you consider that the global pharmaceutical market as a whole is estimated at $825 billion in 2010, according to IMS, vaccines are still a niche business, but can potentially represent one segment of growth for select drug companies.

As sanofi aventis pointed out in its vaccines seminar, vaccines can benefit from a much longer product lifespan than traditional drug products. Moreover, the unique requirements of vaccine development and manufacturing, namely biological competencies, more complex manufacturing processes, and high upfront capital requirements, raise the barriers to market entry and therefore, if executed successfully, one pillar of growth for individual companies. Vaccines for meeting unmet medical needs commonly found in developing nations as well as prophylactic vaccines such as cancer vaccines are important areas of innovation.

As the pharmaceutical industry struggles as a whole to build its revenue sources in the wake of increased generic-drug incursion and fewer new products, vaccines truly have the potential to live up to the axiom, “an ounce of prevention is worth a pound of cure.”

These days, research scientists, much like Rodney Dangerfield, can’t get any respect. The latest evidence of this arrived on Friday, when AstraZeneca (London) proposed to cut 3500 research and development (R&D) jobs by 2014. Read more »

The economic recession—recovering or not—was bound to affect FDA at some point. In his 2010 State of the Union address, President Obama proposed a spending freeze for US government agencies and programs that are not tied to national security. Entitlement programs such as Social Security and Medicare also would not be affected. “Like any cash-strapped family, we will work within a budget to invest in what we need and sacrifice what we don’t,” said the President in his speech. Read more »

Hands up those of you who read the labels on your medication bottles ‘every’ time you’re due to administer a dose? Not many of you I bet. While much publicity highlights the dangers of counterfeit drugs (and rightly so), what about the dangers linked to incorrectly taking genuine medication? Read more »

Only a day after the results of two Phase III clinical trials involving Novartis’s oral therapy for multiple sclerosis (MS) were published in The New England Journal of Medicine (NEJM), the media has leapt on the positive trial data and hailed the therapy as “hope for MS patients” that can “dramatically reduce relapse”. That’s great news, but hold on… the therapy hasn’t even been approved yet! Read more »

Haiti is the only nation in the Latin American and Caribbean region still considered a least developed country (LDC) by the United Nations. After this month’s earthquake devastated the nation of 9.7 million, it has been heartwarming to see hundreds of disaster relief crews and humanitarian organizations respond to the crisis. Pharmaceutical companies have been part of the picture as well—delivering millions of dollars in funds and medicines, either directly to Haiti or through nonprofit organizations. GlaxoSmithKline (GSK) is among the many pharmaceutical manufacturers, including Pfizer, Abbott Laboratories, Amgen, Merck, Eli Lilly, contributing aid to Haiti. Read more »

The numbers are in, and it looks like 2009 produced a bumper crop of biopharmaceuticals. The US Food and Drug Administration approved a record 16 new biopharmaceutical entities last year, as opposed to 10 in 2008, according to a study by the Biotechnology Information Institute. Seven recombinant-protein or antibody products were approved last year, continuing an upward trend for these molecules. Great news, right? Read more »

The European Commission has said it will be taking a close look at patent settlements where an originator has paid off a generic competitor in return for delayed market entry of a generic drug. Only yesterday, the EC released a statement saying that it has asked certain pharmaceutical companies to submit copies of their patent settlement agreements completed between originator and generic companies between July 2008 and Dec. 31, 2009. Read more »