Research into hot melt extrusion (HME) as a solution to improve solubility continues to expand with a partnership between Encap Drug Delivery, a contract development and manufacturing organization in the UK, and the School of Pharmacy at the Queen’s University Belfast (QUB), announced in a press release this week. Read more »
Archive for the 'R&D' Category
Earlier this year, the concept of solar-powered aviation was further propelled from its proverbial runway, testing many limits that had not been previously realized in the realm of energy-efficient transportation. However, as is the case with virtually every achievement since the dawn of civilization, the question remains the same: Where do we go from here?
From May–July 2012, Solar Impulse—with the help of several sponsors, including Bayer MaterialScience, the subsidiary of the pharmaceutical manufacturer Bayer—successfully completed a series of flights (known as Crossing Frontiers) as part of a round-trip journey from Switzerland to Morocco, setting several world records, according to the World Air Sports Federation, in the solar-powered subcategory (including for free distance along a course, and for straight distance with predeclared waypoints). In addition, the mission included the first solar-powered intercontinental flight linking Europe to Africa when Solar Impulse’s HB-SIA plane crossed the Strait of Gibraltar.
An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question. Earlier this year, the New York Times reported that FDA had tracked employee emails in its investigation into the possible leak of agency information by FDA scientists who complained about the agency’s medical device review process. These scientists raised concerns about radiation danger levels.
Yesterday, Sanofi issued a press statement titled “Sanofi provides information on the adaption of its activities in France through 2015.” Read past the headline and you quickly realise that the ‘adaption of activities’ involves eliminating around 900 jobs at the company’s sites France by 2015. You can read the statement here.
Ten biopharmaceutical companies announced the formation of a nonprofit organization called TransCelerate BioPharma, the mission of which is to accelerate the development of new medicines by identifying and solving common drug development challenges. The ten founding companies include Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi. Read more »
MIT Survey Aims to Correlate Product Lifecycle and Manufacturing Site Characteristics with Product Deviations
In the September PharmTech issue, researchers from MIT’s Center for Biomedical Innovation (CBI) describe the interim results from recent research into 34 commercial-scale biopharmaceutical products at 11 international sites. The comprehensive survey on topics related to site characteristics, quality approaches, quality activities, perception of relative consistency of regulators, product-level process details, and product-level compliance performance was deployed over the past 18 months as a secure web-based questionnaire directly to biopharmaceutical manufacturing sites through several different channels. The individuals targeted for inclusion as survey respondents have been manufacturing plant managers or their representatives.
Read the interim results and if you haven’t yet, the survey can be taken on behalf of a biomanufacturing site usin this link.
Earlier this week, on Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) honored nine individuals for their research into and fight against Alzheimer’s Disease (AD) as part of the association’s new Research and Hope Awards. The event was at the Washington, DC, Newseum and featured as keynote speakers Marc Kennedy Shriver, who wrote a book about his father’s experience with Alzheimer’s, and Meryl Comer, an Emmy award-winning journalist.
The evening was about inspiration and motivation to keep up the fight against AD, whether as caregivers, patient advocates, health professionals, or scientists. Read more »
Researchers are trying to find better, cheaper ways to produce biodegradable and bio-based polymers. Although one of the main drivers for this research is to compete with fossil-fuel-based polymers in large-volume, consumer plastics applications, medical applications, such as microcapsules for drug delivery, may also benefit. While it seems odd, the researchers found that waste oil from cooking fried food can be used as a raw material in the polymer production process. Read more »
Innovation is the cornerstone of the pharmaceutical industry. The challenge to innovation not only entails identifying drugs with clinical efficacy but also in being able to produce and deliver the desired drug compound. An upcoming Pharmaceutical Technology webcast, Omega-3 Innovations in Pharmaceutical and Diagnostic Markets, will examine the latest developments for omega-3 prescription drug products, their regulatory status, and recent advances in softgel drug-delivery technologies for omega-3 products. Read more »
On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) will honor nine individuals for their research into and fight against Alzheimer’s Disease (AD) as part of the association’s new Research and Hope Awards. The statistics surrounding AD have been plaguing families for decades. The disease is the sixth leading cause of death in the US today, according to the Alzheimer’s Association, with 5.4 million people currently affected. By the year 2050, one American will develop AD every 33 seconds.
The costs surrounding AD, from both a financial and time perspective, are also disheartening. The Alzheimer’s Association notes that the US spends an estimated $200 billion on AD per year, and families across America and around the globe are all too aware of the intense care and attention that AD patients require. These are just some of the reasons why PhRMA has focused on AD for its award program, which launches this year, replacing the PhRMA Discover’s award program. Read more »