Rumors of change at AstraZeneca have been rumbling through newspapers all week and yesterday the company finally revealed the details by releasing a statement about its restructuring initiatives “to drive productivity and support innovation”. It all sounds very high and important but basically it boils down to job cuts. And lots of them. Read more »
written by Janet Woodcock, MD, Director for FDA’s Center for Drug Evaluation and Research
Targeting a drug for small subgroups of patients is a new way to find effective therapies. This is often called personalized medicine, and it’s one of today’s most promising areas of new drug development. Last year, FDA approved two important targeted medicines: Xalkori (crizotinib), a lung cancer drug that targets tumors with the abnormal ALK gene, and Zelboraf (vemurafenib), a drug to treat malignant melanomas that have a certain gene mutation. Both drugs were approved with companion diagnostic tests to identify if patients have a susceptible tumor.
Today, the FDA approved Kalydeco (ivacaftor) to treat a specific subgroup of patients with cystic fibrosis (CF). Cystic fibrosis is an inherited genetic disease that affects a person’s lungs and other organs and may lead to an early death. What makes the availability of Kalydeco even more unique is that the drug’s developer, Vertex Pharmaceuticals, teamed up with the Cystic Fibrosis Foundation to develop and study the drug.
Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry. Several pharmaceutical majors continue to invest in this emerging field as evident by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics. Read more »
Pharmaceutical drug development is becoming more and more expensive, with a high incidence of products failing late-stage trials. Governments and healthcare payers are demanding medicines that offer a balance of benefit and cost. Could personalized medicines and diagnostics offer a solution to both? Read more »
When should there be restrictions on the dissemination of basic research results? This question has arisen in the context of papers from independent laboratories submitted to the journals Science and Nature. Ron Fouchier and colleagues from the Erasmus Medical Center in Rotterdam, the Netherlands and a team headed by Yoshihiro Kawaoka of the University of Wisconsin-Madison, were both studying the H5N1 strain of flu virus, which causes avian flu. Avian flu can decimate flocks of poultry, but is rarely transmissible to humans. Nevertheless, because of the close proximity in which humans and poultry reside, there is concern that the virus could someday acquire the ability to infect mammals, and become the source of a pandemic. Both laboratories, working independently, identified mutations in H5N1 that allowed mammal-to-mammal transmission, using ferrets as the experimental model. Read more »
Ever wish you were a fly on the wall in another laboratory? Well, a new journal website offers the industry opportunities to do just that—to see through video how other scientists carry out particular experiments and processes. Read more »
New Jersey is known to many as a pharmaceutical mecca on the international stage with several leading pharmaceutical majors headquartered and/or with operations in the state. So to say that lawmakers need to create an economic climate conducive to foster growth is an understatement.
Geron announced earlier this week that it was discontinuing its clinical trial evaluating the use of embryonic stem cells for the treatment of spinal cord injury. The company said it planned to discontinue its embryonic stem cell research program, and focus instead on its oncology pipeline. The reason given was economic. According to the company press release, “The decision to narrow Geron’s technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company’s research and clinical-stage assets.” In other words, the company did not expect to recover enough revenue soon enough from the therapy to justify the expense of the remaining trials and the expense of continuing development. Read more »
Topical drugs are an important sector in the pharmaceutical market, particularly as pharmaceutical companies seek innovative ways to improve drug delivery and patient compliance. An upcoming webcast on Dec. 7th by Pharmaceutical Technology gains insight from leading industry experts on how to optimize topical drug formulations and manufacturing. Read more »
The coming patent cliff and the nation’s continuing economic problems have tightened many drugmakers’ R&D budgets. Cancer research has remained a priority, however, as GE Healthcare’s recent $1-billion investment in oncology demonstrates. Two recent studies show the importance of this research by offering glimmers of hope. Read more »
From PharmTech.com