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Science Policy Around the Web – October 25, 2016

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By: Nivedita Sengupta, PhD

Source: pixabay

Clinical Trials

EMA becomes first major drugs agency to publish clinical-study reports online

On 20th October, the London-based European Medicines Agency (EMA) published details of the full clinical-trial data that it received from pharmaceutical companies, some 100 clinical reports, about two EMA-approved medicines, carfilzomib, a cancer drug, and lesinurad, a gout treatment. The disclosures make the EMA the first major drug regulatory agency to completely publish the results of clinical investigations that drug developers submit while applying for the agency’s approval to market medicines in the European Union. “These clinical study reports (CSR) are much more detailed than the papers that drug firms publish in scientific journals. It includes both positive and negative results, and details of drugs’ adverse effects,” says Larry Peiperl, the chief editor of PLoS Medicine.

Under the rules the EMA brought in six years ago, it had released results of such studies only if third parties asked for them using freedom-of-information requests. However, those rules allowed some drug firms to drag the agency to court to try to prevent their data from being released, arguing it as commercially confidential. However, patients and clinicians have waited long, and about 700 medical and patient organizations had lobbied for clinical data release under the All Trials campaign. “The EMA’s CSR policy adopted in 2014 will benefit both academic research and the practice of medicine as a whole,” says EMA executive director Guido Rasi. It will help academicians to independently re-analyze data even after a medicine has been approved, and will help drug developers to learn from the experiences of others.

The EMA intends to release all CSRs in applications that were submitted since 1st January 2015. It will only edit some commercially confidential information like individual patient data before release. After the clearance of backlog, the EMA says that it will offer public access to around 4,500 clinical reports each year.

Some drug firms are still resisting the release of their data by the EMA. In the latest legal battle this July, an interim judicial EU court order blocked the EMA from releasing toxicity studies on a veterinary medicine called Bravecto (fluralaner), and clinical-study reports on Translarna (ataluren), a treatment for Duchenne muscular dystrophy. The two drug firms concerned, Intervet and PTC Therapeutics, argued that the release of data would infringe on their rights to protect commercially confidential information. However, the EMA has appealed against both decisions on 29th September, and says that it sees the cases as a test of its policy. (Alison Abbott, Nature News)

Biotechnology

In a first, mouse eggs grown from skin cells

For the first time, stem cell researcher Katsuhiko Hayashi of Kyushu University in Fukuoka, Japan, and colleagues have reprogrammed fibroblasts from the tip of an adult mouse’s tail to make eggs, which upon fertilization grew into healthy mice. Earlier, adult body cells were reprogrammed to generate stem cells (induced pluripotent stem cells – iPSCs), which were further induced into becoming a wide variety of other cells but never eggs. Egg cells are much trickier as they represent ultimate flexibility which can create all the bits and parts of an organism from raw genetic instructions. “This is very solid work, and an important step in the field,” says developmental biologist Diana Laird of the University of California, San Francisco. This major development could make it possible in near future to study the formation of gametes — eggs and sperm — an unknown process that takes place inside fetuses. Moreover, if the experiments gets extended to human cells, it could make eggs easily available for research and may eventually lead to infertility treatments.

In this experiment, Hayashi and colleagues made artificial ovaries by extracting ovarian support cells from albino mouse embryos, which were then mixed with primordial germ cell‒like cells created from tail-tip skin cells from a normally pigmented mouse. After 11 days of maturation followed by fertilization, the eggs were transplanted into the uteruses of female mice. Six pups with dark eyes were born, indicating that they came from the tail-tip eggs and not eggs accidently extracted from the albino mice along with the ovarian support cells. The baby mice grew up apparently healthy and have produced offspring of their own.

As ovarian cells from mouse embryos were still needed to support the growth of eggs in vitro this could be a potential problem when trying to replicate the experiments in humans. “It’s yet unclear how support cells in ovaries foster egg development. Researchers can’t yet reproduce the supporting cells in the lab and so need to get those cells from embryos,” Hayashi says. (Tina Hesman Saey, ScienceNews)

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Written by sciencepolicyforall

October 25, 2016 at 10:55 am

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