This week’s headlines include several new stem Cell Therapy developments, FDA regulatory news, an update on the state of biotech venture capital investments and an interesting study on the effectiveness of vaccines.
A court decision on 23 July could help to tame the largely unregulated field of adult stem-cell treatments. The US District Court in Washington DC affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient’s own processed stem cells. The case hinged on whether the court agreed with the FDA that such stem cells are drugs.
If you like this story, please see our blog titled “New Strategies Key to the Clinical Manufacturing of Stem Cells for Therapeutic Use”
Israel-based Pluristem Therapeutics Inc has received an invitation from the U.S. National Institutes of Health to submit its placenta-based stem cells to the agency for evaluation in treating acute radiation syndrome (ARS). ARS results from exposure to high doses of ionizing radiation from a nuclear event, such as a nuclear power plant accident. Candidate drug evaluations could include dosing, dose schedule optimisation and efficacy studies and will be performed at contract facilities of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH).
If you like this story, please see our blog titled “Optimizing Media for Clinical Manufacturing of Stem Cells for Therapeutic Use”
The first half of the year delivered a long string of red flags on the venture side of the business. Startups were finding it harder than ever to gain new rounds as investing plunged in the second quarter of the year. And that same bottom line was reached by every group that crunches the numbers. Over the last quarter biotech companies scraped together $697 million in 90 deals, a stinging 42% drop compared to the same period a year ago and the lowest level the National Venture Capital Association–which got its numbers from Thomson Reuters–has seen since the first quarter of 2003.
If you like this story, please see our blog titled “Are Perfusion Cell Culture Systems the Future for Cell Culture Based Biomanufacturing”
Fitch Ratings expects the Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 as compared to 2011 while the industry faces several ongoing operational risks, according to a new report. Fitch believes that the total of 30 new primary care and specialty medicines cleared for marketing in the U.S. during 2011 will be difficult to beat this year. Despite a strong first quarter with eight new molecular entities (NMEs) approved, the total of 14 new approvals in the first half of 2012 (1H’12) lags behind the 18 new approvals in the same period of 2011.
If you like this story, please see our blog titled “Strategies for Enhancing Media to Improve Antibody Production in CHO Cells”
TheMiami Project to Cure Paralysis received permission from theFDA to begin a Phase I clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal cord injuries (SCIs). Found mainly in the peripheral nervous system, Schwann cells are essential to sending appropriate electrical signals through the nervous system, and Miami Project scientists and supporters believe they are key to finding cures for paralysis. In what will reportedly be the only FDA-approvedCell Therapy-based clinical trial for sub-acutespinal cord injury in the U.S., investigators plan to transplant a patient’s own Schwann cells at the injury site in the hope of ascertaining safety that will allow further trials to proceed.
If you like this story, please see our blog titled “Employing Innovative Platforms for Large Scale Stem Cell Culture”
Researchers have grown small blood vessels in a lab using stem cells from fat gathered through liposuction. Such cultured blood vessels might someday play a role in transplant operations, including heart bypass surgery. In bypass surgery, transplanted blood vessels are used to reroute blood around severely blocked arteries. Current techniques have limitations, however, and these preliminary study results suggest that tissue-engineered blood vessels might help doctors surmount certain hurdles, the researchers said.
If you like this story, please see our stem cell blog titled “The Arduous Path to the Clinic – Plan Early to Avoid Late Attrition”
Lack of sleep can reduce the effectiveness of vaccinations, according to a new study. Researchers measured the sleep patterns of 125 adults who received the three-shot course of the vaccine to protect against hepatitis B. The immune systems of participants who slept less produced fewer antibodies in response to the vaccine and blood tests showed that they did not meet the standard of protection from the virus.
If you like this story, please see our blog titled “Strategies for Improving Viral Yield in Vaccine Manufacturing”