The FDA offered up an early retrospective of the 2014 year of approvals Friday with a rundown the regulator feels pretty good about. “Our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel drugs in 2014 compared to 27 in 2013,” FDA commissioner Margaret Hamburg wrote on the agency’s FDA Voice blog.
The world of technology is growing at a rapid pace, nothing new, but next year could involve some major cashing in for some health tech industries. With the help of some leading analyst firms, Business Insider put together a list of the trends that are predicted to be really booming next year.
Evolva Holding SA (“Evolva”, SIX: EVE) today announced that Emergent BioSolutions Inc. (“Emergent”, NYSE: EBS) has acquired Evolva’s anti-bacterial programme, the EV-035 series. The lead compound in the EV-035 series is the broad-spectrum antibiotic GC-072, which is being developed with US government biodefense funding. For Evolva, this transaction is worth up to USD 70.5 million plus royalties.
Healthcare workers treating Ebola victims are at a great danger of contracting the disease, as recent events in western Africa have shown. Currently available protective suits tend to require complicated procedures when putting on and taking off, are difficult to breathe in, and obscure the clinician’s face. A team at Johns Hopkins has developed, and just won a grant from the U.S. Agency for International Development (USAID) to further perfect, a new protective suit for use when treating highly infectious patients.
Ebola dominated the news in the second half of the year. Other important news was the debate on maintenance of certification, the first baby born after uterine transplant, and the change in HHS leadership.
Cathal Garvey used to work in cancer research. Now he is the scientific director of IndieBio, a biotech accelerator based in Cork, Ireland which is about to open a branch in San Francisco. Garvey originally studied genetics. “I got into genetics after seeing a documentary about it when it was quite young.” he says.”I had already decided that I was going to be a biologist at an even younger age. And then I thought ‘Oh my God, living things operate on a code.’”
Maryland is not waiting for the new year or a new governor to start taking applications for a program intended to boost business development around colleges and universities.
The state is now taking applications for its new Regional Institution Strategic Enterprise Zone program(called the “Rise Zone” program for short). It requires two application stages.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical study of ADXS-HPV (ADXS11-001) alone or in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The trial is expected to begin patient enrollment in early 2015.
With new articles published in journals every week and scores of labs constantly at work, scientists at this university stay productive.
And a new ranking has found that university researchers live up to that standard — when it comes to science research, this university is one of the most prolific in the world.
NHLBI is soliciting applications from small businesses to develop and validate novel in vitro human cell-based tools for predicting the responses of individual patients to cystic fibrosis transmembrane conductance regulator (CFTR)-directed therapeutics for cystic fibrosis (CF) lung disease. Proposed research projects are expected to focus on the development of highly innovative cell-based systems that recapitulate a patient-specific CFTR phenotype to create a personalized study platform to examine response to CFTR-directed therapeutics. The models developed must be based on live cells from humans harboring CFTR mutations associated with CF. While the primary goal of this initiative is to promote precision medicine and optimization of treatment at the personal level, it may also yield as a secondary benefit the ability to select appropriate treatments for CF at an earlier age.
