Category Archives: Biotechnology

Breakthrough Therapy Designation is described on the FDA website as "a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)." It was signed into law in 2012, with the first full approval of a breakthrough designation candidate being only one year later. As of March 30, 2017, FDA has granted breakthrough therapy designation to 170 of the 505 total requests, and eventually approved 55 breakthrough therapy designated products. The concept makes sense. If a new drug that aims to treat serious and life-threatening conditions shows unprecedented effect in early clinical trials, patients should not have to wait to receive treatment. A group called Friends of Cancer Research worked with partners in advocacy, regulation, drug development, and bipartisan congressional champions to take breakthrough therapy designation from concept to an expedited FDA development program. This ensures patient access to revolutionary drugs is as quick and effective as possible. A drug that receives breakthrough therapy designation is eligible for all FDA fast track features, intensive FDA guidance on an efficient development program (as early as … Continue reading →

ALACHUA, Fla., April 3, 2017 /PRNewswire/ --Sid Martin Biotechnology Institute (SMBI), the leading biotechnology incubator at the University of Florida, has been awarded the Randall M. Whaley Incubator of the Year award for 2017, the highest award given by the International Business Innovation Association (InBIA). InBIA is the world's leading organization for advancing business incubation, acceleration and entrepreneurship. SMBI was named Incubator of the Year among more than 7,500 incubators worldwide. The annual award, sponsored by the Friends of the University Science Center in Philadelphia, recognizes the top global business incubation program and includes a cash prize. The award was presented on March 28th at the InBIA's 31st Annual International Conference on Business Incubation. Accepting the award for SMBI were Mark S. Long, Director, and Merrie Shaw, Assistant Director. SMBI also received another award, the 2017 Technology/Science Entrepreneurship Center Program. David L. Day, Assistant Vice President for Technology Transfer at the University of Florida, said, "We are honored for the Institute to be recognized as the best in the world incubator. It is a tribute to our staff and their outstanding efforts helping startups grow great innovations and new solutions into successful businesses that will make the world a better … Continue reading →

SDSU College of Agriculture and Biological Sciences BROOKINGS The South Dakota State University Swine Club, along with various campus organizations and industry partners, will host a presentation by Julie Borlaug on April 12 to address the controversy surrounding the use of biotechnology in food production. Her presentation takes place at 7:00 p.m. at the Performing Arts Center on the SDSU campus. There is no charge to attend the event, but a free-will donation of canned goods for the Brookings Food Pantry is appreciated. As society moves farther and farther away from modern production agriculture, it creates a potential disconnect between the people who raise the food and the ones that consume it, explains Madelyn Regier, SDSU Swine Club president and an agricultural education and animal science major. The SDSU Swine Club believes that it is essential for consumers and the general public to better understand modern agriculture so we can all work together in feeding the worlds growing population in a safe and sustainable manner. Julie Borlaug is the granddaughter of Norman E. Borlaug, known as the father of the Green Revolution. She serves as the assistant director of partnerships at the Borlaug Institute for International Agriculture at Texas A&M … Continue reading →

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that results from an ongoing Phase II clinical trial of Puma's investigational drug PB272 (neratinib) were presented at the 2017 American Association for Cancer Research Annual Meeting (AACR) that is currently taking place in Washington, D.C. The presentation entitled, Neratinib in HER2 or HER3 mutant solid tumors: SUMMIT, a global, multi-histology, open-label, phase 2 basket study, was presented as a plenary session by David Hyman, M.D., Director of Developmental Therapeutics at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator of the trial. The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of PB272 administered daily to patients who have solid tumors with activating HER2 or HER3 mutations. All patients received loperamide (16 mg per day initially) prophylactically for the first cycle of treatment in order to reduce the neratinib-related diarrhea. Included in the presentation were data on 141 patients enrolled in the neratinib monotherapy arm of the trial, including 124 patients with HER2 mutations and 17 patients with HER3 mutations. This included patients with 21 unique tumor types, with the most common being breast, lung, bladder and colorectal cancer. … Continue reading →

NEW YORK, NY / ACCESSWIRE / March 31, 2017 / Prana Biotechnology and Xenetic Biosciences both saw their company's stock prices soar on news of a broader, more global product distribution. Prana is continuing to expand its presentation of PBT-434, while Xenetic is moving ahead with its strategic planning goals to make its product technology available to a larger geographical area. RDI Initiates Coverage: Prana Biotechnology Limited https://ub.rdinvesting.com/news/?ticker=PRAN Xenetic Biosciences Inc. https://ub.rdinvesting.com/news/?ticker=XBIO Prana Biotechnology advanced 37.65% to close at $3.40 on Thursday. The stock traded in a wide range between $4.58 and $2.75 during the day on a volume of 11.95 million shares traded. The company has presented new data from its Reach2HD trial at the American Neurological Association Annual Meeting held in Baltimore. Its primary candidate drug, PBT-434, demonstrated pre-clinical evidence that the drug will help with the treatment of movement disorders of patients with Parkinson's Disease. Prana Biotechnology, an Australian company, for the half-year period ending December 31, 2016, reported total operating expenses of $6.05 million AUD, a pre-tax income of $3.65 million AUD, and a loss of $0.68 AUD per share. Access RDI's Prana Biotechnology Research Report at: https://ub.rdinvesting.com/news/?ticker=PRAN Xenetic Biosciences accelerated to advance 44.30% to close … Continue reading →

By Elizabeth Johnson Leading pharmaceutical and biotechnology companies chose INTERPHEX 2017 to launch their newest products, with 20 companies debuting new technology at the pharmaceutical and biotechnology industry trade show held March 21-23 at the Jacob K. Javits Convention Center in New York City. In its 38th year, INTERPHEX offered attendees a mix of content including more than 104 conference education sessions, INTERPHEX Live discussions, hundreds of exhibits and product launches. The show experienced attendee growth, compared with 2016, and attributes much of that to its robust program. INTERPHEX offers its customers the opportunity to bring their entire teams and engage in education for everyone, said Melissa Ashley, senior vice president of INTERPHEX. She continued, Attendance is free to those who register ahead to support the industry and allow companies full teams to experience all that is happening in the industry. Having grown and evolved from a regional to a national and international event, INTERPHEX selected New York as its home because the city is a gateway that allows people to come from abroad and because there are a lot of customers in the tri-state area. INTERPHEX is reflective of the industry advancing to the future, with organizers working to … Continue reading →

Biotechnology is a top-notch field of study that emerged into the scientific world as a result of revolutions in Biology, Chemistry, Informatics, and Engineering. It is considered to be an applied branch of Biology. Biotechnology helps out this old and respectable field of science keep up with the pace of time and remain competitive in the contemporary world. With a Master in Biotechnology, students will study the use of living organisms and bioprocesses in technology, engineering, medicine, agriculture and results in all kinds of bioproducts, from genetically modified food to serious cutting-edge devices used to carry out gene therapy. Students in Master in Biotechnology programs may also explore bioinformatics, which is the application of statistics and computer science to the field of molecular biology. Bioinformatics is extremely important for contemporary biological and molecular researches because the data amount there grows by geometric progression and it is necessary to have adequate technology to process it. Bioinformatic methods are widely used for mapping and analyzing DNA and protein samples, as well as for the study of genetics and molecular modeling. Biotechnology and Bioinformatics do a great favour to traditional fields of study, refreshing them with new methods of research, which allows their … Continue reading →

March 31, 2017 9:38am NASDAQ:BBC From Zacks: After being stressed by the twin attacks of higher drug pricing and increased regulatory scrutiny, the biotech sector has made a strong comeback in the first quarter of 2017. In fact, BioShares Biotechnology Clinical Trials ETF (BBC Free Report) tops the list of the best performing ETFs of the quarter, with impressive returns of about 27.4%. BBC carries a Zacks ETF Rank of 3 or Hold rating with a High risk outlook. The surge in the fund was largely driven by cheap valuation, robust earnings results and a slew of positive actions taken by the President. In particular, Trump promised to reduce federal regulations by 7580% and streamline the Food & Drug Administration (FDA) approval process. This would make it easier for biotech companies to bring new products to the market. Trumps proposed tax reforms and cash repatriation policy are also supporting the rally (read: Top ETF Stories of Q1 from Wall Street). Apart from these, encouraging industry trends including the possibility of increased M&A activity, an accelerated pace of innovation, promising drug launches, growing importance of biosimilars, cost-cutting efforts, an aging population, expanding insurance coverage, the growing middle class, an insatiable demand … Continue reading →

Shares of Cellect Biotechnology Ltd. (APOP) are up more than 44% over the last 5 trading days. With its shares currently traded on both the NASDAQ and Tel Aviv Stock Exchange, Cellect is the company behind ApoGraft, a breakthrough technology for the isolation of stem cells from any given tissue. Cellect's ApoGraft technology is aiming to turn stem cell transplants into a simple, safe and cost effective process, reducing the associated severe side effects, such as rejection and many other risks, such as Graft versus Host Disease. Graft versus Host Disease, a condition in which the transplanted immune cells attack the recipient's cells, is a common complication associated with *allogeneic stem cell transplantation. (*Allogeneic stem cell transplantation involves transferring the stem cells to the recipient from a genetically matched relative or other donor). The positive results from a clinical trial of ApoGraft that involved 104 healthy donors of blood stem cells reported in February of this year demonstrated that Cellect's ApoGraft is a safe, robust and reproducible process for clinical use. According to the company, the use of the ApoGraft to process human stem cells for bone marrow transplantation resulted in a significant increase in the death of mature immune … Continue reading →

Technology and biotechnology stocks once again top our list of momentum charts to watch. Achaogen Inc. AKAO, -2.26% had an important snapback session on Tuesday, gaining $2.12, or 9.7%, to $23.90 on over 2 million shares traded. The move came on news that venture capitalist Robert Duggan disclosed a 5.7% stake in the late-stage biopharmaceutical company. Volume was the strongest on an up-day all year, and the stock has now bounced off rising trendline support after a 10-day pullback from the top of the channel to the bottom. If the stock can get through resistance, which is now up around Tuesdays high at $24.46, it could challenge recent highs around $26.75-$27.75 on the way to the top of the channel at over $30. Cara Therapeutics Inc. CARA, -7.36% had a nice follow-through on Tuesday, jumping 94 cents, or 5%, to $19.09, on 7.6 million shares traded. The biotech company reported positive results in a trial of a treatment for uremic pruritus, or UP. The stock reached $20.24 intraday, the highest its been since September 2015. It came down in the afternoon and didnt close great, but from the standpoint of the daily pattern as well technicals and volume, the stock … Continue reading →