Category Archives: Biotechnology

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced that H-E-B Meat Plant, a San Antonio, Tex. establishment, is recalling approximately 1,150 pounds of diced chicken thighs due to misbranding and undeclared allergens. There have been no confirmed reports of adverse reactions due to consumption of these products.

Sid Wainer & Son of New Bedford, MA announced the recall of Jansal Valley brand Dried Chili De Arbol Peppers due to presence of allergen, peanuts. No illnesses have been reported to date in connection with this problem. During repacking, the peanut contamination was discovered in the sealed bulk containers of the product.

TAI FOONG USA of Seattle, WA announced the recall of Royal Asia Shrimp Wonton Noodle Soup due to undeclared egg. One allergic reaction complaint has been confirmed to date, due to consumption of the recalled product.

Prestage Foods, Inc., a St. Pauls, N.C. establishment, is recalling approximately 38,475 pounds of ground turkey that may be contaminated with extraneous materials. The fresh ground turkey was produced on September 25 and 26, 2017. There have been no confirmed reports of adverse reactions due to consumption of these products.

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Biotechnology News, FDA Calendar, Events, Clinical Trial ...

Prepare for a cutting-edge career with a bachelor's degree in biological sciences from Miami Dade College. South Florida is home to two major life sciences research hubs and more than 1,300 companies that are creating the future right now and have a high demand for skilled workers. This program responds to the needs of our regions employers.

A capstone internship with a prospective employer or private/public partner moves beyond the classroom, allowing you to put your skills to the test in the real world.

The biotechnology concentration of this bachelors program helps you build the knowledge and skills youll need to succeed in the life sciences. As a biotechnology student, youll learn about:

Biological Sciences students can also choose to graduate with these additional concentrations:

Continued growth in the biotechnology and medical research fields is expected to continue to drive growth in the life sciences industry, especially in the South Florida region, which is rapidly evolving into a hot spot for life sciences research. An education in biotechnology opens doors to careers in a variety of workplaces, including:

These four-year programs combine extensive academic studies with the real-world experience students need to pursue a career in their selected field.

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Biological Sciences - Biotechnology Bachelor of Science ...

Your May 17 article about genetic engineering [Facts, Fears and the Future of Food] is so chock-full of glib falsehoods that I hardly know where to begin. I would have far more respect for the science behind biotechnology if it didnt depend so heavily on half-truths, double standards, unwarranted assumptions, blurred distinctions and conflicts of interest.

Jack Britt says that the same microorganisms move genes between species both in nature and in genetic engineering, and therefore the methods are the same. This is half true. In the latter, various techniques are employed to either bypass or weaken the natural immunity of the organism being manipulated, often literally forcing the DNA into the cells in ways that would never occur in nature. Stating that many organisms are naturally GMO, and therefore implying that we have carte blanche to do whatever we wish, isnt just a stretch, its a whopper.

Britt and Leah McGrath emphasize the precision of these techniques. Again, this is a perversion of the truth. In fact, this is merely a precision of abstractions, because the living organism is then going to move these genes around in ways that cant possibly be controlled or predicted. The only way to even begin to achieve complete control or precision would be to kill the organism, which would obviously be counterproductive. A technology that treats living organisms as though they were dead has extremely questionable scientific validity, not to mention morality.

Both the tone and title of the article perpetuate the same old scientific myths about biotechnology: The facts are with the scientists, the fears (beliefs) are with the uninformed public, and the future of food requires the widespread adoption of these techniques. The public is misinformed, largely because news media like the Xpress have allowed themselves to be used as soapboxes by academic cheerleaders for corporate interests.

As long as we continue to assume that:1. The deterministic gene weve been taught in school and through the media is real.2. The kind of science we now have (which is mostly technology rather than science proper) is the only science possible. And3. Everything a scientist says is scientific by definition,

we will continue to make catastrophic mistakes.

Substantive criticisms of biotechnology do exist, but for some reason, they almost never find their way into the mass media. The opposition only seems weak because its strongest arguments are ignored.

Andy Shaw Easton, Md.

Editors note: Freelance writer Nick Wilson responds in part:I thank you for your passionate response. I appreciate criticism and view it as an opportunity to learn through grappling with different perspectives. Ultimately, Im more than happy to admit my past errors if I come to a new understanding that falls more in line with what I believe to be true. If it comes to my awareness that I have put forth falsehoods, Id absolutely like to remedy that. This is to say that my perspectives are evolving, not fixed. Its important to me to keep learning and growing in the pursuit of truth.

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Letter: Perpetuating 'scientific' myths about biotechnology - Mountain Xpress

As Boulders biotech community continues to thrive and grow, theJennie Smoly Caruthers Biotechnology Buildingdebuted its state-of-the-art E-Wing on Monday.

The 56,340-square-foot E-Wingwill feature next-generation active learning spaces where students learn by doing rather than by being lectured, as well as laboratory space wherecurrent and future faculty in the BioFrontiers Instituteand the Department of Chemicaland Biological Engineering will be able tocontinue their groundbreaking research.

Mondays ribbon-cutting event honored Colorado-based philanthropists John and Anna Sie, whose generous $2 million gift will allow for the creation of an industry co-location space on the E-Wings second floor. The space will be leased to industry partners, allowing local and national biotech companies to bring scientists and resources on-site in order to work side-by-side with university students and researchers.

CU Boulder Chancellor Philip DiStefano and Tom Cech, Nobel Laureate and director of the BioFrontiers Institute, were on hand to officially open the Yuan Yung-Foo Interdisciplinary Bioscience Research Neighborhood and thanked the Sies for their continued support of BioFrontiers and the universitys research mission.

The Sies, whose philanthropic generosity is well known in the state of Colorado and around the world, have provided stalwart support for the BioFrontiers Institute for many years and in many ways, said Cech, a Distinguished Professor of chemistry and biochemistry at CU Boulder. We are truly grateful for their most recent commitment to providing much-needed research facilities where our talented researchers, students and industry partners work together to unravel the complexities of biology with an ultimate goal of enhancing human health and welfare.

Anna and John are among CUs most generous donorstheir gifts are always transformational, DiStefano said. "With their support, we are achieving our vision to become a leader in addressing the humanitarian, social and technological challenges of the 21st century."

Construction on the $32 million E-wing broke ground in March 2016, aided by $15 million in funding from the state of Colorado.

For more information on the E-Wing, visit the BioFrontiers Institutes website.

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Biotechnology building debuts state-of-the-art E-Wing - CU Boulder Today

Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced the release of two abstracts on its drug neratinib that will be presented at the European Society for Medical Oncology (ESMO) 2017 Congress, which will be held September 8 12 in Madrid, Spain. Abstracts are available to the public online on the ESMO website: http://www.esmo.org.

Abstract #1490: Neratinib after trastuzumab-based adjuvant therapy in early stage HER2-positive breast cancer:5-year analysis of the Phase III ExteNET trial.The abstract will be presented as a proffered paper oral session on Friday, September 8.

Abstract #177P:Effects of neratinib on health-related quality of life in early stage HER2-positive breast cancer.The abstract will be displayed as a poster on Monday, September 11.

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer.

U.S. Approval of Neratinib (NERLYNX)

Neratinib was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

Indication

NERLYNX is a tyrosine kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance.More information on the Puma Patient Lynx program can be found at http://www.NERLYNX.com or 1-855-816-5421.

The full prescribing information for NERLYNX is available at http://www.NERLYNX.com. The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

Important Safety Information

There are possible side effects of NERLYNX. Patients must contact their doctor right away if they experience any of these symptoms. NERLYNX treatment may be stopped or the dose may be lowered if the patient experiences any of these side effects.

Diarrhea

Diarrheais a common side effect ofNERLYNX. The diarrhea may be severe, and you may get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 cycles (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea:

Contact your healthcare provider right away if you have severe diarrhea or if you have diarrhea along with weakness, dizziness or fever.

Liver Problems

Changes in liver function tests are common with NERLYNX. The patients doctor will do tests before starting treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. NERLYNX treatment may be stopped or the dose may be lowered if your liver tests show severe problems. Symptoms of liver problems may include tiredness, nausea, vomiting, pain in the right upper stomach area (abdomen), fever, rash, itching or yellowing of your skin or whites of your eyes.

Pregnancy

Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. NERLYNX can harm your unborn baby. Birth control should be used while a patient is receiving NERLYNX and for at least 1 month after the last dose. If patients are exposed to NERLYNX during pregnancy, they must contact their healthcare provider right away.

Common side effects in patients treated with NERLYNX

In clinical studies, the most common side effects seen in patients taking NERLYNX were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis (dry or inflamed mouth, or mouth sores), decreased appetite, muscle spasms, dyspepsia, changes in liver blood test results, nail problems, dry skin, abdominal distention, weight loss and urinary tract infection.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 orhttp://www.FDA.gov/medwatch. Patients and caregivers may also report side effects to Puma Biotechnology at 1-844-NERLYNX (1-844-637-5969).

Please see Full Prescribing Information, available at http://www.NERLYNX.com.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. NERLYNX (neratinib) is approved for commercial use by prescription in the United States as extended adjuvant therapy for early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed as NERLYNX. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the commercialization of NERLYNX and the continued development of its other advanced drug candidates directed at the treatment of HER2-positive breast cancer. The Company believes that NERLYNX has clinical application in the potential treatment of several other cancers that over-express or have a mutation in HER2.

Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the benefits of NERLYNX and neratinib, the Companys clinical trials and the announcement of data relative to those trials. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Companys actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has only recently commenced commercialization and shipment of its only FDA approved product; the Companys dependence upon the commercial success of NERLYNX (neratinib); the Companys history of operating losses and its expectation that it will continue to incur losses for the foreseeable future; risks and uncertainties related to the Companys ability to achieve or sustain profitability; the Companys ability to predict its future prospects and forecast its financial performance and growth; failure to obtain sufficient capital to fund the Companys operations; the effectiveness of sales and marketing efforts; the Companys ability to obtain FDA approval or other regulatory approvals in the United States or elsewhere for other indications for neratinib or other product candidates; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support the Companys drug candidate claims; even if approved, the risk that physicians and patients may not accept or use the Companys products; the Companys reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates; risks pertaining to securities class action, derivative and defamation lawsuits; the Companys dependence on licensed intellectual property; and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170830006310/en/

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Puma Biotechnology Announces Publication of Abstracts for ESMO 2017 - Markets Insider

Merck Ventures has joined the Series A investor syndicate of the British immuno-oncology specialist Macrophage Pharma Ltd.

Merck Ventures extended the 9m (9.8m) Series A investment made by CRT Pioneer Fund, Novo Holdings A/S and Aglaia Biomedical Ventures BV in January with an equal size of investment. Macrophage Pharma said it will use the proceeds to finance Phase I clincial trials of its lead candidate p38MAPi, a macrophage-targeted p38MAP kinase inhibitor and the development of two further macrophage modulators of the tumour microenvironment, currently in discovery stage. Clinical trials are scheduled to start in 2018.

Macrophage Pharmas in January acquired several drug candidates and licenced Esterase Sensitive Motif (ESM) technology platform from Chroma Therapeutics Ltd (Oxford, UK). ESM technology chemically adds specific cell delivery signalling molecules to active drugs as a means of transporting them into macrophages or monocytes. The resulting pro-drug is cleaved by esterases in the cell, accumulating the active substance intracellulary, which results in increased potency and duration of action.

Specific types of macrophages are attracted by tumours, when they come under attack of the immune system, and help to modulate the tumour microenvironment in a manner that promotes cancer survival and that puts the brakes on tumour specific immune responses. Such macrophages are an attractive drug target in immuno-oncology approaches aimed at triggering re-activation of the body's natural immune system to fight cancer but the cells can also be used as drug carriers.

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Macrophage Pharma backed by Merck Ventures - European Biotechnology

Photo: Contributed Photo / Hearst Connecticut Media

Sonics Executive Vice President Lauren Soloff, left, stands with CEC Co-Chairs Joe McGee and William Tong at the Sonics headquarters in Newtown, Conn., in August 2017.

Sonics Executive Vice President Lauren Soloff, left, stands with CEC Co-Chairs Joe McGee and William Tong at the Sonics headquarters in Newtown, Conn., in August 2017.

Connecticut a major player in growing biotechnology sector

The growing biotechnology corridor in the region and improved collaboration between government and manufacturing companies are among the major focuses of the state Commission on Economic Competitiveness, said the co-chairmen of the commission during a recent visit to a Newtown manufacturer.

Life sciences is an area that can really become a major part of Connecticuts growing economy, said Joe McGee, co-chairman of the commission and also the vice president of public policy and programs at Stamford-based Business Council of Fairfield County. Precision medicine and its potential is an economic driver in the state.

McGee, along with co-chairman and state Rep. William Tong, D-147, last week toured Sonics & Materials, a Newtown-based manufacturer of ultrasonic liquid processors, plastic assembly equipment and metal welding systems. Formed in 1969, Sonics has developed a line of advanced ultrasonic liquid processors for applications in DNA sequencing and nanoparticle dispersion.

Its just unbelievable that a company, sitting in Newtown, Connecticut, has a machine that is critical for the sequencing of DNA, McGee said. It just shows you the viability of the Connecticut manufacturing sector.

McGee and Tong said Connecticut is a major player in a burgeoning biotechnology corridor that stretches from New York City into the Nutmeg State. Companies such as Sonics, which employs 75 people, and larger players such as Mount Sinai in Stamford, Boehringer Ingelheim in Ridgefield and Jackson Laboratory in Farmington make Connecticut a force in the life sciences industry, they said.

Tong said the New York City Department of Economic Development recently met with the Connecticut Health Data Collaborative and announced it is investing money to have biotechnology firms migrate into Connecticut.

They need Connecticut and we need them, Tong said. Its a big component of Connecticuts economic future.

Tong said the growing field will help the state reach its lofty expectations associated with the CT 500 program, the goal of which is to create 500,000 private-sector jobs in the state in the next 25 years.

McGee said the biotechnology corridor has a broad reach and it has only recently been targeted as a major economic driver for the state. The Commission on Economic Competitiveness, or CEC, is performing an asset analysis of the industry.

Its one of those things thats been hiding in plain sight, McGee said. There are a lot of places here of significance.

The CEC was created by the state Legislature in 2015 and is made up of lawmakers and private sector leaders with the goal of strengthening and improving the states economic competitiveness.

Lauren Soloff, executive vice president at Sonics, said McGee and Tong talked at length with employees and had a lunch outside after the tour. Soloff, a Westport resident, said the co-chairmen discussed how companies such as Sonics can partner with community colleges and vocational schools to strengthen the curriculum for advanced manufacturing programs.

Its nice to shine a bright light on some of the positive things happening in Connecticut, she said. It was an extremely positive meeting. They are both realists, but optimistic. It was one of the more upbeat visits weve ever had.

cbosak@hearstmediact.com; 203-731-3338

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Connecticut a major player in growing biotechnology sector - Danbury News Times

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In September the International Conference on Natural Product Biotechnology (ICNPB)will be held at Aberdeen Exhibition and Conference Centre (AECC) in collaboration with the major International Conference on the Mechanism of Action of Nutraceuticals (ICMAN) and theInternational Union of Basic and Clinical Pharmacology (IUPHAR) Natural Products Section joint conference.

ICNPB takes place on 25-26 September, before ICMAN-IUPHAR on 27-29 September. These conferences willbring together the life science and biotechnology communities to discuss natural resources, sustainable ingredients and ways of using them to produce nutraceuticals and pharmaceutical ingredients.

Conference director Jim Brown said: We are looking forward to a fantastic week at the AECC, learning about the great science thats going on is this field.Its an area where Scotland hasgreat strengths, with some really innovative businesses drawing on our marine and agri-food resources, coupled with thereal depth of expertise and knowledge embeddedin our research networks.

The conference received a grant from VisitAberdeenshire, which helped secure the conference for the city. Jenni Fraser, business development director of VisitAberdeenshire said: For Aberdeen to have attracted three globally renowned conferences shows real confidence in the region. Hosting association congress like this generates significant income to the area, and the Natural Products Biotechnology conference alone will generate over 200,000 for the local economy through hotel bed nights, restaurants and other visitor attractions. We are looking forward to welcoming the conference and delegates to Aberdeen.

Steven Daun, associations sales manager at AECC commented: We are delighted to be hosting this event in Aberdeen; showcasing the world class research that takes place in the city and the wealth of life science knowledge that we have here in Scotland. With ICNPB being held in conjunction with ICMAN-IUPHAR, delegates can benefit from attending both events with one visit.

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Life Science and Biotechnology communities head for Aberdeen - Conference News

Collecting leachate from a capped landfill site. Credit: Bangor University

Far from being a load of rubbish, landfill sites should be considered one of the great untapped resources in the search for new enzymes for biotechnology, and could fuel more efficient biofuel production.

A new research paper in mSphere by biologists at Bangor and Liverpool universities has for the first time identified the enzymes which degrade natural materials such as paper and clothing in landfill sites.

James McDonald, from Bangor University's School of Biological Sciences, who led the research said:

"There is a current impetus to search for new enzymes to improve biomass conversion processes. Our hypothesis is that, due to the volume of waste materials they hold, landfill sites represent a repository of unexplored biomass-degrading diversity. There is significant potential to identify new enzymes of ecological and biological significance."

Cellulose and lignin occur naturally in plant-based materials and take longer to decompose than other waste products. As a result of this, the majority of landfill waste consists of lignin and cellulose. In their plant form, they can be used as the basis for biofuel production, and identifying more effective enzymes for this process would improve the yield from this source.

Scientists have been searching for a number of years for the most effective enzymes which break down the cellulose and lignin within the residual natural fibres. The obvious place to search has been in the rumen of sheep and cows, who eat grasses, and the guts of also other plant eaters such as elephants and termites.

Surprisingly perhaps, landfill sites share many of the same characteristics as the digestive systems of these animals: they are dark, anoxic or un-oxygenated spaces, with a high content of cellulose. It was therefore to landfill sites, which are artificially created 'systems', that this group of scientists turned to find new plant-degrading enzymes.

Within in the paper, the authors describe how they used the liquid or 'leachate' within landfill sites as a source of microbes to decompose cotton, and analysed not only the families or taxa of bacteria, but also identified which bacteria produce groups of enzymes to degrade cellulose.

Emma Ransom-Jones, a postdoctoral researcher at Bangor University, and lead author of the study said:

"Understanding exactly how the cellulose and lignin decompose, and the sources of the active enzymes in the process will enable us to determine ways to improve the degradation of waste in landfill sites, and potentially use this as a source for biofuel production."

Explore further: Enzyme shows promise for efficiently converting plant biomass to biofuels

More information: Emma Ransom-Jones et al. Lignocellulose-Degrading Microbial Communities in Landfill Sites Represent a Repository of Unexplored Biomass-Degrading Diversity, mSphere (2017). DOI: 10.1128/mSphere.00300-17

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Biotechnology researchers turn to landfill sites - Phys.Org

Evotec's immunology spin-out Topas Therapeutics has inked a multi-year R&D collaboration with pharma major Eli Lilly. The initial focus of research, which will be financed by Eli Lilly, is on identification of antigens that specifically induce a T regulatory cell response in inflammatory and auto-immune disorders.

Using the company's nanoparticle platform, the collaboration will initially focuson identification of inflammatory or autoimmunity-inducing antigens that trigger immune tolerance through activation of regulatory T cells responses in liver stem cells. Specifically, Topas targets peptide-loaded nanoparticles towards liver sinusoidal endothelial cells (LSECs), which are one of the body's premier sites to induce tolerance against bloodborne antigens by generating peptide-specific regulatory T cells.

Under the terms of the agreement, Topas will be responsible for conducting pre-clinical proof-of-principle studies in collaboration with Lilly to generate drug candidates. According to the contract, Lilly may licence and advance development of all candidates originating from the collaboration. Topas will receive R&D funding and participate in the future success of any compounds in-licensed by Lilly. Financial details of the collaboration have not been disclosed.

Topas Therapeutics was spun out in March from Evotec's subsidiary Bionamics GmbH. The company, which uses a groundbreaking nanoparticle technology to target autoimmune and inflammatory diseases via the induction of antigen-specific immune tolerance in the liver, has14m of venture capital fromEpidarex Capital, EMBL Ventures and Gimv in its pockets. Evotec is its largest shareholder.

Topas has several candidate peptides under preclinical development, the most advanced expected to come to the clinic in 2018 is intended to treat multiple sclerosis.

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Topas Therapeutics lands option deal with Eli Lilly - European Biotechnology