• EC Approves Shire's Recombinant Parathyroid Hormone for Hypoparathyroidism

    The European Commission granted  conditional marketing authorization for  Shire’s full-length recombinant human parathyroid hormone Natpar® (rhPTH[1-84]) used as adjunctive therapy in adult patients with chronic hypoparathyroidism whose serum calcium levels can’t adequately be controlled using standard treatment of calcium and vitamin D.The approval is the first in Europe for a hormone therapy for this indication, and was was based on data from the placebo-controlled Ph
  • PTSD Heritability Evidence Discovered

    Not long ago, psychiatric syndromes such as post-traumatic stress disorder (PTSD) were often dismissed, leaving patients to languish in fear and despair. Thankfully, advances in psychiatric and molecular medicine have allowed physicians to accurately diagnose PTSD symptoms and begin treating patients with various forms of therapeutic interventions. However, the underlying biological mechanisms that lead to disorders like PTSD have remained elusive.Now, a new study from the Psychiatric Genomics C
  • Anticancer T Cells Occupy Biopolymer Camp Sites in the Solid Tumor Wild

    Merely injecting anticancer T cells into the body is like dropping Survivorman into the wilderness, leaving him stranded and hoping that he can cope with whatever dangers come his way. T cells, however, are not as hardy as Survivorman. In fact, they are downright finicky. If they find themselves in an environment that lacks the right nutrients and means of eliminating wastes, they die within a couple of days. Also, they may surrender all hope, and stop working, if they are exposed to the self-de
  • GE Healthcare FlexFactory Selected for UBP's Taiwan mAb Facility

    United BioPharma (UBP) will use GE Healthcare’s FlexFactory ™ manufacturing platform at its new facility in Taiwan’s Hsinchu Industrial Park, focusing on late-stage clinical and commercial production capacity of therapeutic monoclonal antibodies, the companies said today.FlexFactory is a centrally automated, flexible biomanufacturing platform designed to allow manufacturers to quickly and easily establish biopharmaceutical manufacturing capacity within an existing building or a
  • Advertisement

  • Pfizer to Use Domain Therapeutics' bioSensAll Platform in GPCR Collaboration

    Domain Therapeutics will use its bioSensAll™ platform to profile the signaling of mutant G protein-coupled receptors (GPCRs), through a collaboration designed to improve and accelerate the validation of novel GPCR drug targets.No value was disclosed for the collaboration, which is intended to validate potential targets across a range of therapeutic indications by studying the structure-function relationships of various amino acid substitutions in each of the GPCRs. The indications were als
  • Enamine, EMBL Agree to Library Synthesis and Drug Discovery Services Collaboration

    Ukraine-based Enamine and the European Molecular Biology Laboratory (EMBL) agreed to a collaboration through which Enamine will provide library synthesis, medicinal chemistry, and biological services for EMBL’s small-molecule cancer drug discovery programs. Enamine will establish a team of full-time equivalent medicinal chemists to work on the project, which is focused on the development of cancer therapeutics with novel mechanisms of action, the organizations state.EMBL has an existing re
  • Enamine, EMBL Agree to Library Synthesis and Drug Discovery Services Collab

    Ukraine-based Enamine and the European Molecular Biology Laboratory (EMBL) agreed a collaboration through which Enamine will provide library synthesis, medicinal chemistry and biological services for EMBL’s small molecule cancer drug discovery programs. Enamine will establish a team of full time equivalent medicinal chemists to work on the project, which is focused on the development of cancer therapeutics with novel mechanisms of action, the organizations state.EMBL has an existing relati
  • CRISPR and Stem Cells Identify Novel Chlamydia Drug Targets

    Researchers at the Wellcome Trust Sanger Institute and their colleagues at the University of British Columbia have developed a novel method for studying how chlamydia interacts with the human immune system. They used a combination of gene editing and stem cell technologies to make the model that helped lead to the discovery of two genes from our immune system, IRF5 and IL-10RA, as key players in fighting a chlamydia infection. The results, reported in  Nature Communications , iden
  • Advertisement

  • EpimAb Raises $25M in Series A to Progress Bispecific Antibodies into Phase I

    Shanghai-based EpimAb Biotherapeutics raised $25 million in a Series A round of fundraising round to support the progress of its lead bispecific antibody candidate into Phase I trials next year. The financing was led by Oriza Seed Capital, and included investments by Decheng Capital, 3D Bioventures Capital and Trend Investment Group.“Today’s funding will give us the opportunity to broaden our pipeline and advance our first oncology program towards the clinic with plans to submit the
  • OncoMed Halves Workforce to Save Cash after Multiple Trial Failures

    Cancer therapeutics firm OncoMed is halving its workforce in a bid to save cash, after a disastrous two weeks during which its two lead candidates fail in Phase II trials, and partner, Bayer Pharma, decided not to exercise its option to license another two clinical candidates . OncoMed said it would now concentrate its efforts on earlier-stage clinical programs, and look for new partners for some of its drug candidates.The layoffs, announced late yesterday, will save about $60 million over the n
  • In Colorado, Politicians Choosing Fear Tactics over Science

    In Boulder County, Colorado, the fight against science by anti-GMO politicians continues this month. Though GMOs have increased yields and reduced environmental impact, county officials are attempting to block GMO crops from being grown on leased open land, a decision that flies in the face of science.
    This weekend’s Denver Post covers the story, explaining why Boulder County, and all of us, should choose science over fear tactics.
    Boulder County this month continued its misguided campaign
  • Food Choices Swayed by 'Behavior' Genes

    Do you crave fatty foods or salty snacks? Does the thought of chocolate make you swoon? Or do you—as you know you should—delight in fruits and vegetables? Whatever your food preferences, you are likely aware that they’re not strictly a matter of willpower. For better or worse, your diet is shaped by environmental, cultural, and social factors—and your genetics.Although people with eating disorders such as anorexia and bulimia have been evaluated for genes that influence d
  • Advertisement

  • Immune Pharma to Pursue Spinoff of Cancer Subsidiary Cytovia

    Immune Pharmaceuticals said today it will pursue a possible spin-off of its oncology subsidiary Cytovia in a restructuring intended to refocus the parent company on inflammatory disease and dermatology, as well as bolster its finances.Cytovia will focus on developing and commercializing novel immuno-oncology and hematology therapeutics, led by Ceplene ®(histamine dihydrochloride) , an immunotherapy treatment in late-stage development in combination with low-dose interleukin 2 (IL-2) for the
  • argenx Files for $74.75M Public Offering of ADS

    argenx, a Netherlands-headquartered firm developing antibody-based therapeutics for autoimmune diseases and cancer, filed for a $74,750,000 public offering of American Depository Shares to progress its lead autoimmune diseases antibody fragment toward Phase III development and advance a second anticancer antibody candidate through mid-stage studies.argenx is developing a pipeline of products based on its SIMPLE Antibody ™ platform. In its Form S-1 registration document, the firm said it pl
  • New Mass Spec Method Quickly Identifies Drug-Resistant Microbes

    Rapid identification of clinical samples for dangerous and drug-resistant types of bacterial infections is essential for physicians to accurately diagnose patients and administer the appropriate drug therapy. Now, new research from a team of scientists—presented recently at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)—describes a method for quickly assessing microbial pathogenesis using equipment already owned by most hospitals. The researchers
  • CytoSorbents Wins $1M SBIR Phase II Contract

    CytoSorbents said today it has been awarded a 2-year, roughly $1 million Small Business Innovation Research (SBIR) Phase II contract to further the development of its flagship product CytoSorb ® as a medical countermeasure for fungal mycotoxin blood purification.CytoSorb is an extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure, and death in common criti
  • Zai Lab Licenses Paratek's Late-Stage Aminomethylcycline Antibiotic for China

    Chinese firm Zai Lab is paying Paratek Pharmaceuticals $7.5 million upfront for an exclusive license to develop, manufacture, and commercialize the latter’s late-stage, broad-spectrum antibiotic omadacycline in China, Hong Kong, Macau, and Taiwan. Paratek will also be eligible to receive development, regulatory, and commercial milestones, plus sales royalties. Development of the drug in the designated territories will be overseen by a joint steering committee.Omadacycline is a once-daily o
  • Beta Blocker Found to Protect against Skin Cancer

     A new study finds that carvedilol, a drug typically used to treat high blood pressure, can protect against the sun-induced cell damage that leads to skin cancer. [Bradley T. Andresen PhD, Western University of Health Sciences]  
  • HitGen, TSRI, Calibr Partner on DEL Drug Discovery for Multiple Therapeutic Areas

    The Scripps Research Institute (TSRI) and its affiliate, the California Institute for Biomedical Research (Calibr) established a drug discovery and development collaboration with China’s HitGen, to identify new drug candidates in therapeutic areas including oncology, regenerative medicine and virology.The collaboration, which is HitGen’s fourth announced in 2017, will exploit the firm’s DNA-encoded library (DEL) technology to identify new small molecule leads against targets id
  • An Earth Day No-Brainer: Use Science To Conquer Famine

    Since 1970, we’ve recognized Earth Day every April 22.  The idea came from former Wisconsin Senator Gaylord Nelson.  After witnessing the massive 1969 oil spill in Santa Barbara, he became inspired to bring environmental protection to the forefront in Washington and arranged for a national teach-in on the environment as the Vietnam War raged on.
    One determined public servant helped transform anti-war energy into a larger conversation about protecting Mother Earth.
    Senator Nelson
  • An Earth Day No-Brainer:
 Use Science To Conquer Famine

    Since 1970, we’ve recognized Earth Day every April 22.  The idea came from former Wisconsin Senator Gaylord Nelson.  After witnessing the massive 1969 oil spill in Santa Barbara, he became inspired to bring environmental protection to the forefront in Washington and arranged for a national teach-in on the environment as the Vietnam War raged on.
    One determined public servant helped transform anti-war energy into a larger conversation about protecting Mother Earth.
    Senator Nelson
  • Naked Mole-Rats Use Glucose-Fructose Switch to Survive Suffocating Conditions

    The naked mole-rat is even more remarkable than we knew. Renowned for its longevity, resistance to cancer, and ability to adopt the ambient temperature as its own body temperature, this unprepossessing rodent, this cold-blooded mammal, also has a previously unknown metabolic trick up its sleeve—or tucked into its wrinkled skin.The naked mole-rat, or sand puppy, can generate energy from fructose, bypassing the usual glucose pathway, which requires oxygen. This metabolic quirk explains how t
  • XBiotech Says EC Approval of Colorectal Cancer Antibody Is Unlikely

    XBiotech doesn’t hold out much hope that it will win European approval for its anticancer antibody therapeutic Xilonix ™ as a treatment for advanced colorectal cancer, after a European Medicines Agency (EMA) committee queried the clinical relevance of the treatment.XBiotech met with the European Medicines Agency to discuss the Day 180 List of Outstanding Issues related to its marketing authorization application (MAA) for the interleukin-1α- (IL-1α)-targeting True Hum
  • Oxford Cancer Biomarkers Licenses China Rights for Three Colorectal Cancer Tests

    Oxford Cancer Biomarkers (OCB) said it will expand the use of three of its in vitro diagnostic tests for colorectal cancer into China through a partnership with My-BioMed Biotechnology (MBM).The value of the collaboration was not disclosed.MBM, a China-focused precision medicine company launched last year, has gained rights to OCB’s ColoTox, ColoProg, and ColoPredict tests, and will build a biomedical laboratory in Ningbo Meishan Free Trade Zone.The three tests are among four biomarker dia
  • Preventing Graft-Versus-Host Disease in Stem Cell-Transplant Recipients

    An international group of scientists led by investigators at the Technical University of Munich (TUM) says it has discovered molecular mechanisms that might prevent the development of graft-versus-host disease (GVHD) in individuals receiving stem cell transplants. During GVHD transplanted stem cells become T lymphocytes, which are supposed to fight intruders such as bacteria. Instead, they start attacking the recipients already weakened body.Researchers from TUM and the Memorial S
  • Cause of Stroke Immunodeficiency Uncovered

    As if the devastating effects on the brain after having a stroke weren’t enough, new research from investigators at the Roslin, located on the University of Edinburgh's Easter Bush Campus, points to immune cells being damaged as a result of the acute neurologic event. Findings from the new study—published recently in Nature Communications through an article entitled “ Adrenergic-mediated loss of splenic marginal zone B cells contributes to infection susceptibility after stroke
  • Pharco, MPP Ink Deal for Affordable HCV Therapy in High Prevalence Countries

    The Medicines Patent Pool (MPP) inked a license and technology transfer agreement with Egyptian drug manufacturer Pharco Pharmaceuticals covering affordable supply of the late-clinical-stage pan-genotypic hepatitis C virus (HCV) drug, ravidasvir (PPI-668), in certain low- and middle-income countries (LMICs) with  high hepatitis prevalence, including Russia, Ukraine, Egypt and Iran.Ravidasvir is a direct-acting antiviral (DAA) NS5A inhibitor that has been evaluated successfully as combinatio
  • Earth Day: Reflecting On The (Major) Role Of Science In Agriculture

    Each year on April 22, we celebrate Earth Day, and have the chance to pause and reflect on the health, safety, and future of our planet. As we think about the importance of environmental protection and its impact on our lives, science plays an important role to help support and address solutions to environmental challenges. In honor of this year’s 47th annual Earth Day, GMO Answers reached out to Janet Carpenter, an agricultural economist, for her insights into some of today’s agricu
  • Announcing Buzz of BIO Winners at #BIO2017

    We’re very pleased to announce the winners for the 2017 Buzz of BIO contest of the BIO International Convention.
    Remember, you can still apply to present at the BIO International Convention. Company presenters tend to receive double the number of requests than non-presenters, and schedule twice as many meetings than non-presenting companies. Learn more and apply here.
    We’re pleased to introduce you to our winners:
    Technologies of TomorrowNanopareil, LLC produces ultra-high capacity s
  • BIO Convention Plays Key Role in Nevada’s New Model for Population Health

    Dr. Joseph Grzymski had an idea for a pitch. As the lead investigator for a Nevada-based project that would create a new model for understanding population health, his research team needed a way to make genetic testing available to thousands of people.
    Grzymski, an associate research professor of computational biology and microbiology at the Desert Research Institute (DRI) in Reno, knew just the company that could help: the personalized genetics company, 23andMe. But what was the best way to get
  • Diet Therapy Could Slow Cancer by Cutting Certain Amino Acids

    Cancer cells have an unnatural appetite for certain amino acids—nonessential amino acids that healthy cells produce themselves, usually in amounts sufficient for ordinary metabolism. If cancer cells are denied these amino acids, they are weakened. They grow and proliferate more slowly. It is possible, moreover, that they could be more vulnerable to conventional cancer treatments, such as chemotherapy and radiotherapy.The potential for diet therapies against cancer is being explored by a te
  • H3, Foundation Medicine Extend Precision Oncology Collaboration

    Eisai subsidiary H3 Biomedicine said today it has extended its more than 2-year-old collaboration with Foundation Medicine to discover and develop precision medicines in oncology.The value of the expanded collaboration was not disclosed.H3 is a member of Eisai’s global Oncology Business Group focused on cancer genomics based drug discovery by developing small molecules for cancer treatment . H3 and Foundation Medicine launched their collaboration in February 2015, joining Foundation Medici
  • Immune Pharma Licenses Cancer Treatment's Latin America Rights to Pint

    Immune Pharmaceuticals said today it has signed a letter of intent to license the lead asset of its oncology subsidiary Cytovia, the cancer treatment Ceplene ® (histamine dihydrochloride), throughout Latin America to Pint Pharma.As part of the deal, set to be finalized within 30 days, Pint has agreed to invest $4 million into Cytovia. The money will be used exclusively for oncology-related activities, the companies said.Under the licensing agreement, Pint will oversee registration of Ceplene
  • Education Sessions for #BIOWC17 Announced

    Education program session titles and speakers for the 2017 BIO World Congress on Industrial Biotechnology are now available on the conference website. The education program features seven diverse content tracks over three days of the conference, drawing speakers from across the globe. #BIOWC17 is the world’s largest industrial biotechnology and partnering event, and it will be held July 23-26, 2017 at the Palais des congrès de Montréal in Montréal, Québec,
  • UniQure Says It Will Not Pursue EC Marketing Renewal for Glybera Gene Therapy

    UniQure confirmed that it will not be looking to renew European marketing approval of the familial lipoprotein lipase deficiency (LPLD) gene therapy Glybera ® (alipogene tiparvovec) when the existing EC authorization expires later this year. The firm’s CEO, Matthew Kapusta, said the decision wasn't related to any risk–benefit concerns. Rather, UniQure indicated that there wasn’t enough demand for the treatment, given the significant costs associated with maintaining a manuf
  • Key Microscopy Advance May Open Door to New Therapies for Disease

    Scientists at Columbia University say they have made a significant step toward breaking the so-called "color barrier" of light microscopy for biological systems, allowing for much more comprehensive, system-wide labeling and imaging of a greater number of biomolecules in living cells and tissues than is currently attainable. The advancement has the potential for many future applications, including helping to guide the development of therapies to treat and cure disease, according to the investiga
  • AbbVie's Veliparib Fails in Two Phase III Cancer Combination Therapy Studies

    AbbVie’s investigational oral poly(ADP-ribose) polymerase (PARP) inhibitor veliparib failed in two Phase III combination therapy trials in patients with squamous non-small-cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). The firm confirmed that both studies failed to meet their primary endpoints and said full results would be published or presented at forthcoming medical meetings.AbbVie vp for oncology clinical development, Gary Gordon, M.D., Ph.D., pointed out that resea
  • Resistant Superbugs Meet Natural Foe in Phage Therapy

    When people get sick, they often think of bacteria as the cause of their illness and wouldn’t even begin to think of bacteria as having the capability of becoming infected themselves. Yet, scientists have known for decades about viruses that specifically attack bacteria—called bacteriophages or phages for short. Originally proposed as a therapeutic tool by French-Canadian microbiologist Félix d'Herelle in 1926, looking at these viral invaders again may help solve the growing p
  • Detox Molecule Moonlights as Regulator of T-Cell Metabolism

    Glutathione (GSH), best known for its antioxidant activity, is busier than we knew. The molecule also helps to regulate the metabolic activity of T cells. Although GSH is not needed for early T-cell activation, it promotes T-cell growth, sustaining immune responses to infection and cancer. This previously unknown function of GSH suggests new possibilities in autoimmune and immuno-oncology research.The new finding that GSH sits at the nexus of cellular metabolism and immune activation emerged fro
  • Lion Biotechnologies, MD Anderson Plan Clinical Trials of TIL Cancer Therapy

    Lion Biotechnologies will partner with The University of Texas MD Anderson Cancer Center to carry out multiarm clinical trials assessing the company’s tumor-infiltrating lymphocyte (TIL) therapy in ovarian cancer, various sarcomas, and pancreatic cancer, through a collaboration whose value was not disclosed.The multiyear strategic alliance will evaluate TIL therapy in multiple solid tumor cancers using two different TIL manufacturing processes. Lion and MD Anderson will both have manufactu
  • Earth Day 2017: Celebrating Soil Health!

    Saturday, April 22, 2017, is Earth Day.  At BIO, Earth Day is a reminder of the many ways that biotechnology has helped revolutionize farming and make it more environmentally friendly.  Not only are the world’s farmers producing more food than ever before, we’re able to do it in ways that conserve water, preserve soil nutrients, lessen the need for pesticide applications and reduce greenhouse gas emissions.
    One of the little-known environmental benefits of GMO crops is the
  • BioMed Realty Plans £35M Expansion of Babraham Research Campus

    BioMed Realty said today it will undertake a £35 million (about $45 million) expansion at the Babraham Research Campus in Cambridge, UK, that will nearly double its existing space for early-stage and growing biomedical users.The expansion will entail the construction of two new buildings totaling 108,000 square feet. The new buildings will consist of integrated laboratory and office facilities for life science companies that require expansion space and want to be within the environment and
  • Stem Cells Primed to be on Alert to Repair Tissue Damage

    Scientists report in a paper (“HGFA Is an Injury-Regulated Systemic Factor that Induces the Transition of Stem Cells into GAlert “) in Cell Reports about a new approach to speed recovery from a wide variety of injuries.“Our research shows that by priming the body before an injury, you can speed the process of tissue repair and recovery, similar to how a vaccine prepares the body to a fight infection,” said lead author Joseph T. Rodgers, Ph.D., who began the
  • MeMed Wins $9.2M DTRA Contract for PoC IVD to Reduce Antibiotic Misuse

    Israeli firm MeMed won a contract worth up to $9.2 million from the U.S. Department of Defense (DoD) Defense Threat Reduction Agency (DTRA) to complete the development of a point-of-care in vitro diagnostic platform that can distinguish between bacterial and viral infections and so help to prevent antibiotic misuse.MeMed’s diagnostic platform uses infection-specific immune system responses as immunological fingerprints to identify and distinguish between bacterial, viral, and noninfectious
  • Failed CF Drug Firm Nivalis to Merge with Immunotherapeutics Specialist Alpine

    Seattle-based immunotherapeutics firm Alpine Immune Sciences has agreed a merger with Nivalis Therapeutics, which has been evaluating potential strategic alternatives since January this year, after its lead cystic fibrosis (CF) drug, cavosonstat, failed Phase II evaluation. The stock-based transaction to combine the firms will see Alpine merged with a wholly owned Nivalis subsidiary. The joint entity will retain the Alpine Immune Sciences name, and will be owned 74% by Alpine shareholders,
  • ICYMI – NYT: The Cost of Not Taking Your Medicine

    We’ve long known that prescription medicines can yield substantial savings in other areas of healthcare spending by reducing costly hospitalizations, surgeries, visits to the emergency room and other non-drug drivers of health spending. More importantly, they also offer incredible life-saving and life-enhancing benefits to patients.
    Unfortunately, not all patients take their medicines as prescribed – which has a huge cost for both their personal health and for the healthcare system a
  • Thermo Fisher Scientific Sets Up Pathology Institute

    Thermo Fisher Scientific signed an agreement with the Institute of Medical Genetics and Pathology at University Hospital Basel, Switzerland, to establish the first partner in the Next Generation Sequencing Companion Dx Center of Excellence Program. The new initiative designed to develop and refine Thermo Fisher’s NGS-based research assays from its Oncomine™ oncology portfolio with the intent to eventually introduce them into the clinic as companion diagnostics.Both organizations will
  • Pfizer, HitGen Launch Drug Discovery Collaboration

    Pfizer will bolster its drug discovery effort by partnering with HitGen to discover unique small-molecule leads by building and screening novel DNA-encoded libraries (DELs), through a collaboration announced today whose value was not disclosed.The multiyear research collaboration and licensing agreement will apply HitGen’s technology platform and research capabilities toward the design, synthesis, and screening of multiple proprietary DELs for Pfizer’s drug discovery efforts, the com
  • A Codon’s Flanking Codons Affect Translational Efficiency

    When a ribosome cruises along messenger RNA (mRNA), it may stall at a particular codon, depending on which codons are nearby. In other words, codon context can influence the efficiency with which mRNA is translated and amino acids are attached to growing protein chains.New details about codon-context effects have been uncovered by scientists based at the University of Utah. These scientists, Kelly T. Hughes, Ph.D., and Fabienne F.V. Chevance, Ph.D., report that mRNA translation at a given codon
  • Theranos Settles with CMS

    Theranos will pay a $30,000 fine and will not operate a clinical laboratory for 2 years, under a settlement with the Centers for Medicare and Medicaid Services (CMS) that resolved more than a year of wrangling between the company and the regulator.The settlement, announced by the company yesterday, reduced the penalties Theranos could have faced had CMS prevailed against the company in court. As part of the settlement, CMS has withdrawn its revocation of the company’s Clinical Laboratory I

Follow @Biotech_News_AU on Twitter!