Biotech News

  • Lilly to invest $470M in new North Carolina drug plant
    by Kristin Jensen on 22 Gennaio, 2020 at 9:00 pm

    Factory will employ 460 after it becomes operational in 2023.  

  • Safety risks highlighted in FDA letter on Sarepta's Vyondys
    by Jonathan Gardner on 22 Gennaio, 2020 at 5:11 pm

    In rejecting Vyondys last August, one FDA official wrote that, without confirmatory trials for either of Sarepta's muscular dystrophy drugs, it's difficult to judge whether they're worth the risk.

  • Drug trial success a consolation prize for Akcea, Ionis
    by Ned Pagliarulo on 22 Gennaio, 2020 at 4:55 pm

    Although Novartis chose not to license Akcea and Ionis' high triglyceride drug, positive data could open up new development opportunities.

  • FDA Greenlights First Treatment for Rare Autoimmune Eye Disease
    by Jonathan Smith on 22 Gennaio, 2020 at 4:10 pm

    An antibody drug developed by the Irish biopharma Horizon Therapeutics has been approved by the FDA for the treatment of adults with the rare autoimmune condition thyroid eye disease. The approval of the drug came ahead of schedule, with the decision originally expected in March. The drug, a monoclonal antibody, is branded as Tepezza. Thyroid eye disease, also known as Graves’ ophthalmopathy, is an autoimmune condition where antibodies inflame muscles behind the eye, causing bulging of the eyes. This can lead to eye pain and double vision. The condition is often seen in people with autoimmune diseases targeting the thyroid gland, such as Graves’ disease. Prior to Horizon Therapeutics’ Tepezza, there was no drug approved for thyroid eye disease. “This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non‑surgical treatment option,” stated Wiley Chambers, Deputy Director of the FDA’s Division of Transplant and Ophthalmology Products. Tepezza is designed to treat thyroid eye disease by inhibiting a protein called insulin-like growth factor-1. This protein contributes to the inflammation in the eye muscles in thyroid eye disease, so blocking it can reduce the bulging of the eyes. The FDA’s approval was based on results from a phase III trial announced in 2019, The post FDA Greenlights First Treatment for Rare Autoimmune Eye Disease appeared first on Labiotech.eu.

  • Kintai’s obesity drug that works via the gut microbiome moves closer to the clinic
    by Angus Liu on 22 Gennaio, 2020 at 3:45 pm

    Microbes that live in the gut are believed to play an important role in human metabolism. Kintai Therapeutics, a Flagship Pioneering portfolio company, says its drug candidate that leverages the microbiome showed sustained weight loss, as well as markers of improved glucose control and liver health in rodents.

  • Off-The-Shelf Lung Cancer Vaccine Clinical Trial Gets €20M Boost
    by Jonathan Smith on 22 Gennaio, 2020 at 3:03 pm

    The French-Belgian company PDC*Line Pharma has raised a €20M Series B round to fund an ongoing phase I/II trial of its off-the-shelf therapeutic vaccine for lung cancer. The total €20M consists of €13.9M in equity investments and €6.1M in loans and subsidies from the Walloon Region of Belgium. PDC*Line’s current investors took part in the round, as well as five newcomers. The new participants included the South Korean investors Korean Investment Partners, Shinhan Cognitive Start-up Fund, and UTC 2019 Bioventure Fund, as well as Belgian investors SRIW and Sambrinvest. PDC*Line will use the money to fund an ongoing phase I/II trial of its lead candidate therapeutic vaccine for non-small-cell lung cancer. The trial began last September, and is scheduled to be completed in August 2022. Lung cancer needs more effective treatments as it’s one of the most deadly forms of cancer, and more than half of people diagnosed die within one year. While checkpoint inhibitors are often used to treat this form of cancer, they only help a small fraction of patients. “Checkpoint inhibitors have around 25% of patients responding on average,” Eric Halioua, CEO of PDC*Line, told me. “The objective of our treatment is to get more than a 50% response rate.” PDC*Line’s treatment is based on a type of immune cells called dendritic cells. The post Off-The-Shelf Lung Cancer Vaccine Clinical Trial Gets €20M Boost appeared first on Labiotech.eu.

  • Targovax plans checkpoint combo trial after posting early data on oncolytic virus
    by Nick Paul on 22 Gennaio, 2020 at 12:51 pm

    Targovax has shared data from an early-phase trial that administered ONCOS-102 to mesothelioma patients. The response rate was lower in the ONCOS-102 arm than in the control cohort, but Targovax saw positives elsewhere, leading it to outline plans to pair the drug with a checkpoint inhibitor.

  • Korean VCs pile into PDC*line to bankroll NSCLC vaccine trial
    by Nick Paul on 22 Gennaio, 2020 at 11:13 am

    PDC*line Pharma has turned to Korean investors to help raise a €13.9 million ($15.5 million) series B round. The money will fund a phase 1/2 trial of a therapeutic vaccine in patients with non-small cell lung cancer that got underway last year.

  • How Does Compound Management Influence Drug Development Success?
    by Sponsored Post on 22 Gennaio, 2020 at 9:00 am

    Any compounds you use during drug discovery and development have started their journey long before they ended up in your lab. They have been collected, stored, processed, and then finally delivered to your bench. The process of compound management is highly complex and requires input from a number of experts. Just one little hiccup can ruin an entire research project and cost time and money.  “Compound management involves organizing the long-term storage of compounds in a high-security area and delivering individual compounds or associated collections of compounds to project teams in a short timeframe,” explains Olivier Casamitjana, Senior Vice President and Global Head of Compound Management at Evotec. “By receiving and registering compounds from the outside and organizing the delivery of compounds in the right format, concentration, and volume, compound management can contribute to a project’s success.”  Inaccurate compound management can greatly impact research projects. Loss or destruction of samples, delays in study onset, and high costs are just a few consequences of bad compound management. Therefore, compounds have to be stored with great care at exactly the right temperature, the right humidity, and the right luminosity in secured locations. This requires a high level of expertise.  Building a unique global compound management network Evotec has five compound management teams located in Europe and the US. The post How Does Compound Management Influence Drug Development Success? appeared first on Labiotech.eu.

  • FDA Publishes Initial Rejection Letter of Sarepta's Vyondys 53 for DMD
    on 22 Gennaio, 2020 at 12:00 am

    The CRL not only brings up the potential toxicities of the drug, but also raises questions about the drug’s efficacy.

  • 2020 Could be a Defining Year for SQZ Biotech
    on 22 Gennaio, 2020 at 12:00 am

    Armon Sharei, chief executive officer of SQZ Biotech, said 2020 is going to be an exciting year for the company as it anticipates having clinical data available from its first trial by the end of this year.

  • Few Companies Focus on Growing Threat of Superbugs: Report
    on 22 Gennaio, 2020 at 12:00 am

    A report released by the Access to Medicine Foundation shines a light on just how small the pipeline and discovery programs aimed at superbugs are.

  • Newly ID'ed T-Cells Have Potential to Become Universal Cancer Therapy
    on 22 Gennaio, 2020 at 12:00 am

    The researchers essentially identified a new T-cell and its receptor that appears able to search out and kill a broad range of cancer cells, including lung, skin, blood, colon, breast, bone, prostate, ovarian, kidney and cervical cancer cells.

  • The Next Big Thing in Birth Control: Amphora Offers Women a Missing Option
    on 22 Gennaio, 2020 at 12:00 am

    Amphora is a viscous and bioadhesive contraceptive, packaged in a prefilled applicator.

  • Boosting Proteins Could Help Remove Tangles and Plaques Associated With Alzheimer's
    on 22 Gennaio, 2020 at 12:00 am

    Research conducted at Temple University is showing a potential new way to address the onset of Alzheimer’s disease through the use of pharmacological chaperones.

  • China Coronavirus Update: What it is, How Dangerous it is, What is Being Done
    on 22 Gennaio, 2020 at 12:00 am

    The new coronavirus infection appears connected to a seafood market in Wuhan City in China, which has more a population of more than 11 million.

  • Why Should Professionals Seek out Employers with Diverse Workforces?
    on 22 Gennaio, 2020 at 12:00 am

    Let’s review the reasons why professionals seek out employers with diverse workforces.

  • T-Cell Discovery Could Herald Universal Cancer Immunotherapy
    by Jonathan Smith on 21 Gennaio, 2020 at 6:23 pm

    An international research team has found a new type of T-cell that could lead to cell immunotherapies able to treat cancers beyond the reach of current CAR T-cell therapies. Market-approved CAR T-cell therapies including Yescarta and Kymriah have revolutionized cancer treatment by modifying immune T-cells to hunt down cancer cells. However, these treatments are only approved to treat rare forms of blood cancer.  An international team led by scientists based at Cardiff University, UK, has found a new type of T-cell that could form the basis of a therapy for many types of cancer. According to a study published in Nature Immunology, a cell therapy based on these T-cells doubled the survival time of mice with leukemia, and killed melanoma cells in vitro. “If this transformative new finding holds up, it will lay the foundation for a ‘universal’ T-cell medicine, mitigating against the tremendous costs associated with the identification, generation, and manufacture of personalized T-cells,” stated Awen Gallimore, Professor at Cardiff University, who was not one of the study authors. The key advantage of the newly discovered cells lies on proteins called T-cell receptors, or TCRs, which are located on the surface of the cell and are responsible for identifying and killing cancer cells. The post T-Cell Discovery Could Herald Universal Cancer Immunotherapy appeared first on Labiotech.eu.

  • 5 biopharmas to watch as the decade's last earnings kick off
    by Ned Pagliarulo and Jacob Bell on 21 Gennaio, 2020 at 5:01 pm

    Novartis will have fresh Zolgensma sales numbers, while Biogen faces down analysts one more time on its aducanumab plans. Two biotechs, meanwhile, could give early glimpses into their first-ever drug launches. 

  • BeiGene cancer drug data sets up China duel with Merck
    by Jonathan Gardner on 21 Gennaio, 2020 at 4:55 pm

    Merck's Keytruda won the first PD-1 approval in China for a type of lung cancer, but Beigene's tislelizumab could make a run.

  • Alternate sites of care: The changing face of healthcare delivery
    by Parijat Sharma & Matt Ruple on 21 Gennaio, 2020 at 3:35 pm

    As the care setting evolves and diversifies, stakeholders throughout the healthcare ecosystem have to evolve in kind.

  • GSK nabs speedy review for one of its top prospects
    by Ben Adams on 21 Gennaio, 2020 at 2:30 pm

    With a new research team, outlook and more than a little help from the tech world, GSK has been quietly going about shoring up its pipeline.

  • How Biotech Startups Can Have a Stronger Position When Scaling Up
    by Jonathan Smith on 21 Gennaio, 2020 at 1:52 pm

    Scaling up the manufacturing process can be a daunting task for any biotech startup. Evelina Vågesjö, CEO of Swedish gene therapy biotech Ilya Pharma, and Jesper Hedberg, Director of the Testa Center facility, explained how testing at innovation facilities such as incubators and accelerators can help avoid big pitfalls in the scaling process later on.  At some point, a biotech startup will need to produce its product at a big scale. For example, regulators such as the FDA and EMA require a Good Manufacturing Practice standard for drugs to be approved. However, the process of scaling up production in the biotech world isn’t easy. “When you go up in scale, things start to happen,” Hedberg told me. “There are a lot of things that on a small scale take 20 minutes, which is perfectly doable, but then, on a large scale, it takes three days… You then perhaps need to look at technical alternatives to that particular technique.” One way for a startup to navigate this tricky step is to take the manufacturing of its technology for a test drive. Organizations such as the US SOSV, the Danish Accelerace, and the Dutch Planet B.io offer accelerator program services. While each type of ‘innovation facility’ varies, they typically provide startups with a lab space for hire, The post How Biotech Startups Can Have a Stronger Position When Scaling Up appeared first on Labiotech.eu.

  • WHO berates 'lack of innovation' when it comes to antibiotic pipeline
    by Ben Adams on 21 Gennaio, 2020 at 1:39 pm

    The World Health Organization has called out Big Pharma for its dearth of antibiotic innovation amid a growing threat of antimicrobial resistance.

  • Chi-Med stops pivotal pancreatic cancer trial upon early success
    by Nick Paul on 21 Gennaio, 2020 at 1:18 pm

    Hutchison China MediTech has stopped a phase 3 trial of surufatinib in pancreatic neuroendocrine tumors early for positive efficacy. An independent data monitoring committee found the trial had hit its primary endpoint by the time of an interim analysis, enabling Chi-Med to stop the study and start work on a filing for approval.