Biotech News

  • Hopkins team invents non-viral system for getting gene therapy into cells
    by Arlene Weintraub on Dicembre 6, 2019 at 4:31 pm

    Noninfectious viruses used to deliver gene therapy can still sometimes touch off dangerous immune responses. A team from Johns Hopkins Medicine has developed an alternative method for transporting large therapies into cells—including genes and even the gene-editing system CRISPR. It’s a polymer nano-container that biodegrades inside of cells.

  • We're not for sale, Alexion executives declare
    by Jonathan Gardner on Dicembre 6, 2019 at 4:10 pm

    After meeting with hedge fund Elliott Advisors, the biotech said its product switching strategy and drug pipeline will drive more value than seeking buyers.

  • Update: Cancer Immunotherapy Biotech Files for Insolvency
    by Jonathan Smith on Dicembre 6, 2019 at 2:50 pm

    Update (06/12/2019): Following the phase III failure of its immunotherapy drug for colorectal cancer in the summer, the German company Mologen has filed for insolvency. Published 06/08/2019 A DNA immunotherapy drug developed by the German company Mologen has failed to improve the survival of patients with colorectal cancer in a phase III trial. The phase III trial tested the potential of Mologen’s lead DNA immunotherapy drug lefitolimod as a monotherapy to control colorectal cancer in patients who were in between chemotherapy sessions.  Disappointingly for Mologen, patients given the company’s drug lefitolimod didn’t survive longer than patients given regular care after chemotherapy, with both groups averaging around 22 months. Mologen’s drug lefitolimod is a dumbbell-shaped DNA molecule that activates a protein called Toll-like receptor 9, which is involved in mobilizing the immune system against tumors and infections. The drug previously showed potential for controlling colorectal cancer in between chemotherapy sessions in a phase II trial, but these results weren’t supported in the recent phase III results. Having failed as a monotherapy, it’s possible that Mologen’s drug could work combined with checkpoint inhibitor drugs, which have become the staple drug to use in cancer combination therapies. As a result, Mologen is shifting its focus to combining lefitolimod with other cancer therapies, The post Update: Cancer Immunotherapy Biotech Files for Insolvency appeared first on Labiotech.eu.

  • Dutch Startup Gets €9M to Create First Lab-Grown Pork Prototype
    by Clara Rodríguez Fernández on Dicembre 6, 2019 at 12:01 pm

    Dutch startup Meatable has raised €9M in a seed round that will allow the company to host a tasting of its first prototype of lab-grown pork by summer 2020.  The fundraising was led by the German VC BlueYard Capital, which had participated in Meatable’s previous €3M round last year. New investors include business angels Albert Wenger of Union Square Ventures and Taavel Hinrikus, founder of the European unicorn TransferWise. Part of the funding also comes from the EU’s Eurostars Programme. Meatable is developing a method to grow meat from a single animal cell. By taking animals out of the equation, this ‘cultivated’ meat could contribute to animal welfare while reducing greenhouse emissions, and land and water use. The technology, developed at the University of Cambridge, allows the transformation of animal stem cells into muscle cells, which are important for the mouthfeel, and fat cells, which contribute to the taste.    “The new funds will be used to expedite the first prototype to the summer of 2020, and to allocate more resources to post-production and scaling,” said Krijn de Nood, CEO of Meatable.  The concept of lab-grown meat has been around for a long time — Churchill is known for having predicted it back in the 1930s. But it wasn’t until 2013 that Mark Post, The post Dutch Startup Gets €9M to Create First Lab-Grown Pork Prototype appeared first on Labiotech.eu.

  • FDA hits Ipsen's $1B drug with clinical hold over safety signal
    by Nick Paul on Dicembre 6, 2019 at 9:12 am

    The FDA has placed two trials of palovarotene on partial clinical hold eight months after Ipsen gained the drug in its $1 billion (€900 million) takeover of Clementia Pharmaceuticals. FDA staff took the action in response to cases of early growth plate closure in children on the retinoic acid receptor gamma agonist.

  • Biogen's Rorschach readout continues as detailed Alzheimer's data divide experts
    by Nick Paul on Dicembre 6, 2019 at 7:17 am

    Biogen has shared the detailed data on aducanumab that it hopes will secure FDA approval in Alzheimer’s disease. The Clinical Trials on Alzheimer's Disease presentation cleared up some questions about the data set without delivering a telling blow for either side of the debate.

  • Cancer gene therapy backed by Blackstone gets trial win
    by Jonathan Gardner on Dicembre 6, 2019 at 12:02 am

    Results released Thursday are the first to be presented from a Phase 3 study of the therapy, which was recently made the cornerstone of a new company launched by Blackstone and Ferring.

  • Gilead Fends Off Monopoly Accusation from HIV Advocacy Group PrEP4All
    on Dicembre 6, 2019 at 12:00 am

    Earlier this week, an HIV-prevention advocacy group, PrEP4All Collaboration, filed a petition with the U.S. Patent and Trademark Office (PTO) alleging that Gilead Sciences intentionally delayed the development of a safer HIV drug.

  • BioSpace Movers & Shakers, Dec. 6
    on Dicembre 6, 2019 at 12:00 am

    Pharma and biotech companies strengthen their leadership teams and boards with this week's hires.

  • Biogen Alzheimer’s Plans Met with Hope, Some Skepticism
    on Dicembre 6, 2019 at 12:00 am

    Biogen’s plan to seek regulatory approval for aducanumab as a potential new treatment for Alzheimer’s disease is being met with hope for a needed therapy for a dreaded disease, but also some skepticism regarding its long-term efficacy and, ultimately, potential.

  • A conversation with Bob Volkmann, Founder of BioPharma Works– remotely managing multi-functional ...
    on Dicembre 6, 2019 at 12:00 am

    Saurabh Kapure, Vice President, Business Development, USA for Jubilant Biosys, recently sat down with Bob Volkmann, PhD, Founder and Chief Scientific Officer, at BioPharmaWorks.

  • FerGene’s Bladder Cancer Phase III Trial Hits Its Mark
    on Dicembre 6, 2019 at 12:00 am

    FerGene, a gene therapy company formed by Ferring Pharmaceuticals and Blackstone Life Sciences, reported that its Phase III trial of nadofaragene firadenovec (rAd-IFN/Syn3) met its primary endpoint.

  • Prescription Drug Prices Dip Slightly in the U.S., the First Time in 45 Years
    on Dicembre 6, 2019 at 12:00 am

    Prescription drug prices dropped 1% last year, the first time such a drop has occurred in the United States in 45 years. The drop was driven primarily by a greater reliance on generic drugs and much slower increases in branded drugs, according to a government study.

  • After Five Potential Blockbuster Wins This Year, Novartis Sees 25 More on Its Horizon
    on Dicembre 6, 2019 at 12:00 am

    Over the course of the past year, Novartis has seen significant success with the approval of five drugs that have blockbuster potential and the company sees an additional 25 potential blockbuster drugs in its pipeline.

  • Research Roundup: Metformin and Healthy Aging and More
    on Dicembre 6, 2019 at 12:00 am

    Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

  • Veritas Genetics Lays Off 50, Ceases US Operations in Light of Weak Investments
    on Dicembre 6, 2019 at 12:00 am

    Veritas Genetics was offering whole-genome sequencing for about $600, going head-to-head with companies like 23andMe and Ancestry.com. Earlier this week there were reports the company laid off 50 staffers and now they’ve announced they are ending operations in the U.S.

  • Alexion Board Rejects Stakeholder Recommendation to Sell the Company
    on Dicembre 6, 2019 at 12:00 am

    Shares of Alexion Pharmaceuticals have jumped nearly 5% after the company’s board of directors rejected a push for a sale of the company from one of its largest stakeholders, U.K.-based Elliott Advisors, Ltd.

  • The clearest picture of Biogen's Alzheimer's drug is still fuzzy
    by Jacob Bell on Dicembre 5, 2019 at 11:00 pm

    Biogen laid out its best case for aducanumab on Thursday, but even more detailed data couldn't clear up the uncertainties that have made its surprising decision to revive the drug so controversial.

  • Novartis partners with Amazon to revamp manufacturing
    by Kristin Jensen on Dicembre 5, 2019 at 8:43 pm

    The collaboration is one of many efforts underway at the Swiss pharma to more effectively manage a sprawling network of clinical and manufacturing sites. 

  • FDA knocks down Enzyvant candidate on manufacturing concerns after plant inspection
    by Kyle Blankenship on Dicembre 5, 2019 at 8:31 pm

    Privately held biotech Enzyvant was hoping its first shot at an FDA approval with a rare immunodeficiency disease candidate would come up in its favor. But the FDA has dashed those hopes, citing manufacturing concerns in a response letter—at least, for now.

  • Chutes & Ladders—Sanofi strategy chief Mansuri set to step away
    by Kyle Blankenship on Dicembre 5, 2019 at 7:04 pm

    Mansuri will step down from Sanofi strategy role; Ratliff takes lead at AMRI after brief LabCorp stint; Caraway taps Williams for chief role.

  • Novartis highlights 4 drugs of future in laying out R&D vision
    by Andrew Dunn on Dicembre 5, 2019 at 4:42 pm

    With more than 160 drugs in clinical testing, Novartis executives highlighted a few lesser-known therapies they will prioritize in the next few years.

  • Trial setback strikes blow to Sage antidepressant ambitions
    by Ned Pagliarulo on Dicembre 5, 2019 at 4:20 pm

    SAGE-217 failed to meet the main goal of a Phase 3 depression study, a result that cut the drugmaker's market value by roughly $4 billion.

  • Sage crushed by MOUNTAIN as phase 3 depression data fall short
    by Nick Paul on Dicembre 5, 2019 at 1:15 pm

    Sage Therapeutics’ key phase 3 trial in major depressive disorder has missed its primary endpoint. The failure of SAGE-217 to beat placebo wiped more than 50% off Sage’s share price as investors digested the implications of the data for a critical asset.

  • German Biotech Raises €7M Series A to Treat Acute Heart Failure
    by Jonathan Smith on Dicembre 5, 2019 at 1:01 pm

    4TEEN4 Pharmaceuticals has raised a Series A round of €6.9M to fuel the development of a first-in-class antibody drug that could reduce mortality in acute heart failure. The round was led by Brandenburg Kapital, a subsidiary of the German investment bank Investitionsbank des Landes Brandenburg. Other investors in the round, including business angels and private investors, were not disclosed.  4TEEN4 Pharmaceuticals, a German company previously known as Sphingotec Therapeutics, will use the money to begin phase I trials of its lead antibody drug. The trials are expected to launch in 2020. The antibody drug is designed to treat acute cardiovascular conditions such as acute heart failure, a condition where the heart is suddenly unable to pump enough blood to sustain the body. While treatments of chronic heart failure have improved over the last few decades, there are not enough effective treatments for acute heart failure. Around 4-7% of hospitalized patients with the condition die.  4TEEN4’s lead drug blocks the protein DPP3, which is released during heart failure. This protein disrupts the cardiovascular system’s efforts to control the damage, leading to organ failure. The company expects that blocking it could improve patient survival. Andreas Bergmann, CEO of 4TEEN4, stated that DPP3 is linked to many other conditions that involve organ failure, The post German Biotech Raises €7M Series A to Treat Acute Heart Failure appeared first on Labiotech.eu.