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Cell and gene therapies for rare diseases often present unique obstacles that can be overcome using in silico approaches. Learn how in our on-demand webinar, and meet us at BIO to discuss how Premier Consulting can advance your CGT program to its next milestone. Premier Consulting. Built for Biotech℠.
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Today's Big NewsMay 23, 2023 |
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July 18-19, 2023 | Jersey City, NJ More panels and case studies providing real, practical experiences and solutions, including topics surrounding Investor Relations and Government Affairs. Save $500 when you Register before May 30th!
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| By Max Bayer ReNAgade Therapeutics is unveiling after closing a $300 million series A in the largest private fundraising round of the year to date. The new company's joint venture with Orna Therapeutics has already spawned a collaboration with Merck & Co. |
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By Nick Paul Taylor Wave Life Sciences’ antisense oligonucleotide WVE-004 has come up short in an early-phase trial. A year after Biogen and Ionis killed off a similar asset, the biotech is waving goodbye to WVE-004 after getting a look at early-phase clinical trial data in amyotrophic lateral sclerosis and frontotemporal dementia. |
By James Waldron April was a tricky month for Affimed. We already knew that a phase 2 fail prompted the end of plans to develop a bispecific antibody as a monotherapy in lymphoma. Now, Affimed has revealed that the resulting reorganization also meant a quarter of its employees were shown the exit. |
By Helen Floersh At ASCGT's annual meeting, the company presented new data showing the efficacy of its VivoVec and TumorTag tech in preclinical models of folate-receptor expressing tumors. |
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Explore the whole transcriptome with a prep that generates libraries in under 4.5 hours - including rRNA depletion - and delivers superior gene detection sensitivity with FFPE and low inputs. View the Data.
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By Annalee Armstrong Bristol Myers Squibb’s idiopathic pulmonary fibrosis therapy reduced the rate of lung function decline in a phase 2 study, providing the evidence needed to start thinking about a late-stage trial. |
By Nick Paul Taylor Achieve Life Sciences’ smoking cessation drug candidate cytisinicline has hit the mark in a second phase 3 clinical trial, filling in a key gap in the evidence needed to support approval. But, amid lingering doubts about the asset’s commercial prospects, Achieve still has a sub-$200 million market cap. |
By Annalee Armstrong CohBar and Morphogenesis will morph into TuHURA Biosciences in an all-stock transaction that will see the newly formed, publicly held company work on addressing the major limitations of existing immuno-oncology treatments. |
By Zoey Becker At Teva's recent investor day, CEO Richard Francis unveiled the company's new "focused" strategy, including a plan to cull some "loss-making" products in the generics portfolio. |
By Dave Muoio Scrutiny into Texas Children's Hospital's gender-affirming services for minors comes weeks after a Request to Examine was issued to Dell Children's Medical Center, which, per reports, has since lost several of its practitioners. |
By Andrea Park When Abbott reeled in FDA approval for its first leadless pacemaker last spring, it was playing catch-up with Medtronic, whose Micra implant became the first such device greenlighted by the regulator in 2016. Now, however, Abbott is hoping to leap ahead of the competition by being the first to earn the FDA’s blessing for a dual-chamber version of the technology. |
By Ben Adams A working drug to help reduce weight in obese patients has long been a dream within many pharma companies. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we''ll discuss the recent biopharma layoff trends, plus Elizabeth Holmes, Sarepta Therapeutics, Abbott's FDA approval, and the rest of the week's headlines. |
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Whitepaper ChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations. Sponsored by: Elucidata Corp., Cloud SAAS in Life Sciences R&D |
Whitepaper Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties. Sponsored by: Twist Bioscience |
eBook Discover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success. Sponsored by: EvidentIQ |
Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
Whitepaper This paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing. Sponsored by: Blue Matter, strategic consultants in the life sciences |
Research Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
Whitepaper For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
Whitepaper Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
Whitepaper Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| July 18-19, 2023 | Jersey City, NJ |
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