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Today's Big NewsJun 1, 2023 |
| By Max Bayer Eikon Therapeutics has added three clinical-stage candidates and a suite of preclinical assets to its portfolio after raising more than $600 million since launching. |
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By James Waldron Novartis has acquired a priority review voucher from Pharming for the bargain price of $21.1 million, thanks to some canny dealmaking dating back a few years. |
By Nick Paul Taylor AstraZeneca is abandoning a play for the inflammatory bowel disease market. After seeing clinical trial timelines spiral, the Anglo-Swedish drugmaker has stopped development of a would-be rival to products sold by AbbVie and Johnson & Johnson. |
By Annalee Armstrong It took the FDA 500 days to impose a partial clinical hold on Molecular Template’s clinical trial for a CD38-directed cancer candidate but just 55 to lift it. |
By Nick Paul Taylor Bayer is joining Blueprint Medicines, Incyte and Pfizer in the race to develop a selective CDK2 inhibitor, paying Cedilla Therapeutics an undisclosed sum for a preclinical challenger to the more advanced rivals. |
By James Waldron Genfit has added a third liver failure candidate to its portfolio courtesy of a licensing deal with Seal Rock Therapeutics potentially worth up to 100 million euros ($107 million) in biobucks. |
By James Waldron Infinity Pharmaceuticals can breathe easy—the risk of its merger with MEI Pharma being derailed by a surprise outside bid appears to have passed. |
By Max Bayer Ariceum is paying $2.5 million in cash for British biotech Theragnostics. The acquisition brings with it a couple of assets, for which the German company could end up handing out an additional $41.5 million in milestone payments. |
By Eric Sagonowsky After winning FDA approvals one month apart, Pfizer and GSK are set to launch competing RSV vaccines this fall. |
By Anastassia Gliadkovskaya More than a quarter of patients believe the payment experience has gotten worse. Four in 10 patients said they’re likely to cancel or postpone care without an accurate cost estimate. And nearly three-quarters of patients find an online option for payments to be important. |
By Andrea Park A year after its neuromodulation device became the first non-drug treatment cleared by the FDA to relieve chronic pain associated with fibromyalgia, NeuroMetrix is one step closer to adding another first-of-its-kind indication to the technology. |
By Joseph Keenan Alcanza Clinical Research and Climb, a software provider, have inked a partnership focused on streamlining digital clinical trials for sites and patients. |
By Kevin Dunleavy In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA warned on Tuesday. Some compounding pharmacies are using unauthorized versions of semaglutide, according to the FDA. |
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| This week on "The Top Line," we discuss the 20 most influential people in biopharma, plus a topical gene therapy, a new opioid overdose medication, and the rest of the week's headlines. |
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| eBookSee how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
| WhitepaperThis paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
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| 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 |
| WhitepaperThis 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 |
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| WhitepaperExplore 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 |
| WhitepaperFor 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 |
| WhitepaperLearn 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
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| WhitepaperExplore 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 |
| WhitepaperPlanning 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 |
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