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From risk mitigation to program-level country and site strategy, IQVIA helped help this sponsor prove operational feasibility for six concurrent global studies. Download the case study.
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| By Fraiser Kansteiner,Zoey Becker,Angus Liu,Eric Sagonowsky,Kevin Dunleavy Many of the drugs on this list will be well known to industry watchers. Last year, bluebird, plus CSL Behring and uniQure, nabbed three gene therapy nods in quick succession. Elsewhere, Novartis’ established gene therapy Zolgensma continues to orbit the top of the price rankings. |
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By Nick Paul Taylor Novartis is buying a gene therapy candidate from the cash-constrained Avrobio, striking an unusual deal that will see it pay $87.5 million without committing milestones or royalties to land the clinical-phase asset. The news comes months after Novartis was reported to be lining up a takeover of Avrobio. |
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. |
By Andrea Park Less than two years after Pear Therapeutics went public in a SPAC deal worth $1.6 billion—which in turn came after the digital therapeutics maker had raised more than $400 million in venture capital—its assets were sold in an auction this week for just over $6 million. |
By Teresa Carey 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. |
By Fraiser Kansteiner It looks like Intercept Pharmaceuticals’ Ocaliva has a tough road ahead in nonalcoholic steatohepatitis after a panel of FDA advisers voiced concerns with the company's application package. |
By Nick Paul Taylor Moderna has early clinical evidence that its mRNA technology can treat a rare disease by replacing intracellular proteins. Participants in the phase 1/2 trial experienced a 66% overall relative risk reduction in the frequency of life-threatening events, encouraging the biotech to keep studying the candidate. |
By Kevin Dunleavy Diabetes and weight loss juggernaut Novo Nordisk has presented data from a phase 3 trial that show an oral version of its obesity drug Wegovy performs comparably to its original injected therapy. In the study, patients who received a 50 mg daily dose lost an average of 15.1% of their weight over 68 weeks compared to 2.4% for those on placebo. |
By Annalee Armstrong After a five and a half month wait, Mirati Therapeutics finally has the answer it’s been waiting for on a lung cancer med called sitravatinib. The therapy didn't work. |
By Angus Liu AbbVie and Genmab's CD20-targeted bispecific epcoritamab has won an FDA blessing in diffuse large B-cell lymphoma. The drug boasts what analysts view as a best-in-class profile against potential competition from Roche and Regeneron. |
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 Eric Sagonowsky After the recent high-profile loss of exclusivity for AbbVie's megablockbuster immunology drug Humira, industry watchers' eyes moved to Johnson & Johnson's Stelara as one of the next major drugs expected to face biosimilar competition. Tuesday, the industry got more information about when exactly that clash might occur. |
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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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Patient affordability can be complex, but it is essential to address as cost continues to be a driver of medication non-adherence, compromising overall health outcomes. This insightful executive summary provides key insights on the latest solutions. Download now.
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| Whitepaper Modern software development and its impact on addressing clinical trial complexity. Sponsored by: YPrime |
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