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Biogen’s new data, presented at the Alzheimer’s Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.
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Biopharma is entering its second-quarter earnings season riding high on a wave of massive deals and venture capital flow, plus a clearing of regulatory and policy overhangs. What can industry watchers expect to hear on the upcoming investor calls?
Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Following recent meetings with the FDA and European Medicines Agency, Mereo Biopharma is designing a Phase III study of alvelestat to treat alpha-1-antitrypsin deficiency-associated lung disease.
With some proactive measures, you can make it more likely your stocks will remain yours in the event of a layoff.
Peter Marks described the steps the agency is taking to advance the development of gene therapies for rare disorders. This could spell good news in the near future for Sarepta Therapeutics.
BioNTech inked an exclusive worldwide license and collaboration agreement with OncoC4 to develop and commercialize its investigational anti-CTLA-4 antibody ONC-392 for solid tumors.
Takeda will advance its experimental drug for plaque psoriasis, TAK-279, to Phase III later this year after the TYK2 inhibitor met its primary and secondary endpoints in a Phase IIb study.
Karuna Therapeutics released data Monday from the Phase III EMERGENT-3 trial showing that KarXT met the primary endpoint, significantly improving symptom severity.
As demand for biotech talent increases, the need to offer competitive pay to the average employee puts financial pressure on companies to increase CEO pay as well.
Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
Sangamo Therapeutics lost two powerhouse partners Friday after it reported that both Novartis and Biogen discontinued focusing on gene regulation therapies in the neurology space.
On Feb. 28, Novavax issued a candid warning to investors: it may not be able to continue operations beyond February 2024. BioSpace takes a deep dive into the vaccine maker’s prospects.