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A cautionary tale illustrates how forging a deal with a Big Pharma can have unexpected and far-reaching tax consequences.
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Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
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Eisai Co., Ltd. and Biogen Inc. announced that three additional detailed analyses from the Phase IIb clinical study, evaluating the efficacy and safety of lecanemab for mild cognitive impairment due to Alzheimer’s disease and mild AD, were published in the peer-reviewed journals.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The Financial Times reported Thursday that WuXi AppTec is looking to sell its cell and gene therapy manufacturing unit, with facilities in Philadelphia, while WuXi Biologics wants to offload some of its production sites in Europe.
BMO Capital Markets analyst Evan Seigerman called it “another positive indication” for Eli Lilly, whose top-selling diabetes and weight loss drugs are gaining market share as manufacturing continues to expand, while noting the drugmaker could start to benefit heading into third quarter earnings.
Stephen Majors from the Alliance for Regenerative Medicine, which hosts the conference, spoke with BioSpace about what the more than 2,000 attendees can expect to learn next week in Phoenix about the pressing issues confronting the industry.
ImmunityBio will lay off 15 employees in California, mostly in El Segundo, effective Nov. 25. The company is also letting go 16 employees later this month.
To say that 2seventy bio’s short two years of existence have been dramatic is an understatement. CEO Chip Baird told BioSpace transparency and a committed staff have kept the biotech going through thick and thin.
Big Pharma companies Bayer and Johnson & Johnson are downsizing their New Jersey workforces while Pfizer cuts jobs in Ireland. Many of the layoffs are effective by the end of the year.
Eli Lilly’s investment in the LEAP Research and Innovation District in Lebanon, Indiana, has now jumped to more than $13 billion.
Designed to create hundreds of jobs and add up to $1 billion to Massachusetts’ gross domestic product by the start of 2030, MassBio’s five-year strategic plan addresses challenges including skill gaps and talent shortages.
Bristol Myers Squibb wins approval for the first novel schizophrenia drug in decades; Pfizer pulls Oxbryta from the market; new IVF and abortion laws could derail women’s health research; Roche touts CDK inhibitor deal and obesity pipeline and BioSpace heads to Meeting on the Mesa.
Amgen’s motion for dismissal was denied after a New York judge agreed the company did not sufficiently disclose to shareholders back taxes and penalties owed to the Internal Revenue Service.