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The EPIC Act has been proposed with bipartisan and industry support to give small molecule drugs the same protection against price negotiation as biologics, but concerns over how to balance the federal budget could prevent a short-term fix to the IRA.
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At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
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Lilly expects to deliver strong financial and operational performance in 2023, highlighted by volume-driven revenue growth; potential launches for donanemab, mirikizumab, lebrikizumab and pirtobrutinib; potential regulatory submissions for tirzepatide in obesity; and numerous other anticipated pipeline advancements.
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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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Despite an uncertain legislative path to becoming law, the BIOSECURE Act has already impacted the biopharma industry’s confidence in Chinese service providers and prompted efforts to diversify manufacturing partners.
Taysha Gene Therapies looks to move past its pipeline culls and staff reductions by moving its lead asset into a possible billion-dollar market.
As congressional pressure increases on WuXi AppTec and other China-based companies over alleged ties to the Chinese government, India’s contract development and manufacturing organization sector could benefit.
Moderna on Tuesday announced it has been awarded $176 million by a consortium funded by the Biomedical Advanced Research and Development Authority to develop an mRNA-based vaccine to counter H5N1 avian influenza.
Donanemab, which will be marketed as Kisunla, will compete with Biogen and Eisai’s Leqembi.
Eli Lilly is expanding its radiopharmaceutical portfolio with a $140 million upfront payment to Radionetics Oncology and the exclusive future right to acquire the biotech for $1 billion.
This week on Denatured, Head of Insights Lori Ellis and guests discuss the implications of not addressing the DE&I data gaps for the future.
Samsung Biologics announced Tuesday it has signed its largest contract ever—a $1.06 billion manufacturing deal with an unnamed pharmaceutical company headquartered in the U.S.
Cartesian Therapeutics’ mRNA CAR-T therapy met its primary endpoint in a mid-stage trial for the chronic autoimmune disorder and expects to raise $130 million via private placement equity financing.
The Department of Justice and Securities and Exchange Commission are investigating two senior employees of Cassava Sciences in connection with allegations of data manipulation for its Alzheimer’s disease candidate simufilam.