Drug Delivery
Drugmakers will have until the end of February to decide whether they want to participate in the second round of Medicare negotiations or not. CMS has until June 1 to send an initial offer for the adjusted prices.
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Suddenly the hottest thing in biopharma isn’t a new indication, disease target or modality—it’s manufacturing, and all of pharma is going to be vying for capacity and talent.
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.
Eli Lilly topped the list of the 20 biggest pharmas by market cap with a more than 39% improvement year-to-date in its share price. Other companies have not been so lucky.
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After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh speculate on the impending Trump administration, discuss current challenges faced by CEOs and weigh investment in GLP-1s.
The letters come amid the Outsourcing Facilities Association’s ongoing lawsuit against the FDA over the regulator’s decision to end the shortage for tirzepatide.
The Novo-Catalent deal now moving ahead highlights unprecedented investment in manufacturing, while also standing out as an exception to the unspoken rule of keeping M&As to less than $5 billion this year.
The FDA cited issues with a manufacturing facility as the reason for the rejection. J&J is currently “working closely” with the regulator to resolve these problems.
Novo’s latest investment comes just days after the U.S. FTC greenlit the highly contentious acquisition of Catalent, which analysts expect will help the pharma expand its production capacity.
Now that they’ve received the go-signal from both U.S. and EU anti-trust regulators, Novo Holdings and Catalent expect to wrap up their deal in the coming days.
The Institute for Clinical and Economic Review flagged five drugs whose prices were raised in 2023 with no evidence to support it. Meanwhile, the makers of these drugs have been reporting double-digit sales growth for many of these products.
A week after dining with Trump and his team at Mar-a-Lago, leaders at Pfizer and Eli Lilly have publicly stated that they intend to collaborate with the incoming administration on key issues affecting the pharma industry.
Ending the diagnostic journey for patients, particularly those with rare diseases, improves patients’ quality of life while reducing costs to healthcare systems.