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Novo Nordisk’s shares fell 6% on Tuesday afternoon after its second quarter earnings report showed a slight miss for the Wegovy pill vs. consensus.
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If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.
The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.
The Phase 3 failure of AstraZeneca and Ionis Pharmaceuticals’ antisense therapy in transthyretin amyloid cardiomyopathy last month left the space reeling—and readjusting. BioSpace looks at five contenders and where they currently stand.
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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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The additional cuts, which will primarily occur between 2027 and 2029, will cost some $6 billion as the pharma tries to ride out a post-COVID headache while facing stiff patent headwinds for major products like the blood thinner Eliquis.
Latigo Biotherapeutics is looking to raise up to $285.2 million for a non-opioid analgesic, while BlossomHill Therapeutics is eyeing up to $129.1 million in proceeds for its oncology pipeline.
Pathos AI could pay more than $2 billion to a Jiangsu Alphamab Biopharmaceuticals subsidiary for a late-stage bispecific antibody-drug conjugate for breast cancer, while the financial details of the AstraZeneca agreement were not disclosed.
Positive two-year follow-up data for Otsuka Pharmaceuticals’ IgA nephropathy drug Voyxact could support the FDA’s ongoing review of Vertex Pharmaceuticals’ povetacicept, CEO Reshma Kewalramani said on the company’s second quarter earnings call.
Supernus Pharmaceuticals and Indivior Pharmaceuticals are outlining a combined expected $2.2 billion in annual revenue, plus $125 million in cost savings that will include “natural redundancies.”
BioNTech’s leadership transition was announced earlier this year, with CEO Ugur Sahin and CMO Özlem Türeci leaving to start a new mRNA company. Guido Oelkers of Swedish Orphan Biovitrum AB will take over as CEO in early 2027.
Novo Nordisk was banking on the inflammatory benefits of its investigational therapy ziltivekimab to improve cardiovascular outcomes. Last week’s Phase 3 failure dashed not just the Danish pharma’s hopes but that of other drugmakers working on the same pathway.
The hack is unlikely to affect Amgen’s financial reporting and other operations, nor does the pharma expect its ability to meet patient needs will be compromised.
As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market.
After an FDA advisory committee voted 9-3 on Wednesday against recommending Capricor Therapeutics’ Duchenne muscular dystrophy cardiomyopathy drug for approval, stakeholders allege an “ulterior motive” and “biased intentions.”