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The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee meetings last week for Replimune and Capricor Therapeutics only created more confusion and frustration.
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Pharma is definitely interested in making more deals. But what biotechs will come under the magnifying glass? BioSpace takes a look at companies that analysts see as near-term targets for buyouts.
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.
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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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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.
Asked on a second quarter earnings call if Pfizer could direct more money to M&A amid a feeding frenzy across the pharma industry, CEO Albert Bourla defended his strategy.
The anti-TL1A antibody from Merck’s 2023 Prometheus buy delivered positive mid-stage results in a skin condition but failed in a certain type of lung disease, the Big Pharma revealed alongside second-quarter earnings.
Lower vaccine demand across every market and more acute pressures in Germany led BioNTech to lower the midpoint of its sales outlook by almost 20%.
While both drugmakers face looming patent cliffs, analysts say joining forces could help Bristol Myers Squibb replenish its eroding portfolio—while the strategic case for AstraZeneca seems to be more mixed.
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.”