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A legal dispute between the FDA and Eli Lilly over whether the highly anticipated obesity candidate retatrutide is indeed a biologic has come to a head as the company prepares to submit the medicine for approval.
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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.
FDA
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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Eli Lilly’s shares rose nearly 5% to $1,170 apiece in premarket trading as the company reported $23 billion in revenue for the second quarter. The company’s market cap is $1.02 trillion as of the end of July.
IPO
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
Amgen has discontinued Phase 1 obesity candidate AMG 513, leaving MariTide as its sole weight loss asset. Meanwhile, executives said the company’s late-stage pipeline is largely full and future business development will focus on earlier-stage opportunities.
Novo Nordisk CEO Maziar Mike Doustdar on a second quarter earnings call argued that failure is par for the course in the drug development business. The Danish pharma is focused on building out its pipeline to move past recent clinical roadblocks.
FDA
The industry has been abuzz since the weekend when talks of a potential mega-merger between Bristol Myers Squibb and AstraZeneca were reported. Meanwhile, Pfizer, Merck and others release second quarter earnings, with some disclosing pipeline discontinuations and cost-cutting measures. Finally, all eyes turn to the FDA in the wake of heated advisory committee meetings for Capricor Therapeutics and Replimune.
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.