Drug Pricing News & Analysis
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Live headlines from leading pharma and regulatory news sources. Links open original articles.
Travere wins long-awaited approval for kidney disease drug
The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1 billion annually.
J&J leans on Tremfya, cancer drugs to overcome Stelara losses
A growing multiple myeloma franchise helped the pharmaceutical giant top Wall Street's expectations and surpass $15 billion in first-quarter drug sales.
Lilly boosts ADC portfolio with CrossBridge Bio deal
Worth up to $300 million, the buyout is Lilly's latest of an ADC maker and adds technology for making "dual-payload" therapies.
Novo teams with OpenAI; Ideaya gets muted response to eye drug data
Novo intends to "fully integrate" AI capabilities across its operations. Elsewhere, Regeneron made its first foray into radiopharmaceuticals and a GSK cancer drug showed early promise.
Spyre drug for inflammatory bowel disease shows promise in early study
The therapy, which works similarly to Takeda's blockbuster Entyvio, showed remission rates that suggest a "best-in-class" profile, the company said.
Allogene data suggest ‘off-the-shelf’ CAR-T could delay relapse in lymphoma
Initial results from a high-stakes trial indicate the biotech may have finally found a niche in lymphoma care for a donor-derived cell therapy.
Revolution pancreatic cancer drug nearly doubles survival in key trial
The subject of buyout rumors this year, Revolution posted Phase 3 results one analyst called a "game changer" in a tough-to-treat tumor.
Connected medical devices: Smarter care starts here
Connected medical devices are transforming healthcare and clinical trials, driving advances in patient care and next-gen therapies shaping the future.
FDA tells Eli Lilly to round up more safety info on key obesity launch Foundayo
Even as Eli Lilly gets underway with its next major obesity launch in Foundayo, the FDA's approval letter for the oral treatment shows lingering reservations about multiple "unexpected serious" risks
J&J, chasing $100B year, sports immunology ‘dual powerhouse’ of Tremfya and new launch Icotyde
Protagonist Therapeutics-partnered Icotyde has the potential to become one of Johnson & Johnson's "largest products ever," CEO Joaquin Duato said on the company's first-quarter earnings conference
Novo taps OpenAI to deploy AI across R&D, manufacturing and corporate functions
The AI will be used to analyze complex datasets and shrink R&D timelines, Novo said. It'll additionally use the tech to seek efficiencies across manufacturing and corporate functions.
Pfizer rebuked by FDA for misleading Adcetris ads on Facebook
The FDA has scolded Pfizer over Facebook ads for the cancer drug Adcetris, accusing the Big Pharma of failing to adequately communicate the indication, contraindications and risks.
Despite uncertainties, Travere’s Filspari emerges as first FDA-approved FSGS treatment
From a negative phase 3 readout and a seemingly tightening regulatory climate to a grueling three-month review extension, Travere has defied the odds, securing Filspari a landmark FDA approval as the
Regulatory tracker: FDA signs off on generics for AstraZeneca's Farxiga
In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for
Lilly’s Jaypirca shows fixed-duration power in ‘ambitious’ phase 3 CLL trial win
Eli Lilly has chalked up another victory in the chronic lymphocytic leukemia space, as its BTK inhibitor Jaypirca delivered its fourth positive phase 3 readout in the blood cancer, this time as an ind
ViiV launches ‘Still Here’ campaign aimed at reminding young people about HIV
GSK and Shionogi’s ViiV Healthcare is seeking to raise awareness around what the company sees as a forgotten element in HIV: young people with the infection.
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