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The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Partners. The readout also represents the second late-stage win for the Merck and Kelun-Biotech asset, called sac-TMT.
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After a sluggish 2025, biotech IPOs have roared back to life. Fueled by resilient stock performances and improving market sentiment, the total number of public debuts so far this year has already eclipsed 2025’s total.
Biopharma is entering its second-quarter earnings season riding high on a wave of massive deals and venture capital flow, plus a clearing of regulatory and policy overhangs. What can industry watchers expect to hear on the upcoming investor calls?
Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
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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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Erika Cheung testified that the data manipulation happened “frequently,” in order to make the company’s lead asset look good to investors.
Hong Kong-based Prenetics Group Limited, a medical diagnostic startup, is making its debut on the Nasdaq through a merger with Artisan Acquisitions Corp. The deal is valued at $1.25 billion.
FDA external advisors will meet to consider Pfizer and BioNTech data in support of booster shots. The two companies also expect to file for Vaccine Authorization for children in the coming months.
The FDA awarded a number of designations for Takeda’s candidate drug EXKIVITY in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.
Amylyx’s decision to submit the NDA, announced Wednesday morning, came on the heels of recent discussions with the FDA, including a pre-NDA meeting held on July 15.
Data coming in about the COVID-19 pandemic shows some promising overall trends, with other more disturbing ones, particularly in breakthrough infections of the fully vaccinated.
FDA has been actively greenlighting a number of efforts over the last few days to push therapies for rare or serious diseases that have largely unmet medical needs. Here’s a look.
The mobile app, dubbed Brisa, has been designed to help patients record their disease progression regardless of condition and treatment plans.
Brukinsa was approved for MSL patients who have received at least one anti-CD20-based regimen.
According to the study, people who get sick enough to be hospitalized due to the virus might eventually suffer from a full-blown autoimmune disease later on.