News
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FEATURED STORIES
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
GSK and Hansoh Pharmaceutical’s antibody-drug conjugate success validates their partnership, one of the many deals in which Big Pharma has tapped a China company for promising cancer candidates.
The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics.
Roche’s decision to discontinue the Ionis-partnered trials came soon after the biotech sustained a late-stage failure in ATTR-CM.
Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.
The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.
The late-stage miss is “surprising,” Stifel analysts said, given that Wainua’s mechanism of silencing transthyretin protein expression has previously proven effective.
GSK and Alector first partnered in 2021 to advance two antibodies for neurodegenerative diseases. Both assets have since failed to show significant clinical benefit.
An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
After being bought by Bain for $3.3 billion, Tanabe has reached a deal to sell its manufacturing unit and 17 products.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.