News
Biogen’s new data, presented at the Alzheimer’s Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.
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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.
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.
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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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The U.K.-based biotech is set to enter mid-stage studies for its depression drug this year, while two other GABAA modulators are poised for clinical trials in 2026.
Speaking at BIO2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory landscape.
The new version of the bill will still need to go through the entire House and Senate.
Andembry is the first monthly Factor XIIa inhibitor for the prevention of HAE attacks and will be available to patients “before the end of June,” CSL announced.
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines.
Findings that U.S. companies can sue foreign rivals despite limited business operations in the country could dissuade drug developers from targeting the U.S. market, potentially benefiting domestic producers of biosimilars.
BioNTech said in 2022 that it faced “threats of a groundless patent infringement suit” from a company that was “unable to bring to market any product to help in the fight against COVID-19.” Now, the mRNA biotech is buying that very company.
Sanofi paid a more than 300% premium on its acquisition of Vigil Neuroscience, suggesting a fierce battle to seal the deal. Across biopharma, companies are sometimes willing to put it all on the line for the right buyout. Novartis’ recent acquisition of Regulus for $800 million upfront provides a case study.
The program will bring together experts from across the FDA for a team-based review, rather than having an application move across numerous offices within the agency before getting a yay or nay.
Nearly $30 million in tax incentive awards are expected to add 1,519 new life sciences jobs in Massachusetts, with about 52% of the positions spread over Boston and Cambridge. Vertex, which received the largest award, will create hundreds of roles in Boston.