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 regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its extended-release subcutaneous formulation of octreotide, which would allow more convenient once-monthly dosing for patients with acromegaly.
Monday’s lawsuits from Eli Lilly are the first to be filed by the pharma since the regulator officially removed tirzepatide from its drug shortage database earlier this month.
Starboard Value contends that Kenvue, with strong consumer health brands like Tylenol and Listerine, is underperforming its rivals, according to The Wall Street Journal.
Nucleus RadioPharma’s two sites are meant to help address the industry’s lack of manufacturing and development capabilities, as well as geographic limitations associated with the short half-life of many radioactive components.
Seaport Therapeutics, kick started by the former leaders of Karuna Therapeutics, has raised $225 million in an oversubscribed Series B to fund a pipeline of neuropsychiatric medicines.
Novo Nordisk on Monday reported the oral version of its drug semaglutide reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes by 14% in a large Phase III trial.
Sanofi will sell a 50% controlling stake in consumer healthcare unit Opella to private equity firm CD&R, with the French government taking a stake as well to ensure the business remains in the county.
In a short statement Friday, Lykos Therapeutics expressed optimism about a recent meeting with the regulator to discuss next steps for the embattled program, following the FDA’s rejection in August 2024.
BMO Capital Markets analyst Evan Seigerman in a note to investors said the late-stage data for Vertex’s experimental non-opioid pain medication “reaffirms our confidence in the strength of suzetrigine’s profile.” However, William Blair analysts view these data as “an incremental positive” as the company faces challenges in targeting the acute pain market.