Drug Development

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Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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If approved by the FDA, Karuna Therapeutics’ investigational agonist of muscarinic acetylcholine 1 receptors M1 and M4 would provide the first new mechanism of action for schizophrenia patients in decades.
The companies, which have been partners for a decade on various research programs, are pooling their efforts in two early-stage programs for Alzheimer’s and Huntington’s diseases using RNA-targeting medicines.
Non-small cell lung cancer patients treated with the drug combination saw a statistically significant and clinically meaningful improvement in progression-free survival compared to AstraZeneca’s osimertinib.
After picking up magrolimab in a $4.9 billion purchase of Forty Seven, a second Phase III study is being discontinued for the anti-CD47 antibody, this time in acute myeloid leukemia.
Pivotal clinical trials in Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis are expected to read out this fall. Here’s a closer look.
Following promising results in major depressive disorder, Alto Neuroscience on Tuesday reported positive data for its investigational drug ALTO-100 in post-traumatic stress disorder.
Shares were up over 60% in premarket trading on news that the company’s anti-FcRn antibody exhibited dose-dependent reductions in IgG levels, drivers of inflammation in many autoimmune diseases.
The COVID-19 pandemic highlighted a need for local production of vaccines. Now, German pharma company BioNTech has said it will start manufacturing vaccines in Africa.
The company’s olezarsen cleared a late-stage study, eliciting a sharp reduction in triglyceride levels in patients with familial chylomicronemia syndrome. Ionis plans to submit a New Drug Application to the FDA.
The Swiss pharma is one step closer to bringing Lutathera into the front-line setting, with data from the Phase III NETTER-2 study showing that the radiotherapy met its primary endpoint.