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Walking with assistance

Biogen’s ALS drug is approved, but there’s more to come

April 26, 2023
By Lee Landenberger
Despite the approval of Biogen Inc.’s Qalsody (tofersen) for treating amyotrophic lateral sclerosis (ALS), there are still hurdles for the drug to clear, including a confirmatory study and setting a price. Because the U.S. FDA granted Qalsody accelerated, not full approval, there are plenty more data to collect in the ongoing confirmatory phase III Atlas study of those who develop ALS symptoms during the trial compared to placebo. The randomized, double-blind, placebo-controlled study is being conducted with those carrying the superoxide dismutase 1 gene genetic mutation but are symptom free.
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Little support seen for AI as inventor at US PTO

April 26, 2023
By Mark McCarty
The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being.
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Regulatory actions for April 26, 2023

April 26, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arbutus, Atea, GSK, Hipra, In8bio, Invivyd, Myrtelle, Santhera, Stoke, Tarsier, Virios.
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Biogen logo

Uncertainty, then approval for Biogen’s ALS drug

April 25, 2023
By Lee Landenberger
A twisted, uncertain path has led to a U.S. FDA approval for Biogen Inc.’s Qalsody (tofersen), the first drug targeting a genetic cause of amyotrophic lateral sclerosis (ALS). Qalsody is for ALS associated with a mutation in the superoxide dismutase 1 (SOD1) gene. Patients with SOD-1 mutations account for 2% of ALS cases.
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Regulatory actions for April 25, 2023

April 25, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carl Zeiss Meditec, Insulet, Proprio.
Read More

Little support seen for AI as inventor at US PTO

April 25, 2023
By Mark McCarty
The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being.
Read More
Woman holding head, low battery symbol

US FDA turns to patients to deepen understanding of long COVID

April 25, 2023
By Mari Serebrov
As it requested, the U.S. FDA got an earful April 25 as people with long COVID and their caregivers shared their experiences with the condition that has no approved, or even authorized, treatment and is not that well understood, given its range of symptoms that vary from person to person.
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Postponed stamp on calendar

FDA pushes back PDUFA date for Daiichi Sankyo’s quizartinib

April 25, 2023
By Tamra Sami
Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies.
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Map of Australia with pills, vials and syringe

Australia begins first overhaul of its health technology assessment process in 30 years

April 25, 2023
By Tamra Sami
Australia’s Department of Health is seeking input from the public on the country’s health technology assessment process that informs decisions about what drugs or devices should be reimbursed and under what circumstances a therapy should be subsidized and at what cost to the taxpayer.
Read More
Spravato

China greenlights Janssen’s nasal spray antidepressant

April 25, 2023
By Doris Yu
Xian Janssen Pharmaceutical Ltd. obtained marketing approval in China for Spravato (esketamine hydrochloride nasal spray) in combination with an oral antidepressant to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Unlike existing antidepressants on the market, which can take weeks to take effect, the newly approved nasal spray shows effects right away.
Read More
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