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BioWorld - Sunday, October 1, 2023
Home » Topics » Neurology/Psychiatric, BioWorld

Neurology/Psychiatric, BioWorld
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Kissei withdraws NDA for rovatirelin for spinocerebellar degeneration in Japan

July 21, 2023
By Tamra Sami
No Comments
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.
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Cross-section of brain

Stroke of luck for Idorsia and failing GPCR drug Pivlaz as Sosei Heptares offers $463M

July 20, 2023
By Caroline Richards
No Comments
Sosei Heptares is fulfilling its ambition for growth in the Asia-Pacific region by buying the Japanese and South Korea businesses of Swiss biotech Idorsia Ltd. for ¥65 billion (US$463 million), potentially freeing Idorsia from its struggle to prove its stroke drug, Pivlaz (clazosentan), is effective enough to warrant approval in key Western markets.
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Argenx ADS to balance sheet with whopper $1.1B raise

July 19, 2023
By Randy Osborne
No Comments
The picture keeps getting brighter for Argenx SE which, having targeted $750 million in a financing after positive phase II data, priced a global public offering of $1.1 billion, one of history’s larger rounds. Amsterdam-based Argenx capitalized on positive top-line data from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy.
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Conference data for July 19, 2023: AAIC

July 19, 2023
No Comments
New and updated clinical data presented by biopharma firms at the Alzheimer's Association International Conference, including: Eli Lilly.
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3D illustration of a nerve cell

Argenx sticks to its knitting in CIDP as phase II Adhere data fit Wall Street just right

July 18, 2023
By Randy Osborne
No Comments
Argenx SE’s top-line results from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP) sparked buzz about other developers in the space with similar mechanisms of action to Vyvgart Hytrulo, such as Immunovant Inc.
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Lilly’s phase III of donanemab in Alzheimer’s slows decline

July 18, 2023
By Lee Landenberger
No Comments
Strong and complete phase III results for Eli Lilly and Co.’s donanemab for treating early Alzheimer's disease (AD) will no doubt inspire more comparisons with recently approved Leqembi (lecanemab). The newly released data for donanemab show it significantly slowed cognitive and functional decline for those with amyloid-positive early symptomatic AD, which lowered the disease-progression risk.
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Conference data for July 18, 2023: AAIC

July 18, 2023
No Comments
New and updated clinical data presented by biopharma firms at the Alzheimer's Association International Conference, including: Acumen, Alnylam, Athira, Biovie, Coya, Nkgen, Prothena, Taurx.
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Amyloid plaque on nerve cell

US CMS proposes loosening its leash on amyloid PET scans

July 18, 2023
By Mari Serebrov
No Comments
Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial.
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Dtx brings siRNA candidates to Novartis in $1B merger

July 17, 2023
By Lee Landenberger
No Comments
Novartis AG just added muscle to its siRNA development effort by buying Dtx Pharma Inc. in an M&A deal that could total $1 billion. Novartis is getting a preclinical asset, DTx-1252, which just received the U.S. FDA’s orphan drug designation on June 8. Dtx is developing the siRNA candidate for treating the neuromuscular disease Charcot-Marie-Tooth disease type 1A (CMT1A). Basel, Switzerland-based Novartis will pay Dtx $500 million up front and make payments of up to $500 million in milestones completions.
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Concept of business partnership

‘Anytime is great’ for deals: Sangamo/Lilly in $1.19B pact, Mirum/Travere’s valued at $445M

July 17, 2023
By Randy Osborne
No Comments
Dealmaking proved alive and well, with Sangamo Biosciences Inc. disclosing a tie-up worth as much as $1.19 billion with a subsidiary of Eli Lilly and Co., while Mirum Pharmaceuticals Inc. pledged to acquire for $445 million the bile-acid product portfolio owned by Travere Therapeutics Inc.
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