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news.European Commission approves Novartis’ Itvisma to treat SMA
With this decision, Itvisma becomes the only gene replacement therapy which is currently approved for this wider patient population within the EU. Itvisma works by providing a functional
With this decision, Itvisma becomes the only gene replacement therapy which is currently approved for this wider patient population within the EU. Itvisma works by providing a functional
Under the agreement, Insilico will lead efforts using AI to identify molecules that meet predefined scientific and early development criteria. Takeda will take the lead in advancing selected
The deal includes a strategic equity investment by AimedBio in Inocras and a joint research agreement between the two companies. Additionally, the whole genome sequencing (WGS) capabilities of
This decision was issued in a Complete Response Letter (CRL) which cited deficiencies at a third-party manufacturing facility producing OLC. The FDA did not raise concerns related to
Under this agreement, Innovent will handle the marketing, distribution and promotion of the product within the region, while Eli Lilly will continue to manage manufacturing, supply and development. Verzenios
The MOIP has issued Patent Number 10-2960889, providing protection for Anixa’s breast cancer vaccine approach in South Korea through 2040. This specific composition-of-matter patent is exclusively licensed from
Under the terms of the deal, Theravance Biopharma shareholders will receive $17 per share. Shareholders will also receive a contingent value right (CVR) entitling them to 80% of
The FDA has requested further information, primarily focusing on the manufacturing control strategy of the biological component of NASP and on deficiencies related to contract manufacturing facilities. It
This Jaypirca CHMP recommendation for CLL applies across all lines of therapy, regardless of previous Bruton tyrosine kinase (BTK) inhibitor treatment. Following this recommendation, the Jaypirca application moves
The initial phase of the partnership, valued at up to $15m and running until 2027, may be expanded if scientific milestones are met and both parties agree. The