Biopharmaceutical Manufacturing, Upstream, Downstream …
WEBThe original concerns of the US regulatory agency over the manufacturing of Eli Lilly’s Ebglyss seem to have been resolved, as the FDA greenlit the antibody drug on Friday. FDA designations boost AI-driven cell therapy approach for Duchenne muscular dystrophy. The FDA has granted Orphan Drug and Rare Pediatric Disease Designations to Somite ...
Agilent snaps up biologics CDMO BIOVECTRA
WEBJul 25, 2024 · Biologics driving M&A as Agilent snaps up specialist BIOVECTRA for $925 million. As advanced therapies drive increasing market consolidation, the US giant Agilent Technologies has acquired the Canadian contract development and manufacturing organization (CDMO) BIOVECTRA for $925 million. The deal, which was financed by cash and debt financing ...
FDA grants breakthrough designation to Amgen and …
WEBAug 8, 2024 · Verona's ensifentrine garners favorable reviews ahead of anticipated US launch for COPD. AstraZeneca’s fasenra asthma drug shows promise for COPD treatment. New wave of potential therapies to bring ‘paradigm shift’ in COPD treatment. Sanofi to accelerate ‘smokers lung’ treatment after phase 3 trial success. With the FDA’s ...
AstraZeneca invests $135M on expanding biologics facility in …
WEBAug 29, 2024 · AstraZeneca has announced plans to expand its existing manufacturing operations at the Sweden Biomanufacturing Center in Södertälje, a Swedish town located near Stockholm. The company will spend $135 million in the expansion, making it the largest single investment in the facility since it was inaugurated back in 2021.
Rentschler opens production line as CDMO demand surges
WEBJul 16, 2024 · CDMOs with expertise in the production of advanced therapy medicinal products (ATMPs) are in high demand due to the high complexity of therapies such as cell and gene therapies. The global market for CDMOs in advanced therapy medicinal products (ATMPs) was worth and is expected to hit £34.5 billion by 2033.
FDA delays Regeneron's linvoseltamab approval due to …
WEBAug 22, 2024 · Regeneron submitted linvoseltamab, a bispecific antibody treatment for relapsed/refractory multiple myeloma, for FDA priority review in February this year.. The drug works to destroy cancer cells by binding to both a cancer protein, BCMA, and the CD3 receptor on a patient’s T cells. The antibody has been tested in a phase 1/2 trial and after a median of 14 months follow-up the objective and ...
New wave of potential therapies to bring ‘paradigm shift’ in COPD …
WEBMar 25, 2024 · According to data and analytics firm GlobalData, this new wave of potential therapies will bring a shift in the treatment paradigm for COPD. The company predicts total sales for Dupixent to reach $21.4 billion globally by 2029, and ensifentrine is forecast to record sales of $1.1 billion by 2029. Asiyah Nawab, pharma analyst at GlobalData, said ...
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FDA greenlights first CAR-T therapy for multiple sclerosis trials
WEBAug 22, 2024 · The California-based company announced this week that the FDA had cleared an investigational new drug application (IND) for its drug candidate IMPT-514, a CD19/CD20 bispecific CAR-T cell therapy in development for patients with multiple sclerosis (MS). Almost three million people worldwide have been diagnosed with MS.
Nxera Pharma’s partnered schizophrenia candidate shows promise
WEBAug 29, 2024 · Results from a phase 2 trial of the candidate schizophrenia drug, currently known as NBI-1117568, show that it met the primary trial endpoint of a significant improvement in the Positive and Negative Syndrome Scale (PANSS) total score. The San Diego-based biotech Neurocrine Biosciences licensed the …