News – Page 11
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NewsAstraZeneca and Daiichi’s Enhertu wins first-in-decade US oncology approval
FDA approval of the drug in combination with Perjeta initiates a $150 million milestone payment to Daiichi Sankyo from AstraZeneca under their joint collaboration.
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NewsGaelic Labs boosts its beta lactam manufacturing with Athlone deal
The move consolidates Ireland’s two leading producers of the antibiotics.
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NewsAI-discovered IL-17 inhibitor from Ascletis Pharma shows best-in-class potential
New phase I data suggests the oral small molecule ASC50 could help address immunology conditions such as psoriasis.
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NewsCHMP recommends cancer medicines by SFL Pharmaceuticals and Serum Life Science Europe
The EMA’s human medicines committee also recommended approval of drugs by GSK, Moderna, STADA, Lupin Europe and Cytokinetics.
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NewsNanexa collaboration to enhance Moderna’s mRNA drug delivery
Moderna’s $500 million deal with Nanexa will focus on improving long-acting injectable drug delivery, potentially improving mRNA medicines.
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NewsOff-the-shelf dual-antibody immunotherapy shows myeloma potential
The combination of two J&J biologics demonstrates a significantly improved treatment response for the most aggressive form of multiple myeloma in new phase II data.
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NewsThermo Fisher Scientific expands its bioprocessing capabilities in Asia
Investments in India, Korea and Singapore aim to reinforce its support for the region’s biopharma sector.
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NewsEurope edges closer to formalising new ‘Pharma package’ industry rules
Progress made in the region’s approach to critical medicines and antibiotics as the EU Council and EU Parliament agree a new deal.
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NewsLilly to establish third new US manufacturing facility in Alabama
Announcement of Eli Lilly and Company's fourth new US manufacturing plant is expected within the next few weeks.
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NewsPfizer boosts its obesity plans with $2bn GLP-1 YaoPharma deal
The move builds on its recent billion-dollar acquisition of the obesity-focused biopharma company Metsera.
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NewsImpurities findings could enhance peptide drug safety
EpiVax and Cubrc research supports FDA guidance on impurity risk assessment in generic peptides.
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NewsGamida Cell wins cell therapy first in severe aplastic anaemia from FDA
The US approval for the Ayrmid company’s novel transplant option Omisirge adds to its existing licence in haematological malignancy.
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CSL opens $1bn Australian vaccine and antivenom manufacturing facility
The Melbourne site adds Australia to a select group of nations with advanced cell-based influenza vaccine capabilities.
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NewsEuropean Pharmacopoeia updates monoclonal antibody standards
The Ph. Eur. Commission also adopted seven new monographs and two new general chapters at its recent 183rd session.
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NewsTakeda expands its ADC and immuno-oncology pipeline as Innovent deal closes
The $11bn collaboration with the Chinese biopharma company gives Takeda the rights to several next-generation candidates.
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NewsBristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi
The FDA’s latest authorisation makes it the most widely approved of any CD19-directed CAR T therapy in cancer.
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NewsFDA appoints another new CDER director, selecting Dr Tracy Beth Høeg
She will become the fifth leader at the Center, following the surprise retirement decision by her soon-to-be predecessor Richard Pazdur.
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J&J biologic Imaavy achieves EU first in generalised myasthenia gravis
The monoclonal antibody becomes the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.
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CDER director Richard Pazdur to retire from FDA
In the interim, Dr Tracy Beth Høeg will serve as acting director for FDA's Center for Drug Evaluation and Research.
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Regeneron and Tessera partner to develop gene therapy for AATD
The in vivo, one-time gene editing therapy has potential to transform outcomes for alpha-1 antitrypsin deficiency (AATD).