All articles by CE – Page 71
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NewsPotential blockbuster drugs to watch in 2023
Lecanemab for Alzheimer's and the first potential gene therapy primed for US launch for haemophilia A are two potential blockbuster Drugs to Watch™, says a 2023 report.
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NewsAstraZeneca to acquire CinCor in nearly $2b deal
For a transaction value of nearly $2b, AstraZeneca is set to acquire CinCor Pharma, Inc., including rights to hypertension drug baxdrostat.
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NewsFDA grants accelerated approval for Leqembi
Alzheimer’s drug Leqembi has been accepted via the US Food and Drug Administration (FDA)’s Accelerated Approval pathway.
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NewsMajor M&A deals on 2023 agenda, says report
Subin Baral, EY Global Deals Leader, Life Sciences, recounts the global M&A trends in 2022 and predicts activity for 2023 in EY’s 2023 M&A Firepower report.
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NewsFDA grants priority review of glofitamab for lymphoma
Glofitamab for relapsed or refractory large B-cell lymphoma has been granted priority review by the US Food and Drug Administration (FDA).
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NewsGSK to pay $40 million to license multiple T cell engagers
A $40 million agreement will enable GSK to exclusively license up to four bi- and multi-specific T cell engaging antibodies.
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NewsCould BioNTech's new partnership accelerate personalised mRNA therapy trials?
The UK Government and BioNTech’s new partnership aims to accelerate clinical trials of personalised immunotherapies for cancer and infectious disease vaccines.
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NewsFDA accepts Biologics License Application for RSV vaccine
The Biologics License Application for nirsevimab as the first protective option against RSV for all infants has been accepted by the the US Food and Drug Administration (FDA).
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NewsModerna to obtain first acquisition for $85 million
Moderna has agreed on its first acquisition for $85 million, enabling it access to cell-free DNA synthesis and amplification technologies.
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NewsFirst-in-class telomerase inhibitor aids transfusion independence in clinical trial
Telomerase inhibitor imetelstat benefitted both major subtypes of lower risk MDS in a Phase III trial for the first time.
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NewsEMA validates Enhertu® Type II variation application for lung cancer
The Type II variation application for Enhertu® for adults with advanced non-small cell lung cancer has been validated by the EMA.
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NewsGilead’s $658.5m immunotherapy collaboration
Gilead will develop immunotherapy products through a $658.5m agreement with EVOQ Therapeutics using EVOQ’s NanoDisc technology.
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NewsWuXi STA opens its first oral solids continuous manufacturing line
Operation has begun for CRDMO WuXi STA's first continuous manufacturing line for oral solids, in Wuxi city, China.
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NewsJanssen submits marketing application for bispecific antibody
Approval for Janssen’s talquetamab to treat relapsed/refractory multiple myeloma has been submitted to the European Medicines Agency.
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NewsFirst patient enrolled in cisplatin-induced ototoxicity Phase II trial
A Phase II proof of concept trial evaluating SENS-401 for cisplatin-induced ototoxicity has enrolled its first patient.
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NewsFirst treatment approval for advanced ASPS
A Phase II trial has led to the FDA approval of atezolizumab for individuals over two years old with advanced alveolar soft part sarcoma.