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Novartis releases long-term data for SMA gene therapy
Long-term follow-up study data for Zolgensma®, Novartis’ one-time gene therapy for spinal muscular atrophy (SMA), has shown promising overall milestone achievements.
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AstraZeneca 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.
FDA grants accelerated approval for Leqembi
Alzheimer’s drug Leqembi has been accepted via the US Food and Drug Administration (FDA)’s Accelerated Approval pathway.
Major 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.
FDA 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).
GSK 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.
Could 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.
FDA 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).
Moderna 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.
First-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.
EMA 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.
Gilead’s $658.5m immunotherapy collaboration
Gilead will develop immunotherapy products through a $658.5m agreement with EVOQ Therapeutics using EVOQ’s NanoDisc technology.
WuXi 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.
Janssen 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.
First 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.
First 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.
